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16 June 2016Americas

Federal Circuit confirms Genzyme patents as invalid

The US Court of Appeals for the Federal Circuit decided on June 14 that the two patents involved in a dispute between Biomarin Pharmaceuticals and Genzyme Therapeutic Products are unpatentable due to being obvious.

The case was an appeal from decisions of the Patent Trial and Appeal Board.

Biomarin claimed that the two patents, US patent numbers 7,351,410 and 7,655,226, which are owned by Genzyme, are invalid as they are obvious.

The patents, titled “Treatment of Pompe’s Disease”, are protections for an injection containing human acid α-glucosidase which are directed to treating Pompe’s disease.

Pompe’s disease is a genetic condition associated with a deficiency or absence of lysosomal enzyme acid α-glucosidase, which in a healthy individual would break down glycogen to glucose.

The inability to do this results in glycogen accumulating in the muscles in excessive amounts.

In 2013, Biomarin filed petitions requesting inter partes review of the ‘410 and ‘226 patents.

The board reviewed the two patents, saying they were obvious based on a press release and several references.

On the contrary, Genzyme, who owns the patents, argued that because of its combination of references described in the experiments, a person of ordinary skill would not find those experiments obvious.

The board’s findings were reaffirmed by the Federal Circuit, which concluded that a person of ordinary skill would have had a reasonable expectation of success based on the combination of references argued for in court.

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