Last updated: February 4, 2026
What is the case about?
Perrigo Pharma International D.A.C. filed a patent infringement lawsuit against Actavis Laboratories UT Inc. in the District of Delaware, asserting that Actavis's generic version of Perrigo’s branded pharmaceutical infringed on Perrigo’s patent rights.
Case Timeline and Key Events
- Filing date: February 17, 2015.
- Patent asserted: U.S. Patent No. 8,544,022 (the '022 patent), covering a specific formulation of a drug.
- Initial claims: Perrigo alleges Actavis's generic infringes the '022 patent by marketing a similar drug without licensing rights.
- Patent validity: Perrigo's patent was challenged through an inter partes review (IPR) conducted by the Patent Trial and Appeal Board (PTAB). The PTAB canceled several claims of the patent, significantly narrowing its scope.
Legal Proceedings and Decisions
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District court ruling (2017): The court granted Actavis's motion for summary judgment of non-infringement. The court found that the accused product did not meet the patent’s specific claim limitations.
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Patent validity challenge: The PTAB’s IPR process invalidated key claims of the '022 patent, undermining Perrigo's infringement claims. The cancellation occurred in 2016, prior to the district court decision.
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Remand and additional proceedings: Perrigo appealed, but the case was settled in 2018, with Perrigo agreeing to license the patent to Actavis, ending litigation.
Patent and Litigation Strategy
- Perrigo aimed to enforce a patent covering a unique formulation, protecting market exclusivity.
- Actavis’s defense focused on non-infringement and patent invalidity, challenging the patent’s claims through IPR.
- The invalidation of patent claims through IPR was instrumental in diminishing Perrigo’s infringement position.
Implications for Patent Litigation in Pharma
- The case underscores the importance of patent validity if enforcement is sought.
- PTAB’s effectiveness in invalidating patent claims influences district court proceedings, often leading to settlement.
- Settlement is common following IPR invalidations, impacting market competition.
Legal and Business Impact
- Market Access: Actavis gained market entry following patent invalidation, reducing Perrigo’s market share.
- Patent Strategy: Companies increasingly rely on IPRs to defend or challenge patents, affecting enforcement strategies.
- Settlement Trends: The case reflects a pattern where patent disputes in pharma often culminate in licensing agreements or settlements post-IPR.
Key Takeaways
- Patent validity challenges through IPR significantly weaken infringement claims.
- Courts often favor non-infringement arguments once patent claims are invalidated.
- Strategic use of settlement and licensing can mitigate lengthy litigation.
- Patent protection in the pharmaceutical industry remains highly complex, with invalidation avenues available at PTAB influencing district court outcomes.
- The case exemplifies how patent litigation interacts with regulatory and market strategies.
FAQs
1. How does PTAB’s invalidation affect district court cases?
It weakens patent enforcement claims, often leading to settlements or licensing agreements.
2. Why did Perrigo settle the case?
The invalidation of key patent claims through IPR diminished their infringement claims, making continued litigation less favorable.
3. Can a patent survive IPR challenges?
Yes, some patents withstand IPR challenges, but many are partially or wholly invalidated, as in this case.
4. How common is settlement after patent invalidation?
It is common because invalidation reduces the value of the asserted patent, encouraging licensing or settlement.
5. What does this case imply for future pharma patent litigations?
It highlights the importance of patent robustness and the strategic use of IPR proceedings in litigation planning.
Citations
[1] Case docket for Perrigo Pharma International D.A.C. v. Actavis Laboratories UT Inc., No. 1:15-cv-00291 (D. Del.)
