Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc.

Hеublein, Inc., v. Stickle be made. See (Fed.Cir.1983). 1550, 1564

716 F.2d VI. reasons, this court foregoing For the court’s claim construc- the district vacates summary grant tion and vacates non-infringement. judgment proceedings. remands for further court the district Finally, this court affirms jurisdiction determination. personal court’s AFFIRMED-IN-PART, VACATED- IN-PART, AND REMANDED PHARMACEUTICALS,

MOMENTA INC., Plaintiff-Appellee, Sandoz, Inc., Plaintiff-Appellee,

v. PHARMACEUTICALS, AMPHASTAR Sys- INC., Medication International Pharmaceuticals, tems, Ltd., Watson Inc., Inc., Pharma., De- and Watson fendants-Appellants. 2012-1062, 2012-1103, 2012-1104. Nos. Appeals, United States Court of Federal Circuit.

Aug.

Mansour, Emily C. Johnson and James E. Tysse; Lerman, and L. Rachel of Los Angeles, CA. RADER,

Before Judge, Chief DYK and MOORE, Judges. Circuit MOORE, Judge. Circuit Pharmaceuticals, Amphastar Inc., Inter- Systems, Ltd., national Medication Watson Pharmaceuticals, Inc., and Watson Phar- ma., (collectively, Inc. Amphastar) appeal the district court’s order denying the Emergency Stay Motion to Dissolve or preliminary injunction entered this case. applied Because the district court an undu- ly interpretation narrow of the Hatch- harbor, Waxman safe 35 U.S.C. 271(e)(1), grant we vacate the of pre- liminary injunction and remand for further proceedings consistent opinion. with this

Background

This case is a litigation involving generic version of Lovenox (enoxaparin), a drug prevents blood clots. Enoxa- parin weight is a low molecular version of heparin, naturally occurring molecule. Frank, Jr., Robert S. Choate Hall & Heparin polymer, is a polysac- known as a LLP, Boston, MA, argued Stewart charide, up made of long sugar chains of plaintiffs-appellees. both himWith on the Heparin molecules. a single is not defined brief Eric J. Marandett. Of counsel Instead, heparin molecule. molecules have plaintiff-appellee the brief for for San- (1) diversity length considerable doz, Inc., Steindler, was Thomas P. pоlysaccharide chain McDermott, LLP, Emery Will & of Wash- component disaccharide units and the cor- ington, DC. responding distribution of disaccharide unit Millett, sequences polysaccharide Patricia A. Akin Gump Strauss LLP, DC, Hauer & Feld chains. FDA Letter to Pharma- Washington, Aventis ceuticals, Inc., 23, 2010, argued plaintiffs-appellants. July With her Docket (FDA Pierce, on the brief Anthony Letter), were T. Mark No. FDA-2003-P-0273 J.A. a mixture of a enoxaparin is that it is weight of the molecular example, 291. For 5,000 weight low molecular number of different varies between heparin molecules fact, Aventis, Likewise, the di- 40,000 heparin Id. molecules. daltons. and Lovenox, vary two dif- the FDA to can between asked units marketed saccharide and each of components, acid of generic uronic for a version deny approval ferent unit can disaccharide positions on the appli- four enoxaparin via an ANDA unless Id., The natu- 291-92. modified. J.A. (1) be characterized completely either cant stems heparin to diversity ral inherent isolating, purifying, and se- enoxaparin by pro- used to biosynthetic pathway from the unique polysaccharide each of its quencing Id., J.A. 292. the molecule. duce chains, impossi- claimed was which Aventis (2) ble; manufacturing pro- used Aventis’s by breaking the produced is Enoxaparin cess; clinical trials to conducted pieces, into smaller heparin polysaccharide (the efficacy very type of safety and prove hepa- Because the oligosaccharides. called approval ANDA duplicative studies the a starting material is diverse set rin avoid). to FDA Let- process designed molecules, up made enoxaparin is also ter, rejected FDA Aventis’s J.A. 286. The lengths and disaccharide chain different explained that the arguments, аnd instead diversity in the to the corresponding units “statutory provisions do not de- ANDA molecules. Id. Ad- heparin mix of original type or amount of information scribe diversity is introduced based ditional applicant an ANDA must submit molecule is way heparin in which the ingredient active demonstrate weight into the low molecular broken down drug is the same as generic Id., Thus, 292-93. heparin product. JA ingredient [reference the active drug a small molecule like typical unlike Id., result, a As a enoxaparin up drug].” is made J.A. 294. penicillin, range Congress recognized of different molecules. FDA concluded that FDA discretion with that the has “broad diversity poten- molecular raises may the information consid- respect [it] Drug the Food and problem light tial finding on the ‘sameness’ of making er (FDA’s) new Administration’s abbreviated Id. ingredient.” an active (ANDA) drug application approval process. by generic used com- typically ANDAs are discretion, FDA with this Consistent approval ge- to market a panies to obtain criteria, five or “standards for identified existing drug. neric version of an Unlike identity,” “together provide sufficient (NDA), an ANDA drug application new that generic information to conclude enox- applicant required is not submit ingredient active aparin has the ‘same’ typically extensive clinical studies same Id., Lovenox.” J.A. 295. These criteria drug’s safety and prove needed to alia, included, “[equivalence in di- inter Instead, efficacy. applicant the ANDA blocks, fragment map- building saccharide studies to establish that its must submit oligosaccharide spe- ping, sequence drug bio-equivalent to the reference explained FDA that such cies.” Id. The drug. The ANDA must also include suffi- by “exhaustive di- equivalence proven ge- information to establish that the cient heparin enoxaparin purified with gеstion of ingredients active neric has same III) I, II, enzymes (heparinases digesting drug. as the reference means, acid, among other and nitrous building disaccharide yield the constituent using with complication The obvious Id., J.A. enoxaparin.” gain approval comprising for blocks application ANDA poten- generic enoxaparin 300. These disaccharides can then market-place. by a Momenta tially “separated quantified” be received to mar- techniques, including capillary enoxaparin July ket number of more than a (CE), year Amphastar’s before phase high approval. reverse electrophoresis Being (RP- only generic enoxaparin version of liquid chromatography has performance HPLC), generated benefits: its sales exchange revenues of strong high anion (SAX- per million quarter. J.A. 189. performance liquid chromatography $260 HPLC). approval Amphastar’s version of enoxa- Id. parin, and the resultant ruinous competi- suggested identity The FDA also tion of generic another version drug, of the of the disaccharides could be determined unique threatened this position. market via techniques, including standard mass Understandably unwilling give up a bil- spectroscopy, spectroscopy, modify- NMR yearly revenue, lion dollars in Momenta ing reagents, enzymes. or modifying initiated present litigation days two techniques identify These the nature of Amphastar after received final FDA ap- sugars the constituent and their substitu- to market proval generic its enoxaparin. patterns, including tion the sulfation and Momenta is the assignee of United acetylation patterns, as well as “whether ('886 7,575,886 States Patent No. patent). possesses, among disaccharide other patent The '886 generally relates “to structures, 1, anhydro a ... ring” аnalyzing methods for heterogeneous pop- Id., Detecting structure. J.A. 300-01. ulations of sulfated polysaccharides, e.g. 1, presence anhydro of a ring heparin ... [e.g., [and] enoxapa- LMWH particularly important structure is for patent rin.]” '886 col.4 11.53-55.Claim 6 is proving equivalence “[equiva- because typical. It is a method analyzing lence in building disaccharide blocks to- enoxaparin sample presence “for the gether with equivalence molecular amount of a naturally occurring non sugar weight generic distribution shows that ... that results from a method of making 1, enoxaparin anhydro ring contains enoxaparin (3-eliminative included reducing structure at ends of be- cleavage benzyl with a depolym- ester and percent tween 15 percent and 25 of its erization.” Id. col.64 11.35-39. Momenta 68, poly(oligo)saccharide chains.” n. Id. independent 15, also asserted claims which J.A. 301. assesses the level of non-naturally occur- Amphastar company was the first to file 53, ring sugar, and which allows selection generic an ANDA for a version of enoxa- appropriate of an batch. These claims are parin. It submitted its ANDA to the FDA similar to claim 6. The asserted claims 2003, in March subsequently engaged generally require digestion of an enoxapa- in a lengthy patent litigation with Sanofb- rin sample heparin with a degrading en- Aventis. Amphastar ap- received FDA zyme, separation followed the use of a proval generic to market enoxaparin its on method to presence detect the of the non- September Despite the fact that naturally occurring sugar resulting from Amphastar company was the file an first cleavage. signal B-eliminative ANDA, Pharmaceuticals, Momenta Inc. corresponding non-naturally occur- Sandoz, Mоmenta), (collectively Inc. ring can sugar analyze then be used to who develop generic collaborated to sample comparison test based on a with a enoxaparin product, bring were the first to reference standard. Id. col.6411.40-57. Analysis Amphastar alleged

