Introduction
The lawsuit between Tris Pharma, Inc. and Teva Pharmaceuticals USA, Inc. (Case No. 2:20-cv-05212) is a significant patent infringement case that has garnered attention in the pharmaceutical industry. This article provides a detailed summary and analysis of the key points, legal arguments, and the court's decisions in this case.
Background of the Case
Tris Pharma, Inc. developed and markets QuilliChew ER®, a chewable extended-release medication for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD). This product is the first of its kind, combining the benefits of a chewable tablet with extended-release formulation[3].
In 2020, Teva Pharmaceuticals USA, Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA to produce and market a generic version of QuilliChew ER®. Tris Pharma, Inc. responded by filing a lawsuit against Teva, alleging infringement of several patents related to QuilliChew ER®[5].
Patents-in-Suit
The patents at the center of this litigation include:
- U.S. Patent Nos. 9,545,399 (the ’399 patent)
- U.S. Patent Nos. 9,844,544 (the ’544 patent)
- U.S. Patent Nos. 9,844,545 (the ’545 patent)
- U.S. Patent Nos. 11,103,494 (the ’494 patent)
- U.S. Patent Nos. 11,103,495 (the ’495 patent)[1].
Nature of the Case and Issues Presented
The case revolves around Teva's alleged infringement of Tris Pharma's patents through its ANDA product. Teva raised defenses of obviousness and indefiniteness against the asserted claims.
Obviousness Defense
Teva argued that the claims were obvious because multiple prior art references collectively disclosed chewable extended-release products. However, the court found that prior art taught that extended-release formulations could not be chewed or crushed while maintaining their effectiveness. The court also considered the long felt need for such a product and industry praise, which supported a finding of non-obviousness[1].
Indefiniteness Defense
Teva claimed that the term "essentially the same" in the patent claims was indefinite because it lacked objective boundaries. The court disagreed, stating that a person of ordinary skill in the art (POSA) would understand how to conduct a visual comparison of the drug's pharmacokinetic (PK) profile[1].
Infringement Analysis
The court conducted a thorough analysis of whether Teva's ANDA product infringed the asserted claims.
Therapeutic Effect Duration
Teva argued that its product did not infringe the claim requiring a therapeutic effect lasting longer than 10.8 hours. However, the court found that the label indicated a significant therapeutic effect, satisfying the infringement requirement[1].
Barrier Coating
Teva's product had a barrier coating of 17% w/w, which was just below the claimed range of 18% to 55% w/w. The court rejected Teva's argument based on the disclosure-dedication rule, finding that the broader range in the specification did not preclude the claimed range[1].
Single Mean Plasma Concentration Peak
Teva argued that its product did not infringe the claims related to the timing of the plasma concentration peak. The court found that the relevant inquiry was not the exact timing but rather where the peak was located, and since 51% of the length of Teva's product's range occurred within the claimed range, it was found to infringe[1].
Figure 1 Claims
The court also found that Teva's ANDA product infringed the claims related to Figure 1, as the proposed label included a graph similar to Figure 1, despite minor differences in labeling[1].
Trial and Court Decision
The case went to a bench trial from May 23 to May 26, 2022. The court, presided over by Judge Kevin McNulty, issued its opinion on August 16, 2022.
- Validity of Patents: The court found that most of the asserted claims were valid and not obvious. It rejected Teva's indefiniteness arguments, concluding that a POSA would understand the terms used in the patents[5].
- Infringement: The court determined that Teva's ANDA product directly infringed all of the asserted claims[5].
Impact of the Decision
The court's ruling delays Teva from commercializing its generic version of QuilliChew ER® until at least 2033, when the infringed patents expire. This decision is a significant victory for Tris Pharma, Inc., protecting its innovative product from generic competition for an extended period[3].
Key Takeaways
- Innovation Protection: The case highlights the importance of patent protection for innovative pharmaceutical products.
- Legal Defenses: The court's rejection of obviousness and indefiniteness defenses underscores the need for robust and clear patent claims.
- Infringement Analysis: The detailed analysis of infringement shows the court's meticulous approach to determining whether a generic product infringes patented claims.
- Market Impact: The decision has significant implications for the market, delaying generic competition and maintaining Tris Pharma's market exclusivity.
FAQs
Q: What is the main product at the center of the litigation between Tris Pharma and Teva Pharmaceuticals?
A: The main product is QuilliChew ER®, a chewable extended-release medication for the treatment of ADHD.
Q: What were the key defenses raised by Teva Pharmaceuticals in the litigation?
A: Teva raised defenses of obviousness and indefiniteness against the asserted patent claims.
Q: How did the court rule on the obviousness defense?
A: The court found that the prior art did not collectively disclose a chewable extended-release product, and industry need and praise supported non-obviousness.
Q: What was the outcome of the infringement analysis?
A: The court found that Teva's ANDA product directly infringed all of the asserted claims.
Q: What is the impact of the court's decision on Teva's ability to market a generic version of QuilliChew ER®?
A: The decision delays Teva from commercializing its generic version until at least 2033, when the infringed patents expire.
Cited Sources
- Tris Pharma, Inc. v. Teva Pharms. USA, Inc. - Robins Kaplan LLP
- Life Sciences Court Report & COVID-19 Impact on District Court - JD Supra
- Milbank Wins Patent Validity and Infringement Trial Victory for Tris Pharma - Milbank LLP
- TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. - Justia
- Tris Pharma, Inc. v. Teva Pharm. U.S. - VLEX
