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6 January 2022AmericasMuireann Bolger

Hatch-Waxman can’t offer ‘safe harbour’ defence in gene therapy case

Sarepta Therapeutics won’t be able to rely on a “safe harbour” provision to protect its gene therapy invention from a patent infringement suit from biotech Regenxbio and the University of Pennsylvania, a Delaware court has ruled.

Judge Richard Andrews handed down the decision at the US District Court for the District of Delaware on Tuesday, January 4.

Regenxbio and the trustees of the  University of Pennsylvania sued Sarepta for patent infringement in September 2020, claiming that its therapy infringed the university’s patent, US patent number 10,526,617.

The '617 patent claims a “cultured host cell containing a recombinant nucleic acid molecule encoding the capsid protein”.

Regenxbio and the university claim that Sarepta manufactured and used the patented cultured host cells to make “recombinant adeno-associated virus” gene therapy products.

Sarepta argued that the complaint should be dismissed for failure to state a claim as the allegations relate to activities that fall within the “safe harbour” protection of the Hatch-Waxman Act.

The safe harbour provision holds that it is not an act of infringement to make, use, offer or sell a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products”.

Judge Andrews explained: “Before the Hatch-Waxman Act was enacted, any manufacture, use, or sale of a patented invention during the patent term was an act of infringement, even if it was for the sole purpose of obtaining Food and Drug Administration (FDA) regulatory approval.”

Sarepta argued that its “infringing activities” were solely in order to secure a biologics license application from the FDA, and it was consequently protected under the “safe harbour” provision.

However, Regenxbio successfully argued that “safe harbour” does not apply here as a matter of law because the patented products are not subject to FDA premarket approval.

Judge Andrews ruled that Sarepta was not just using the patented cultured cells in order to introduce a generic competitor, but rather was using the ‘617 patent to “develop its own patentable product” and was therefore unable to claim “safe harbour” protection.

Judge Andrews denied Sarepta’s motion to dismiss the lawsuit.

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More on this story

Big Pharma
25 August 2022   Safe harbour provisions can be relied on but their boundaries are still being defined, explain Jeanna Wacker and Tasha Francis Gerasimow of Kirkland & Ellis.
Generics
18 July 2023   Generic drug makers are watching two cases that will determine whether pharmaceutical firms can deduct—rather than capitalise—legal fees for defending against patent infringement suits, say Carina Federico and Anne Li of Crowell & Moring.
Big Pharma
27 January 2021   The US Court of Appeals for the Federal Circuit has dismissed an attempt by Valeant Pharmaceuticals to overturn a ruling that restricted where Hatch-Waxman Act patent lawsuits can be filed.

More on this story

Big Pharma
25 August 2022   Safe harbour provisions can be relied on but their boundaries are still being defined, explain Jeanna Wacker and Tasha Francis Gerasimow of Kirkland & Ellis.
Generics
18 July 2023   Generic drug makers are watching two cases that will determine whether pharmaceutical firms can deduct—rather than capitalise—legal fees for defending against patent infringement suits, say Carina Federico and Anne Li of Crowell & Moring.
Big Pharma
27 January 2021   The US Court of Appeals for the Federal Circuit has dismissed an attempt by Valeant Pharmaceuticals to overturn a ruling that restricted where Hatch-Waxman Act patent lawsuits can be filed.