Momenta by “manufacturing the '886 fringed in preliminary “The issuance sale” for commercial enoxaparin generic discretion for a junction ... is a matter of J.A. 58. claimed methods. using the discretion, however, That district court. Amphastar “in- asserted Momenta light reviewed in not absolute and must be manufacturing process in their cluded equitable governing standards of the ... a meth- enoxaparin sodium batches of Corp. v. injunctions.” Intel issuance per- that a defined determining od for Tech., Inc., 995 F.2d Sys. ULSI chains that oligosaccharide centage (Fed.Cir.1993). To determine whether ... a non- include up enoxaparin make injunction appropriate, the preliminary sugar that includes naturally occurring “(1) weighs including factors district court structure, which meth- 6-anhydro ring sufficiently the movant has estab whether patent.” J.A. 57. infringes the '886 od a reasonable likelihood success infringing that this lished alleged Momenta also merits; “FDA necessary the movant would testing was because whether manufacture to include generic a requires injunction harm if the irreparable suffer process analysis the manufacturing in its (3) granted; not whether the balance were enoxaparin of its sub- of each batch favor; hardships in the movant’s tips ... a confirm that includes [it] stance to injunction impact, any, the if 1, 6-anhydro ring structure.” J.A. 56. a public grant on the interest.” Id. The a tem- moved for and received Momenta injunction can be overturned preliminary restraining prevent order to porary a “by showing that the court made clеar en- generic harm of additional irreparable judgment weighing error of relevant 4. The district try Amphastar. J.A. factors or exercised its discretion based a granted Momenta subsequently court clearly erroneous upon error of law injunction based its belief preliminary Genentech, Inc. v. findings.” factual Novo Amphastar’s quality that control batch (Fed.Cir. Nordisk A/S, 1361, 1364 108 F.3d infringed patent. the '886 J.A. testing 1997). seeking injunc party As the Amphastar emergency later filed two 30. tion, the burden is on Momenta to estab preliminary motions for relief from the extraordinary re lish is entitled to this injunction, court denied. district prove In a likelihood of lief. Id. order merits, appealed the must Amphastar sequentially success on the Momenta injunction and the two denials preliminary likely prove Amphastar infringes that its injunction. preliminary from the for relief Conversely, Amphastar if es patent. Id. appeals three were consolidated. These unlikely that Momenta is to suc tablishes appeals jurisdiction have to hear these We infringement, prelim claim of ceed on its to 28 U.S.C. 1292. After hear- pursuant inary injunction likely appropriate. case, argument stayed in this we ing oral Id. injunction. stay, preliminary opposition preliminary its however, was not a final decision on the junction, Amphastar argued, among other now Amphastar’s appeal. merits of We within the things, testing that its falls incorrectly explain why the district court harbor, safe scope of Hatch-Waxman likely that to suc- concluded Momenta 271(e)(1). Section 35 U.S.C. infringement ceed on the merits of its not be an act of indicates that shall claim, “[i]t preliminary and conclude ... ... use infringement injunction must be vacated. Classen, solely reasonably ... invention uses 659 F.3d at alterations Momenta). related and submission made Amphastar’s Because of information under Federal law which testing batch is carried out as a condition manufacture, use, regulates the or sale of post-FDA approval for the sale of enoxa- ” drugs.... The district court found that parin, argues Momenta it falls outside the alleged infringing activity “the involves the scope of the safe harbor. plaintiffs’ patented quality use of control Second, despite its allegations and con- testing methods on each commercial batch cessions, Momenta asserts the safe harbor enoxaparin that will be sold after FDA not apply does because “the does not (Mo- 31; approval.” J.A. see also J.A. 56 require particular the use of the procedure complaint menta’s alleging that the “FDA is claimed patent.” '886 Id. at requires” testing). While acknowl- Instead, Momenta claims that edging Amphastar’s patent- use of the interpretation FDA’s statutory its man- purpose ed method was for the develop- date in response its letter to Aventis’s ing FDA, information to submit to the petition, J.A. allows a variety of district court nevertheless concluded testing methods to be used to establish apply safe harbor does not to Amphas- equivalence, both for the submission of an testing: “although tar’s the safe harbor ANDA and for undisputedly required provision permits infringing otherwise ac- batch testing. Appellee’s Br. at 41. Mo- tivity that is regulato- conducted to obtain argues menta that the availability of other ry approval a product, it does not per- acceptable testing methods means that mit generic manufacturer to continue in Amphastar’s alleged use of the

that otherwise infringing activity after ob- method is not required by FDA, the and is taining approval.” such J.A. 23. reach- therefore outside of the safe provi- harbor ing сonclusion, the district court fo- sion. primarily cused on the legislative history harbor, quoted safe in one of our parties The thus present us with con- cases, prior Classen Immunotherapies, flicting views about scope of the safe IDEC, (Fed. Biogen

Inc. v. 659 F.3d 1057 harbor. If Amphastar is correct that its Cir.2011). J.A.23. post-approval actually activities fall within scope 271(e)(1), § of 35 U.S.C. Momen- appeal, On Amphastar argues that the unlikely ta is to succeed on its claim of district court took an unduly restrictive infringement and preliminary injunc- harbor, view of the safe and that its activi- likely tion is inappropriate. Genentech, ties fall within the plain language of 35 108 F.3d at 1364. In order to determine 271(e)(1). U.S.C. Momenta counters whether the preliminary injunction ap- was that the district court correctly held that case, propriate in this we must first ascer- the safe harbor does not apply Amphas- tain scope of the Hatch-Waxman safe testing First, tar’s for two reasons. Mo- 271(e)(1). provision, harbor 35 U.S.C. menta argues that the safe harbor does not apply to post-approval activity: “In

Classen, squarely this court held that ‘[t]he I. [safe does not apply harbor] to information may be routinely reported statutory “[A]ll to the FDA construction ... cases long marketing approval after begin has been with the language of the statute.” ” Appellee’s obtained.’ Br. at (quoting Co., Barnhart Sigmon v. Coal 534 U.S. processes or other technology, 941, doma 450, 151 L.Ed.2d

438, 122 S.Ct. manipulation volving specific genetic site (2002). interpreting step “first reasonably solely uses techniques) lan whether to determine statute is development and submis- related to the unambigu plain at issue has guage a Federal under sion particular regard to meaning with ous of information manufacture, regulates which law v. Shell case.” Robinsоn dispute use, veterinary bio- drugs sale of or or 843, 117 S.Ct. Co., 519 U.S. Oil logical products. (1997). language If the L.Ed.2d 808 is no there unambiguous, is the statute clearer in its could not have been Congress if must cease inquiry step: “Our second long as the use of of words: as choice unambiguous language is statutory “rea- solely for uses patented invention con coherent and statutory scheme is ‘the and submit- sonably developing related” to ” v. (quoting United States Id. sistent.’ ‍‌‌‌‌‌‌‌​‌‌​‌‌‌‌‌​‌‌​​‌​‌​​‌‌‌​‌‌‌‌​​‌​​​​​‌‌‌‌‌‌‍to “a Federal pursuant ting 235, 240, Enters., Inc., U.S. Ron Pair manufacture, use, or regulating law” (1989)). L.Ed.2d 290 109 S.Ct. infringe- drugs, it is not “an act of sale of plain the text of a statute Whether ment.” by reference “is determined ambiguous Although the Hatch-Waxman safe itself, context specific language enacted the con provision harbor used, and the broad language is approval pro of the then-novel ANDA text a whole.” Id. of the statute as er context cess, does not refer 35 U.S.C. 341, 117 at S.Ct. 843. Food, portion of the Federal ence the and Patent Drug Competition Price describing the Drug, and Cosmetic Act (Hatch-Waxman Act Term Restoration requirements, e.g., U.S.C. ANDA (1984) (codi- Act), Public Law No. 98-417 Instead, Congress used more 355(j). 271(e)) part fied in relevant 35 U.S.C. language to define expansive flexible statutory system to “balance the up set 271(e)(1), referring general scope §of against innovation need to stimulate development “the and submission ly to furthering public interest.” goal of a Federal law which information under 1, 2, manufacture, use, (Aug. at 2714 or sale of Rep. pt. regulates H.R. 2686, unambigu 1984), language 2714. This This broad drugs.” 1984 U.S.C.C.A.N. embodied, under ously in in the “safe to submissions part, applies is balance 271(e)(1), law, “regu that the law providing § federal provision of 35 U.S.C. harbor” (with added) manufacture, use, or sale of lates the emphasis provides which Limiting scope of 35 U.S.C. drugs.” that: just § the submission of infor infringement act It shall not be an Food, to the Federal pursuant mation use, sell, make, or sell within the offer or to generally, Act Drug, and Cosmetic import or into the United United States Food, ANDA of the Federal provision (other than invention States specific, in would Drug, and Act Cosmetic drug veterinary biologi- or a new animal in violation of read into the statute words (as in those terms are used cal by Congress. chosen express language Food, Drug, and the Federal Cosmetic 1913) 4, which also consistent interpretation Act and the Act of March is statutory of the scheme. using manufactured recom- with the rest primarily a limita- RNA, impose wanted to DNA, hybri- Congress When recombinant binant Food, Drug, 330, 344, on the Federal Corp., tion based tone U.S. 99 S.Ct. Act, (1979) (“We it expressly Cosmetic referenced the 60 L.Ed.2d 931 must in example, provi- it.”). Act. For the safe harbor take the statute as we find sion, Congress excluded “a new animal applies statute here to any patent- use of a (as veterinary drug biological product or ed invention as long as the use is “reason- Food, in those terms are used the Federal ably development related to the and sub- Drug, and Act Act Cosmetic and the of mission of information under a Federal law 1913)” using genet- March made certain regulates manufacture, use, 271(e)(1) (em- techniques. § ic 35 U.S.C. 271(e)(1). drugs----” § sale of 35 U.S.C. added). Likewise, phasis Congress when light provisions, these the only just wanted to limit the statute to a certain coherent and interpretation consistent submission, example kind of the sub- “a Federal law which regulates the manu- mission of an ANDA application under facture, use, or sale of drugs” is that it 355(j), § it specifically U.S.C. referenced must be enough encompass broad sub- statutory governing section those sub- pursuant missions made to the Federal example, For missions. the subsection Foоd, Drug, and Cosmetic Act. Since there immediately following harbor, the safe ambiguity is no language used Congress infringement defined as an act of 271(e)(1), Congress 35 U.S.C. our in- application the submission of “an under quiry into scope of the safe harbor is Food, 505(j) section of the Federal Drug, Robinson, complete. 519 U.S. at and Cosmetic Act at 21 U.S.C. [codified Congress S.Ct. 843. When the intent of 505(b)(2) 355(j) or described in ] section expressed clearly so consistently Act for a in a such claimed throughout statute, there is neither the or the use of which in a patent.” is claimed need nor the occasion to refer to the legis- 271(e)(2)(A). 35 U.S.C. history. lative Id. scope closely infringement Unlike related Hatch-Waxman safe harbor does not stop 271(e)(2), provision, Congress 35 U.S.C. reasonably activities related to develop- not link did the safe harbor to the submis- ment of information submitted application sion of an under Instead, ANDA. the safe harbor applies Food, Drug, the Federal and Cosmetic “to the submission of 271(e)(1) (not Act. Compare 35 U.S.C. an formation under a regu- Federal law which act infringement of when used for “the manufacture, use, lates the or sale drugs development and submission of informa- veterinary biological products.” As law”) tion under a Federal with 35 U.S.C. long allegedly infringing as the use is “for 271(e)(2)(A) (it § infringement is an act of reasonably uses related” to the develop- application to submit “an under section ment and submission of that information it 505(j) Food, Drug, of the Federal and Cos- is not an act of infringement, regardless of 505(b)(2) metic Act or in described section where that requirement resides in the law. Act”). change of such We cannot the stat- analysis is not groundbreaking: utory language. import We will not 271(e)(2) 271(e)(1). Supreme essentially Court came to § limitation of into “[Ojur same in In Lilly conclusion 1990. Eli & obligation is to takе statutes as we Medtronic, Inc., Co. v. Chakrabarty, explained find them.” the Court Diamond v. 447 303, 315, 2204, phrase U.S. 100 that “the ‘a which reg- S.Ct. 65 L.Ed.2d Federal law (1980); also, manufacture, use, 144 e.g., see Reiter v. ulates the Sono- or sale of

