Federal court rules using a CMO doesn’t invalidate drug patents

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Court rules on use of CMO and losing a drug patent.

A federal court has ruled that hiring contract manufacturing organizations (CMO) cannot be used as a cause for a drug patent owned by a pharma or biotech company to be invalidated under what is referred to as the “on sale” bar.

The ruling handed down earlier this week from the U.S. Court of Appeals for the Federal Circuit stems from a lawsuit that pitted Hospira against Medicines Co. (Medco), Regulatory Affairs Professional Society reported. In that suit, Hospira argued that because Medco hired a CMO--the now defunct Ben Venue--before it had patented the blood thinner Angiomax (bivalirudin) that it lost its patent due to what is called the on-sale bar.

Under U.S. law, if a product is “on-sale” for more than a year before a patent application is filed, any patent issued is invalid and the rights under a patent are lost.

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Hospira argued that Medco’s use of Ben Venue violated the on-sale bar.

In its ruling, however, the court said, “The most natural conclusion to draw from all of the evidence presented in this case is that Ben Venue sold contract manufacturing services--not the patented invention--to MedCo.”

The court went on to say in its ruling that based on the evidence, "Under MedCo’s instructions and using an API (active pharmaceutical ingredient) supplied by MedCo, Ben Venue acted as a pair of ‘laboratory hands’ to reduce MedCo’s invention to practice.”

The CMO’s invoices, the court said, supported the decision because they stated, “Charge to manufacture Bivalirudin lot.”

Additionally, the court said that the act of stockpiling a patented invention by a pharmaceutical company using CMO services doesn’t mean that the patents of that drug should be invalidated. 

The ruling gives pharmaceutical companies that rely on CMO services some relief and prevents a disruption in the manufacturing of drugs.

- check out the RAPS article

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