Tuesday, April 4, 2017

Zolmitriptan - USA

On Mar 29, 2017, District court of Delaware issued Trial opinion in Zomig (Zolmitriptan) case. 

Plaintiffs Impax Laboratories, AstraZeneca UK ("AZUK"), and AstraZeneca AB ("AZAB") brought suit against Defendants Lannett Holdings, Inc. and Lannett Company, Inc. for infringement of U.S. Patent Nos. 6, 750,237 and 7,220, 767 ("the Dearn patents"). The Dearn patents claim invention of a nasal formulation for zolmitriptan. Zolmitriptan is a member of the triptan class of drugs, which treat migraines. AstraZeneca Pharmaceuticals LP holds New Drug Application No. 21450 for zolmitriptan nasal spray. Zolmitriptan nasal spray, as well as other zolmitriptan products, are marketed as Zomig.

Plaintiffs brought this infringement suit after Defendants filed Abbreviated New Drug Application No. 206350. Defendants stipulated to infringement.I (D.I. 136). Defendants argue, however, that (1) Plaintiffs do not have standing to bring suit, (2) the Dearn patents are invalid as anticipated, and (3) the Dearn patents are invalid as obvious. The Court held a three day trial on September 6, 7, and 8, with closing arguments on the 9th

CONCLUSION: Defendants have failed to prove the Dearn patents are invalid. If desired, Defendants should request an opportunity to cross-examine Ms. Allen within one week. If Defendants do not make that request, the parties should submit an agreed upon form of final judgment within two weeks.

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