Background
The litigation between Biogen International GmbH and Mylan Pharmaceuticals Inc. revolves around a patent infringement dispute concerning the treatment of multiple sclerosis (MS) using the drug dimethyl fumarate (DMF). Biogen, the owner of U.S. Patent 8,399,514 (the ’514 Patent), alleged that Mylan's attempt to market a generic DMF product infringed on their patent rights[4][5].
The Hatch-Waxman Act and ANDA Approval
The dispute began when Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic DMF product, which is bioequivalent to Biogen's branded product, Tecfidera®. Under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), Mylan sought approval to market the generic product before the expiration of the ’514 Patent[4][5].
District Court Proceedings
In June 2017, Biogen filed a lawsuit against Mylan in the Northern District of West Virginia, alleging patent infringement. Mylan counterclaimed for a declaratory judgment that the ’514 Patent was invalid and not infringed. The district court, presided over by Senior Judge Irene M. Keeley, held a four-day bench trial to determine the validity of the patent claims[2][4].
District Court Decision
The district court found that Mylan had satisfied its burden of demonstrating, by clear and convincing evidence, that the asserted claims of the ’514 Patent were invalid for lack of written description under 35 U.S.C. § 112. The court determined that the specification of the patent did not adequately describe the specific dose of 480 mg/day of DMF (DMF480) as a therapeutically effective treatment for MS. The court also rejected Biogen's argument that a skilled artisan would have recognized the efficacy of DMF480 based on the disclosures in the specification[2][4][5].
Appeal to the Federal Circuit
Biogen appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit. The appeal was heard by Circuit Judges O’Malley, Reyna, and Hughes. Biogen argued that the district court erred in its written-description analysis and raised several ancillary arguments. However, the Federal Circuit upheld the district court's decision, finding that the district court did not clearly err in determining that the ’514 Patent claims were invalid for lack of written description[4][5].
Key Issues and Findings
- Written Description Requirement: The Federal Circuit reiterated that whether a claim meets the written-description requirement is a question of fact, reviewed for clear error on appeal from a bench trial. The court found that the specification itself must demonstrate possession of the invention, and in this case, it did not adequately describe the DMF480 dose as an independent therapeutically efficacious dose for MS[4][5].
- Skilled Artisan Testimony: The district court found that the Biogen expert’s opinion that a skilled artisan would be drawn to the DMF480 dose from the disclosures in the specification was neither credible nor persuasive. This finding was upheld by the Federal Circuit[4].
- Judicial Estoppel: The district court also concluded that Biogen was judicially estopped from arguing the distinction between clinical and therapeutic efficacy in its post-trial briefing, as it had changed its positions according to the exigencies of the moment. However, Judge O’Malley’s dissent argued that the district court’s treatment of the estoppel issue was reversible legal error[4].
Dissenting Opinion
Circuit Judge O’Malley dissented from the majority opinion, arguing that the district court’s conclusion on judicial estoppel was incorrect and that Biogen’s later establishment of the therapeutic efficacy of DMF480 should have been considered in the written-description analysis. However, the majority held that these arguments were superfluous given their conclusion that the district court did not clearly err in finding the ’514 Patent invalid[4][5].
Impact and Implications
The decision in this case has significant implications for pharmaceutical companies and the patent litigation landscape. It underscores the importance of ensuring that patent specifications provide clear and detailed descriptions of the claimed inventions, particularly in the context of specific dosages and therapeutic efficacy. This case also highlights the challenges faced by innovator companies in defending their patents against generic challengers under the Hatch-Waxman Act[4][5].
Key Takeaways
- Patent Specification: The specification must clearly describe the claimed invention, including specific dosages and therapeutic efficacy.
- Written Description Requirement: This requirement is a question of fact reviewed for clear error on appeal from a bench trial.
- Skilled Artisan Testimony: Expert testimony must be credible and persuasive to support the written-description requirement.
- Judicial Estoppel: Changing positions according to the exigencies of the moment can lead to judicial estoppel.
- Hatch-Waxman Act: The Act allows generic manufacturers to challenge innovator patents, but they must demonstrate invalidity or non-infringement by clear and convincing evidence.
Frequently Asked Questions (FAQs)
Q: What was the main issue in the Biogen v. Mylan litigation?
A: The main issue was whether the ’514 Patent claims were valid, specifically whether they met the written-description requirement under 35 U.S.C. § 112.
Q: What is the Hatch-Waxman Act, and how does it relate to this case?
A: The Hatch-Waxman Act allows generic drug manufacturers to seek FDA approval before the expiration of the innovator's patent. In this case, Mylan sought approval for a generic DMF product, leading to the patent infringement dispute.
Q: Why was the ’514 Patent found invalid?
A: The ’514 Patent was found invalid because the specification did not adequately describe the specific dose of 480 mg/day of DMF as a therapeutically effective treatment for MS.
Q: What role did judicial estoppel play in the case?
A: The district court found that Biogen was judicially estopped from arguing certain points due to changing its positions, but this was a point of contention in the dissenting opinion.
Q: What are the implications of this decision for pharmaceutical companies?
A: The decision emphasizes the need for clear and detailed descriptions in patent specifications, particularly for specific dosages and therapeutic efficacy, to defend against generic challenges.
Cited Sources
- Biogen International GmbH v. Mylan Pharmaceuticals Inc., No. 20-1933, U.S. Court of Appeals for the Federal Circuit, November 30, 2021.
- Biogen International GMBH et al v. Mylan Pharmaceuticals Inc., No. 1:2017cv00116, U.S. District Court for the Northern District of West Virginia, June 18, 2020.
- Biogen International GmbH and Biogen MA Inc. v. Mylan Pharmaceuticals Inc., C.A. No. 1:17-cv-00116-IMK-JPM, Patently-O, June 24, 2020.
- Biogen Int’l GMBH v. Mylan Pharms. Inc., Robins Kaplan LLP.
- APPENDICES - UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, No. 2020-1933, Supreme Court, March 16, 2022.
