MEMORANDUM OPINION AND ORDER
In this action, Bayer Schera Pharma AG and Bayer Healthcare Pharmaceuticals Inc. (collectively “Bayer”) allege that Defendants’ proposed marketing of generic versions of Bayer’s brand-name oral contraceptive Yasmin will infringe on Bayer’s patent rights. Bayer initiated this litigation after Defendants Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. (collectively ‘Watson”), and Defendant Sandoz, Inc. filed Abbreviated New Drug Applications (“ANDAs”) with the U.S. Food and Drug Administration (“FDA”) to market generic versions of Yasmin. (See Cmplt. ¶¶ 14,15) Bayer alleges that Defendants’ ANDA filings constitute infringement and inducement of infringement of U.S. Patent No. 5,569,652 (“the '652 patent”), which Bayer holds. (Cmplt. ¶¶ 20, 21, Ex. 1)
Defendants have moved for judgment on the pleadings pursuant to Fed.R.Civ.P. 12(c). (Docket No. 78) Under well established Federal Circuit precedent, Bayer cannot state a patent infringement claim based on Defendants’ ANDA filings unless it can show that the '652 patent claims a use for Yasmin that has been approved by the FDA under Bayer’s New Drug Application (“NDA”) for Yasmin. For the reasons stated below, this Court has determined that the '652 patent does not claim a use for Yasmin that has been approved by the FDA. Accordingly, Defendants’ motion for judgment on the pleadings will be GRANTED.
BACKGROUND
Watson and Sandoz each filed ANDAs seeking permission to market a generic version of Yasmin (Cmplt. ¶¶ 14, 15), and both submitted Paragraph IV certifications to the FDA alleging that Bayer’s patents are invalid or will not be infringed by the use, manufacture, or sale of a generic version of Yasmin. (Id. ¶¶ 18,19) Watson and Sandoz each sent statutorily-required ANDA notice letters to Bayer in March 2008. (Id. ¶¶ 18, 19) On April 17, 2008, Bayer filed the instant action against Defendants for infringement of the '652 patent. (Id. ¶¶ 20, 21) Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), Bayer’s filing of this action triggered an automatic thirty-month stay on the FDA’s approval of Defendants’ respective ANDAs. The thirty-month stay as to each ANDA expired earlier this month. 1
Bayer’s Complaint asserts claims against Defendants for infringement and inducement of infringement of the '652 patent under 35 U.S.C. § 271(e)(2)(A), which provides that it “shall be an act of infringement to submit [an ANDA] for a drug claimed in a patent or the use of which is claimed in a patent.”
(See
Cmplt.
Bayer alleges that the '652 patent — the “patent-in suit” — claims a use for Yasmin that has been approved by the FDA. (Cmplt. ¶ 21; Bayer Br. 1-2, 12-24) In support of this argument, Bayer notes that — in connection with its NDA for Yasmin — it notified the FDA that the '652 patent claims the drug for which it sought approval. As a result, the FDA listed the '652 patent in its Approved Drug Products with Therapeutic Equivalence Evaluations text (“the Orange Book”). (Cmplt. ¶¶ 20-21)
Claim 11 of the '652 patent — which is the central patent claim at issue in this case 2 — asserts the following “method-of-use” claim for Yasmin:
A method of simultaneously achieving, during pre-menopause or menopause, a contraceptive effect, an anti-androgenic effect, and an antialdosterone effect in a female patient in need thereof comprising administering an effective amount of dihydrospirorenone and an effective amount of an estrogenic compound, wherein said effective amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, anti-androgenic effect, and an anti-aldosterone effect in said female patient.
(Cmplt., Ex. 1 ('652 Patent, Claim 11)) 3
DISCUSSION
I. MOTION TO DISMISS STANDARD
“To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, .to ‘state a claim for relief that is plausible on its face.’ ”
4
Ash
II. THE ANDA FRAMEWORK
“The Hatch-Waxman Act strikes a balance between two potentially competing policy interests — inducing pioneering development of pharmaceutical formulations and methods and facilitating efficient transition to a market with low-cost, generic copies of those pioneering inventions at the close of a patent term.”
