5 March 2015Americas

Myozyme patents invalidated in first biopharma IPR rulings

The US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) has handed down what are thought to be the first written decisions in inter partes review proceedings that concern the biopharmaceutical industry.

The PTAB deemed all challenged claims of two patents covering biotechnology company Genzyme’s orphan drug Myozyme (alglucosidase alfa) unpatentable. A third patent directed to the drug, owned by Duke University, was also invalidated.

IPRs allow companies to challenge issued patents on the basis of prior art. The disputes can be raised under title 35, sections 102 and 103 of the US Code.

California-based BioMarin Pharmaceutical filed petitions in 2013 to review the Myozyme patents.

Myozyme is an enzyme replacement therapy that treats Pompe disease, a rare metabolic disorder that causes muscle weakness. Pompe disease is characterised by the deficiency of an enzyme, resulting in accumulation of glycogen in the muscles and heart.

In 2006, the US Food and Drug Administration (FDA) approved Myozyme for the treatment of children aged eight or under.

Genzyme owns two patents involved in the IPRs: US patent numbers 7,351,410 and 7,655,226. The patents cover a method of treating Pompe disease by intravenous administration of enzyme alpha-glucosidase (GAA) on a bi-weekly schedule.

Duke University, in North Carolina, owns a third patent covering the drug.

In its decisions, the PTAB found that the claims in Genzyme's two challenged patents were obvious in light of prior art, which included a press release published by Duke University that announced the FDA had designated Myozyme as an orphan drug.

The prior art also included two scientific papers from 1988 and 1991 that identified the administration of GAA as a treatment for Pompe disease.

In the third decision, the PTAB said the challenged claims of Duke's patent were invalid based on obviousness.

A spokesman for Genzyme said: “At this point I can say that we strongly disagree with this decisions and plan to appeal to the US Federal Circuit."

BioMarin did not respond to LSIPR’s request for comment.

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