1356 expansive. Cara in statute is “under” up naturally summons drugs’ more Labs., Nordisk Ltd. v. Novo co Pharm. statutory scheme image of an entire 1670, U.S.-, A/S, 1683- 132 S.Ct. pro- just particular a regulation,” and (2012). 84, “Under 661, 666, L.Ed.2d 678 the law. 496 U.S. vision of beyond just the “most (1990) law” extends federal 2683, (empha- 110 L.Ed.2d S.Ct. by the required information” added). histo- barebones legislative Although the sis FDA, all “mate encompasses instead only mentioned harbor ry of the safe regulatory 2683, 2, rials the demands at 669 n. 110 S.Ct. drugs, id. Id. process.” the safe concluded that Court nevertheless devices, to medical also extended harbor harbor it clear that the safe While of “a Federal law part also were which set of “activities related applies to a broad manufacture, use or regulates the regulatory process,” Merck to the federal Food, namely Federal drugs,” sale of 2372, KGaA, 202, at 125 S.Ct. 545 U.S. 674, Act, id. at Drug, and Cosmetic important an limitation: the use there is 2683. S.Ct. reasonably related to must be “for uses of infor- development and submission expan- later reaffirmed The Court 271(e)(1). mation,” “Reason- 35 U.S.C. view, appar- think it explaining: “we sive related,” however, does not mean ably text statutory ent from 271(e)(l)’s must patented of the invention infringement from use exemption infor- necessarily result submission of inventions extends to all uses of “Congress FDA: did not develop- mation to the reasonably related to the that are 271(e)(l)’s to the devel- limit safe harbor any ment submission (Food, for inclusion Drug, opment and Cos- of information [ under FDCA FDA; Act) nor did it create Integra v. Li- submission metic Merck KGaA ].” 193, 202, only to the re- I, Ltd., exemption applicable 545 U.S. fesciences an ANDA for 2372, (сiting filing relevant 162 L.Ed.2d 160 search S.Ct. generic drug.” Merck at 110 S.Ct. Lilly, Eli 496 U.S. 2683). at rejected 545 U.S. S.Ct. expressly Merck KGaA KGaA Instead, explained that the safe only applies that the harbor Court the notion safe all “exempted infringement developed during a clinical harbor to information ‘reasonably patented compounds at 202 n. 125 S.Ct. 2372. uses trial. 545 U.S. infor- Instead, process developing clear related’ to the statutory “the text makes mation for submission under federal berth for the use of provides wide manufacture, use, or regulating the related to the law patented drugs activities drugs.” (emphasis Id. regulatory process.” Id. distribution federal added). Thus, re- original). explicitly the Court (emphasis light 125 S.Ct. 2372 was lim- jected the notion that exemption for uses rea- unqualified necessary to seek and “to the activities sonably development to the ited related “[tjhere information, generic drug.” long Id. As sim- submission infringer “has a reasonable excluding for as the accused ply no room in the statute believing” patent- that use of the exemption on basis for certain information from the that might yield information in which ed invention phase the basis of the of research in a to include sub- appropriate “would be particular or the submis- developed it is FDA, ‘reasonably that use is Id. mission to the it could be included.” sion in which added). ‘development and submis- to the use of the word related’ (emphasis

1357 harbor). Thus, ... Federal consider sion of information under safe we this infor- ” 207, 125 purposes 2372. mation law.’ Id. at S.Ct. “submitted” for turn to the question statute. We then whether these submissions are within the II. safe harbor. At are met with the outset we Integra Merck KGaA v. Lifesciences in question contention that the information I, Ltd., 193, 2372, 545 U.S. 125 S.Ct. FDA,

was not to the see 35 “submitted” (2005), Supreme L.Ed.2d 160 Court 271(e)(1) (“... solely § for U.S.C. uses held that patented uses of inventions reasonably dеvelopment related to the and research, preclinical the results of which ”), ... submission of information but rath ultimately are not in a included submission ANDA by er was retained holder. We FDA, to the are nevertheless exempted agree. generic do not as a Amphastar, from infringement by the safe harbor pro- ANDA, an manufacturer under can 208, vision. Id. at S.Ct. 2372. The enoxaparin not sell batch of unless it has explained Court that strength quality established that its 271(e)(l)’s Congress did not limit safe consistent with the standards set forth in harbor development of informa- compendium. the relevant official See 21 tion for inclusion in 351(b). a submission to the 331(a), §§ FDA regulations U.S.C. FDA; nor an exemption did it create require that all records associated with a applicable only to the research relevant produced drugs, including batch of these filing for approval ANDA records, batch for at “be retained least 1 Rather, generic it drug. exempted year expiration after date of the 211.180(a). infringement uses of patented all batch.” 21 C.F.R. These compounds “reasonably related” to the readily records “shall be available for au process of information by developing thorized the FDA at inspection” any 211.180(c). think submission under federal law regu- time. 21 C.F.R. We manufacture, use, lating requirement maintain distribu- records for FDA tion of inspection require drugs. satisfies the reasonably ment that the uses be related 206, Thus, at Id. S.Ct. and submission of in an act infringement to use It disputed formation to the FDA. is not compounds preclinical studies which parties pro that these records are ultimately were not to the FDA submitted develop duced in order submit to where “there a reasonable basis for [was] proof Amphastar the FDA that the prod believing experiments [would] comply ucts with a law. The Federal fact tyрes produce of information that are that the FDA most does not cases actu relevant to an NDA.” at IND or Id. ally inspect change does not records 125 S.Ct. 2372. they the fact that are the “development However, Immunotherapies, submission of under a Classen 271(e)(1); IDEC, Biogen Federal law.” Inc. v. F.3d 35 U.S.C. cf. KGaA, (Fed.Cir.2011),

Merck 545 U.S. S.Ct. we held “does not (holding apply may that uses are not ulti to information FDA, mately routinely long included in a submission to to the reported the be FDA exempted by marketing are nonetheless the after has been ob- approval above, Moreover, regu- FDA as described in studies At issue Classen were

tained.” all records require the such batch the association between lations to evaluate year and after the of childhood vaccinations for at least timing “be retained batch,” immune-mediat- developing certain risk of C.F.R. expiration date themselves The studies 211.180(a), ed disorders. that such records “shall and FDA, any by the but were not mandated inspec- readily available for authorized be to re- required holder was vaccine license time, 21 FDA at C.F.R. by tion” experience FDA “adverse to the port 211.180(c); see also C.F.R. effects, it formation,” side such as adverse 211.188, 211.186, (requiring 211.194 §§ of vaccine studies. as a result acquired records,” production and control “master that the § 600.80.We found 21 C.F.R. See records,” and control production “batch license by the vaccine studies conducted records”). “laboratory Failure according patented methods holder requirements could re- comply with these be- by insulated the safe harbor were not Am- suspension or revocation of sult not facilitate mar- cause the studies did approval to market phastar’s ANDA by “expediting] de- generic drug keting 355(e). §§ drug. 335a(g), See U.S.C. regulatory velopment of information Furthermore, testing such is “a condition Classen, 659 F.3d at 1070. approval.” into drug’s] approval and release” [the course, We, by are bound the Classen commerce, 211.165(d), 21 C.F.R. thus en banc or decision unless is overruled mar- acting predicate ability as a to the Accordingly, the by Supreme Court. ANDA-approved drug pub- ket the to the provision harbor does scope of the safe lic. may extend to “information that be FDA in FDA, The submissions to the this case long after routinely reported to the they implicate marketing approval anything has been obtained.” are but “routine” — very ability to continue its Amphastar’s case, however, within fits well Clas- FDA for its ANDA and to contin- approval because the information submitted is sen manufacturing marketing enoxapa- ue continued necessary both that, rin under its ANDA. We also note ability of the ANDA and to the to market where the stud- unlike Classen Here, the submissions generic drug. by the performed ies were not mandated FDA, not “routine submissions” to the are FDA, generat- information is not here instead are submissions are re- but voluntarily by the manufacturer but is ed Am- quired approval. to maintain FDA man- requirements generated laboratory phastar required to conduct obligated penalty ufacturer is under of law identity strength determination circumstances, such to follow. Under ingredient active for each batch of gath- can to have be said been 211.165(a). 21 C.F.R. enoxaparin. See FDA and solely ered for submission to the according This test must be done Classen, not, primarily as in for non-FDA in an official patented methods described urges Momenta us to purposes. While compendium, this case United (USP). adopt pre-/post-approval distinction Pharmacopeia States See court, 351(b) by the district we cannot: used (Any as tо “determination U.S.C. turn artificial dis- Classen did not on this made strength, quality, purity shall be tinction, plain language and the in accordance with the tests or methods pre-approval statute is not restricted assay compendium.”). set forth such however, harbor, able. The safe does not post- therefore hold that We activities.1 “reasonably re- noninfringing that are mandate the use of a alter- approval studies development only and submission lated to the native when one exists. The limita- law which under a Federal harbor is that tion safe the use must manufacture, use, or sale regulates “reasonably development related to the be scope of fall within the drugs” pursuant and submission of information” 271(e)(1) § safe harbor. regulating to a federal law the “manufac- ture, use, drugs veterinary or sale of case, concedes that In this Momenta biological products.” U.S.C. “are conducted in order Amphastar’s tests 271(e)(1). protection § The safe harbor’s satisfy requirements the FDA’s is not limited to the dire situation where com- enoxaparin each batch of is sold patented only way invention is the mercially actually is after In- develop and submit the information. drug.” Ap- name the same as brand stead, expressly the safe harbor allows the added); (emphasis Br. at 40-41 see pellee’s submitter the freedom to use an otherwise the “FDA (allegation also J.A. 56 means to patented develop necessary testing). requires” the accused Under information demanded the “Federal construction 35 U.S.C. proper good law.” This makes sense because it 271(e)(1), Amphastar’s § the fact that test- liability infringement eliminates when “satisfy ing is carried out to the FDA’s is, effect, that act of infringement re- requirements” means it falls within the quired by government part the federal as harbor, though sсope of the safe even continuing safety efficacy moni- activity approval. carried out after Un- is toring approved of an It drug. also avoids Classen, allegedly infring- where the like here, the situation where a has re- ing activity “may” eventually have led to approval, kept ceived but is nevertheless submission, dispute an FDA there is no from the market based on an FDA man- Amphastar’s allegedly this ease that testing requirement. dated fringing activities are carried out to “satis- fy requirements.” the FDA’s The district interpretation predicated Momenta’s is 271(e)(1) interpretation court’s upon assumption the incorrect that “sole- erroneous. Under the correct construc- 271(e)(1) ly” in the context of 35 U.S.C. tion, Momenta cannot establish a likelihood means that the invention must be infringement of success on and the prelimi- providing the “sole” means of the informa- nary injunction must vacated. be Genen- tion apply. for the safe harbor to This is tech, Inc., 108 F.3d at 1364. language not the of the statute: under 35 271(e)(1), long U.S.C. as the use is argues

