unusedbrandon-bourdages-shutterstock-com-us-supreme-court--1
Brandon Bourdages / Shutterstock.com
25 November 2016Americas

AstraZeneca opposes Mylan’s request for SCOTUS hearing

AstraZeneca and Acorda have asked the US Supreme Court not to hear an appeal from Mylan challenging a Federal Circuit ruling.

The opposition from the two pharmaceutical companies came after Mylan filed a petition for a writ of certiorari with the Supreme Court in September.

In January 2014, Mylan filed an abbreviated new drug application (ANDA) with the Food and Drug Administration (FDA), seeking approval to market the generic of Acorda’s Ampyra (dalfampridine).

Acorda then sued Mylan in the US District Court for the District of Delaware for patent infringement.

Mylan also filed two ANDAs seeking approval to market generic versions of AstraZeneca’s Onglyza (saxagliptin) and Kombiglyze (metformin and saxagliptin). AstraZeneca sued Mylan in Delaware.

The case was heard at the US Court of Appeals for the Federal Circuit in March this year, where the court affirmed the decision made in the district court.

Mylan had moved to dismiss the cases on the ground that Delaware could not exercise personal jurisdiction over the case.

Mylan is incorporated in West Virginia. It submitted its ANDAs to the FDA in Maryland, and did much if not all of the preparation of its ANDA filings in West Virginia.

The company had registered to do business in Delaware, and intended to direct sales of its drugs into Delaware.

The district court had concluded that Delaware had “sufficient contacts” related to the subject of these cases that it could exercise specific personal jurisdiction over Mylan.

According to the Federal Circuit: “Mylan’s ANDA filings … have a substantial connection with Delaware because they reliably, non-speculatively predict Delaware activities by Mylan.”

Mylan appealed against the decision, asking the Supreme Court to answer the question: “Whether the mere filing of an ANDA by a generic pharmaceutical manufacturer is sufficient to subject the manufacturer to specific personal jurisdiction in any state where it might in future market the drug.”

In the latest development, on Monday, November 21, AstraZeneca and Acorda both filed briefs which stated that the Federal Circuit’s decision represents a straightforward application of settled jurisdictional principles to the “artificial act of infringement”.

They further claim that “other arguments that Mylan offers in favour of review uniformly fall flat”.

According to Mylan, the Federal Circuit’s decision had “profound implications” for the pharmaceutical industry because it subjects ANDA filers to “effectively national jurisdiction”.


More on this story

Americas
15 September 2017   Agriculture company Dow has asked the US Supreme Court to review a dispute centring on damages for infringement of patents related to genetically engineered soybeans.
Americas
9 March 2021   AstraZeneca has won a three-year legal battle against UK generics manufacturer Mylan Pharmaceuticals over its asthma inhaler patents.

More on this story

Americas
15 September 2017   Agriculture company Dow has asked the US Supreme Court to review a dispute centring on damages for infringement of patents related to genetically engineered soybeans.
Americas
9 March 2021   AstraZeneca has won a three-year legal battle against UK generics manufacturer Mylan Pharmaceuticals over its asthma inhaler patents.