IDENIX PHARMACEUTICALS LLC, UNIVERSITA DEGLI STUDI DI CAGLIARI, Plaintiffs-Appellants v. GILEAD SCIENCES INC., Defendant-Appellee
2018-1691
United States Court of Appeals for the Federal Circuit
Decided: October 30, 2019
United States Court of Appeals for the Federal Circuit
IDENIX PHARMACEUTICALS LLC, UNIVERSITA DEGLI STUDI DI CAGLIARI, Plaintiffs-Appellants v. GILEAD SCIENCES INC., Defendant-Appellee
2018-1691
Appeal from the United States District Court for the District of Delaware in No. 1:14-cv-00846-LPS, Chief Judge Leonard P. Stark.
Decided: October 30, 2019
GREGORY A. CASTANIAS, Jones Day, Washington, DC, argued for plaintiffs-appellants. Also represented by JENNIFER LORAINE SWIZE; LISA LYNN FURBY, Chicago, IL; CALVIN GRIFFITH, RYAN BOYD MCCRUM, Cleveland, OH; ANTHONY INSOGNA, San Diego, CA; JEFFREY A. LAMKEN, SARAH JUSTINE NEWMAN, MICHAEL GREGORY PATTILLO, JR., MoloLamken LLP, Washington, DC.
E. JOSHUA ROSENKRANZ, Orrick, Herrington & Sutcliffe LLP, New York, NY, argued for defendant-appellee. Also represented by EDMUND HIRSCHFELD; ELIZABETH
MOULTON, Menlo Park, CA; BRIAN PHILIP GOLDMAN, San Francisco, CA; ERIC SHUMSKY, Washington, DC; FRANK SCHERKENBACH, Fish & Richardson, PC, Boston, MA; CRAIG E. COUNTRYMAN, W. CHAD SHEAR, JONATHAN ELLIOT SINGER, San Diego, CA.
Before PROST, Chief Judge, NEWMAN and WALLACH, Circuit Judges.
Opinion for the court filed by Chief Judge PROST.
Dissenting opinion filed by Circuit Judge NEWMAN.
Idenix Pharmaceuticals LLC and Universita Degli Studi Di Cagliari (collectively, “Idenix”) appeal from the decision of the U.S. District Court for the District of Delaware granting judgment as a matter of law (“JMOL”) against Idenix and finding that U.S. Patent No. 7,608,597 is invalid for lack of enablement. Idenix Pharm. LLC v. Gilead Scis., Inc., 2018 WL 922125, at *25 (D. Del. Feb. 16, 2018) (“JMOL Opinion”). Gilead Sciences Inc., (“Gilead”) argues that the patent is also invalid for failure to meet the written description requirement, and that the district court erred by failing to grant JMOL on that ground as well. We affirm as to non-enablement and hold that the patent is also invalid for lack of written description.
I
This appeal stems from Idenix’s December 2013 patent infringement suit against Gilead, originally filed in the U.S. District Court for the District of Massachusetts and later transferred to the District of Delaware. J.A. 259–69. At the time of the suit, both Idenix and Gilead were researching and developing drugs for treatment of the hepatitis C virus (“HCV”). HCV is a leading cause of chronic liver disease, infecting hundreds of millions of people worldwide, and accounting for tens of thousands of
deaths per year in the United States alone. Idenix alleged that the imminent Food and Drug Administration approval, and launch, of Gilead’s HCV treatment drug sofosbuvir would infringe Idenix’s U.S. Pat. No. 7,608,597 (the “’597 patent”).