Novo Nordisk AJS v. Caraco Pharm. Labs., Ltd.,
“The Hatch-Waxman Act ... requires a pioneer drug manufacturer to notify the FDA of all patents that ‘claim [ ] the drug for which the [NDA] applicant submitted the application.’ ”
Eli Lilly & Co. v. Teva Pharm. USA Inc.,
“A manufacturer that seeks to market a generic drug may submit an ANDA for approval by the [FDA], rather than submitting a full New Drug Application (‘NDA’) showing the safety and efficacy of the generic drug.”
Eli Lilly & Co.,
“As part of the approval process, an ANDA applicant must make a certification addressing each patent listed in the Orange Book that claims the drug.”
Eli Lilly & Co.,
“If a generic manufacturer wishes to seek FDA approval for a use not covered by a method-of-use patent for a listed drug, it must make a ‘section viii statement.’ ”
Novo Nordisk A/S,
Here, Watson and Sandoz each filed an ANDA seeking permission to market a generic version of Yasmin (Cmplt. ¶¶ 14, 15), and both submitted Paragraph IV certifications alleging that Bayer’s patents are invalid or will not be infringed by the use, manufacture, or sale of a generic version of Yasmin.
(Id.
¶¶ 18, 19) “When an ANDA certifies under paragraph IV, the applicant must provide the patentee a detailed basis for its belief that the patent is not infringed, that it is invalid, or that it is unenforceable.”
Eli Lilly & Co.,
“[A] generic drug manufacturer may file an ANDA before a patent expires and, in so doing, allege non-infringement and invalidity of the patent.”
Allergan Inc. v. Alcon Labs.,
35 U.S.C. § 271(e)(2) “simply provides an ‘artificial’ act of infringement that creates case-or-controversy jurisdiction to enable the resolution of an infringement dispute before the ANDA applicant has actually made or marketed the proposed product.”
Warner-Lambert Co. v. Apotex Corp.,
III. DEFENDANTS ARE ENTITLED TO JUDGMENT ON THE PLEADINGS
Defendants contend that “a method-of-use patent holder, such as Bayer may not bring an action under 35 U.S.C. § 271(e)(2) for infringement of a method-of-use patent that does not claim a use approved by the FDA under the patent-holder’s New Drug Application (‘NDA’).” (Def. Br. 2) Defendants further argue that Bayer’s § 271(b) inducement claim fails, because a method-of-use patent holder “may not sue an ANDA applicant under 25 U.S.C. § 271(b) for inducing infringement of its patent if the ANDA applicant is not seeking FDA approval for the use claimed in the patent and if the use claimed in the patent is not FDA-approved.” (Id.)
Bayer does not dispute these legal principles. (Bayer Br. 1) Instead, Bayer argues that “[t]he Generics lose this motion because Yasmin is FDA-approved for oral contraception plus the two additional pharmacological effects [ie., an anti-androgenic effect, and an anti-aldosterone effect].” (Bayer Br. 8-9) Athough the “Indications and Usage” section of Yasmin’s FDA-approved label states that ‘YASMIN is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive” and mentions no other indication or use (Def. Ex. C Yasmin Label)), Bayer contends that “patented FDA-approved uses may reside outside (even wholly outside) the Indications section of the label.” (Bayer Br. 2) In the alternative, Bayer contends that the issue of whether the '652 patent’s method-of-use has been FDA-approved presents “a question of fact unsuitable for resolution on the pleadings.” (Id.)
In arguing that Yasmin is FDA-approved for the method-of-use covered by the '652 patent, Bayer cites to,
inter alia,
the “Clinical Pharmacology” section of Yasmin’s FDA-approved label, to the fact that the '652 patent is listed in the Orange Book, and to its marketing materials, which apparently promote Yasmin for uses other than oral contraception. None of
The “Indications and Usage” section of Yasmin’s FDA-approved label, as well as the FDA’s letter approving Bayer’s NDA for Yasmin, make clear — as a matter of law — that the FDA has approved Yasmin only for use as an oral contraceptive. Because the only FDA-approved use of Yasmin is oral contraception, and because the FDA has not approved the method-of-use set forth in the '652 patent, Defendants are entitled to judgment on the pleadings concerning Bayer’s infringement claims.
A. Section 271(e)(2)(A) Claims 1. Applicable Law
In
Warner-Lambert Co. v. Apotex Corp.,
In
Warner-Lambert,
Apotex — a generic manufacturer' — filed an ANDA seeking approval to market a generic formulation of the drug gabapentin at the expiration of Warner-Lambert’s epilepsy method patent.
