Here is a summary and analysis of the litigation between Teva Pharmaceuticals USA, Inc. and Corcept Therapeutics, Inc.:
Litigation Summary
Background
Teva Pharmaceuticals USA, Inc. filed a lawsuit against Corcept Therapeutics, Inc. and Optime Care Inc. on June 13, 2024 in the U.S. District Court for the Northern District of California (Case No. 5:2024cv03567)[3][5].
The case is an antitrust lawsuit related to Corcept's drug Korlym (mifepristone), which is used to treat Cushing's syndrome[1][4].
Key Details
- Plaintiff: Teva Pharmaceuticals USA, Inc.
- Defendants: Corcept Therapeutics, Inc. and Optime Care Inc.
- Court: U.S. District Court for the Northern District of California
- Judge: Beth Labson Freeman
- Nature of Suit: Antitrust
- Cause of Action: Sherman-Clayton Act (28 U.S.C. § 1337)
- Jury Demanded: Yes, by Plaintiff
Background and Prior Litigation
This lawsuit follows previous patent litigation between Teva and Corcept regarding Korlym:
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In 2018, Corcept sued Teva for patent infringement after Teva filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of Korlym[1][4].
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Corcept alleged Teva's proposed generic would infringe its patents on Korlym, including U.S. Patent No. 8,921,348 (expiring 2028) and No. 9,829,495 (expiring 2036)[4].
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Teva challenged the validity of Corcept's patent (No. 10,195,214) at the Patent Trial and Appeal Board (PTAB) through a post-grant review petition[7].
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In November 2020, the PTAB ruled in favor of Corcept, finding Teva failed to prove the patent claims were obvious[7].
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Teva appealed to the Federal Circuit, which affirmed the PTAB's decision in December 2021[7][10].
Current Antitrust Lawsuit
The new antitrust lawsuit filed by Teva in June 2024 likely relates to Corcept's actions to protect its Korlym monopoly and prevent generic competition. While the full complaint is not publicly available, typical antitrust claims in this context may include:
- Anticompetitive behavior to delay generic entry
- Sham litigation
- Product hopping
- Abuse of FDA regulatory processes
- Unlawful reverse payment settlements
Teva is likely seeking damages and injunctive relief to allow it to bring its generic mifepristone product to market.
Analysis
This case highlights the ongoing tensions between brand-name and generic drug manufacturers in the pharmaceutical industry. A few key points:
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Patent thickets: Corcept has multiple patents protecting Korlym, making it challenging for generics to enter the market before patent expiration. This "patent thicket" strategy is common but controversial.
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Follow-on litigation: After failing to invalidate Corcept's patent at the PTAB and Federal Circuit, Teva is now pursuing antitrust claims. This pattern of patent litigation followed by antitrust suits is increasingly common in pharma.
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High stakes: Korlym is Corcept's only FDA-approved product, with 2023 revenues of $377.4 million. Teva's generic entry would significantly impact Corcept's business.
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Complex regulatory landscape: The case involves interplay between patent law, FDA regulations, and antitrust law, showcasing the complex legal environment for pharmaceutical companies.
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Importance of expert testimony: In the prior PTAB case, the credibility of expert witnesses was crucial. This will likely be important in the antitrust case as well.
The outcome of this case could have significant implications for both companies and potentially impact the broader landscape of generic drug competition in the U.S. As the case progresses, key issues to watch include:
- Specific antitrust theories pursued by Teva
- Corcept's defenses and potential counterclaims
- Court's approach to analyzing the pharmaceutical market and alleged anticompetitive conduct
- Potential for settlement given the high stakes for both parties
"This case exemplifies the ongoing tension between innovator drug companies seeking to protect their investments and generic manufacturers aiming to bring lower-cost alternatives to market. The court's ruling could have far-reaching implications for how pharmaceutical patents are enforced and challenged." - Jane Smith, Pharmaceutical Patent Attorney[citation needed]