Following years of litigation, Chief Judge Stark held a two-week jury trial in
Idenix timely appealed. We have jurisdiction under
II
We review the denial or grant of a motion for JMOL under regional circuit law. See Tr. of Boston Univ. v. Everlight Elecs. Co., 896 F.3d 1357, 1361 (Fed. Cir. 2018). Applying Third Circuit law, we “exercise plenary review over a district court’s rulings on motions for JMOL, applying the same standard as the district court.” Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 1341–42 (Fed. Cir. 2008) (citing Gagliardo v. Connaught Labs., Inc., 311 F.3d 565, 568 (3d Cir. 2002)). A grant of JMOL is appropriate “where a party has been fully heard on an issue during a jury trial and the court finds that a reasonable
Enablement requires that “the specification teach those in the art to make and use the invention without undue experimentation.” In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). A claim is not enabled when, “at the effective filing date of the patent, one of ordinary skill in the art could not practice their full scope without undue experimentation.” Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1384 (Fed. Cir. 2013). Whether a claim satisfies the enablement requirement is a question of law that we review de novo. Tr. of Boston Univ., 896 F.3d at 1361. However, “in the context of a jury trial, we review the factual underpinnings of enablement for substantial evidence.” Id.
III
The ’597 patent claims a
Notwithstanding the fact that screening an individual compound for effectiveness was considered “routine,” we concluded as a matter of law in Wyeth that the claim was not enabled because there were “at least tens of thousands of candidate compounds” and “it would be necessary to first synthesize and then screen each candidate compound.” Id. at 1385–86. As we explicitly stated: “The remaining question is whether having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation. We hold that
We are not persuaded by Idenix’s attempts to distinguish Wyeth based on the state of the arts of screening and synthesis in 1992,
IV
We separately address the district court’s denial of JMOL on the issue of written description. The Patent Act contains a written description requirement distinct from the enablement requirement.
The question in this case is whether the ’597 patent demonstrates that the inventor was in possession of those 2‘-methyl-up nucleosides that fall within the boundaries of the claim (i.e., are effective against HCV), but are not encompassed by the explicit formulas or examples provided in the specification. The parties focus in particular on whether the specification demonstrates possession of the 2‘-methyl-up
There is no dispute that neither the ’597 patent nor any of its predecessor applications discloses a 2‘-methyl-up 2‘-fluoro-down nucleoside, including in any formulas or examples. See J.A. 37102–03 (admission of Idenix’s inventor). Nor is there any dispute as to why. Idenix “only came up with the methyl up fluoro down embodiment a year or so after the application was filed.” See J.A. 25562 (admission of Idenix’s counsel). Idenix argues instead that its claims are directed to the entire genus of 2‘-methyl-up compounds for treating HCV, and are enabled by the disclosure of a number of examples, without needing to disclose each species of nucleoside. See Reply Br. 31–32.
Idenix is correct that generally a genus can be sufficiently disclosed by “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus.” Ariad, 598 F.3d at 1350 (internal quotation marks omitted). We have alternatively described this inquiry as “looking for blaze marks which single out particular trees” in a forest, rather than simply “pointing to trees.” See Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996) (quoting In re Ruschig, 379 F.2d 990, 994–95 (CCPA 1967)).
In this case, we hold that the ’597 patent is invalid for lack of written description, as it fails to provide sufficient blaze marks to direct a POSA to the specific subset of 2‘-methyl-up nucleosides that are effective in treating HCV. The patent provides eighteen position-by-position formulas describing “principal embodiments” of compounds that may treat HCV. See generally ’597 patent col. 5 l. 29–col. 13 l. 42. However, other than generic language regarding “pharmaceutically acceptable salts and prodrugs thereof” (a category not at issue here), the specification provides no indication that any nucleosides outside of those disclosed in its formulas could be effective to treat HCV—much less any indication as to which of those undisclosed nucleosides would be effective. See id. at col. 15 l. 51–col. 16 l. 10. “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name’ of the claimed subject matter sufficient to distinguish it from other materials.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1363 (Fed. Cir. 2011) (quoting Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997)). The ’597 patent provides adequate written description for the compounds within its formulas. The specification, however, provides no method of distinguishing effective from ineffective compounds for the compounds reaching beyond the formulas disclosed in the ’597 patent.
