Last updated: February 4, 2026
- Plaintiff: Allergan, Inc.
- Defendant: TWi Pharmaceuticals, Inc.
What is the core dispute?
Allergan alleges patent infringement related to a generic version of a branded pharmaceutical product. The case focuses on Allergan's patents covering the formulation and manufacturing processes of its drug, which TWi sought to produce a generic version of.
Which patents are in dispute?
The patents involve:
- U.S. Patent No. 8,603,483
- U.S. Patent No. 8,713,388
Both patents cover specific formulations and methods of making the drug.
What claims are made?
Allergan asserts that TWi’s generic products infringe claims covering:
- The composition of the drug (including specific excipients)
- The manufacturing process
Allergan seeks declaratory judgment of infringement and injunctive relief to prevent TWi’s market entry.
What defenses has TWi raised?
TWi claims:
- The patents are invalid due to obviousness under 35 U.S.C. § 103
- The patents are unenforceable based on alleged inequitable conduct during prosecution
- The products do not infringe the patents as claimed
Litigation process and key rulings
- Initial Filing (2016): Complaint filed alleging patent infringement.
- Summary Judgment (2018): TWi moved to dismiss or for summary judgment on patent validity and non-infringement.
- Court Decisions: The court denied TWi’s motion to dismiss, allowing the case to proceed to trial on issues of infringement and validity.
- Trial (dates unspecified): The trial focused on whether TWi’s formulation infringed the patents and whether the patents were valid.
Implications and outcomes
As of the latest available information, the case remains unresolved with ongoing proceedings. The outcome will impact TWi’s ability to market generic versions of the drug and influence patent enforcement strategies in pharmaceutical patent litigation.
Legal and Market Context
- Patent Litigation in Pharma: Patent disputes are common when generics threaten branded drug markets.
- Stakeholders: Allergan, now part of AbbVie, holds significant patent portfolios for blockbuster drugs.
- Market Impact: Successful infringement suits can delay generic entry, affecting drug pricing and market share.
Key Takeaways
- The dispute centers on formulations and manufacturing patents related to Allergan’s drug.
- TWi contest both patent validity and infringement claims.
- The case emphasizes the importance of robust patent prosecution and clear claims to defend against validity challenges.
- Litigation outcomes influence market competition and drug prices.
- This case illustrates the strategic use of patent litigation to delay generic entry.
FAQs
Q1: When was the case filed and what is its current status?
The case was filed in March 2016. As of the latest update, proceedings are ongoing with no final judgment announced.
Q2: What patents are at the center of the dispute?
U.S. Patent Nos. 8,603,483 and 8,713,388, covering formulations and manufacturing methods.
Q3: What defenses has TWi presented?
TWi claims patent invalidity on grounds of obviousness and unenforceability, alongside non-infringement assertions.
Q4: How does this case influence the pharmaceutical litigation landscape?
It exemplifies patent litigation strategies used to extend market exclusivity and delay generics.
Q5: What is the potential market impact?
A favorable ruling for Allergan could prevent TWi from launching a generic, maintaining higher drug prices for longer.
Citations:
[1] Case docket for Allergan, Inc. v. TWi Pharmaceuticals, Inc., 1:16-cv-00620, U.S. District Court for the District of Delaware.
