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28 November 2023Big PharmaSarah Speight

Teva and Eli Lilly end patent clash over migraine drug

Rival drugmakers have dropped lawsuit following invalidation of Teva patents in September | Move comes after judge overturned jury verdict handing $176.5m to Teva.

Teva Pharmaceuticals has dropped its patent lawsuit against Eli Lilly over migraine treatment Emgality, in a joint move by the rival drugmakers that closes the door to future litigation over the patents.

Israeli pharma giant Teva sued Eli Lilly in 2021, accusing the US firm of infringing two patents covering Teva’s migraine treatment Ajovy—US patent numbers 11,028,160 and 11,028,161.

On Wednesday, November 22, the firms notified the US District Court for the District of Massachusetts that the case would be voluntarily dismissed with prejudice, with each party bearing its own costs regarding the action.

The development follows the invalidation of the ‘160 and ‘161 patent by a US Patent and Trademark Office (USPTO) tribunal in September, which determined they would have been obvious over prior art.

Also in September, a Massachusetts district court judge overturned a jury verdict that was set to hand $176.5 million to Teva in a separate patent infringement case against Eli Lilly over Emgality.

That case related to three patents—US Patents 8,586,045, 9,884,907 and 9,884,908—which relate to a method for treating a headache by blocking the binding function of the CGRP protein.

Judge Burroughs determined that the patents were invalid on the basis of inadequate written description and lack of enablement. The claims had “a broad scope due to their lack of structural limitations”, Judge Burroughs wrote, also noting that the court did not “overturn a jury verdict lightly”.

Rivalry over headache drugs

Teva and Eli Lilly have been competing over migraine treatments for some years. Eli Lilly’s Emgality is a prescription medicine used to prevent migraines in adults, and is given via an injection. In June 2019, it became the first drug to be approved by the US Food and Drug Administration (FDA) for reducing the frequency of episodic cluster headache attacks.

Ajovy from Teva was approved by the FDA the previous year for the preventative treatment of migraines in adults, with Amgen’s Aimovig also granted approval around the same time.

Both Teva and Eli Lilly’s drugs are anti-CGRP products, which target one of the pain chemicals associated with migraines. The active ingredient in Teva’s Ajovy is a G1 antibody also known as fremanezumab (‘fmab’), whereas Lilly’s Emgality is based on the active ingredient galcanezumab (‘gmab’).

Teva earned $377 million from worldwide Ajovy sales last year, and Eli Lilly earned $650 million from Emgality, Reuters reported.

The case dismissed last week was Teva Pharmaceuticals v Eli Lilly. Finnegan acted as counsel for Eli Lilly, and Goodwin Procter for Teva.

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17 January 2023   The pharma company’s arguments focusing on ‘inventive step’ failed to convince a London court that the Israeli generic drug maker had infringed, explains Azadeh Vahdat of EIP.
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4 January 2024   California-based drugmaker lost Hatch-Waxman Act case after judge ruled it had failed to show patent infringement | Corcept CEO ‘confident’ decision will be reversed on appeal.
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19 October 2023   Luxemboug court agrees with European Commission that ‘beneficial arrangement’ between Teva and Cephalon delayed generic market entry of sleep disorder drug | Teva and subsidiary Cephalon to pay around €30m each plus costs.

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19 October 2023   Luxemboug court agrees with European Commission that ‘beneficial arrangement’ between Teva and Cephalon delayed generic market entry of sleep disorder drug | Teva and subsidiary Cephalon to pay around €30m each plus costs.