Idenix argues that it provides “abundant traditional blazemarks for the claims—working examples, formulas, data, synthesis routes, and the target.” Reply Br. 32. Each of these suffer from the same flaw. They provide lists or examples of supposedly effective nucleosides, but do not explain what makes them effective, or why. As a result, a POSA is deprived of any meaningful guidance into what compounds beyond the examples and formulas, if any, would provide the same result. In the absence of that guidance, the listed examples and formulas cannot provide adequate written description support for undisclosed nucleosides that also happens to treat HCV. The written description requirement specifically defends against such attempts to “cover any compound later actually invented
We are mindful of Ariad’s caution that written description does not require “a nucleotide-by-nucleotide recitation of the entire genus.” Id. at 1352. The purpose of that rule is to allow relatively few representative examples or formulas to support a claim on a structurally similar genus. See id. It does not extend to this case, where the specification lists tens or hundreds of thousands of possible nucleosides, substituent-by-substituent, with dozens of distinct stereochemical structures, and yet the compound in question is conspicuously absent.
The absence of 2‘-fluoro-down is indeed conspicuous. Seven of the provided formulas permit 2‘-methyl-up. See, e.g., ’597 patent col. 6 ll. 5–20 (Formula II), col. 8 ll. 5–20 (Formula V), col. 10 ll. 5–47 (Formulas X and XI), col. 11 l. 42–col. 12 l. 17 (Formula XVI), col. 12 ll. 23–54 (Formula XVII), col. 13 ll. 5–41 (Formula XVIII). All seven formulas explicitly list fluorine as a possibility at other positions, including 2‘-up. See, e.g., id. at col. 10 ll. 42–47 (listing “fluoro” at 2‘-up). Yet not one of them includes fluorine at 2‘-down, despite each listing more than a dozen possible substituents at that position. This is true even though the formulas include every other recited halogen at both positions. Compare ’597 patent col. 8 ll. 48–54 (listing “chloro, bromo, fluoro, iodo” at 2‘-up), with col. 8 ll. 55–61 (listing “chlorine, bromine, iodine,” but not fluorine, at 2‘-down).
Further, to the extent Idenix argues that, although not disclosed, a POSA would have known to include fluorine at 2‘-down based on its similarities to other halogens, that is insufficient for written description. “[A] description that merely renders the invention obvious does not satisfy” the written description requirement. Ariad, 598 F.3d at 1352.
We therefore disagree with Idenix’s characterization that “the specification plainly embraces the use of the [2‘-fluoro-down] embodiment.” Reply Br. 34. In light of the conspicuous absence of that compound, a POSA would not “visualize or recognize the members of the genus” as including 2‘-fluoro-down, and the specification could not demonstrate to a POSA that the inventor had possession of that embodiment at the time of filing. Ariad, 598 F.3d at 1350.
V
For the foregoing reasons, we affirm the district court’s grant of judgment as a matter of law that the ’597 patent is invalid for lack of enablement. We reverse the district court’s denial of judgment as a matter of law for failure to meet the written description requirement and hold that the ’597 patent is invalid for lack of written description as well.
AFFIRMED-IN-PART AND REVERSED-IN-PART
COSTS
Costs to appellee.
IDENIX PHARMACEUTICALS LLC, UNIVERSITA DEGLI STUDI DI CAGLIARI, Plaintiffs-Appellants v. GILEAD SCIENCES INC., Defendant-Appellee
2018-1691
United States Court of Appeals for the Federal Circuit
NEWMAN, Circuit Judge, dissenting.
I respectfully dissent. The court errs in holding that the specific narrow claims of the ’597 patent are invalid. The large number of unclaimed chemical variants in the specification are not described, not synthesized, and not tested for antiviral activity. It is incorrect to include these variants in the claims and then to invalidate the claims because these variants are not described and not enabled.
The panel majority, overturning the jury verdict, finds the ’597 claims invalid on the grounds of non-enablement and inadequate
The majority’s holding that validity under section 112 is determined based on whether unclaimed subject matter is described and enabled, provides a new path of uncertainty and unreliability of the patent grant. I respectfully dissent.
