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4 May 2021AmericasMuireann Bolger

Novartis withdraws bid to block US Regeneron imports

Pharmaceutical company Novartis has abandoned its attempt to halt US imports of Regeneron’s Eylea pre-filled syringes amid concerns that such a ban could hinder public access to essential treatments.

The US International Trade Commission (USITC) confirmed that it had closed the case on Monday, May 3, following a request filed by Novartis last month.

The dispute at the ITC arose in June 2020, when Novartis filed a motion for summary determination that Regeneron directly infringed its patent, US number 9,220,631, which covers a treatment for retinal diseases.

Novartis further alleged that Regeneron violated section 337 of the Tariff Act of 1930 by importing into the US and selling “certain pre-filled syringes for intravitreal injection” or “syringes that are pre-filled with ophthalmic medication, and components of such syringes, including barrels, plungers, and stoppers”.

The company requested that the USITC issue Regeneron with “a limited exclusion order” along with a “cease and desist” order.

Novartis also filed infringement claims over the same patent at the US District Court  for the Northern District of New York.

In that complaint, Novartis held that the United States Patent and Trademark Office issued the ’631 patent, entitled “Syringe,” in 2015 to inventors Juergen Sigg, Christophe Royer, Andrew Bryant, Heinrich Buettgen and Marie Picci and that Novartis owns the rights, titles and interests in the patent.

Regeneron, according to the filing, unlawfully uses Novartis’s patented syringe technology and infringes the ’631 patent through the marketing, sale and distribution of its Eylea product.

Novartis’ subsequent decision to withdraw the complaint with the ITC came when agency staff had recommended that no import ban be imposed for at least three years if Novartis won its case, highlighting concerns about the restriction of public access to medicines.

In early April, Novartis filed an unopposed motion to terminate the investigation in its entirety based on its withdrawal of the complaint.

The motion indicated that Regeneron did not oppose the motion, and Regeneron did not file a response to the motion.

“Although Novartis disagrees with staff, it takes seriously the concerns staff noted,” the company said in its request to terminate the investigation.

Novartis will now await the outcome of the patent infringement proceedings in New York.

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7 March 2022   Regeneron has failed to convince a Manhattan district court to drop a lawsuit claiming that it developed COVID-19 treatments using Allele’s fluorescent protein invention without its permission.
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19 April 2022   In a victory for Novartis, the Delhi High Court in India has issued a permanent injunction against two India-based companies which had allegedly sought to make a generic version of the Hepatitis C treatment, Revolade.

More on this story

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3 February 2022   Novartis escaped an antitrust countersuit brought by Regeneron earlier this week, with a New York court dismissing the suit which had been filed in response to Novartis’ patent complaint.
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7 March 2022   Regeneron has failed to convince a Manhattan district court to drop a lawsuit claiming that it developed COVID-19 treatments using Allele’s fluorescent protein invention without its permission.
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19 April 2022   In a victory for Novartis, the Delhi High Court in India has issued a permanent injunction against two India-based companies which had allegedly sought to make a generic version of the Hepatitis C treatment, Revolade.