Background of the Case
Onyx Therapeutics, Inc. (now part of Amgen) engaged in a significant patent infringement lawsuit against Cipla Limited, an Indian pharmaceutical company. The dispute centered around Cipla's attempt to market a generic version of Onyx's drug Kyprolis (carfilzomib), which is a proteasome inhibitor used to treat multiple myeloma[1][4].
Nature of the Case and Issues Presented
Onyx Therapeutics sued Cipla Limited in response to Cipla's filing of an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of Kyprolis. Cipla's ANDA included a Paragraph IV certification, asserting that the claims of Onyx's patents (the '042, '125, and '112 Patents) were invalid, unenforceable, or would not be infringed by the manufacture, use, importation, sale, or offer for sale of Cipla's generic product[4].
Patents in Dispute
The litigation involved three key patents held by Onyx Therapeutics:
- U.S. Patent No. 7,417,042 ('042 Patent): One of the Compound Patents.
- U.S. Patent No. 8,207,125 ('125 Patent): Another Compound Patent.
- U.S. Patent No. 7,737,112 ('112 Patent): Known as the Formulation Patent[4].
Infringement Claims
Onyx alleged that Cipla's proposed generic product would infringe claims 23 and 24 of the '042 Patent, claim 1 of the '125 Patent, and claims 31 and 32 of the '112 Patent. Cipla stipulated to the infringement of these claims for both the 30 mg and 60 mg dosages of their ANDA product[3][4].
Cipla's Defense: Invalidity and Obviousness
Cipla argued that the asserted claims of the patents were invalid due to obviousness. They claimed that the modifications made to create carfilzomib (the active ingredient in Kyprolis) were obvious to a person of ordinary skill in the art (POSA). However, the court found that Cipla failed to prove obviousness by clear and convincing evidence.
Obviousness to Try and Reasonable Expectation of Success
The court held that even if Cipla had proven that the modification was obvious to try, they failed to demonstrate a reasonable expectation of success. Onyx presented unrebutted evidence that a POSA would have had numerous options for increasing solubility, and there was substantial uncertainty surrounding modifications to the compound YU-101[1].
Objective Indicia and Industry Skepticism
The court also considered objective indicia of non-obviousness, including long-felt unmet need and industry skepticism. Onyx demonstrated that Kyprolis met a significant need for improved treatment of multiple myeloma, which was supported by the FDA's fast-track designation. Additionally, the inventors faced skepticism in developing an irreversible proteasome inhibitor[1].
Prior Art and Double Patenting
Cipla argued that a 2003 research memorandum constituted prior art that rendered carfilzomib obvious. However, the court found that the individuals associated with the memorandum had signed consulting agreements with Proteolix (the company involved in the development of carfilzomib), requiring them to assign any inventions to Proteolix. This precluded the use of the memorandum as invalidating prior art under § 103(c)(1)[1].
Cipla also argued for obviousness-type double patenting (OTDP) over claim 15 of the '099 patent, which claims YU-101. The court rejected this argument, finding that Cipla failed to demonstrate that a POSA would have been motivated to modify YU-101 to arrive at carfilzomib. Additionally, the '099 patent and the Compound Patents did not share an inventive entity or common inventors, a requirement for OTDP[1].
Formulation Patent
The court held that because the asserted claims of the Formulation Patent require the active ingredient to be carfilzomib, Cipla's obviousness argument failed. Since the court determined that carfilzomib was not obvious, a formulation containing carfilzomib could not be obvious either[1].
Jurisdiction and Business Activities
The court established jurisdiction over Cipla Limited due to their systematic and continuous contacts with Delaware, including selling pharmaceutical products and deriving substantial revenue from these sales[2].
Conclusion of the Litigation
The district court ultimately ruled in favor of Onyx Therapeutics, finding that Cipla failed to prove the invalidity of the patents due to obviousness or other grounds. This decision prevented Cipla from marketing their generic version of Kyprolis until the patents expire.
Key Takeaways
- Patent Infringement: Cipla stipulated to the infringement of Onyx's patents for both 30 mg and 60 mg dosages of their ANDA product.
- Invalidity Defense: Cipla's defense of invalidity due to obviousness was rejected by the court.
- Objective Indicia: The court considered objective indicia such as long-felt unmet need and industry skepticism to support the non-obviousness of the patents.
- Prior Art and Double Patenting: Cipla's arguments regarding prior art and double patenting were unsuccessful.
- Jurisdiction: The court established jurisdiction over Cipla Limited based on their business activities in Delaware.
FAQs
What was the main issue in the Onyx Therapeutics, Inc. v. Cipla Limited case?
The main issue was whether Cipla's generic version of Kyprolis (carfilzomib) infringed Onyx's patents and whether these patents were valid.
What patents were involved in the litigation?
The litigation involved U.S. Patent Nos. 7,417,042, 8,207,125, and 7,737,112.
How did the court rule on Cipla's obviousness defense?
The court found that Cipla failed to prove obviousness by clear and convincing evidence and that there was no reasonable expectation of success in making the modifications to create carfilzomib.
What role did objective indicia play in the case?
Objective indicia, such as long-felt unmet need and industry skepticism, supported the non-obviousness of the patents.
Why was Cipla's argument on prior art rejected?
Cipla's argument on prior art was rejected because the individuals associated with the research memorandum had signed consulting agreements requiring them to assign any inventions to Proteolix, precluding the use of the memorandum as invalidating prior art.
Cited Sources:
- Robins Kaplan LLP Law Firm, "Onyx Therapeutics, Inc. v. Cipla Ltd."
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT, "Case 1:16-cv-00988-UNA Document 1 Filed 10/24/16"
- District of Delaware, "ONYX THERAPEUTICS, INC., v. CIPLA LIMITED, et al."
- FindLaw, "Case opinion for United States District Court D Delaware ONYX THERAPEUTICS INC v. CIPLA LIMITED"