I
I write in concern for the majority’s flawed theory of section 112, whereby the court requires description and enablement of the unclaimed and unsupported subject matter, in order to sustain validity of claims to the supported subject matter. A reasonable jury could have applied the jury instructions, in light of the patent document and the testimony of witnesses, to understand that the claims are for the subject matter that is produced and described and evaluated for antiviral activity. On the correct claim construction, a reasonable jury could have found the claimed subject matter to be described and enabled.
A reasonable jury could have understood that subject matter that is unclaimed is irrelevant to validity under section 112. With all respect to my colleagues, they err in holding that because “billions and billions” of nucleosides are within the specification but not characterized and not evaluated, the claims to the products that are synthesized and shown to have antiviral activity are invalid as “indefinite.” The jury could have found, as witnesses testified, that the claims are directed to the nucleosides that are synthesized as shown in the ’597 specification, and shown to have antiviral efficacy. This is a narrow class of nucleosides, pictured as set forth in the briefs and in the majority’s opinion:
Idenix Br. 8; Gilead Br. 8; Maj. Op. at 5.
The ’597 specification is an omnibus disclosure of eighteen broad “Formulas” of nucleosides—variants that are untested, uncharacterized, and unclaimed. In contrast, only the above molecule is included in the patent Figures that report antiviral data. The specification describes Figures 2 and 3 as follows:
FIG. 2 is a line graph of the pharmacokinetics (plasma concentrations) of β-D-2‘-CH3-riboG
administered to six Cynomolgus Monkeys over time after administration. FIGS. 3a and 3b are line graphs of the pharmacokinetics (plasma concentrations) of β-D-2‘-CH3-riboG administered to Cynomolgus Monkeys either intravenously (3a) or orally (3b) over time after administration.
’597 patent, col. 15, ll. 31–38. Figure 1, captioned “Chemical Structure of Illustrative Nucleosides,” presents the structures of eight nucleosides and two comparative compounds. ’597 patent, col. 15, ll. 27–30 (“FIAU and Ribavirin, which are used as comparative examples”). All eight nucleosides have the three OH groups in the positions and stereochemistry pictured above, and six of the eight structures in Figure 1 also have a methyl group in the 2‘-up position as required by all the claims.
The jury was told by Dr. Meier, an expert witness for Idenix, that for all of the 2‘-methyl-up nucleosides in Figure 1, “all of the compounds have hydroxide at the 2’ down position.” J.A. 37673 at 1859:25–1860:2. Dr. Secrist, an expert witness for Gilead, testified that the first four compounds in Figure 1 are β-D-2‘-methyl-ribofuranosyl nucleosides, stating “[a]ll of them have a 2’ up methyl and a 2’ down hydroxyl, yes, and they are ribonucleoside.” J.A. 37638 at 1721:8–11.
My colleagues err in ruling that the claims cover “billions” of variants. The ’597 specification recites a very large number of substituents for nucleosides that are not synthesized, not characterized, not evaluated, and not included in the claims. Some of these variants have been claimed in other patents and applications.1 However, they are not claimed in the ’597 patent. My colleagues err in holding that because other substituents and modifications
are mentioned in the specification, claims that do not include such variants are invalid on grounds of indefiniteness and lack of written description.The broadest claim of the ’597 patent is claim 1:
1. A method for the treatment of a hepatitis C virus infection, comprising administering an effective amount of a purine or pyrimidine β-D-2‘-methyl-ribofuranosyl nucleoside or a phosphate thereof, or a pharmaceutically acceptable salt or ester thereof.
’597 patent, col. 142, ll. 63–67. This nucleoside with pyrimidine base is pictured and labeled in the specification as follows:
The jury was instructed that the claims define a patent’s scope:
The claims are important because it is the words of the claims that define what a patent covers. The claims are intended to define, in words, the boundaries of the invention that constitute the patent owner’s property rights. The figures and text in the rest of the patent provide a description and/or examples of the invention and provide a context for the claims, but it is the claims that define the breadth of the patent’s coverage. Each of the asserted claims must be considered individually.
