FDA Approved Use Prevents Hatch-Waxman Patent Infringement Claim: Federal Circuit

Practical Law Legal Update 0-518-9732 (Approx. 5 pages)

FDA Approved Use Prevents Hatch-Waxman Patent Infringement Claim: Federal Circuit

by PLC Intellectual Property & Technology

Key Litigated Issues

In the consolidated appeals of Bayer Schering Pharma v. Lupin Ltd. and Bayer Schering Pharma v. Sandoz, Inc., the key issues before the US Court of Appeals for the Federal Circuit were whether:

The FDA approved the Yasmin drug for all the uses claimed in the patent-at-issue.
The defendants' ANDAs sought FDA approval for the same uses.

Background

Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals, Inc. (Bayer) manufacture the drug, Yasmin. The FDA approved the use of Yasmin for oral contraception and the only use in the Indications and Usage section of the drug label attached to the FDA approval letter was for oral contraception. Bayer listed three patents, including US Patent No. 5,569,652 ('652 Patent), in the Orange Book in connection with Yasmin.

Watson Pharmaceuticals, Inc. and Watson Laboratories (Watson), Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin), and Sandoz, Inc. all filed Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of Yasmin. The defendants' respective ANDAs followed the language of the original New Drug Application (NDA) filed by Bayer's predecessor for Yasmin and requested approval to use the generic versions only for oral contraception. Each defendant included a paragraph IV certification under the Hatch-Waxman Act that the three patents that Bayer listed in the Orange Book in connection with Yasmin are either invalid or would not be infringed by the manufacture, use or sale of their generic versions of Yasmin (21 U.S.C. § 355(j)(2)(A)(vii)(IV)). Each defendant also sent Bayer a notice of its ANDA.

Bayer sued Watson and Sandoz in April 2008 and Lupin in July 2010 under Section 271(e)(2)(A) of the Patent Act for infringement of the '652 Patent.

The claimed method in the '652 Patent recites that the claimed method achieves three simultaneous effects in premenopausal or menopausal women:

A contraceptive effect.
An anti-androgenic effect, which reduces the activity of male hormones and can be effective in treating conditions such as hirsutism or acne.
An anti-aldosterone effect, which can reduce excess water retention in the body.

All of the defendants' ANDAs concern only the use of the generic form of Yasmin for oral contraception and not for the combination of uses claimed in the '652 Patent.

Watson and Sandoz moved for judgment of noninfringement on the pleadings. The US District Court for the Southern District of New York granted their motion. The district court explained that an action for infringement of a method-of-use patent can be brought under Section 271(e)(2)(A) only if the FDA had approved the use claimed in the patent under the patent-holder's NDA. The district court held that because the FDA had not approved Yasmin for the uses claimed in the '652 Patent, Bayer could not state a claim for patent infringement. Based on that decision, Bayer and Lupin stipulated to a final judgment in their separate action.

Bayer appealed both judgments and the Federal Circuit consolidated both cases for appeal.

Outcome

In its April 16, 2012 decision, the Federal Circuit affirmed both of the district court's final judgments. Relying on its precedent from Warner-Lambert Co. v. Apotex Corp. and Allergan, Inc. v. Alcon Laboratories, Inc., the Federal Circuit held that the defendants' conduct would be infringement only if their ANDAs sought approval for drug uses protected by the '652 Patent.

The court reasoned that because the defendants' ANDAs are identical to Bayer's predecessor's Yasmin NDA, the use or uses for which the ANDAs seek FDA approval are the same as the uses for which the FDA gave its approval when it granted Bayer's predecessor's NDA. Therefore, the Federal Circuit had to determine whether the FDA approved the use of Yasmin for the combination of the three effects claimed in the '652 Patent. The Federal Circuit ultimately held that the FDA did not approve Yasmin for these three uses and affirmed the district court's dismissal of Bayer's claims.

FDA Approval of Yasmin was Limited to Use as an Oral Contraceptive

The Federal Circuit rejected Bayer's argument that Yasmin's FDA-approved label recognizes FDA approval of all three effects claimed in the '652 Patent based on the "Pharmacodynamics" subsection of the "Clinical Pharmacology" section of the label. This subsection states that Yasmin exhibits anti-aldosterone activity and has the potential for anti-androgenic activity based on animal studies.

The Federal Circuit emphasized that FDA approval of the method for inducing these additional effects requires a showing that Yasmin was safe and effective for simultaneously obtaining those three effects in patients needing those effects. Acknowledgement of the safety and efficacy of that specific method of use would be evidenced by including it in the Indications and Usage section of the label. Here, neither the Clinical Pharmacology section of Yasmin's label nor anything else on the label provides any safety or efficacy information associated with the possible use of Yasmin in treating patients for inducing all three effects claimed in the '652 Patent.

Bayer's Evidence Does Not Support Its Interpretation

The Federal Circuit also rejected Bayer's evidence to support its argument that the references to anti-aldosterone and anti-androgenic activity in the Clinical Pharmacology section of the Yasmin label indicate that the FDA approved the use of Yasmin to induce the three effects claimed in the '652 Patent. Bayer relied specifically on:

The FDA regulation for listing patents in the Orange Book.
A doctor's declaration that the anti-aldosterone and anti-androgenic effects are stated on Yasmin's label.
A former FDA official's declaration that Yasmin was approved for anti-aldosterone and anti-androgenic effects.
FDA approved marketing materials for Yasmin.

The court determined that while this evidence shows that the FDA was aware that Yasmin could cause the effects claimed in the '652 Patent, none of the evidence addressed the critical question of whether the FDA found Yasmin to be safe and effective for inducing those effects in premenopausal or menopausal patients. Absent that finding of safety and efficacy, and the recognition of these effects on Yasmin's label, the Federal Circuit determined that the ANDA proposed label cannot induce infringement of the method of use claimed in the '652 Patent.

Dissent

The dissent argued that the majority's ruling is in error because:

The portion of the FDA label where a product's properties are described is irrelevant to whether the patent is infringed by the sale or use of the product.
Evidence showed that the three effects claimed in the '652 Patent were demonstrated when Bayer's predecessor presented Yasmin to the FDA for approval.
Patent infringement is a fact question and cannot be resolved on pleadings by adverse inferences or assumptions.
Bayer's complaint contains well pleaded and well supported factual allegations and states a plausible claim of patent infringement.

Practical Implications

A branded drug manufacturer having a method-of-use patent should obtain FDA approval of all uses and effects claimed in the patent based on a finding of safety and efficacy to ensure that it can sue generic manufacturers for infringement of the method-of-use patent on the filing of an ANDA seeking approval of the generic drug for the approved uses.

FDA Approved Use Prevents Hatch-Waxman Patent Infringement Claim: Federal Circuit | Practical Law