Momenta also that even if 35 271(e)(1) “reasonably related to the post-approv- U.S.C. extends activities, and submission of information” under a Amphastar’s testing al statute, relevant it not an act of protected infringe- because there are FDA en- non-infringing “Solely” reasonably dorsed alternatives avail- ment. “uses modifies results, puzzled by 1. We are the dissent’s claim that submission of those test those test ’’solely” clearly generated “solely” the use of the words and "submitted” results were for an require pre-approval equally clearly us to limit the statute to FDA submission and were plain meaning agency. "Solely” activities. This is not the "submitted” example, limit those words. For if the FDA re- "submitted” in no manner quired post-approval testing subsequent "pre-approval testing.” with 1360 um, 21 in case the USP. See U.S.C. ‍‌‌‌‌‌‌‌​‌‌​‌‌‌‌‌​‌‌​​‌​‌​​‌‌‌​‌‌‌‌​​‌​​​​​‌‌‌‌‌‌‍and submission this development

related 351(b) (Any § “determination information,” place any not but does purity shall be made strength, quality, in- patented on when the other restriction in the tests or methods of infringing. accordance with may be used without vention in assay compendium.”). set forth such patented of the inven- long As as the use drug product, that “For each batch of there generate information tion is done laboratory determina- appropriate to a relevant shall be pursuant be submitted will law, identity strength tion of ... and that use falls within the safe federal KGaA, 21 ingredient....” at 205- each active C.F.R. Merck 545 U.S. harbor. 211.165(a). 206, regulations § FDA character- 125 2372. Momenta is therefore S.Ct. testing FDA as “a condition for possibility [the that the that the ize this incorrect other, drug’s] and release” into com- non-patent- the use of accept would 211.165(d). ed, FDA merce. C.F.R. testing methods for precludes appropriate of information also mandates maintenance of and submission type testing. relying on the safe har- records related to this See Amphastar from 211.180(a) (production, con- in case.2 C.F.R. bor this trol, records and distribution associated reading Even if Momenta’s strained drug a must be retained for with batch of supportable, Amphastar’s the statute was year expiration at least one after the date clearly allegedly infringing activities are batch); see also 21 C.F.R. according carried out to the dictates of the 211.188, 211.186, (requiring §§ 211.194 Food, Act. Drug, Federal and Cosmetic records,” production “master and control Act, Amphastar prohibited Under the records,” production “batch and control selling drug if it is adulterated. 21 records”). “laboratory 331(a). A if drug U.S.C. is adulterated purports drug entry enoxaparin, drug to be a listed in an official The USP for USP, compendium, example litigation, for but at issue this states: “About 20 1, actuality composition. percent differs U.S.C. of the materials contain a 6- (de- 351(b); anhydro reducing see also U.S.C. derivative on the end of 321© chain, fining compendium”). range being “official In order to the between 15 and (USP percent.” demonstrate that a is not adulterat- J.A. 365 Revision Bul- 2008). ed, letin, Thus, testing pursuant must be carried out Official December compendi- “enoxaparin” methods order to be as defined in the articulated might produce Although parties argue steps not useful do FDA- acts other data, testing long quality during mandated control man- "as as there is a basis reasonable "solely” believing produce ufacturing purposes for that the will [act] done developing submitting types information to of information that are relevant to [a FDA, Merck, suggests 545 U.S. at FDA].” dissent because submission to Amphastar interpreted uses the method while 125 S.Ct. 2372. We have manufacturing language to sell in commerce of the safe harbor to allow al- infringing activity leged infringers “data its does not meet the "sole- to use from tests for ly” approval,” more such as fund limitation in statute. is not than Abtox, statute, reading raising purposes. tenable and is indeed and other business contrary precedent. Supreme Corp., Court Inc. v. Exitron 122 F.3d (Fed.Cir.1997) (holding alleged interpreting the that the cases safe harbor make clear fringer's [of that the safe harbor is not limited to acts “intent or alternate uses test qualification only produce for the FDA are irrelevant to its to in- data] acts, shield”). protects but all even interim research voke the section drag product entry, Amphastar’s testing the marketed is carried out to USP percent 15 and 25 of contain between must “satisfy requirements,” Appel- FDA’s Id,.; 1, 6-anhydro derivative. see also 40-41, lee’s аt it unlikely Brief makes 351(b) if (drug 21 adulterated U.S.C. Momenta on will succeed the merits of its in to be a an official com- purports claim. infringement The district court’s strength, quality, purity but its pendium findings respect irreparable with to the from the standard set forth in the differs harm, hardships, public balance of the also includes a compendium). USP all, extent, interest factors were to some 1, 6-anhydro specific test deriva- on predicated its erroneous conclusion tive, analysis a which “involves HPLC of that Momenta’s' patent likely infring- enoxaparin sodium solution depolymerized by Amphastar’s product. ed See J.A. by heparinases.” a mixture of J.A. 369 (applying presumption a irreparable of (USP <207>). Method As district harm in “showing view of Momenta’s of in- 6, 16, explained: court and 53 of “Claims (ex- fringement validity”); J.A. 29 analyze to a patent the '886 describe how plaining light of “showing sample enoxaparin to ensure its con- merits, likelihood of success on the formity Monograph to the USP standard.” hardship balance of tips [Momenta’s] by Amphastar required J.A. 8. favor”); (public J.A. 30 interest favors to this test in order to ensure its use patent protection rights by secured val- enoxaparin is not adulterated. U.S.C. 351(b). patents). id Because Momenta has not testing, generates This which pursuant information for submission established likelihood of success on its Food, Act, Drug, and therefore Cosmetic infringement, claim of preliminary squarely scope falls within the of the safe junction must be vacated. harbor. remand, On may district court Finally, suggests the dissent that we want to consider whether Momenta’s ad- reject any disequilibrium

must between Amphastar’s mission that pat- use of the sections 201 and 202 of the Hatch-Wax- “satisfy ented invention is to the FDA’s Act, is, man the safe harbor should requirements” makes this case amenable patent not be available unless a term ex- summary judgment non-infringe- Dissenting Op. tension is also available. at Amphastar. ment in favor of Because 1370-71. This is not correct. The Su- dispositive, safe harbor issue is we preme Lilly equi- noted that Court Eli arguments need not reach the other always librium was achieved. See Eli appeal. Lilly, 496 U.S. at 2683. S.Ct. rejected too interpreta-

We have this strict VACATED AND REMANDED. harbor, explaining tion of the safe “statutory symmetry preferable but not Abtox, (hold-

required.” F.3d Costs devices, ing that II Class medical Appellants. Costs to subject “rigorous premarket are not to a approval process” and thus cannot receive extensions,

patent term are nonetheless RADER, Judge, dissenting. Chief harbor). covered the safe definition, By patent right defines a ' III. property princi- exclude. Consistent with ples, infringer patent of a valid is an interpretation the correct of 35 Under 271(e)(1), trespasser. remedy admission for tres- U.S.C. Momenta’s unlawful trespassing pay and refuses to lights law as property in this area of passing, trespass others, royalty reasonable make trespass- is removal of the well as acknowl- lawful. er. Indeed even Constitution exclude right owner’s edges arrogance court would allow this This Const, I, 8,§ cl. art. trespassers. U.S. by expanding continue the limited reach Thus, proper- to the traditional exceptions 271(e)(1). expansion U.S.C. get-out-of-jail-free to a ty remedy amount of the law purpose the law circumvents the trespasser. Accordingly, such card for the binding precedent of Clas- ignores and only sparingly occur with must exceptions Immunotherapies, Biogen sen Inc. v. this license allows awareness (Fed.Cir.2011). IDEC, 659 F.3d 1057 Sad- to reign trespass- free continue

wrongdoer ly will manu- this result render worthless ing. facturing patents. According- test method public readily applauds the role of ly, respectfully The I must dissent. patents delivery in the and marketрlace life-saving drugs of I. technology products modern like smart- time, many At the same incre-

