Background and Context
The litigation between Biogen International GmbH, Biogen MA, Inc. (collectively Biogen), and Mylan Pharmaceuticals Inc. revolves around a patent infringement dispute concerning the treatment of multiple sclerosis (MS) using the drug dimethyl fumarate (DMF). The case is rooted in the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), which allows generic drug manufacturers to seek approval before the expiration of the original patent[2][4].
The Patent in Question
Biogen owns United States Patent 8,399,514 (the ’514 Patent), which claims a method of treating MS with a specific dose of DMF, namely 480 mg/day. This patent was issued in 2011 and is central to the dispute[2][4].
Initiation of Litigation
In June 2017, Biogen filed a lawsuit against Mylan in the United States District Court for the Northern District of West Virginia, alleging patent infringement. Mylan had sought FDA approval to market a generic DMF product for treating MS through an Abbreviated New Drug Application (ANDA)[2][4].
Mylan's Counterclaim
Mylan counterclaimed for a declaratory judgment that the ’514 Patent was invalid and not infringed. The counterclaim focused on the lack of written description in the patent specification, a critical requirement under 35 U.S.C. § 112[2][4].
District Court Ruling
Following a bench trial, the district court, presided over by Senior Judge Irene M. Keeley, determined that the asserted claims of the ’514 Patent were invalid for lack of written description. The court found that the specification did not reasonably convey to a person of ordinary skill in the art (POSA) that the inventors had actually invented a method of treating MS with a therapeutically effective dose of DMF480 as of the priority date, February 8, 2007[2][3][4].
Key Findings of the District Court
- The specification lacked clear evidence that a POSA would recognize DMF480 as a therapeutically effective dose for treating MS.
- Biogen’s expert testimony was deemed "neither credible nor persuasive" in supporting the claim that a POSA would be drawn to the DMF480 dose from the disclosures in the specification.
- The court noted significant omissions from the specification and rejected Biogen’s attempt to combine selectively plucked disclosures to support the claims[2][4].
Appeal to the Federal Circuit
Biogen appealed the district court’s decision to the United States Court of Appeals for the Federal Circuit. The appeal challenged the district court’s finding that the ’514 Patent claims were invalid for lack of written description[2][4].
Federal Circuit Ruling
The Federal Circuit, in an opinion filed by Circuit Judge Reyna, affirmed the district court’s judgment. The court held that the district court did not clearly err in determining that Mylan had established its burden of showing, by clear and convincing evidence, that the asserted ’514 Patent claims were invalid for lack of written description under 35 U.S.C. § 112[2][4].
Dissenting Opinion
Circuit Judge O’Malley filed a dissenting opinion, arguing that the district court erred in its written-description analysis and in its application of judicial estoppel. However, the majority opinion found these arguments superfluous given their affirmation of the district court’s decision[2][4].
Rehearing Denied
On March 16, 2022, the Federal Circuit denied Biogen’s combined petition for panel rehearing and rehearing en banc, solidifying the earlier decision that invalidated the ’514 Patent claims for lack of written description[5].
Expert Testimony and Clinical Data
The case highlighted the importance of expert testimony and clinical data in patent litigation. Biogen’s expert, Dr. Wynn, and Mylan’s expert, Dr. Greenberg, both neurologists with extensive experience in treating MS, provided conflicting opinions on whether the specification supported the therapeutic efficacy of DMF480. The district court found Dr. Wynn’s testimony unpersuasive, emphasizing that the specification did not teach a POSA that DMF480 would be therapeutically effective for treating MS[2][4].
Implications and Takeaways
Written Description Requirement
The case underscores the stringent requirements for written description in patent specifications. The Federal Circuit’s affirmation of the district court’s decision emphasizes that the specification itself must demonstrate possession of the invention, and selective disclosures are insufficient to support claims[2][4].
Clinical Efficacy and Patent Claims
The litigation highlights the distinction between clinical efficacy established through later studies and the written description required at the time of patent filing. Biogen’s later establishment of the therapeutic efficacy of DMF480 did not retroactively validate the patent claims[4].
Judicial Estoppel
The dissent raised concerns about the district court’s application of judicial estoppel, suggesting that Biogen’s positions on clinical and therapeutic efficacy were inconsistent. However, the majority found this issue superfluous given the clear error standard applied to the written-description analysis[4].
Key Takeaways
- Written Description: The specification must clearly convey to a POSA that the inventors had actually invented the claimed method.
- Clinical Efficacy: Later clinical data does not validate patent claims if the specification lacks adequate written description at the time of filing.
- Expert Testimony: The credibility and persuasiveness of expert testimony are crucial in patent litigation.
- Judicial Estoppel: Consistency in legal positions is important to avoid judicial estoppel.
FAQs
What was the main issue in the Biogen v. Mylan litigation?
The main issue was whether the ’514 Patent claims were invalid for lack of written description under 35 U.S.C. § 112.
What was the outcome of the district court ruling?
The district court ruled that the asserted claims of the ’514 Patent were invalid for lack of written description.
Why did the Federal Circuit affirm the district court’s decision?
The Federal Circuit affirmed the decision because the district court did not clearly err in determining that Mylan had established its burden of showing that the ’514 Patent claims were invalid for lack of written description.
What role did expert testimony play in the case?
Expert testimony from neurologists was crucial, but the district court found Biogen’s expert testimony unpersuasive regarding the therapeutic efficacy of DMF480.
What is the significance of the written-description requirement in this case?
The written-description requirement emphasizes that the patent specification must clearly demonstrate possession of the invention, and selective disclosures are insufficient to support claims.
Cited Sources
- Biogen International GmbH v. Mylan Pharmaceuticals Inc., No. 20-1933, United States Court of Appeals for the Federal Circuit, November 30, 2021.
- APPENDICES - Supreme Court, United States Court of Appeals for the Federal Circuit, No. 2020-1933, March 16, 2022.
- Biogen International GMBH et al v. Mylan Pharmaceuticals Inc., No. 1:2017cv00116, United States District Court for the Northern District of West Virginia, June 18, 2020.
- Biogen Int'l GMBH v. Mylan Pharms. Inc., Robins Kaplan LLP.
- Federal Circuit Denies Rehearing in Biogen v. Mylan, Haug Partners.
