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1 April 2021MedtechAlex Baldwin

PTAB invalidates Sanofi injector patent

Mylan Pharmaceuticals has succeeded in getting the  Patent Trial and Appeal board (PTAB) to invalidate an injector patent held by French pharmaceutical company  Sanofi.

Sanofi’s patent, registered under  RE47,614, covers a “drug delivery device and a method of manufacturing a drug delivery device”. Claims 2-15 of the patent are dependent on this outline, with 16-18 being independent.

Mylan argued that the Sanofi patent was obvious, with reference to three prior arts: de Gennes (US 4,144,957), Venezia (US 2,882,901) and Burren (US 2007/0021718 A1).

The Burren and Venezia arts described a spring-loaded injection device and a hypodermic syringe assembly respectively. De Gennes disclosed “self-centring clutch release bearings.”

Sanofi hit back that the de Gennes art was not analogous to the ‘614 patent and “not pertinent to a problem with which the ‘614 patent is involved”.

However, the board found “de Gennes reasonably pertinent to axially fixing two components relative towards each other, a problem addressed by the inventors of the ’614 patent”. Therefore, it ruled de Gennes as analogous.

The panel of three judges was  swayed by Mylan’s argument for obviousness in a ruling handed down on March 26, on the grounds of all prior arts and ruled that claims 1-18 of the ‘614 patent were unpatentable.

However, the judges also denied, in part, Mylan’s motion to exclude evidence.

The judges wrote: “The nature of our proceedings, in which the same panel that decides admissibility also serves as the fact-finder, disfavours exclusion in these circumstances. Moreover, because we do not rely on the materials petitioner seeks to exclude in making our conclusions in this case, we dismiss as moot this aspect of petitioner’s motion.”

Sanofi has the right to appeal the decision to the Federal Circuit.

Mylan first submitted two petitions (due to word count constraints) for an inter partes review of Sanofi’s patent on October 7, 2019.

The US Patent and Trademark Office granted the institution of the inter partes review on April 2, 2020.

The board heard oral arguments from both Mylan and Sanofi on January 13, 2021, in Alexandria, Virginia.


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13 April 2021   UK company C4X Discovery has agreed an exclusive licensing deal with Sanofi worth a potential €414 million, which will see the French pharmaceutical company develop anti-inflammatory therapies.