phones. Supreme Court has observed that The mental advances contribute to these monu- 271(e)(1) alone of can be “not text or, case, mental advances this en- plainly comprehensible.” Lilly Eli & Co. delivery their These public. hance Medtronic, Inc., 661, 669, v. 496 U.S. represent incremental inventions also diffi- (1990). S.Ct. 110 L.Ed.2d 605 The cult expensive technology. and advances text, purpose ought of this to inform case, example, Amphastar For in this had however, application, its is evident from strong patented incentive to invent this legislative history. legislative The his- first-filer, manufacturing method. As the 271(e)(1) tory of includes more than days it would have obtained 180 of market letters, reports, House 25 statements and exclusivity only generic as the seller of the many pages Congressional and of testimo- right per quar- worth million $260 ny. —a A review of this extensive material Nevertheless, Amphastar ter. could not that section 202 of shows the Hatch-Wax- Instead, paten- make that invention. Act, 271(e)(1), man enacted as had the investment, tee Momenta made the did the purpose overruling sole of this court’s research, engineered the new method Products, holding Roche Inc. v. Bolar patent. disclosed '886 (Fed. Co., Pharmaceutical 733 F.2d 858 Cir.1984). 271(e)(1) particular, ap- In point, Amphastar stepped At that in and situations, plied only namely limited took Momenta’s invention with- experiments pre-approval to obtain permission out and used it to manufacture approval: each commercial batch sells on the mar- Amphastar purpose ket. Indeed continues to tres- of is to experimentation years pass promises trespass establish with fact, repeatedly patented drug product, pur- come. In as the court when the acknowledges, Amphastar only pose prepare able to is to for commercial activi- ty begin after a valid compete by taking pat-' patent with Momenta its which will infringement. Amphastar expires, patent ented invention. has not de- is not a method, veloped but instead de- Since the Committee’s Subcommittee on its own Admin, con- erties and the Justice the H. began Environment and the Health bill, Ap- Judiciary, Cong. on the 98th this the Court Comm. sideration (1984) (letter Pravel, held that from Bernarr R. the Federal Circuit peals for President, experimentation infringe- Property American Intellectual type (“Section Products, Association) v. Bolar Inc. 202 is intended ment. Roche Law (Fed. Co., 23, 1984, F.2d April Pharmaceutical to reverse the decision of Cir.1984), Appeals for the the Court of Appeals the Court of for the Federal Cir experi- Products, Circuit held Federal in Roche Inc. v. Bolar Phar cuit (Fed.Cir. drug product prior Co., mental use 733 F.2d 858 maceutical patent claiming date of expiration 1984).”); Congression Memorandum constitutes drug product Service, Library of Con al Research only pur- though the fringement, even American Law Division to House gress, experiments pose is to seek Committee, Judiciary located H.R.Rep. approval FDA for the commercial sale 98-857, (1984), at 27 pt. No. n.18 1984 expires. It drug patent of the after the U.S.C.C.A.N. 2686 2711. experimen- view that

is the Committee’s pre- Roche v. Bolar held that the limited activity not have adverse tal does FDA approval experiments ap- obtain patent owner’s impact economic on proval infringed patent. still a valid See during patent, the life of a exclusivity (“The F.2d at district court cor- 733 861 activity of such would prevention but rectly recognized the issue this case patent owner’s commercial extend the a pat- is narrow: does the limited use of exclusivity beyond patent expiration testing investigation ented date. strictly drug approval related to FDA 1, at 45-46 H.R.Rep. pt. No. during requirements the last 6 months (1984), 2647, 2678-2679 1984 U.S.C.C.A.N. patent a of the term of the constitute use added). (emphases which, licensed, patent unless statute added)). (emphasis In makes actionable?” of section 202 of the bill provisions Bolar, § overturning Roche v. al- reversing net effect of the hold- have the companies to con- pharmaceutical lowed Products, in Roche Inc.

ing of the court FDA experiments ap- duct such to obtain Co., Pharmaceutical 733 F.2d v. Bolar The new enabled those proval. section (Fed.Cir.1984). process companies begin approval (1984), 98-857, pt. at 27 H.R.Rep. No. force, patent is still in so that while at 2711. also See 1984 U.S.C.C.A.N. they approval begin can FDA obtain and Patent Law Innovation Reform: immediately selling patent’s life. after on H.R. 3605 the Sub- Hearing Before Otherwise, safety testing processes Courts, Liberties and the comm. on Civil patent’s have to wait until after the would H. Comm. on the Admin. Justice a in time creating lag life ends thus when (1984) (state- Judiciary, Cong. 98th yet patent would not be force Tribe, of Laurence H. Professor of ment companies could not enter the market School) (“Section 202, Law, Harvard Law approval: FDA pending is to overturn Roche v. the thrust of which complete applica- In order Pat- legislatively”); Innovation and Bolar manufacturer must con- generic tion the Hearing on H.R. 3605 ent Law Reform: Courts, drug tests. In order to certain on Civil Lib- duct the Subcomm. Before only type testing, agreed section 202 tion section facilitate this pre-approval experiments: limited general еxception of the creates bill Thus, infringement. rules of patent provision purpose foregoing of the may a manufacturer obtain generic permit generic drug is to manufactur- patented drug product of a dur- supply experimen- in the limited engage er to patent the life of the and conduct ing necessary tal activities which are purpose if the using tests pre-marketing approval obtain applica- tests is to submit an of those patent expires before a so that actual approval. FDA for tion to competition generic drug between the original drug begin and the can immedi- (1984) (statement Rec. Cong. ately patent covering origi- after the Kastenmeier, Rep. Robert W. Chairman of nal drug expires. Section 202 does not Courts, Liber- the Subcommittee Civil any activity authorize which would Justice, ties and the Administration deprive of the owner sale of Judiciary) (emphases on the Committee single during tablet the life of a added). patent. fact, valid the limited test- The Pharmaceutical Manufacturers As- ing activity required to obtain FDA analysis sociation echoed the Chairman’s generic drug would not purpose of the bill: normally result in the use of even a single generic therapeu- tablet for its sponsors and supporters leg- purpose during tic life of valid agreed beginning islation have from the patent. generic products should not be ap- proved marketing prior expi- to the Innovation and Patent Law Reform: patent ration of a valid un- as extended Hearing on H.R. 3605 Sub Before return, legislation. der the there has Courts, comm. on Civil Liberties and the pre- compromise agreement been a H. Admin. Justice Comm. on the of of testing could be conducted (1984) (memo Judiciary, Cong. 98th prior expiration of patent, rаndum of Alfred B. Engleberg, Patent extended, marketing so that could begin Counsel, Industry Generic Pharmaceutical Therefore, immediately thereafter. the Association) added). (emphases bill reverses the Roche v. Bolar decision The executive branch favored an even permit to a generic company to “use” a more than exception pro- limited the one patented product pur- for the limited posed in section 202 and enacted as pose completing testing of neces- 271(e)(1). Nevertheless, clearly un- sary approval. for FDA derstood the of section 202 boundaries Innovation and Patent Law pre-approval experimental Reform: be use. Hearing on H.R. 3605 the Sub Before This letter sets forth the Administra- Courts, comm. on Civil Liberties and the First, ... tion’s views on H.R. 3605 Admin. Justice the H. Comm. on the of of section 202 of title II should be amended (1984) (letter Judiciary, Cong. 98th permit experimental a drug use of from Pharmaceutical Manufacturers Asso non-patentee only during period ciation) added). (emphases patent which the is in affected restora- industry,

