Teva Wins on Detailed Patent Claims: Federal Circuit Upholds Headache Patents
By Prashant Kotian, PhD Researcher (Chemistry), ICT Mumbai
In a landmark decision, the Court of Appeals for the Federal Circuit has reversed a district court's judgment, upholding Teva Pharmaceuticals' headache patents against Eli Lilly's claims of invalidity. The case centered around the detailed patent claims for humanized anti-CGRP antagonist antibodies, which are crucial for treating headaches.
Teva Pharmaceuticals International GmbH and Teva Pharmaceuticals USA, Inc. (collectively, "Teva") sued Eli Lilly and Company ("Lilly") for infringing Teva's U.S. Patent Nos. 8,586,045 ("the '045 patent"), 9,884,907 ("the '907 patent"), and 9,884,908 ("the '908 patent") (collectively, the "headache patents"). The headache patents claim a method of using humanized anti-CGRP antagonist antibodies to treat headache. Lilly challenged these patents, arguing they were unpatentable for obviousness. The Patent Trial and Appeal Board (Board) initially determined that the antibody patents were unpatentable, but affirmed the headache patents as valid.
Teva brought the suit against Lilly in September 2018, alleging that Lilly indirectly infringed the headache patents via its Emgality product. A jury found that Lilly willfully infringed the headache patents and did not prove them invalid for lack of written description or enablement. Lilly then moved for judgment as a matter of law (JMOL) of invalidity on written description and enablement, which the district court granted.
The Federal Circuit reviewed the district court's JMOL de novo, emphasizing that the jury's verdict should be reinstated unless it overwhelmingly favored Lilly. The Federal Circuit concluded that the jury could have reasonably found that Lilly failed to prove its invalidity case by clear and convincing evidence.
The written-description requirement of 35 U.S.C. section 112(a) mandates that a patent's specification must "reasonably convey[]" that, as of the filing date, the inventor had possession of the claimed subject matter. The enablement requirement requires that the specification must contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.
The Federal Circuit found that Teva's specification met these requirements. The specification disclosed just one humanized anti-CGRP antagonist antibody, "G1," but also disclosed prior-art methods of humanization. The specification also stated that anti-CGRP antagonist antibodies may be made by any method known in the art. The Federal Circuit concluded that a person of ordinary skill in the art would have understood from the specification that all humanized anti-CGRP antagonist antibodies would treat headache.
This decision highlights detailed patent claims in the pharma industry. The ruling reinforces the need for inventors to provide comprehensive descriptions and enablement of their inventions to withstand challenges of invalidity. This case serves as a reminder of the significance of precise and thorough patent documentation in protecting innovative pharmaceutical compositions.
Explore the implications of this case for the pharma industry at patent-analytics.thechemsolver.com PharmaLaw #PatentLitigation #DrugPatent #CGRPAntibodies
What we do
See if this applies to one of your matters
We run genus/species (Markush) claim coverage analysis, Section 3(d) compliance screening, and prior-art structural triage on real chemical structures: not keyword search. If a case like this one is live for you, we'll run a free sample on a compound of your choosing.