Case Overview
The case of Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc., filed as Civil No. 14-7992 (NLH/AMD) in the U.S. District Court for the District of New Jersey, involves a patent infringement dispute related to Horizon Pharma's PENNSAID® 2%, a topical diclofenac sodium formulation for treating osteoarthritis pain in the knees[1][4][5].
Patents-in-Suit
The litigation centered around several U.S. patents, including U.S. Patents Nos. 8,252,838, 8,563,613, 8,871,809, 9,066,913, 9,101,591, 8,546,450, 8,217,078, 8,618,164, and 9,132,110. These patents are associated with the formulation and properties of PENNSAID® 2%[1].
Claim Construction Disputes
A significant aspect of the case was the dispute over the construction of several key terms in the patents.
"Impurity A"
Horizon proposed that "impurity A" should be construed as USP Diclofenac Related Compound A RS (USP Compound A), arguing that a person of ordinary skill in the art (POSA) would understand this reference. However, Actavis countered that the specification lacked sufficient information to identify "impurity A" with certainty. The court ultimately found the term indefinite because the specification did not provide clear identity information for "impurity A"[1].
"Formulation Degradation"
The second term in dispute was "the formulation degrades by less than 1% over 6 months." Horizon's proposed construction relied on specific examples from the specification, but Actavis argued that this approach improperly imported limitations from the specification into the claims. The court agreed with Actavis, finding the term indefinite due to the lack of clear storage conditions and degradation criteria in the specification[1].
"Consisting Essentially Of"
The term "consisting essentially of" was also contentious. Horizon argued that the Nautilus standard, which pertains to the definiteness of claim boundaries, should not apply to the basic and novel properties of the invention. Actavis, however, argued that these properties were part of defining the claim scope and thus should be subject to the Nautilus standard. The court sided with Actavis, finding the terms related to basic and novel properties, such as "better drying time," to be too imprecise and indefinite[1].
Obviousness Challenge
Actavis challenged the validity of the patents by arguing that the changes made to create PENNSAID® 2% from the earlier PENNSAID® 1.5% formulation would have been obvious to a POSA. Actavis contended that prior art and general experience in formulating drugs would have guided a POSA to make the necessary changes, such as increasing the concentration of diclofenac sodium, using ethanol as a penetration enhancer, and selecting appropriate thickening agents[4].
Trial and Expert Testimony
The case involved a seven-day bench trial with testimony from several experts. Actavis's expert, Dr. Bozena Michniak-Kohn, and Horizon's experts, Dr. Annette Bunge and Dr. Norman Weiner, among others, provided insights into the formulation and its properties. The court considered extensive evidence and post-trial submissions before making its decision[4].
Court Decision
The court accepted Actavis's position that the changes to the formulation were obvious based on prior art and the expertise of a POSA. The court found that the prior art would have informed a POSA about the necessary components and methods to improve the earlier formulation, making the claimed invention not patentable due to obviousness[4].
Key Takeaways
- Claim Construction: The case highlights the importance of clear and definite language in patent claims. Terms that are ambiguous or lack sufficient support in the specification can be found indefinite.
- Obviousness: The decision underscores that obviousness is a question of law based on underlying factual findings. Prior art and the expertise of a POSA play crucial roles in determining whether an invention is obvious.
- Expert Testimony: Expert testimony is vital in patent litigation, especially in cases involving complex technical issues.
- Patent Validity: The validity of patents can be challenged on multiple grounds, including indefiniteness and obviousness.
Frequently Asked Questions (FAQs)
Q: What was the main issue in the Horizon Pharma v. Actavis case?
A: The main issue was the dispute over the construction of key terms in the patents related to PENNSAID® 2% and whether the changes to the formulation were obvious.
Q: Why did the court find the term "impurity A" indefinite?
A: The court found "impurity A" indefinite because the specification did not provide sufficient information to identify it with certainty.
Q: What was Actavis's argument regarding the obviousness of the PENNSAID® 2% formulation?
A: Actavis argued that the changes to create PENNSAID® 2% from PENNSAID® 1.5% would have been obvious to a POSA based on prior art and general experience in formulating drugs.
Q: Who were the key experts involved in the trial?
A: Key experts included Dr. Bozena Michniak-Kohn for Actavis, and Dr. Annette Bunge and Dr. Norman Weiner for Horizon.
Q: What was the outcome of the case?
A: The court ruled in favor of Actavis, finding that the claimed invention was not patentable due to obviousness.
Sources:
- Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc., Civ. No. 14-7992 (NLH/AMD), 2016 U.S. Dist. LEXIS 109068 (D.N.J. Aug. 17, 2016).
- HZNP Medicines LLC v. Actavis Laboratories UT, Inc., Finnegan.
- Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc., Case 1:15-cv-06131-NLH-AMD Document 1 Filed 08/11/15.
- Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc., UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY, Civil No. 14-7992 (NLH/AMD) (D.N.J. May. 12, 2017).
- HORIZON PHARMA IRELAND LIMITED et al v. ACTAVIS LABORATORIES UT, INC. et al, Patexia.