On the other side of the period. Existing patentees tion have re- Industry upon indicating Generic Pharmaceutical accepted Associa- lied doctrine Courts, Liberties and invention for the Subcomm. on Civil that use Admin, Comm, H. obtaining regulatory ap- Justice on purpose of of of (1984) (let- Judiciary, Cong. 98th patent. Upsetting proval infringes Pharmaceutical Manufacturers ter only inhi- this sort could of expectations Association) (see above); quote block In- investment, innovation and bit future and Patent Law Hear- novation integrity of the depend upon the Reform: H.R. ing on Subcomm. laws. Before Admin, Courts, Civil Liberties and the and Patent Law Innovation Reform: Comm, Judiciary, the H. on the Justice of H.R. thе Sub- Hearing on 3605 Before (1984) (statement Cong. 742 of Lau- 98th Courts, and the Civil Liberties comm. on Tribe, Law, H. Professor of Harvard rence Admin, H. on the Comm. Justice School) (“Section ‍‌‌‌‌‌‌‌​‌‌​‌‌‌‌‌​‌‌​​‌​‌​​‌‌‌​‌‌‌‌​​‌​​​​​‌‌‌‌‌‌‍202, Law the thrust of (1984) (letter Judiciary, Cong. 98th legisla- Roche v. Bolar which is to overturn Director, Stockman, A. Office from David tively, provide so as to that it is not an Budget, Rep. Ed Management use, make, infringement patent- or sell a Madigan, on Health ward R. Subcomm. purposes ‘reasonably ed invention for re- Comm, Environment, H. on Ener and the lated’ to the submission Commerce) added). (emphasis gy and premarket- of information to obtain FDA’s ing approval engage in the commercial industry expressed pharmaceutical manufacture, use, or sale of the after trespass on ex- permitting about concern added); patent expiration”) (emphasis In- dissipated but this concern rights, clusive novation and Patent Law Hear- 271(e)(1) only al- promises with Reform: H.R. ing on Subcomm. on testing drugs.” See lowed “limited Before Admin, Courts, Civil Liberties and the (1984), H.R.Rep. pt. No. at 29 Comm, Judiciary, H. Justice on the 2686 at 2714. 1984 U.S.C.C.A.N. of (1984) (memorandum Cong. 98th 926 of generic In manufacturer is this ease Counsel, B. Engleberg, Alfred Patent Ge- permitted patented to market Association) Industry neric Pharmaceutical all drug during patent; the life of the (see above); quote block Memorandum generic that the can do is test the Service, Congressional Research submitting purposes data to the of Law Divi- Library Congress, of American approval. Thus, FDA the nature of Committee, Judiciary sion to House locat- de the interference is minimis. 2, H.R.Rep. pt. ed at No. at 27 n.18 added). (1984), 2686, 2711 n. 1984 U.S.C.C.A.N. 18 (emphases Id. at 30 (“In Congress provide would that it 271(e)(1) won Specifically, make, use, infringement is not an to or sell time, quantity, because it was limited patented solely invention for uses rea- 271(e)(1) First, time, § type. and as to sonably related to the and only applies pre-marketing approval. purpose submission of information for the (statement Cong. Rec. 23060 of obtaining premarketing approv- of FDA Kastenmeier, Rep. Robert W. Chairman of drug.”). al of a Courts, the Subcommittee on Civil Liber- Justice, Second, ties and the Administration of quantity type, (see 271(e)(1) Judiciary) only applies experimenta- on the block Committee above); im- quote Innovation and Patent Law tion—and therefore would have limited exclusivity during Hearing pact patentee’s H.R. on the on Reform: Before perimental H.R.Rep. permitted by No. 98- use’ Section 202 patent. the life of the not, (1984), any way, impinge does on the exclu- pt. at 45-46 (see make, right patent sive owner to use 2647 at block U.S.C.C.A.N. 2678-2679 above); and sell the invention for all com- quote Innovation and Patent Law purposes during mercial the life of the Hearing H.R. 3605 on Reform: Before permitted experimental patent. The use Courts, Subcomm. on Civil Liberties Comm, Admin, competitive not result in commer- would the H. on Justice of activity patents (1984) (let cial until all valid ex- Judiciary, Cong. 98th added). pired.”) (emphases from Pharmaceutical Manufacturers ter (see Association) above); quote In block (and The authors of I this section hesi- novation and Patent Law Hear Reform: present through tate to add that I was this ing H.R. on the Subcomm. on Before legislative process) imagine did not Courts, Civil Liberties and the Admin. of 271(e)(1) continuous, would allow com- H. Judiciary, Justice Comm. on the infringing during any portion mercial sales (1984) (statement Cong. 98th of Lau patent. of the life of the As discussed Tribe, Law, H. rence Professor Harvard below, Amphastar already has obtained School) above); (quoted Law Innovation regulatory approval, today this Hearing аnd Patent Law Reform: court rewrites allow Amphastar the law to Courts, H.R. 3605 the Subcomm. on Before infringe patent Momenta’s throughout Civil Liberties and the Admin. Justice the entire Momenta’s and for life of H. Judiciary, Comm. on the 98th purpose obtaining profits on coro- (1984) (memorandum Cong. 926 of Alfred competes mercial sales of a Counsel, Engleberg, B. Patent Generic patentee. with the Association) (see Industry Pharmaceutical legislative history Nowhere can above). quote block court suggestion find particular, the authors made clear 271(e)(1) apply would other than in the apply section would not conducting limited scenario of de minimis sales, i.e., commercial “infringing” (ie., experiments pre-approval to obtain product would not enter the market until FDA approval). legisla- Nowhere in the patent’s H.R.Rep. life. No. 98- after history tive can this court find a hint that 1, (1984), pt. at 45 1984 U.S.C.C.A.N. “infringer” could continue to use its (“This per 2647 at 2678 section does not competitor’s patented method in manufac- mit the commercial sale a patented of ture of each commercial batch for contem- drug by party the using drug the to devel poraneous legisla- sale. Nowhere in the information, op permit such but it does the history any tive can this court find mention commercial sale quantities of research of continuous, post-approval, of the commer- ingredients active to such party.”) (empha cial sales allowed this decision. No- added); sis Innovation and Patent Law legislative history can where this Hearing on H.R. 3605 any suggestion court find that the mere Reform: Before Courts, Subcomm. on Civil Liberties and maintenance or retention of information as H. Admin. Justice Comm. on a part company’s of records is considered a of 271(e)(1). Judiciаry, Cong. 98th trigger submission that would (memorandum fact, Engleberg, of Alfred B. attempt In this court makes no Counsel, history Patent Pharmaceutical legislative Generic examine the this sec- Association) (“The Industry very limited ‘ex- at all—-a telling tion silence. (emphasis of the statute.” course, purposes it proclaims court Of added)), out requiring Maintaining keeping it to find or a ambiguity no 1358. finds To of the section distorts. purpose opposite meaning document has the exact Supreme Court found the contrary, the submitting document. other plainly and “not ambiguous can be statute words, really “submission” means not sub- Lilly, Eli U.S. comprehensible.” See mitting anything strange construction —a 669, 110 court Moreover the S.Ct. 2683. “unambiguous” of an term. ambiguity by discounting to avoid strains interpretation This new would allow al- namely “solely” statutory phrases, critical activity by pharmaceutical compa- most all and “submission.” nies to constitute “submission” and there- continuous, post-approval, To facilitate a justify trespass. a free license to fore use, the court discounts the commercial any inspect drug FDA records of man- can Indeed, “solely.” throughout its word ufacturer seller. See U.S.C. language cites the of the opinion, the court Thus, only manufacturer need “solely.” yet omits the word See statute record, potentially make a which could be 1355-56, 1356, 1356-57, Majority Op. FDA, inspected by the and then activi- properly If one reads 1359-60. ty satisfy meaning this new could “sub- says, the result “solely” as the statute mission.” Amphastar’s activity is not must be that infringing activity within the statute. Its Therefore, reading of all the words in solely submitting developing a reading the statute and of those words in Instead, Amphas- the FDA. information to light legislative history of their shows that purpose tar uses this method for the 271(e)(1) only permits a limited amount on the manufacturing sell pre-аpproval experiments to obtain market commerce. Thus, approval. the statute limits exception “solely for uses reason- Second, the court claims that the mere ably related to the and sub- satisfy records can the “sub- retention of information under a Federal law 271(e)(1). mission of By §in requirement mission” manufacture, use, regulates or can essentially stating that “submission” veterinary biological prod- drugs sale of really submitting, this new inter- mean not pretation requirement reads this out ucts.”

statute as well. plain meaning

Specifically, despite II. of information” to mean of “submission already This court has decided company actually submitting informa- statute in meaning of this Classen. FDA, interprets court tion to the 271(e)(1) majority pro- “§ Classen held of information” to mean the “submission exception infringe- to the law of vides part information as mere retention of expedite ment in order to Majority Op. records. company’s regulatory approval information (“We requirement that to main- think counterparts patented products. generic inspection tain records for FDA satisfies apply does not to information statute that the uses be reason- requirement may routinely reported be development and sub- ably related to the FDA, marketing approval has Thus, long after FDA. of information to the mission (empha- at 1070 been obtained.” 659 F.3d consider this information ‘submitted’ we added). support, approval, experimental looked to limited It sis As Classen use. is history: pre-approval Amphastar not legislative Report “The is re- because has already approval. plete legislation Appellant that the obtained See with statements Br. 7 premarketing approval (Amphastar approval received FDA ge- concerns 19, 2011.); on Septembеr Majority Op. drugs. Report emphasizes neric (“It here, also avoids the situation developed information which can be ‘The ”). approval where a has received ... provision type under this is the which is ” Thus, activity post-approval. its is It is approval required drug.’ to obtain of the not added). Amphastar limited because uses Mo- (emphases at 1071 Id. menta’s invention on a continuous basis Supreme Classen also looked to Court the manufacture of each commercial batch precedent, Lilly such Eli v. & Co. Med during patent. the life of Momenta’s tronic, Inc., 2683, U.S. S.Ct. It experimental Amphastar is not because 110 L.Ed.2d 605 and Merck KGaA uses Momenta’s invention manufactur- I, Ltd., Integra v. 545 U.S. Lifesciences ing each commercial batch of its 125 S.Ct. 162 L.Ed.2d 160 contemporaneous sale on the market (2005): “Every examining decision (in commerce) to obtain profits and to 271(e)(1) statute has appreciated compete with Momenta. This is a com- premarketing approval directed to ge by mercial use of an competitor invention counterparts neric before expira compete trespass on the inventor’s added). tion.” (emphasis Id. at 1071 right. Amphastar’s exclusive use is not particular, Classen stated: for premarketing approval and there- definitively fore Classen holds colleague in strays Our dissent 271(e)(1) apply does not here. precedent, statute and in arguing that any activity by any entity concerning To opposite way, come out the exact any adversely patented product or meth- court first claims Classen did not turn on exempted od is from infringement the pre-/post-approval Majori- distinction. 271(e)(1), provided only that the infor- ty Second, Op. 1358. the court claims mation ‘reasonably obtained is related merely Classen held that does submitting any information under the not apply to “routine” submissions. FDCA,’ (Moore, J., at [659 F.3d Therefore, opines: case, this court “This dissenting) (emphasis dissent), ] ‘in- however, fits well within Classen because cluding post-ap- regarding the information necessary submitted is proval uses.’ Id. Such a massive en- both to the continued of the largement statutory exemption ability ANDA and to the to market incorrect. Here, generic drug. the submissions are (bold added). FDA, emphasis Id. 1072 n. 4 ‘routine submissions’ to the but instead are required submissions that are Here, Amphastar uses pat- Momenta’s approval.” Majority maintain FDA Op. ented method manufacture of each definition, By commercial batch it sells. its use is not to obtain FDA approval. outset, At the this court must stretch too only One can market a that far to claim Classen did not turn on a pre- already approved. has Amphastar is not /post-approval distinction. The dissent ac- using patented Momenta’s pre- tually helps identify method for in holding Clas- (“pre-marketing with Classen “The reconciled stated: dissent The Classen sen. Instead, in this deci- the court approval”). the district court that majority concludes language as the dissent uses the same harbor of sion the safe incorrectly interpreted “I (“post-approval”; conclude 271(e)(1) because, ma- Classen according to the § to all uses 271(e)(1) pre-approv- harbor extends that the safe is limited jority, reasonably submitting I are related Accordingly, conclude that ... al activities. FDCA, all under the includ- any extends to uses information harbor that the safe submitting post-approval ing regarding information reasonably related that are uses”). FDCA, includ- should instead re- This decision under post-approval court to resolve the issue regarding quest the entire ing information ” (emphases add- F.3d at 1083 en banc. uses.... ed). by char- distinguishes The court Classen amici cer- in that case as not

