Patent Approval is not Always Perfect

As folks in the medical and biotech fields sometimes discover, FDA approval and patents can be intertwined.

FENTORA — a powerful, short-acting anesthetic developed by Cephalon , Inc. — is covered by two patents.  When Watson Pharmaceuticals Inc. began to market generic forms of FENTORA, Cephalon sued to stop them.

However, in a recent patent lawsuit the court ruled that Watson’s generic was in fact a different salt form and therefore did not infringe the two patents.

Cephalon disagrees with that verdict.  Their position is that if their salt forms and Watson’s were indeed so different, the FDA should not have approved Watson’s product as a generic form of FENTORA, but as a distinctly separate drug.

Cephalon is now suing the FDA for wrongfully approving a new drug under the generic rules.

Sometimes statements made in one court proceeding (the patent lawsuit) can be used against the party in another forum (an FDA lawsuit).

(Cephalon was recently purchased by Teva Pharmaceuticals, Inc.)

There are pitfalls and potholes on the way to a bulletproof patent. You need a strong, experienced patent attorney to protect your work – it’s not an option.  Barbara Luther has almost a decade of experience obtaining FDA approvals, plus 20 years of experience in intellectual property.

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