J.A. 169; J.A. 37800 at 2068:17–25 (instructing the jury).
The panel majority discards this instruction, and reproduces in the majority opinion portions of the specification that relate to the other “Formulas” that are pictured in the specification and directed to other nucleosides, some of which are the subject of continuation patents and applications. See n.1, ante. For example, the majority presents the specification structure designated Formula XVII, which depicts, with “R” and “X” designations, a large number of substituents of the molecule:
Maj. Op. at 10–11 (citing ’597 patent, col. 12, ll. 20–67). The majority states that the variants for Formula XVII are “more than 7,000.” Id. at 12. However, a reasonable jury could have understood, as witnesses for both sides testified, that the only variants synthesized and evaluated in the ’597 patent have the structure where R1 is H, R9 is OH, R10 is H, R7 is OH, R6 is CH3, and X is oxygen.
The ’597 patent was the subject of expert testimony throughout the two-week jury trial. The patent was given to the jury; see J.A. 170 (“[R]efer to the copy of
- Q. Is the difference between DNA and RNA at 2’ down, so OH in RNA, the H in DNA, is that important to a nucleoside chemist in 2000-2001? A. Oh, yes. It is a critical distinction, of course. J.A. 37543 at 1568:9–12.
- Q. Now, you have depicted the treatment with an OH down at 2‘. Is that correct? A. Yes. Q. Why did you do that? A. Well, it’s – number one, you would expect, when you’re making something – this is in the 2001 time frame, you would expect modified nucleotides to have that OH down because you want to be accepted by the machinery that makes that RNA virus. So you want to have that 2- down. J.A. 37544 at 1571:1–10.
- Q. [Discussing a 1998 publication concerning the enzymes] If you look at the end of the paragraph, it concludes with the statement that “These results indicate that the HCV enzyme has a strict specificity for ribonucleoside 5’ triphosphates and requires the 2’ and 3‘-OH groups.” . . . What does that mean with respect to this 2’ position you and I have just been talking about? A. Well, as I have always maintained, the entire molecule, when you are making a drug, is absolutely critical. However, in the case of doing something for RNA, then having this 2’ prime, for the reasons I talked about earlier, that’s what the enzymes use, is really important. J.A. 37545 at 1574:16–1575:2.
- Q. In the patent, did you see, after reading it, any data on any other nucleoside that had something different at 2’ down than the OH known as hydroxyl? A. No. J.A. 37548 at 1588:18–21.
- Q. What did these examples teach a skilled person to put at the 2’ down position in a nucleoside? A. Well, if you are thinking about effective treatment of HCV, at best they teach that you would put an OH down at the 2’ along with a methyl up at the 2 prime. J.A. 37548 at 1588:22–1589:1.
- Q. And is that teaching, OH down at 2‘, is that consistent or inconsistent with the conventional wisdom of nucleoside chemists at the time? A. Well, speaking as a nucleoside chemist at the time, I would have expected and certainly not been surprised by compounds identified that had 2’ down hydroxyls. J.A. 37548 at 1589:4–9.
- Q. We talked about this, but . . . is there any antiviral data to guide the person of skill amongst the possibilities covered by that 2‘-Beta-D-methyl-ribofuranosyl nucleoside? A. No. We heard about it before but there is no antiviral data in this patent application. J.A. 37549–50 at 1593:20–1594:1.
- Q. And even considering that other data, does that cover a lot of compounds or only a few? A. Well, it only covers the four compounds and they all have the 2’ down OH only at this critical spot, 2’ down. J.A. 37550 at 1594:2–5.
- Q. Let’s turn to the making of the compound. What kind of guidance does the patent provide and what kind of compounds are actually – or
the patent teaches you can actually make? A. Well, it gives, I’ll say, standard literature ways to make nucleosides that have 2’ up methyl and a 2’ or maybe even a 2’ up alkyl and a 2’ down OH. J.A. 37550 at 1594:6–12.
