Fed Circ. upholds some Teva migraine drug patents, invalidates others

The logo of Teva Pharmaceutical Industries is seen during a news conference in Tel Aviv
REUTERS/Amir Cohen
  • Lilly, sued by Teva for infringement, challenged patent validity
  • Patents covering Teva's Ajovy treatment not obvious
  • Teva patents covering antibodies themselves found invalid

(Reuters) - The U.S. Court of Appeals for the Federal Circuit on Monday affirmed a Patent Trial and Appeal Board decision that upheld the validity of three Teva Pharmaceutical Industries Ltd's patents related to its migraine drug Ajovy, while also affirming PTAB decisions that invalidated six others at Eli Lilly and Co's request.

Lilly failed to prove that parts of all of the patents were invalid based on prior art that allegedly disclosed the antibody treatment, U.S. Circuit Judge Alan Lourie wrote for a three-judge panel.

Teva's attorney Willy Jay of Goodwin Procter declined to comment, and Teva didn't immediately respond to a request for comment. Lilly also declined to comment, and its attorney William Raich of Finnegan, Henderson, Farabow, Garrett & Dunner didn't immediately respond to a request for comment.

Teva sued Eli Lilly in Boston federal court in 2017 and 2018, alleging its Emgality migraine drug infringed the patents. In response, Lilly challenged the patents' validity at the PTAB, arguing the relevant parts of them were obvious based on a combination of prior art publications including clinical trials, studies and an earlier patent.

Israel-based Teva's sales of Ajovy totaled $183 million last fiscal year, while Indianapolis-based Eli Lilly's Emgality sales were nearly $363 million over the same period.

The PTAB ruled that three of the patents were valid, while six others were obvious. Lourie, joined by U.S. District Judges William Bryson and Kathleen O'Malley, affirmed the rulings in three separate Monday decisions.

In his decision upholding the three patents covering methods of treating migraines with the antibodies, Lourie agreed with the board that the relevant parts of Teva's patents weren't obvious because a reasonable artisan wouldn't have expected the treatment to be effective.

Lourie rejected Lilly's challenges to the board's interpretation of the patents and its standard for determining a "reasonable expectation of success."

In two other decisions affirming that the relevant parts of the six patents directed to the antibodies themselves were invalid, Lourie supported the PTAB's decisions that they were obvious based on the prior art.

In those rulings, Lourie discounted Teva's argument that a skilled artisan wouldn't have combined the prior art to make the antibodies for therapeutic use.

He also rejected Teva's argument that the board failed to consider both Ajovy and Emgality "have received industry-wide acclaim, satisfied a long-felt need, achieved unexpected results, faced industry skepticism, and achieved commercial success," which it said indicated that the patents weren't obvious. Lourie found that there was no "nexus" between the "extremely broad" parts of the patent at issue and the commercial product of Ajovy.

The cases are Teva Pharmaceuticals International GmbH v. Eli Lilly and Co, U.S. Court of Appeals for the Federal Circuit, Nos. 2020-1747 through 1752, and Eli Lilly and Co v. Teva Pharmaceuticals International GmbH, U.S. Court of Appeals for the Federal Circuit, Nos. 1876 through 1878.

For Teva: Willy Jay of Goodwin Procter

For Lilly: William Raich of Finnegan, Henderson, Farabow, Garrett & Dunner

Read more:

U.S. court rules for Teva in migraine patent dispute with Eli Lilly

Teva accuses Lilly in U.S. court of infringing migraine drug patents

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Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets, for Reuters Legal. He has previously written for Bloomberg Law and Thomson Reuters Practical Law and practiced as an attorney. Contact: 12029385713