In connection with its ANDA, Apotex filed a paragraph IV certification, which represented that its generic product would not infringe Warner Lambert’s neurodegenerative method-of-use patent, because Apotex was not seeking approval to use gabapentin for the treatment of neurodegenerative diseases, but only for the treatment of epilepsy.
Id.
at 1353. Warner-Lambert nonetheless sued Apotex for patent infringement, contending that Apotex’s ANDA infringed on Warner-Lambert’s
Warner-Lambert contended that under § 271(e)(2), “a patent claiming a use of a drug is infringed by the filing of an ANDA irrespective of whether approval is sought to market the drug for the patented use.” Id. at 1355. This argument was soundly rejected:
Warner-Lambert’s proposed interpretation is inconsistent with both of the stated purposes of the Hatch-Waxman Act, and would confer substantial additional rights on pioneer drug patent owners that Congress clearly did not intend to confer. If Warner-Lambert’s interpretation were correct, for example, an NDA holder would be able to maintain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA. It would then be able to use section 271(e)(2)(A) as a sword against any competitor’s ANDA seeking approval to market an off-patent drug for an approved use not covered by the patent. Generic manufacturers would effectively be precluded altogether from entering the market.
Id. at 1359.
Warner-Lambert
has consistently been cited for the proposition that an infringement claim against an ANDA filer cannot be premised on a method-of-use patent where that use is not FDA-approved.
See, e.g., Allergan,
2. Bayer Fails to State a Claim for Patent Infringement Because Yasmin is Only FDA-Approved for Oral Contraception
Under
Warner-Lambert,
the critical question in resolving the instant motion is whether Yasmin is FDA-approved for
A method of simultaneously achieving, during pre-menopause or menopause, a contraceptive effect, an anti-androgenic effect, and an antialdosterone effect in a female patient in need thereof comprising administering an effective amount of dihydrospirorenone and an effective amount of an estrogenic compound, wherein said effective amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, anti-androgenic effect, and an anti-aldosterone effect in said female patient.
(Cmplt., Ex. 1 ('652 Patent, Claim 11))
As an initial matter, Bayer claims that when Defendants filed paragraph IV certifications in connection with their ANDA filings, 5 “they certified that they sought approval for the '652 patented use.” (Bayer Br. 7) Defendants contend, however, that they “propose to market their generic versions of Yasmin exclusively for the drug’s approved, and unpatented, indication of contraception.” (Def. Br. 2)
Nothing in the proposed labels submitted in connection with Defendants’ ANDA filings indicates that they seek FDA approval to market their generic drugs for the '652 patented use.
(See
Defs. Ex. E, F). To the contrary, Defendants’ proposed labeling addresses only an indication for oral contraception.
(Id.;
Defs. Br. 13) This is hardly surprising, because Defendants could not obtain FDA approval to market generic versions of Yasmin for anything other than its FDA-approved use, which Defendants contend is limited to oral contraception.
See Warner-Lambert,
As to the scope of Yasmin’s FDA-approved use, Bayer argues that “[t]he FDA has interpreted the relevant Hatch-Wax-man statutes to encompass ‘uses’ broader than just an indication. In both its formal regulations and practice the FDA has acknowledged that FDA-approved ‘uses’ can be in portions of the labeling other than the Indications section.” (Bayer Br. 13) Bayer’s argument that the FDA has approved the '652 patent’s claim of simultaneous gestagenic, anti-androgenic, and anti-aldosterone effect is founded on the following excerpt from the “Clinical Pharmacology” section of the Yasmin label:
Drospirenone is a spironolactone analogue with antimineralocorticoid activity. Preclinical studies in animals and in vitro have shown that drospirenone has no androgenic, estrogenic, glucocorticoid, and antiglucocorticoid activity. Preclinical studies in animals have also shown that drospirenone has antiandrogenic activity.
As noted above, the “Indications and Usage” section of Yasmin’s FDA-approved label states that ‘YASMIN is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive” and mentions no other indication or use. (Def. Ex. C Yasmin Label)) The FDA letter approving Bayer’s NDA for Yasmin also makes clear that Yasmin has been found safe and effective for oral contraception, and not for other purposes:
This new drug application provides for the use of Yasmin ® Tablets (drospirenone 3 mg/ethinyl estradiol 0.030 mg) for oral contraception. We have completed the review of this application, as amended, ... and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon enclosed labeling text.
