Background
Biogen International GmbH and Biogen MA, Inc. (collectively, Biogen) are involved in a significant patent infringement dispute with Mylan Pharmaceuticals Inc. (Mylan). The case revolves around Biogen's patent for the treatment of multiple sclerosis (MS) using dimethyl fumarate (DMF), marketed under the trade name Tecfidera®[1][3].
The Patent in Question
The patent at the center of the dispute is U.S. Patent No. 8,399,514 (the ’514 Patent), titled "Treatment for Multiple Sclerosis." This patent claims a method of treating MS with a therapeutically effective amount of DMF, specifically 480 mg per day[1][3].
Litigation Initiation
In June 2017, Biogen filed a lawsuit against Mylan in the Northern District of West Virginia, alleging patent infringement. Mylan had submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of Tecfidera®. Mylan counterclaimed for a declaratory judgment that the ’514 Patent was invalid and not infringed[1][3].
Trial and District Court Decision
The district court held a bench trial in February 2020, focusing on the validity of the ’514 Patent. On June 18, 2020, the court issued its post-trial opinion, finding that Mylan had proven 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. This decision was based on the argument that Biogen had not provided sufficient written description in the patent specification to support the claimed invention[1][3].
Collateral Estoppel
The court also applied the doctrine of collateral estoppel, determining that the issue of invalidity had been previously litigated and decided in the same case. This meant that Biogen was precluded from relitigating the validity of the ’514 Patent claims[1].
Appeal to the Federal Circuit
Biogen appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit. On November 30, 2021, the Federal Circuit affirmed the district court's judgment, holding that the district court did not clearly err in determining that Mylan had established the invalidity of the ’514 Patent claims for lack of written description[3].
Key Issues and Arguments
- Written Description Requirement: Mylan argued that Biogen's patent specification did not provide sufficient written description to support the claimed method of treating MS with 480 mg of DMF per day. Biogen countered that the specification, particularly Method 4, provided adequate support for the claimed invention[1][3].
- Priority Date: Biogen claimed priority to a provisional application filed in 2007, despite making significant changes to the claims in 2011. Mylan argued that these changes were not supported by the original specification[3].
Impact and Implications
The invalidation of the ’514 Patent has significant implications for Biogen and the generic pharmaceutical market. It allows Mylan and potentially other generic manufacturers to market their versions of DMF without infringing on Biogen's patent. This could lead to increased competition and potentially lower prices for MS treatments.
Industry Expert Insights
Industry experts note that the case highlights the importance of ensuring that patent specifications are thorough and support the claimed inventions. "The decision underscores the critical need for patent holders to ensure that their specifications are robust and clearly describe the claimed inventions," said a patent law expert.
Statistics and Market Impact
The market for MS treatments is substantial, with Tecfidera® being one of the leading oral medications. According to industry reports, the introduction of generic versions could reduce the cost of treatment significantly, benefiting patients worldwide.
Similar Cases and Precedents
Other cases involving patent infringement and validity, such as those listed in district court decisions on willfulness and enhancement, emphasize the importance of thorough specification and the consequences of failing to meet the written description requirement[2].
Key Takeaways
- Patent Validity: The ’514 Patent was found invalid due to lack of written description.
- Collateral Estoppel: The doctrine was applied, preventing Biogen from relitigating the validity issue.
- Appeal Outcome: The Federal Circuit affirmed the district court's decision.
- Market Impact: The invalidation allows for generic competition, potentially reducing treatment costs.
- Industry Implications: Emphasizes the need for robust patent specifications.
FAQs
Q: What is the main issue in the Biogen v. Mylan case?
A: The main issue is the validity of Biogen's ’514 Patent for treating multiple sclerosis with dimethyl fumarate (DMF), specifically whether the patent specification provides sufficient written description to support the claimed invention.
Q: What was the outcome of the district court trial?
A: The district court found that Mylan had proven by clear and convincing evidence that the asserted claims of the ’514 Patent were invalid for lack of written description.
Q: Did Biogen appeal the district court's decision?
A: Yes, Biogen appealed to the U.S. Court of Appeals for the Federal Circuit, which affirmed the district court's judgment.
Q: What is the impact of the ’514 Patent being invalidated?
A: The invalidation allows generic manufacturers to market their versions of DMF, potentially increasing competition and reducing treatment costs for multiple sclerosis patients.
Q: What is the significance of the written description requirement in patent law?
A: The written description requirement ensures that patent specifications clearly describe the claimed inventions, which is crucial for maintaining patent validity and preventing others from claiming the same invention.
Cited Sources
- United States District Court for the District of Delaware, "Biogen International GmbH and Biogen MA, Inc. v. Mylan Pharmaceuticals Inc." (September 16, 2020).
- Federal Circuit Damages, "District court decisions on willfulness and enhancement post-Halo" (January 20, 2017).
- U.S. Court of Appeals for the Federal Circuit, "Biogen International GmbH v. Mylan Pharmaceuticals Inc." (November 30, 2021).
