The pharmaceutical industry is heavily reliant on patents to protect intellectual property and maintain market exclusivity. However, with the increasing competition from generic and biosimilar manufacturers, patent invalidity claims have become a significant challenge for pharmaceutical companies. In this article, we will delve into the strategies and considerations for handling drug patent invalidity claims, highlighting key legal and regulatory aspects.
Table of Contents
Patent Invalidation Proceedings: An Overview
Patent invalidation proceedings are complex and often involve parallel litigation, requiring counsel to have a deep understanding of the interplay between proceedings and how to optimize the overall strategy for success across each forum. These proceedings can be initiated through post-grant review before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), opposition before the Patent Division of the German Patent and Trademark Office (DPMA) or the European Patent Office (EPO), or nullity action before the Federal Patent Court in Germany.
Hatch-Waxman Act and Patent Litigation
The Hatch-Waxman Act, also known as the Drug Price Competition and Patent Term Restoration Act, provides a framework for the approval of generic drugs and the resolution of patent disputes. Under this act, generic manufacturers can file Abbreviated New Drug Applications (ANDAs) with the FDA, which triggers a patent litigation process if the branded drug manufacturer asserts that the generic product infringes on their patents. The Hatch-Waxman Act also allows for the listing of patents in the FDA’s Orange Book, which includes patents covering the active pharmaceutical ingredient (API), formulation, and treatment methods.
Strategies for Patent Owners
For patent owners, the central strategic considerations involve minimizing admissions about what is a good lead compound and carefully vetting the prior art to ensure specific disclosures of how to modify the lead compound do not leave the API patent claims vulnerable. Additionally, patent owners should focus on litigating infringement and validity of API, formulation, and treatment patents using court decisions as a guide.
Strategies for Generic Manufacturers
For generic manufacturers, the key strategy involves designing around the patent claims to avoid infringement. This can be achieved by carefully reviewing the prior art for specific teachings on how to modify the lead compound and closely related compounds. Generic manufacturers should also be prepared to assert non-infringement defenses based on designing-around the patent claims and asserting that the patent is invalid and/or unenforceable.
Case Study: Genentech v. Sandoz
In the case of Genentech v. Sandoz, the Federal Circuit affirmed the district court’s obviousness determination, stating that the asserted claims in the LFT patents do not represent the invention of a new drug, nor do they recite a novel application of an existing drug. Instead, these claims recite adjusting doses in the presence of side effects, which clinicians routinely do, and which would have been obvious in view of the prior art. This case highlights the importance of demonstrating the novelty and non-obviousness of the invention in patent claims.
Conclusion
Handling drug patent invalidity claims requires a deep understanding of the legal and regulatory framework governing pharmaceutical patents. Pharmaceutical companies must be prepared to litigate infringement and validity of API, formulation, and treatment patents, while also being mindful of the strategies employed by generic manufacturers to design around patent claims. By carefully reviewing prior art and minimizing admissions about lead compounds, patent owners can strengthen their position in patent litigation. Ultimately, a comprehensive understanding of the Hatch-Waxman Act and patent invalidation proceedings is crucial for pharmaceutical companies to protect their intellectual property and maintain market exclusivity.
References
- Holman, C. (2022). Genentech v. Sandoz: Patents claiming methods of managing side effects. PatentlyO. https://patentlyo.com/patent/2022/12/genentech-claiming-infringed.html
- Finnegan. (n.d.). Patent Invalidation Proceedings. Retrieved from https://www.finnegan.com/en/work/practices/patent-invalidation-proceedings/index.html
- Congressional Research Service. (2019). Drug Pricing and the Law: Pharmaceutical Patent Disputes. Retrieved from https://crsreports.congress.gov/product/pdf/IF/IF11214
- Robins Kaplan. (n.d.). Hatch-Waxman Patent Litigation Strategies. Retrieved from https://www.robinskaplan.com/-/media/pdfs/hatch-waxman-patent-litigation-strategies.pdf?la=en
- Mintz. (2023). Why Pharma Companies Should File IPRs. Retrieved from https://www.mintz.com/insights-center/viewpoints/2231/2023-07-24-why-pharma-companies-should-file-iprs