(Def. Ex. B (FDA Approval Ltr.) (emphasis added))
The FDA approves the marketing of prescription drugs for specific purposes that have been proven safe and effective through highly rigorous clinical trials. As noted in
Warner-Lambert,
“[t]he FDA does not grant across-the-board approval to market a drug. Rather, it grants approval to make, use, and sell a drug for a specific purpose for which that drug has been demonstrated to be safe and efficacious.”
Warner-Lambert,
The purpose of the FDA-approved label — as to indications and usage — is to clearly communicate what uses have been proven safe and effective, and FDA regulations explicitly provide that other uses and indications not listed in the “Indications and Usage” section of the label may not be implied based on other sections of the label, such as the Clinical Pharmacology section:
[f]or drug products other than biological products, all indications listed in [the “Indications and Usage”] section must be supported by substantial evidence of effectiveness based on adequate and well-controlled studies as defined in § 314.26(b) of this chapter unless the requirement is waived under § 201.58 or § 314.126(e) of this chapter. Indications or uses must not be implied or suggested in other sections of the labeling if not included in this section.
21 C.F.R. § 201.57(c)(2)(iv) (emphasis added). 6
Alcon Labs. v. Allergan,
Applying
Warner-Lambert,
the
Alcon Labs,
court stated that “Allergan’s claim ... cannot be predicated on a non-controlling use patent.”
Alcon Labs.,
Although Allergan indicates that the Alphagan® label states that the product is “indicated for lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension,” Allergan contends that the use of [the drug] for neuroprotection to treat open-angle glaucoma is also an approved method of use. The Court finds no support for this argument, either in the product label for Alphagan® or in the FDA approval letter for Alphagan®.
Id.
Alcon Labs, is on all fours with the instant action. Like Bayer, Allergan attempted to avoid the holding of Warner-Lambert by arguing that its drug was FDA-approved for uses beyond the “Indications and Usage” section of the Alphagan label. The court examined the FDA-approved label for Alphagan and the FDA letter approving Allergan’s NDA for Alphagan, found no indication for the use contemplated by the patent-in-suit, and rejected Allergan’s argument. This Court has conducted the same analysis and reaches the same conclusion. 7 Defendants are entitled to judgment on the pleadings concerning Bayer’s patent infringement claims asserted under 35 U.S.C. § 271(e)(2)(A).
B. Section 271(b) Claims
The Complaint also asserts induced infringement claims against Defendants un
Bayer argues that Defendants’ proposed labels for their generic versions of Yasmin will induce infringement, because they “do[ ] not restrict the intended use of [their] produces] to the creation of a gestagenic effect in patients.” (Cmplt. ¶¶ 26, 40) Bayer also alleges that because Defendants’ proposed labels disclose drospirenone’s pharmacological profile and provide information “regarding the anti-aldosterone and anti-androgenic properties of drospirenone,” Defendants “will be marketing [their] ANDA produces] with specific intent, and/or with the desire to actively induce, aid, and abet infringement of the '652 patent.” (Cmplt. ¶¶ 27-28, 41-42) The Warner-Lambert court considered and rejected this precise argument:
[T]he ANDA must be judged on its face for what an accused infringer seeks the FDA’s approval to do.... The statute explicitly defines the act of infringement as the filing of the ANDA. The infringement case is therefore limited to an analysis of whether what the generic drug maker is requesting authorization for in the ANDA would be an act of infringement if performed. Here, the request to make and sell a drug labeled with a permissible (non-infringing) use cannot reasonably be interpreted as an act of infringement (induced or otherwise) with respect to a patent on an unapproved use, as the ANDA does not induce anyone to perform the unapproved acts required to infringe.