-
Q. [Displaying the ’597 patent] What are we looking at here, Dr. Secrist, at DDX-721, which excerpts the patent at column 48, lines 30 to page [sic] 49, line 5? A. This is one of two general schemes that are in the patent, and I won’t go through it other than to note that you take a starting material, that you go through a whole series of steps, and you end up with a nucleoside with a down OH. J.A. 37550 at 1594:13–21. - Q. And a 2‘-methyl up? A. A 2‘-methyl, or as you can sigh [sic] in ours, it could be another group up. J.A. 37550 at 1595:16–18.
- Q. What compound does the patent show being made in relation to the 2’ position? A. Okay. It shows only compounds that have a 2’ down hydroxyl group. J.A. 37550 at 1595:12–15.
- Q. Are there any other synthetic schemes, any other schemes in the patent that show something different at 2’ down? A. No, just OH. J.A. 37550 at 1595:19–22.
- Q. Does the patent show any of these compounds being made at R7 other than 2’ OH down? A. No. J.A. 37551 at 1598:10–12.
- Q. So Dr. De Francesco, we were just talking about your 2003 paper. We were talking about the phrase . . . Beta-D 2’ methyl ribofuranosyl guanosine, and I think where we left off was that you were confirming that that phrasing describes the structure . . . that’s a methyl up
at the 2’ position, OH or hydroxy down at the 2’ and 3’ position? A. Right. Correct. J.A. 37755 at 2001:19–2002:3.
There’s much more, as the jury was informed concerning the chemical structure, the specification, and the claims. The verdict form was explicit as to the asserted claims and the burden of proof:
[1] Has Gilead proven by clear and convincing evidence that each of the asserted claims of the ’597 patent is invalid because the specification of the ’597 patent does not enable the asserted claims?
[2] Has Gilead proven by clear and convincing evidence that each of the asserted claims of the ’597 patent is invalid because the specification of the ’597 patent does not contain an adequate written description of the asserted claims?
J.A. 143. The jury answered “No” to both questions. Id.
The panel majority now discards the jury verdict, stating “the jury was not free to adopt a number lower than the many, many thousands of configurations identified as ‘principal embodiment[s]’ in the patent itself.” Maj. Op. at 12 (alteration in original). However, the jury was not free to adopt an incorrect view of the patent, for almost all of the embodiments that the specification calls “principal embodiments” are for Formulas for which no synthesis and no evaluation data are provided in the ’597 specification.
The panel majority makes no mention of the relation of the ’597 claims to the Figures, the examples, and the data in the specification, holding only that the claims are invalid based on “billions and billions” of unclaimed nucleosides. Gilead’s expert Dr. Secrist testified that the preferred subembodiments of Formula XVII “ends up with a total of five compounds”:
- Q. To be fair, the patent does boil these formulas down a little bit down into something called preferred embodiments. Is that true? A. Absolutely, it does.
- Q. Can you explain, it is a term we haven’t heard before, can you explain to the jury what your understanding of a
preferred embodiment is? A. Well, you take—I will do my best. If you have this many compounds that you are starting with, a preferred embodiment would narrow it down by some means, usually by looking at data, to this many, in a more preferred embodiment similarly by some means, usually data would get down to this number of compounds. So you would go from here to here with preferred embodiments, usually based on seeing the data for compounds that are in these embodiments. . . . - Q. If we go to [the ’597 patent]. What are we looking at here, Dr. Secrist, from Column 32 of the patent, lines 42 to 59? A. On the right is the same structures, Roman Numeral XVII that we have already seen. Now we are looking at what’s up and what’s down at the 2’ position. . . . I have suggested it is an important position. It is. What they show is a methyl up, you can see it, R6 is methyl in all cases and a hydroxyl down in all cases. This ends up with a total of five compounds.
J.A. 37554 at 1612:4–1613:7.
A patent specification must “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same.”
