Background
The litigation between Biogen International GmbH and Banner Life Sciences LLC revolves around the infringement of Biogen's U.S. Patent No. 7,619,001 (the '001 Patent), which pertains to methods of treating multiple sclerosis using dimethyl fumarate (DMF) or monomethyl fumarate (MMF)[1][2][5].
The '001 Patent and Its Extension
Biogen's '001 Patent was extended under the patent term restoration provisions of 35 U.S.C. § 156 due to the regulatory review period for its FDA-approved product, Tecfidera, which contains DMF. This extension added 811 days to the patent term, making it valid until June 20, 2020[2][4][5].
Banner's Generic Application
After the five-year data exclusivity period for Tecfidera expired, Banner Life Sciences LLC submitted an application to market a generic version of MMF, relying on the clinical data submitted by Biogen for Tecfidera. This prompted Biogen to sue Banner for patent infringement in December 2018[1][3][5].
District Court Proceedings
Biogen filed the lawsuit in the District of Delaware, which automatically triggered a 30-month stay of FDA approval for Banner's generic MMF product under 35 U.S.C. § 355(j)(5)(B)(iii). Banner responded by moving for a judgment on the pleadings, arguing that the patent term extension only applied to methods of treatment using DMF, not MMF, and thus their product did not infringe the extended portion of the '001 Patent[1][2][5].
Key Arguments and Court Rulings
Scope of Patent Term Extension
The central issue was whether the patent term extension (PTE) under § 156(b) limited the benefit to only those claims covering the FDA-approved product, Tecfidera (DMF), or if it extended to other method claims, including those using MMF. Banner argued that the PTE was restricted to DMF and its salts or esters, excluding MMF. Biogen countered that the extension should cover any product within the original scope of the claims, including MMF, since DMF and MMF share an active moiety[2][3][5].
Active Ingredient vs. Active Moiety
The court delved into the definitions under § 156(f), which specifies that the "active ingredient" includes the active moiety but must be considered in the form administered to the patient. The court cited Federal Circuit cases, particularly Glaxo Operations UK Ltd. v. Quigg and PhotoCure ASA v. Kappos, to support the narrow interpretation that the active ingredient is the material administered, not its metabolite. Thus, DMF was considered the active ingredient, and MMF, being its metabolite, did not qualify for the PTE[2][3][5].
Doctrine of Equivalents
Biogen also argued that the doctrine of equivalents could extend the PTE to MMF-based therapies. However, the court rejected this argument, stating that the doctrine of equivalents cannot recapture subject matter that § 156 expressly excludes through its limitations[2].
District Court Decision
The District Court of Delaware granted Banner's motion for judgment on the pleadings, ruling that Biogen could not extend the benefit of its patent term extension to MMF-based therapies. The court concluded that the PTE only applied to methods of treatment using DMF, its salts, or its esters, and not to MMF[1][2][5].
Federal Circuit Appeal
Biogen appealed the decision to the Federal Circuit, which affirmed the district court's ruling. The Federal Circuit upheld that the scope of the patent term extension under § 156 only includes the active ingredient of the approved product (DMF) or its salts or esters, and does not extend to MMF[3][4][5].
Implications and Practice Tips
This case highlights the importance of understanding the limitations of patent term extensions under § 156. It emphasizes that the extension benefits are strictly tied to the FDA-approved product and its direct derivatives (salts or esters), and do not automatically extend to related compounds or metabolites. This ruling is crucial for companies involved in pharmaceutical litigation and those seeking to market generic drugs, as it clarifies the scope of protection afforded by patent term extensions[2][3].
Key Takeaways
- Patent Term Extension Scope: The PTE under § 156 is limited to the FDA-approved product and its direct derivatives (salts or esters).
- Active Ingredient Definition: The active ingredient is defined as the material administered to the patient, not its metabolite.
- Doctrine of Equivalents: This doctrine cannot be used to extend PTE benefits to excluded subject matter.
- Implications for Generic Drugs: Companies must carefully consider the scope of PTE when developing generic versions of FDA-approved drugs.
FAQs
Q: What was the main issue in the Biogen v. Banner litigation?
A: The main issue was whether the patent term extension (PTE) for Biogen's '001 Patent applied to Banner's generic MMF product.
Q: What is the significance of the active ingredient in patent term extensions?
A: The active ingredient must be the material administered to the patient, not its metabolite, to qualify for PTE benefits.
Q: Can the doctrine of equivalents extend PTE benefits to related compounds?
A: No, the doctrine of equivalents cannot be used to recapture subject matter that § 156 expressly excludes.
Q: What is the impact of this ruling on pharmaceutical companies?
A: The ruling clarifies that PTE benefits are strictly tied to the FDA-approved product and its direct derivatives, which is crucial for companies involved in pharmaceutical litigation.
Q: How does this case affect the development of generic drugs?
A: Companies developing generic drugs must carefully consider the scope of PTE and ensure their products do not infringe the extended portion of the original patent.
Cited Sources
- Biogen Int'l GmbH v. Banner Life Scis. LLC - Casetext
- Bases, and Esters, and Salts, Oh My Limits on PTE Benefits Provide ... - Akin Gump
- Biogen v. Banner: Patent Term Extension Inquiry Centers on 'Active ... - IP Watchdog
- Biogen International GmbH v. Banner Life Sciences, LLC, No. 20-1373 (Fed. Cir. 2020) - Justia
- Biogen Int'l GMBH v. Banner Life Scis. LLC - vLex