Warner-Lambert,
The Complaint’s remaining allegations are likewise insufficient to state a claim for induced infringement. Bayer alleges, for example, that Defendants are “aware ... of the widespread use of Yasmin ... to produce simultaneously a gestagenic, anti-androgenic, and anti-aldosterone effect in premenopausal or menopausal female patients” and that “[t]his use ... would be readily apparent to [Defendants’] customers .... ” (Cmplt. ¶¶ 25, 39) Bayer further alleges that Defendants are aware that “a significant proportion of ... [Yasmin] prescriptions are written with the intent of producing three pharmacological effects— gestagenic, anti-aldosterone, and anti-androgenic,” and that Defendants will thus be marketing their ANDA products “with specific intent, and/or with the desire to actively induce, aid, and abet infringement of the '652 patent.” (Cmplt. ¶¶ 26, 40)
As the Warner-Lambert court explained, such allegations are insufficient to support an induced infringement claim. In that case, Warner-Lambert contended that the generic manufacturer “had to have ‘known’ that physicians were prescribing gabapentin for treatment of neurodegeneration” — the use claimed by the patent-in-suit. The Federal Circuit rejected this allegation as a basis for an induced infringement claim, however:
[M]ere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven. [Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544 , 554 (Fed.Cir. 1990) ] Thus, if a physician, without inducement by [the generic manufacturer] prescribes a use of gabapentin in an infringing manner, [the generic manufacturer’s] knowledge is legally irrelevant.
Warner-Lambert,
Bayer’s claims for induced infringement pursuant to § 271(b) must be dismissed. 8
CONCLUSION
For the reasons stated above, Defendants’ motion for judgment on the pleadings is GRANTED. Bayer’s patent infringement claims are dismissed with prejudice. The Clerk of the Court is directed to terminate Defendants’ motion. (Docket No. 78)
SO ORDERED.
Notes
. On September 2, 2010, this Court denied Bayer’s motion to extend the statutory thirty-month stay with respect to Watson's ANDA.
See Bayer Schera Pharma AG v. Sandoz, Inc.,
No. 08 Civ. 3710(PGG),
. Defendants argue that Claim 11 of the '652 patent is the only relevant claim. (Def. Br. 10 n. 7) In a footnote, Bayer states that it "does not concede that claim 11 is the only relevant claim,” and notes that Defendants have "infringe[d] several other claims of the '652 patent” and that "Bayer chose [to discuss] claim 11 for illustrative purposes.” (Bayer Br. 12 n. 7) The Complaint, however, only makes reference to those claims in the '652 patent that relate to simultaneously achieving a gestagenic, anti-androgenic, and anti-aldosterone effect. (See ¶¶ 25-28, 39-42) In any event, to the extent that other claims in the '652 patent relate to simultaneously achieving a gestagenic, anti-androgenic, and anti-aldosterone effect, this Court has determined that Yasmin is not FDA-approved for this trio of uses, and that instead, it has only been approved for use as an oral contraceptive.
. "Gestagenic” refers to a contraceptive effect. (Bayer Ex. 3 (Shulman Deck), ¶ 20) Aldosterone is defined as "[a] steroid hormone secreted by the adrenal cortex that regulates the salt and water balance in the body.” Dorland’s Medical Dictionary for Health Consumers (2007), http://medicaldictionary.thefreedictionary.com/aldosterone (last visited Sept. 24, 2010). “Anti-aldosterone” effect refers to an inhibitory effect on the "renin-angiotensin-aldosterone system,” which influences electrolyte balance in the body and impacts a number of bodily functions, including fluid retention. (Bayer Ex. 3 (Shulman Deck), ¶¶ 13-14)
Anti-androgenic is defined as "[a] substance that blocks the action of androgens, the hormones responsible for male characteristics.” Dorland’s Medical Dictionary for Health Consumers (2007), http://medical-dictionary.the freedictionary.com/antiandrogen (last visited Sept. 24, 2010). "Anti-androgenic” effect refers to the inhibition of the action of testosterone and other androgens on androgen receptors, which apparently can lead to a reduction in facial hair or acne. (Bayer Ex. 3 (Shulman Deck), 11V 13-14)
.In ruling on Defendants’ motion, this Court has considered — in addition to the Complaint — "those documents attached to the pleadings as an exhibit or any statements or documents incorporated in the Complaint by reference, and ... any documents that are integral to the Complaint or an appropriate
Pursuant to this standard, this Court has considered: (1) Bayer’s '652 patent; (2) the FDA-approved labeling for Yasmin (Def.Ex. C); (3) the FDA approval letter for the NDA Bayer submitted in connection with Yasmin (Def.Ex. B); and (4) the proposed labels Defendants submitted to the FDA in connection with their ANDA filings. The '652 patent is attached as an exhibit to the Complaint. (Cmplt., Ex. 1 ('652 Patent)) The FDA's approval of Bayer's NDA for Yasmin, and the FDA's approval of Yasmin tablets, is referenced in the Complaint. (Cmplt. ¶ 13) The Complaint also makes reference to the proposed labels Watson and Sandoz submitted to the FDA (Def.Exs. E, F) in connection with their ANDA filings. (Cmplt. ¶¶ 14-15, 26-27, 40-41) All of the above-mentioned documents are likewise integral to the Complaint.
