DC Hatch-Waxman decision finding improper venue and failure to state a claim affirmed

Celgene Corp. v. Mylan Pharmaceuticals Inc., et al.

Docket No. 2021-1154 (https://cafc.uscourts.gov/opinions-orders/21-1154.OPINION.11-5-2021_1860406.pdf)


November 5, 2021

Brief Summary:  DC finding of improper venue and failure to state a claim affirmed. Summary:  Celgene sued Mylan for infringement under the Hatch-Waxman Act (HW) following Mylan’s application to the FDA to bring generic pomalidomide (Celgene’s Pomalyst) to market.  The DC found that Celgene’s suit was improperly filed in New Jersey since the defendant Mylan companies are located in West Virginia (“MPI”) and the Netherlands (“NV”).  The FC panel agreed, finding that “Celgene did not show that those defendants committed acts of infringement in New Jersey and have a regular and established place of business there” and “Celgene’s pleadings failed to state a claim upon which relief could be granted.”  Mylan’s ANDA sought FDA approval under HW paragraph IV and Celgene’s multiple suits regarding six patents against Mylan were consolidated (“the first case”, filed in 2017).  In 2019, Celgene sued Mylan regarding three later-issued patents that led to this appeal.  Mylan’s motion to dismiss the first case for improper venue and failure to state a claim was denied by the DC “so that the parties could engage in venue-related discovery.”  Mylan then renewed its motion to dismiss for improper venue which was granted.  The DC also agreed with Mylan that “the ANDA that Celgene itself included with its complaint sought approval only on behalf of MPI…[a]nd Celgene’s pleadings with respect to the involvement of Mylan N.V. in that submission were simply too speculative and conclusory.”  The FC panel reviewed the venue issue de novo under 28 USC section 1400(b), explaining that “[t]he plaintiff has the burden of establishing proper venue under that provision” by “show[ing] either that the defendant ‘resides’ in a particular district or that it ‘has committed acts of infringement and has a regular and established place of business’ there”.  Celgene argued “that the ‘artificial act of infringement stemming from the ANDA submission extends nationwide’ (i.e., wherever the generic drug will be marketed and sold).”  The FC panel, however, explained that “[f]or Hatch-Waxman cases, this means venue is proper ‘where an ANDA-filer submits its ANDA to the FDA,’ not ‘wherever future distribution of the generic is contemplated’” and found that neither MPI nor Mylan Inc. “committed acts of infringement” in New Jersey.  Celgene also argued that Mylan’s act of sending its notice letter to Celgene in NJ was an act of infringement in NJ (“infringement for venue purposes includes all ‘acts that are ‘sufficiently related to the ANDA submission’”).  The FC panel disagreed, writing that “the relevant prong of § 1400(b) restricts venue to ‘where the defendant has committed acts of infringement’—not where the defendant has committed acts related to (but not part of) acts of infringement” (Valeant, FC 2020) (“the employee homes here are not places ‘of the defendant’”; insufficient evidence of “alter ego”).  It also found insufficient evidence that NV was involved in the ANDA filing and that Celgene did not timely amend its complaint.  The DC decision was therefore affirmed.

This entry was posted in Generics / ANDA, Infringement, Jurisdiction, Venue. Bookmark the permalink.

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