While the specific case of Biogen International GmbH v. Sawai USA, Inc. (Case No. 1:17-cv-00875) is not directly detailed in the provided sources, the litigation involving Biogen International GmbH and various generic pharmaceutical companies, such as Mylan Pharmaceuticals Inc., provides valuable insights into the broader context and key issues that might be relevant.
Background
Biogen International GmbH and Biogen MA, Inc. (collectively, Biogen) hold several patents related to the treatment of multiple sclerosis (MS), including the '514 Patent, which claims a method of treating MS with dimethyl fumarate (DMF)[4].
Patent Infringement Claims
In 2017, Biogen filed a lawsuit against Mylan Pharmaceuticals Inc. in the Northern District of West Virginia, alleging patent infringement under the Hatch-Waxman Act. This lawsuit was triggered by Mylan's attempt to gain approval for a generic DMF product for treating MS[4].
Invalidity of the '514 Patent
A crucial aspect of the litigation was the challenge to the validity of the '514 Patent. Mylan counterclaimed for a declaratory judgment that the '514 Patent was invalid and not infringed. The district court held a bench trial specifically on the issue of the patent's validity, focusing on whether the patent met the written description requirement under 35 U.S.C. § 112[1][4].
Written Description Requirement
The court determined that the specification of the '514 Patent did not demonstrate that, as of the priority date (February 8, 2007), the inventors possessed the claimed invention—a method of treating MS with a therapeutically effective amount of DMF (480 mg/day). The court held that the specification itself must show possession of the claimed invention, and inventor testimony or external evidence of actual possession was insufficient[1][4].
Collateral Estoppel
The issue of invalidity was also subject to a collateral estoppel analysis. The court found that the requirements for collateral estoppel were met, including the identity of the issues and that the issue of invalidity was actually litigated in the Mylan case. This meant that the judgment of invalidity in the Mylan case was binding in subsequent cases involving the same patent claims[1].
Appeal and Federal Circuit Decision
Biogen appealed the district court's decision to the Federal Circuit. The Federal Circuit affirmed the district court's judgment, holding that the district court did not clearly err in determining that Mylan had established, by clear and convincing evidence, that the asserted '514 Patent claims were invalid for lack of written description under 35 U.S.C. § 112[4].
Inter Partes Review (IPR)
In a related IPR proceeding initiated by Mylan, the Patent Trial and Appeal Board (PTAB) rejected an obviousness challenge to the '514 Patent claims. This decision estopped Mylan from litigating obviousness issues in the trial court but did not affect the written description challenge[4].
Implications for Biogen and Generic Manufacturers
The invalidation of the '514 Patent has significant implications for Biogen and generic manufacturers. For Biogen, it means the loss of patent protection for a key product, Tecfidera®, allowing generic versions of DMF to enter the market sooner. For generic manufacturers like Mylan and potentially Sawai USA, Inc., it clears the path for the production and marketing of generic DMF products without fear of patent infringement claims.
Key Takeaways
- Patent Validity: The '514 Patent was found invalid due to a lack of written description under 35 U.S.C. § 112.
- Collateral Estoppel: The judgment of invalidity in the Mylan case applies to subsequent cases involving the same patent claims.
- Generic Competition: The invalidation of the '514 Patent allows generic manufacturers to produce and market DMF products.
- Litigation Strategy: The case highlights the importance of thorough specification and the potential for collateral estoppel in patent litigation.
FAQs
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What was the main issue in the Biogen v. Mylan litigation?
- The main issue was the validity of the '514 Patent, specifically whether it met the written description requirement under 35 U.S.C. § 112.
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Why was the '514 Patent found invalid?
- The '514 Patent was found invalid because the specification did not demonstrate that the inventors possessed the claimed invention as of the priority date.
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What is the significance of collateral estoppel in this case?
- Collateral estoppel means that the judgment of invalidity in the Mylan case is binding in subsequent cases involving the same patent claims.
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How does the IPR proceeding relate to the litigation?
- The IPR proceeding rejected an obviousness challenge to the '514 Patent claims, but this did not affect the written description challenge that led to the patent's invalidation.
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What are the implications for Biogen and generic manufacturers?
- For Biogen, the invalidation means loss of patent protection for Tecfidera®. For generic manufacturers, it allows them to produce and market generic DMF products without fear of patent infringement claims.
Sources
- United States District Court for the District of Delaware, "Biogen International GmbH and Biogen MA Inc. v. Mylan Pharmaceuticals Inc." (2020).
- Unified Patents, "IPR2018-01403 - Sawai Pharmaceutical Co Ltd et al. v. Biogen MA Inc" (2020).
- United States Court of Appeals for the First Circuit, "Shash v. Biogen, Inc." (2023).
- United States Court of Appeals for the Federal Circuit, "Biogen International GmbH v. Mylan Pharmaceuticals Inc." (2021).
