Introduction
The litigation between Pfizer Inc. and Breckenridge Pharmaceutical Inc., filed as Case 1:17-cv-01532 in the United States District Court for the District of Delaware, revolves around patent infringement claims related to Pfizer's drug Xeljanz®. Here is a detailed summary and analysis of the case.
Background of the Case
Pfizer Inc., along with its affiliates PF Prism C.V., C.P. Pharmaceuticals International C.V., Pfizer Pharmaceuticals LLC, and Pfizer PFE Ireland, initiated this lawsuit against Breckenridge Pharmaceutical Inc., Pensa Pharma S.A., and Laboratorios del Dr. Esteve, S.A. (collectively referred to as "Breckenridge")[3].
Nature of the Action
The lawsuit alleges that Breckenridge infringed on several of Pfizer's patents related to Xeljanz®, a drug used for the treatment of moderately to severely active rheumatoid arthritis. The patents in question include United States Patent Nos. 6,956,041, 7,091,208, 7,265,221, and RE41,783[2].
Patent Infringement Claims
Pfizer claims that Breckenridge's filing of an Abbreviated New Drug Application (ANDA) No. 209633 with the U.S. Food and Drug Administration (FDA) constitutes an act of infringement. Specifically, Pfizer alleges that Breckenridge's generic version of Xeljanz® would infringe on at least one claim of each of the mentioned patents[2].
Specific Patent Claims
- Patent No. 6,956,041: Pfizer alleges that Breckenridge's actions would constitute infringement of at least claim 1 and active inducement of infringement of at least claim 4 of this patent.
- Patent No. 7,091,208: Similar allegations are made regarding the infringement of at least claim 1 of this patent.
- Patent No. 7,265,221 and RE41,783: Pfizer claims that Breckenridge's actions would also infringe on these patents[2].
Breckenridge's Knowledge and Intent
Pfizer argues that Breckenridge had knowledge of the patents when it submitted the ANDA to the FDA. It is alleged that upon FDA approval, Breckenridge intended to engage in the manufacture, use, offer for sale, sale, and/or importation of the generic tablets, which would further infringe on Pfizer's patents[2].
Relief Sought
Pfizer seeks an order from the court to prevent Breckenridge from infringing the patents. Specifically, Pfizer requests that the effective date of approval for Breckenridge's ANDA be no earlier than the expiration date of the respective patents[2].
Legal Framework and Precedents
The case involves complex patent law issues, including the application of different patent term statutory regimes. The Uruguay Round Agreements Act (URAA) of 1994, which changed the patent term from 17 years from the issue date to 20 years from the earliest effective filing date, is relevant. However, this case does not directly involve the URAA's impact on patent terms but rather focuses on the infringement claims[4].
Court Proceedings and Outcomes
The case was filed on October 30, 2017. The court documents and docket indicate that Pfizer sought injunctive relief to prevent Breckenridge from marketing its generic version of Xeljanz® until the expiration of Pfizer's patents. The outcome of the case would determine whether Breckenridge could proceed with its generic drug application and whether Pfizer's patents would be upheld[3][5].
Analysis and Implications
This litigation highlights the critical importance of patent protection in the pharmaceutical industry. Pfizer's aggressive defense of its patents underscores the company's commitment to safeguarding its intellectual property and maintaining market exclusivity for its products.
Impact on Generic Drug Market
The outcome of this case could have significant implications for the generic drug market. If Pfizer succeeds in its claims, it would delay the entry of Breckenridge's generic version of Xeljanz®, potentially affecting the availability and cost of the drug for patients.
Legal Precedents
The case contributes to the evolving body of law regarding patent infringement and the complexities of patent term calculations. It emphasizes the need for careful consideration of patent laws and regulations when developing and marketing pharmaceutical products.
Key Takeaways
- Patent Protection: The case underscores the importance of patent protection in the pharmaceutical industry.
- Generic Drug Market: The outcome affects the timing and availability of generic versions of patented drugs.
- Legal Complexities: The case highlights the complexities of patent law, particularly regarding patent terms and infringement claims.
- Market Exclusivity: Pfizer's actions aim to maintain market exclusivity for Xeljanz®.
FAQs
What is the main issue in the Pfizer Inc. v. Breckenridge Pharmaceutical Inc. lawsuit?
The main issue is Pfizer's claim that Breckenridge's filing of an ANDA for a generic version of Xeljanz® infringes on several of Pfizer's patents.
Which patents are involved in the lawsuit?
The patents involved include United States Patent Nos. 6,956,041, 7,091,208, 7,265,221, and RE41,783.
What relief is Pfizer seeking from the court?
Pfizer is seeking an order to prevent Breckenridge from infringing the patents and to delay the approval of Breckenridge's ANDA until the expiration of Pfizer's patents.
How does this case impact the generic drug market?
The outcome could delay the entry of Breckenridge's generic version of Xeljanz®, affecting the availability and cost of the drug for patients.
What are the broader implications of this case for patent law?
The case contributes to the evolving body of law regarding patent infringement and highlights the complexities of patent term calculations and infringement claims.
Sources
- Pfizer Inc. et al v. Breckenridge Pharmaceutical Inc. et al, Justia Dockets, https://dockets.justia.com/docket/delaware/dedce/1:2017cv01532/63557
- IN THE UNITED STATES DISTRICT COURT FOR THE ... - RPX Insight, Insight.rpxcorp.com, https://insight.rpxcorp.com/litigation_documents/12757461
- Pfizer Pfe Ireland Pharmaceuticals Holding 1 ..., Unified Patents, https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1:17-cv-01532
- Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical, Inc, Justia Law, https://law.justia.com/cases/federal/appellate-courts/cafc/17-2173/17-2173-2018-12-07.html