Further, acterizing and the the activities parties FDA,” pre- on a while the activi- by turned “mandated tainly thought Classen See, e.g., Clas- here are. Some context is order. distinction. ties /post-approval Rehearing Petition for method here is “mandated” Opposition to sen’s Banc, (“Plaintiff-Appellant *1 Momenta thus far has created only En at Hatch-Waxman, developed only The United successful method agrees with require- and the Federal one can show the FDA’s Supreme by Court States 271(e)(1) only applies Amphastar met. is free to ment has been Circuit: 35 U.S.C. activities, satisfy method to these pre-market invent its own after the com- it chooses to tres- requirements. harbor Instead there is no safe find drug. sales of a it has not ventured to pass. of commercial Because mencement 271(e)(1) post- tests, it way perform into the these An another extension period suggest Amphastar’s hands approval/post-commercialization unfair to Indeed, Price Drug of the to the extent the court is scope are tied. is outside expansion Patent Term Restoration a new of the statute creating Competition anything “mandated” present unworkable difficul- that covers Act and would added). FDA, (emphases unfairly attack inventors application.”) in its this would ties most method. the newest and successful Moreover, did not this court Classen adopted or “man- a method would be Such 271(e)(1) applies any point at state trigger FDA and then by the dated” “necessary both to the con- to information exception. infringement new court’s ANDA and to the approval tinued say, that would be the exact Needless to Ma- generic drug.” market the аbility to system incentivizes opposite Indeed, post-approv- jority Op. 1358. improvement. creation and al, continuous, exact commercial use is the rule. Classen opposite of the Classen III. “premarketing ap- holding its

rested 1070, 1071, “limited F.3d at proval,” 659 271(e)(1) interpretation of This court’s “exper- testing,” id. amount manufacturing essentially render would imentation,” id. re- This court patents method worthless. adoption of studies”; that the FDA’s peatedly states (“post-approval This decision as a standard patented method pre- Momenta’s “not restricted to approval”; “after Ma- activities”) apply. should means that genuinely be cannot 1370 (“the

jority Op. 1358 information here is IV. voluntarily generated by the manufac- Supreme Lilly The Court cases Eli & by generated require- turer but is FDA Medtronic, Inc., 661, Co. v. 496 U.S. 110 obligated ments the manufacturer is under (1990) 2683, 110 S.Ct. L.Ed.2d 605 and (“that follow”), penalty of law to act I, Merck v. Integra KGaA Lifesciences is, effect, in infringement required by Ltd., 545 U.S. 125 S.Ct. government part the federal as of the con- support holding L.Ed.2d tinuing safety efficacy and monitoring of Classen and do not support this decision. (“where approved drug”), id. has holdings Lilly Both Eli and Merck dealt approval, kept received but is nevertheless pre-approval activity with and submis- from the market based on an FDA man- sions, meaning obtaining ap- before (“the testing requirement”), dated Further, proval. suggested neither even fact that Amphastar’s testing is carried out that the mere maintenance or retention of ‘satisfy requirements’ to the FDA’s means part information company’s of a records harbor, scope it falls within the of the safe could be a “submission” to the FDA. Nev- though activity even ertheless, is carried out phrases the court takes approval”), after (“Amphastar’s alleg- opinions those out of context allege 271(e)(1) edly interpretation § its new infringing clearly activities are is con- car- sistent with those cases. ried according out to the dictates of the Food, Act”). Federal Drug, and Cosmetic Lilly, In Eli Supreme Court ad- 271(e)(1) dressed applies whether essence, reasoning repeals this medical devices in drugs. addition to protections incentives and patent act (“This U.S. 110 S.Ct. 2683 case patentee this area. A invents the first presents question whether 35 U.S.C. (at time) best method. Because of 271(e)(1) renders activities that would utility the success and of the inventive patent otherwise constitute infringement method, FDA adopts method as if noninfringing they are undertaken for standard. Because that method is “re- the purpose developing and submitting FDA,” quired by the this court per- would to the Food Drug Administration mit copiers infringe. What incentive (FDA) necessary to obtain remains to in inventing invest a better marketing approval for a medical device Imagine test? a teacher who rewards the Food, under 515 of the Federal Drug, top student allowing peers copy her (FDCA), and Cosmetic Act 90 Stat. her exam answers. say, Needless to 360e.”). U.S.C. approach does violence to law and Supreme Court described how future research incentives in this field. §§ 201 and 202 should be read together. second, activity And what if Section 201 concerns happens early less effec- years patent’s life. Section 202 con- (patented) tive method appears? Will years. cerns the latter Each section is a copiers method, be infringe allowed to reciprocal Impor- counter to the other. Or, instead, too? good because it is not as tantly, Congress intended the sections to and the FDA adopt does not it as the “premarket regulatory deal with approv- standard, then the interpreta- court’s new al”: tion of does not apply copi- first,

ers can infringe the best method but parties agree Act the 1984 second, not the less designed effective method? respond to two unintended subject regulatory patent lengthy were to de- 17-year the term of distortions prior marketed lays and could not be to requirement that cer- produced by the premarket regulatory approval.... Section 201 receive tain must products First, relating to these regulatory approval. provides patents the holder up extended to products to such can be five relating products a patent of ... at the years The distortion other matter not be able practical would as a of the was during patent period rewards the end addressed to financial reap Thus, §by 202 of the Act.... This allows term.... if the early years of the expiration a competitors, prior that can- of product relates to discovery to patent, engage infringing in otherwise without substantial not be marketed regulato- approval, necessary activities to obtain regulatory the testing and ry approval.” run- term will be patent “clock” on his yet he is not able to ning though even (emphasis at 110 S.Ct. 2683 Id. from the invention. any profit derive added). at the The distortion occurred second The 1984Act enacted the two sections to term. patent other of the end Supreme Court re- create balance. Federal Appeals of the Court attempt to create a jected party’s “di- manufacture, Circuit decided sequilibrium” between the two sections. use, invention dur- patented or sale 672,110 at Id. S.Ct. an patent constituted ing the term of 271(a), if see even infringement, act of interpretation This this court’s new purpose conducting for the sole was disadvantage apply case would developing information neces- tests and not patentee § 202 to a who would be able regulatory approval. sary apply for to § 201. The pat- to obtain benefits of Products, Inc. v. Phar- Bolar See Roche a manufacturing patent entee of does not Co., (Fed.Cir. 733 F.2d 858 maceutical extension created in patent obtain 1984). activity not be could Since expansion yet court’s new planned those who commenced competitors § 202 its to in- would allow expira- compete patentee with the until fringe patent. life of its during the term, paten- patent tion the entire this sort of Supreme rejected Court dise- monopoly facto would continue tee’s de Corp. quilibrium. Proveris See Scientific period reg- until for an often substantial Inc., Innovasystems, 536 F.3d v. obtained. In other ulatory approval was (Fed.Cir.2008) (relying on Merck hold words, patent combined effect apply infringe- not does regulatory premarket ap- law and the eligible ment proval requirement was create extension). patent obtain patent term. effective extension interpretation new does not court’s (em- 669-670, 110 S.Ct. 2683 U.S. patent “end of the reserve 202 for the added). phases Therefore: Instead, interpretation term.” its allows continuously infringing activity throughout sought to eliminate this “The Act including “early patent, the life of both ends of the distortion from If, as the years” for 201. court 201 of the Act estab- reserved period. Section claims, § 202 meant to cover the con- pat- extension for patent-term lished tinuous, throughout use products that commercial relating ents to certain law,” life of would be here: “a patent, the there no bal- Federal not “submission.” fact, In between 202. This the ance 201 deci- that sentence is not even in short the improperly Supreme sion cuts of Mo- section the opinion Court’s life patent. menta’s that discusses the basis on which the Instead, Court decided the case. that sen- And, discussed, already this in- new prior tence is in a section the discussing terpretation beyond expands “premarket statute, text of which Supreme the regulatory approval.” See 496 U.S. at naturally Court found “somewhat more interpretation Its S.Ct. 2683. determined, Appeals reads as of the Court activity infringing allows after the but that is plainly comprehensible not already approved has been sale on the anyone’s view.” Id. market. by The sentence cited this not court is Surprisingly, the court claims that its holding even a Supreme definitive “analysis groundbreaking: is not the Su- Court but instead discussion of par- preme essentially Court came to the same In arguments. ties’ looking para- at the conclusion in 1990” and cites Lilly. Eli graphs following one by cited this deci- Majority It Op. 1355-56. has been quoted sion, the Supreme Court states the case easy, that “Words like are the wind.” for the opposing side: “On the other side Saying something that ground- “is not however, of the ledger, one must admit breaking” does it so. not make that naturally while the provision more means what respondent suggests, it Lilly Nowhere in does the Supreme Eli any- somewhat difficult to why understand “essentially come to Court the same con- one would Why want it to mean that. majority clusion” as the here. The Su- should the touchstone of noninfringement preme say Court does not the mere be whether the use related to the devel- maintenance or retention records —with opment and submission of un- no intention to to the FDA submit but that provision der a happens to be included only potentially by could be viewed that, within an Act provisions, its FDA if the FDA requested it—would sat- necessarily issue, not one at isfy regulates as a “submission” the FDA. The drugs?” Id. at Supreme S.Ct. 2683. On Court post- does sanction occasions, other the Federal approval activity. Supreme Circuit advis- Court against es “solely” type does not read the slanted word out from wordsmith- ing. the statute. Merck, Supreme