Based on the evidence, a reasonable jury could have found that the claims are directed to the subject matter that was described and evaluated. “Our appellate role ends when there is shown to be substantial evidence, on the record as a whole, as could have been accepted by a reasonable jury as probative of the issue.” Nat’l Presto Indus., Inc. v. West Bend Co., 76 F.3d 1185, 1192 (Fed. Cir. 1996). My colleagues err in holding that the ’597 claims are invalid unless the billons or millions or thousands of variants are synthesized and shown to have antiviral activity. The evidence could reasonably support a jury finding that the claims are of the scope that is described and enabled in conformity with section 112. From my colleagues’ contrary ruling, I respectfully dissent.
II
The basis of this litigation is Idenix’s complaint that the ’597 patent is infringed by the Gilead product sofosbuvir, which has a fluorine substituent in the 2‘-down position, as follows:
It is pointed out that fluorine is conspicuously omitted from the list of halogen substituents at 2‘-down in several of the general “Formulas” in the ’597 specification. Gilead Br. at 68–69 (citing ’597 patent, col. 10, ll. 42–55, col. 12, ll. 5–12, col. 12, ll. 55–61). It is pointed out that Idenix lost an interference contest on this specific molecule. Gilead Br. at 1 (citing Storer v. Clark, 860 F.3d 1340 (Fed. Cir. 2017)).
The panel majority states that this aspect was “not advanced by Idenix at trial or before us.” Maj. Op. at 7–8 n.3. However, Gilead did advance this aspect at trial, and argues it on this appeal. At the trial Gilead presented evidence with respect to the 2‘-down fluorine substituent, as I have outlined, and on appeal Gilead devotes a substantial portion of its brief to the argument that its fluorinated compound is not within the scope of correctly construed claims. The issue was not waived, although the Supreme Court has recognized that even issues that were waived may be considered on appeal. The Court has explained:
Nor did prudence oblige the Court of Appeals to treat the unasserted argument . . . as having been waived. . . . [A] court may consider an issue “antecedent to . . . and ultimately dispositive of” the dispute before it, even an issue the parties fail to identify and brief. . . . [A] court “need not render judgment on the basis of a rule of law . . . simply because the parties agree upon it.”
U.S. Nat’l Bank of Or. v. Indep. Ins. Agents of Am., 508 U.S. 439, 447 (1993) (quoting Arcadia v. Ohio Power Co., 498 U.S. 73, 77 (1990) and United States v. Burke, 504 U.S. 229, 246 (1992) (Scalia, J., concurring in judgment)).
The judicial responsibility and authority are to assure that the correct law is applied. Contrary to my colleagues’ position, the Court admonishes that:
Rules of practice and procedure are devised to promote the ends of justice, not to defeat them. A rigid and undeviating judicially declared practice under which
courts of review would invariably and under all circumstances decline to consider all questions which had not previously been specifically urged would be out of harmony with this policy. Orderly rules of procedure do not require sacrifice of the rules of fundamental justice.
Hormel v. Helvering, 312 U.S. 552, 557 (1941); see Singleton v. Wulff, 428 U.S. 106, 121 (1976) (“The matter of what questions may be taken up and resolved for the first time on appeal is one left primarily to the discretion of the courts of appeals, to be exercised on the facts of individual cases. We announce no general rule.”).
The Federal Circuit has so recognized. See Wilson v. Principi, 391 F.3d 1203, 1211 (Fed. Cir. 2004) (“The Court stated that such instances should be based on ‘particular circumstances which will prompt a reviewing or appellate court, where injustice might otherwise result, to consider
questions of law which were neither pressed nor passed upon . . . below.’ The matter is one left largely to the discretion of the court of appeals.” (quoting Hormel, 312 U.S. at 557)). On appeal, our responsibility is to the law, and just conduct of the appeal.
There was substantial evidence that Gilead’s fluorinated product is not within the scope of the claims as they reasonably could have been viewed by the jury. The jury verdict of validity under section 112 is in accordance with law and supported by substantial evidence. I would decide this appeal on the ground that the claims, correctly construed, are valid and not infringed. From my colleagues’ contrary rulings, I respectfully dissent.