. Bayer argues that Defendants' filing of Paragraph IV certifications — rather than section viii statements — constitutes an admission that the FDA has approved the '652 patent method-of-use. (Bayer Br. 1, 2) Bayer cites no authority for the proposition that this Court should base its determination concerning the scope of FDA approval on the ANDA filings of a generic competitor.
The issue of whether Defendants should have filed section viii statements rather than Paragraph IV certifications is for the FDA. If Bayer is correct, then presumably the FDA will reject the ANDA applications. That issue, however, has little bearing on the question this Court must resolve: whether the FDA has approved the method-of-use set forth in the '652 patent.
. Bayer argues that this labeling regulation was not in effect when the FDA approved Yasmin. While the FDA approval letter for Yasmin submitted by the parties is undated, (see Def. Ex. B (FDA Approval Ltr.)), it appears that Yasmin was approved on May 11, 2001. (See Def. Req. for Judicial Notice dated Nov. 16, 2009) While it is true that drug products approved prior to June 30, 2001, are subject to the labeling requirements set forth in 21 C.F.R. § 201.80 rather than the provision cited above, (see 21 C.F.R. § 201.56(b)(2)), Section 201.80 contains the same language as 21 C.F.R. § 201.57(c)(2)(iv): "Indications or uses must not be implied or suggested in other sections of labeling if not included in this section.” Compare 21 C.F.R. § 201.80(c)(2)(i) with 21 C.F.R. § 201.57(c)(2)(iv).
. In support of its argument that the scope of FDA approval for Yasmin presents at least a question of fact, Bayer has submitted declarations from an obstetrician and a former FDA official who was involved in the approval process for Yasmin. This Court is convinced based upon the Complaint and its exhibit, the documents incorporated and referenced therein, and documents integral to the Complaint, however, that the instant action must be dismissed. The Court is not required to consider the additional exhibits submitted by Bayer.
Miller v. Potter,
No 07-CV-1767 (JFB)(ETB),
Even if the Court were to consider Bayer's additional exhibits, however, they in no way refute the overwhelming evidence that Yasmin is FDA-approved only for oral contraception. For example, the obstetrician’s alleged belief that claim 11 of the '652 patent reflects an "on-label” use for Yasmin (see Bayer Ex. 3 (Shulman Deck) at ¶¶ 19-24) — because the anti-androgenic and anti-aldosterone effects of the drug are mentioned in the Clinical Pharmacology section of the label — demonstrates only that the doctor misapprehends the nature of FDA approval as it relates to indication and usage.
Similarly, the declaration of a former FDA official involved in the approval of Bayer's NDA for Yasmin (see Bayer Ex. 7 (Allen Deck)) — since retained as an expert by Bayer — is insufficient to raise a factual issue as to whether Yasmin is FDA-approved for a use other than oral contraception. Dr. Allen’s assertion that an FDA-approved use can be discerned from a reference — in a label’s Clinical Pharmacology section — to side effects noted in pre-clinical animal and in vitro studies flatly contradicts the FDA regulation and case law discussed above, and is not credible. Similarly, the declarations establishing that FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) has not objected to Bayer’s promotional materials for Yasmin (Bayer Exs. 9, 10) — which make reference to Yasmin’s alleged anti-androgenic and anti-aldosterone effects — are not sufficient to create an issue of fact as to the scope of Yasmin’s FDA-approved use. Bayer cites no law for the proposition that the FDA's failure to object to marketing materials can broaden the scope of an FDA approved use.
. Because Bayer cannot state a claim for patent infringement or induced patent infringement based on its '652 patent, amending the Complaint is futile and leave to amend will not be granted.
See Salahuddin v. Cuomo,