Litigation Details for TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2020)

TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2020)

Docket		Date Filed	2020-04-28
Court	District Court, D. New Jersey	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Kevin McNulty
Jury Demand		Referred To	Edward S. Kiel
Patents	6,419,960; 9,545,399; 9,844,544
Link to Docket	External link to docket

Details for TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-04-28	206	Opinion	of five patents: United States Patent No. 9,545,399 (“the ’399 patent”), United States Patent No. 9,844,544…the ’544 patent”), United States Patent No. 9,844,545 (“the ’545 patent”), United States Patent No. 11,103,494…,494 (“the ’494 patent”), and United States Patent No. 11,103,495 (“the ’495 patent”) (collectively,…the ’399 patent; claim 37 of the ’544 patent; claims 17, 23, 24, and 28 of the ’545 patent; claim 28…the ’399 patent, claim 37 of the ’544 patent, claims 17, 23, 24, and 28 of the ’545 patent, and claim	External link to document
2020-04-28	223	Opinion	• U.S. Patent No. 4,996,047 (“Kelleher”) (JTX-059) • U.S. Patent No. 6,419,960 (“Krishnamurthy…of five patents: United States Patent No. 9,545,399 (“the ’399 patent”), United States Patent No. 9,844,544…the ’544 patent”), United States Patent No. 9,844,545 (“the ’545 patent”), United States Patent No. 11,103,494…,494 (“the ’494 patent”), and United States Patent No. 11,103,495 (“the ’495 patent”) (collectively,…the ’399 patent; claim 37 of the ’544 patent; claims 17, 23, 24, and 28 of the ’545 patent; claim 28	External link to document

TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC.: A Landmark Patent Infringement Case

In the world of pharmaceutical patents, few cases have been as closely watched as TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. This legal battle, centered around the groundbreaking ADHD medication QuilliChew ER®, has set a precedent in the realm of chewable extended-release formulations. Let's dive into the intricacies of this case and explore its far-reaching implications for the pharmaceutical industry.

The Genesis of the Dispute

The story begins with Tris Pharma, Inc., a New Jersey-based pharmaceutical company that developed QuilliChew ER®, the first long-acting chewable tablet for treating Attention Deficit Hyperactivity Disorder (ADHD)[1]. This innovative product represented a significant leap forward in ADHD treatment, offering patients a more convenient and palatable option for extended-release medication.

Enter Teva Pharmaceuticals

In 2020, Teva Pharmaceuticals USA, Inc., a giant in the generic drug market, set its sights on producing a generic version of QuilliChew ER®[7]. Teva filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to market their generic alternative. This move prompted Tris to file a patent infringement lawsuit, setting the stage for a legal showdown.

The Heart of the Matter: Patent Infringement Claims

Tris alleged that Teva's proposed generic product would infringe on several of its patents:

• U.S. Patent No. 9,545,399 ('399 patent)
• U.S. Patent No. 9,844,544 ('544 patent)
• U.S. Patent No. 9,844,545 ('545 patent)
• U.S. Patent No. 11,103,494 ('494 patent)
• U.S. Patent No. 11,103,495 ('495 patent)[3]

These patents collectively protected the unique formulation and delivery mechanism of QuilliChew ER®, which allowed for extended-release properties even when the tablet was chewed or divided.

Teva's Defense Strategy

Teva's defense rested on two main pillars:

1. Obviousness: They argued that the patents were invalid due to obviousness, claiming that multiple prior art references disclosed chewable extended-release products[1].

2. Indefiniteness: Teva contended that certain claim language, such as "essentially the same," was too vague and lacked objective boundaries[1].

The Trial: A Battle of Experts and Evidence

The case went to trial in the District of New Jersey, with Judge Kevin McNulty presiding. Over four days, both sides presented their arguments, bringing in expert witnesses and dissecting the intricacies of pharmaceutical formulations and patent law[1].

Key Arguments and Evidence

1. Prior Art: Tris argued that while individual elements of their patents might have existed in prior art, the specific combination that allowed for a chewable extended-release formulation was novel and non-obvious[3].

2. Long-felt Need: Tris presented evidence of industry praise and the long-standing need for such a formulation in the ADHD treatment landscape[3].

3. Pharmacokinetic (PK) Profiles: The court delved into complex discussions about PK profiles and how a person of ordinary skill in the art (POSA) would interpret them[1].

The Verdict: A Victory for Innovation

On August 16, 2022, Judge McNulty ruled in favor of Tris Pharma[7]. The court found that:

1. The asserted claims were not invalid for obviousness or indefiniteness.
2. Teva's proposed generic product would directly infringe on Tris's patents.