It is more telling Court what court’s rea- addressed soning applies omits than it whether what cites. The court to research only single relies on a sentence ‍‌‌‌‌‌‌‌​‌‌​‌‌‌‌‌​‌‌​​‌​‌​​‌‌‌​‌‌‌‌​​‌​​​​​‌‌‌‌‌‌‍from tended for for FDA approval Eli submission Lilly, which quotes out of but ultimately context. 496 not submitted to FDA. (“But (“This at U.S. S.Ct. 545 U.S. at 125 S.Ct. 2372 case ‘a phrase regulates presents Federal law question whether pat- uses of manufacture, use, research, or sale of drugs’ preclinical more ented inventions naturally up image summons of an the ultimately results of which are not statutory entire of regulation.”). scheme included in a submission to the Food and Supreme (FDA), was not Drug Court even exempted refer- Administration are encing phrase the same is at issue from infringement 35 U.S.C. Cir.1993). 271(e)(1).”). words, especially This is true at the the case In other preclinical stage drug approval.” experi- of limited an instance presented stage pre-approval performed ments 207, 125 (emphases U.S. S.Ct. drug development. added). post- suggest does Merck Nowhere relies on some court text commercial, infring- continuous approval, sug- appears superficially Merck that to Indeed, permitted. be ing use would expansive interpretation of gest an 271(e)(1) § lays out that is clearly Merck 271(e)(1). But, context, § read in that lan- experimental, for pre-approval, intended meaning entirely. This guage has another limited use. appears suggest to thаt language 271(e)(1) § of any covers sort information particular a “Basic scientific research on But, language actually or submission. without the intent compound, performed appears context issue or a develop particular drug a reason-

to Merck whether information for of intended will compound belief that the cause able approval the submission to FDA for should the sort of effect re- physiological be when information ulti- covered induce, surely to not searcher intends mately drug not submitted because the ‘reasonably development to related in that lacked potential. candidate case to of information’ and submission apparent This context is in the sentences this, It follow from FDA. does not how- quoted majori- next to the sentence 271(e)(l)’s ever, exemption § that ty, which state: excludes ei- infringement categorically We decline to the “reasonable rela- read drugs experimentation on that ther narrowly requirement tion” so as to ren- subject of an FDA ultimately are not )’s 271(e)(i protection der stated (2) use com- patented submission or leading approval FDA for activities to experiments are not ulti- that pounds construed, illusory. drugs Properly all FDA. mately to the Under submitted 271(e)(1) adequate space leaves conditions, exemp- think the we certain experimentation and failure on the sufficiently protect to tion is broad regulatory approval: At least road to compounds in both situ- patented use a drug-maker has reasonable where a 205-06, 125 at S.Ct. [545 ations.” U.S. com- believing that a basis for added) “Moreover, (emphasis ] work, a pound may through particular many of that exist with the uncertainties biological process, produce particu- to spеcific respect to the selection of effect, and physiological lar uses respect with exist as well that, successful, if in research compound research to include in decision what in a appropriate to include would be IND or As a Court has an NDA. District FDA, “rea- use is submission observed, always will not be clear to ‘[I]t sonably “development related” to the ap setting out seek parties ... information under submission exactly proval for their new 271(e)(1). law.” Federal information, and in what which kinds (emphases add- Id. at 125 S.Ct. 2372 agen it will take to win quantities, ed). Intermedies, approval.’ cy’s Inc. v. Ventritex, Inc., importance not F.Supp. Merck does reduce (Fed. 271(e)(1) 'd, is re- (N.D.Cal.1991), of the limitation that aff 991 F.2d 808 “solely reasonably only served uses related ties for not but ANDA also the IND, in- and submission of NDA and does not mean that Holding preclinical formation.” re- part mere retention of documents as reasonably generate search in- expected company’s records could be considered a regulatory formation for does words, “submission” to the FDA. In other simply fall outside because the if painter a house allows a hired owner research fails and does not result a paint his house all shades of regulatory application, id. 125 brown, permission is not to choose cry S.Ct. far from permitting turquoise. neon orange infringement during manufacture of a com- Thus, Merck long while said that as product merely mercial because the activity was intended for submission to fringing generates act also 271(e)(1) approval, § obtain then applies that might someday be submitted to the even if actually the information is not sub- FDA, long marketing approval after (because mitted it predict is difficult to Here, granted. Amphastar’s use of the which drug ultimately candidаtes will be primarily produc- method is for successful), 271(e)(1) it did not say that tion of a commercial product; it is not applies if the activity even was never in- “solely uses reasonably for related to” de- tended to obtain at all. Or if the velopment of information. information was not even intended sub- for point, As another court this claims that mission to FDA. interpre- This court’s explicitly rejected “the Court the notion (that tation the mere retention of informa- 271(e)(1) that ‘to limited the activi- tion part of a company’s records can be necessary ties to seek approval gener- FDA) “submission” is indeed drug.’” Majority But, ic Op. 1356. it is “groundbreaking” Supreme and the Court important to understand what Merck was did not to essentially “come the same con- trying distinguish. context, Read in clusion.” phrase that is referring to allowing 271(e)(1) pre-approval include activi- V. ties drug. for a branded It was not stat- 271(e)(1) ing that included post-approval provision The safe harbor at issue in this a generic drug. activities for In other case, its origin purpose due to in re- words, Supreme emphasiz- Court was Bolar, versing Roche v. receives attention ing “generic drug,” the words not as an that exception permits experimenta- “necessary words approval.” to seek tion. This link to experimentation and its Imagine ordering a computer and stating advancing role in progress of technolo- that “I not do want it my delivered to gy requires commentary some as well. Then, Wednesday.” house on post Too often law patent is misunderstood as your office it to neighbor’s delivered house impeding promoting more than innovation. Thursday. you Obviously, meant proposition, academic called the trag- emphasize “Wednesday,” “my not house.” edy of the scholarly Anti-commons in somе Similarly, this court must read the Su- presentations, suggests exclusive preme Court’s cases as a whole rights impede the flow of information and context. limit experimentation might lead to Just because Merck the next generation technological held ad- could cover pre-approval activi- vance. A. Michael Heller & Rebecca S. technological simple: Innova- advance does Deter Eisenberg, Can Patents not happen. happen It does sever- in Biomedical Anticommons tion.? The (1998). First, experiments advancing reasons. Research, al 280 Science ever, technology rarely, generate if com- of empirical in an era place, In the first Thus owners mercial value. have research, might the reason one ask little, any, or if incentive license inhibit actually- has never notion this academic otherwise, if a pat- even research. Stated studied, no re- Although been verified. poten- to sue license ent owner wanted at- alleged search has substantiated researchers, experiments do not pro- tial fact, “the patent system. tack on the damages. income duce or a source of See hy- predicted by the anti-commons effects id. at in the available not borne out pothesis are Second, in Caulfield, age the modern of technolo- Timothy Human Gene data.” Problems?, gy, technological the character of advance Patents: Chi.-Kent Proof (2009); changed. The era the Bell also American has when Labs L.Rev. see tech could hire the of Sci- or some other center Association for Advancement Proper- ence, engineers essentially promising most Intellectual International op world ty Experiences: Report evеrything A invent has Four Coun- specialization With the vast of all (finding passed. 12 the results tries research, in Japanese technology re- fields of advances survey of U.S. and great an A new very require cooperation. little evidence of searchers “offer ” biotechnology a new in or problem’ “IP-pro- and that direction ‘anticommons relatively produced by cooperation ac- will be technologies remain electronics tected China, in professor Chengdu, a a scientific communi- between cessible to the broad India, in young programmer Bangaluru, an ty”). Surveys of academic researchers Munich, corporation ... at “only percent engineer large a have revealed Germany, Tokyo a at report having delay project, graduate a and none student University, start-up a team at a project pat- to others’ and small abandoned due patent The company Valley. M. & P. Wesley ents.” Cohen John Silicon Walsh, can inform each of them of the Impediments system help to Academic Real search, bring together and their incremental Re in 8 Innovation other Biomedical (Adam 1,10-11 generation B. Policy Economy advances achieve next and the Lerner, Jaffe, tiny of human progress & Scott Stern eds. some corner Josh 2008), http://www.nber. progress. at available org/marschke/mice/Papers/cohenwalsh.pdf Thus, patents for properly remain tool al., (citing P. John Walsh et Viewfrom experimentation and because the research Patents, Material the Bench: Transfers sharing and system encourages publication Research, 309 Science Biomedical of how to of research results. Disclosure (2005)). words, patents In other “quid is the make use the invention research tоols and biomedical innovations quo” patent grant. See pro JEM pace re- significantly do slow Int’l, Ag Supply, Inc. v. Pioneer Hi-Bred from search and do not deter researchers Inc., 124, 142, 122 S.Ct. U.S. projects. pursuing promising (2001). In exchange for dis- L.Ed.2d closure, the inventor receives limited patents have not been reason exclusivity to benefit com- more than stimulate term

proven impede mercialization of his invention. Without LENS.COM, INC., Appellant, exclusivity, at promise

this researchers be turn to corporations would forced to v. secrecy protection their the best CONTACTS, INC., Appellee. 1-800 inventions. Even academic researchers delay may publication results in order to No. 2011-1258. edge the competition, maintain over Walsh, supra & at and the race Cohen United States Court of Appeals, patent helps office counteract Federal Circuit. tendency secrecy by rewarding toward 3, 2012. Aug. “The earlier disclosure. information patents knowledge added to the store of publication/issuance pat-

with the analysis, ent. ... [It] is not insulated from study, experimentation twenty for the years Classen, until patent expiration.” Rather,

659 F.3d through applications im- shared mediately available others to build speeds progress It upon. of scientific words, endeavor. patent sys- other modern experi- tem’s benefits facilitate far than any mentation more hypothetical inhibition.

VI. Every day, Amphastar, competitor of Momenta, is infringing patent. Momenta’s trespass.

This decision allows that More- over, result, to reach that must court ignore its prior own decision in Classen purpose

and the of the statute explained legislative history. Sadly this decision abrogates Momenta’s prop- hard-achieved

erty right and reallocates that entitlement competitors day its sad for property —a and an victory

owners undeserved expense those who decline ‍‌‌‌‌‌‌‌​‌‌​‌‌‌‌‌​‌‌​​‌​‌​​‌‌‌​‌‌‌‌​​‌​​​​​‌‌‌‌‌‌‍invest in difficulty discovery and invention.

Case Details

Case Name: Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc.

Court Name: Court of Appeals for the Federal Circuit

Date Published: Aug 3, 2012

Citation: 686 F.3d 1348

Docket Number: 2012-1062, 2012-1103, 2012-1104

Court Abbreviation: Fed. Cir.