Teva Pharmaceuticals International GmbH et al. v. Eli Lilly and Company (D. Mass. 18-cv-12029).

  • January 5, 2023

Teva accused Lilly of infringing three patents relating to treatment of migraine headaches using anti-CGPR antagonist antibodies, specifically U.S. 8,586,045, 9,884,907, and 9,884,908.  Each of the patents claim priority to a 2005 provisional application and share a common specification. 

Teva suffered an initial setback when six related patents directed to the humanized antibody compositions were unpatentable as obvious during an inter partes review (upheld by the Federal Circuit on appeal).  The method of treatment claims were upheld, however, based on Teva’s argument that the use of the full-length antibody for migraine treatment because, at the time the invention was made, it would not have been expected to cross the blood-brain barrier. 

Earlier this month, Judge Burroughs address the parties’ respective motions for summary judgment.  To begin, she addressed Teva’s assertion that Lilly should be judicially estopped from taking certain positions that Teva says are contrary to positions it took during the IPRs.  She noted that judicial estoppel, which precludes a party from taking opposite positions in different proceedings, is not limited to Article III court proceedings, but could also arise in administrative proceedings like IPRs.  She found that Lilly had argued somewhat opposite positions in the IPR and before the court regarding whether the formation of one of the precursors to the antibody, stating before the PTO that the technique was well-known to those of skill in the art while stating to the court that the technology was “nascent,” but that the positions were not so mutually exclusive as to require estoppel, particularly when drawing all ambiguities in Lilly’s favor as required under the summary judgment standards.  She found the same with respect to the other subjects for which estoppel was sought.

Teva sought summary judgment of no inequitable conduct on Lilly’s claims that Teva intentionally failed to disclose certain prior art publications of which they were aware, as well as results of testing done by the inventors that called into question the viability of the claimed inventions.  With respect to one publication, Teva had included it in IDS’s for two of the three asserted patents, albeit as a part of over 400 other references.  Lilly contended that the reference should have been highlighted as contradicting contentions in the patent applications.  Teva argued that the reference was cumulative to others disclosed and thus not material.  Judge Burroughs found that there was a genuine dispute as to the materiality of the reference.  She noted that, while the reference had overlap with the disclosed documents, it provided additional disclosure that a reasonable jury could find would have influenced an examiner’s decision to allow the claims.  She further noted that, while the specific intent element had not been established as an undisputed fact, a reasonable jury could find that the intent to deceive was the most reasonable inference.

Teva further sought summary judgment of no inequitable conduct on Lilly’s claims relating to petitions to claims of priority in the applications.  The patents were filed claiming priority to an application that had gone abandoned.  When notified of the abandonment, Teva took more than a year to file petitions for correction and indicated to the PTO that the delay was unintentional.  Judge Burroughs found that there were genuine issues of fact as to the intent, as such a finding does not require direct proof (as Teva seemed to assert) but could be based on reasonable inferences.

Lilly sought summary judgment of no willfulness.  Judge Burroughs noted that there was no dispute that Lilly was aware of the patents, and that a reasonable jury could find that Lilly intended to infringe by copying the patented work without a good faith belief that the claims were invalid.

Judge Burroughs granted Lilly’s motion for summary judgment of noninfringement of one of the patents, finding that the Lilly drug’s amino acid sequence clearly was not within the claim scope and that any attempt to assert equivalence would effectively write the claims’ amino acid limitations out.

The case went to trial in October.  After seventeen days of trial, a jury returned a verdict, finding that Lilly had induced infringement of and contributorily infringed  U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908, that the infringement of all three was willful, and that none of the patents failed to meet the written description or enablement requirements.  The jury found that Teva suffered $90 million in lost profits for the period of October 2018 through June 2022, and additionally that Teva was owed $36.7 million in reasonable royalties for past infringement for sales on which lost profits were not asked for or not proven, setting the reasonable royalty rate at 5%.  The jury further identified Teva’s future lost profits that would result from Lilly’s sales from November 2022 through October 2026 to be $49.8 million.  Judge Burroughs closed out 2022 by entering judgment that the asserted patents were not invalid and that Lily willfully infringed the patents through sales of Lilly’s Emgality® product for the treatment of migraines and episodic cluster headaches.  A total of $176,540,000 was awarded as damages, although Judge Burroughs is allowing deferral of this money until 30 days after the latest of a final mandate from the Federal Circuit, a decision from the Supreme Court, or the expiration of a period for appeal or review.  Given the parties’ agreement that Lilly was adequately capitalized to pay the awarded damages, Lilly was not required to post bond.  She reserved the right to amend damages to include any pre-or post-judgment interest, supplemental damages for the June-November 2022 period (during which trial was taking place), and any attorneys’ fees or enhanced damages that might be awarded.  She further reserved the right to amend the judgment should Lilly prevail on its intended motions for judgment as a matter of law and for a new trial.

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