"The court concluded that collectively the art taught that extended-release formulations could not be chewed or crushed while maintaining their effectiveness, and in many cases taught that they should not be chewed."[3]

This ruling effectively prevents Teva from commercializing its generic version of QuilliChew ER® until at least 2033, when the infringed patents expire[7].

Implications for the Pharmaceutical Industry

The Tris v. Teva case has significant implications for the pharmaceutical industry, particularly in the realm of extended-release formulations and generic drug development.

1. Protection of Innovation

This verdict reinforces the importance of patent protection for novel drug formulations. It sends a clear message that innovative combinations of known elements can still be patentable, encouraging continued research and development in the pharmaceutical sector.

2. Challenges for Generic Manufacturers

The case highlights the hurdles generic drug manufacturers face when attempting to enter markets with patented extended-release formulations. It may prompt generic companies to be more cautious in their approach to challenging such patents.

3. Impact on ADHD Treatment

By upholding the patents on QuilliChew ER®, the court has ensured that this unique formulation will remain exclusively available from Tris for several more years. This could impact treatment options and costs for ADHD patients in the near term.

The Appeal Process and Future Developments

Following the district court's decision, Teva initially filed an appeal with the United States Court of Appeals for the Federal Circuit. However, on December 14, 2022, Teva moved to voluntarily dismiss this appeal[9]. This move suggests that Teva may have decided to accept the lower court's ruling or pursue alternative strategies.

Potential Future Challenges

While this case has concluded, it's possible that other generic manufacturers may attempt to challenge Tris's patents in the future. The pharmaceutical industry will be watching closely to see how this precedent influences future patent disputes in the extended-release formulation space.

Lessons for Pharmaceutical Companies

The Tris v. Teva case offers several valuable lessons for pharmaceutical companies:

1. Robust Patent Strategies: Companies should focus on developing comprehensive patent portfolios that protect not just individual components but also unique combinations and formulations.

2. Importance of Clinical Data: Tris's success was partly due to its ability to demonstrate the unique benefits of its formulation through clinical data.

3. Preparation for Litigation: Companies should be prepared to defend their patents vigorously, with strong scientific and legal arguments.

4. Innovation in Formulation: The case underscores the value of innovation in drug delivery and formulation, not just in discovering new active ingredients.

Key Takeaways

• Tris Pharma successfully defended its patents on QuilliChew ER®, a chewable extended-release ADHD medication.
• The court rejected Teva's arguments of obviousness and indefiniteness, upholding the validity of Tris's patents.
• This case sets a precedent for protecting innovative drug formulations, even when individual components may be known in the prior art.
• The ruling delays generic competition for QuilliChew ER® until at least 2033.
• The pharmaceutical industry may see increased caution from generic manufacturers when challenging patents on extended-release formulations.

FAQs

1. Q: What was the main issue in the Tris Pharma v. Teva Pharmaceuticals case? A: The main issue was whether Teva's proposed generic version of QuilliChew ER® would infringe on Tris Pharma's patents for their chewable extended-release ADHD medication.

2. Q: How did the court rule on Teva's obviousness argument? A: The court rejected Teva's obviousness argument, finding that while individual elements might have been known, the specific combination that allowed for a chewable extended-release formulation was not obvious.

3. Q: What impact does this ruling have on ADHD treatment options? A: The ruling ensures that QuilliChew ER® will remain exclusively available from Tris Pharma until at least 2033, potentially affecting treatment options and costs for ADHD patients.

4. Q: How might this case affect future patent disputes in the pharmaceutical industry? A: This case may encourage pharmaceutical companies to invest more in innovative drug formulations and delivery methods, knowing that such innovations can be protected even if individual components are known.

5. Q: What happened to Teva's appeal of the district court's decision? A: Teva initially filed an appeal but later moved to voluntarily dismiss it on December 14, 2022, suggesting they may have decided to accept the lower court's ruling or pursue alternative strategies.

Sources cited: [1] https://www.robinskaplan.com/newsroom/insights/tris-pharma-v-teva-pharms-usa [3] https://www.jdsupra.com/legalnews/tris-pharma-inc-v-teva-pharms-usa-inc-8931776/ [7] https://www.milbank.com/en/news/milbank-wins-patent-validity-and-infringement-trial-victory-for-tris-pharma.html [9] https://cafc.uscourts.gov/opinions-orders/23-1158.ORDER.12-14-2022_2048025.pdf