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June 14, 2005
Supreme Court patent decision
Some years back, patent law was changed so that all patent cases are heard by the US Court of Appeals for the Federal Circuit. The idea behind this change was to have an expert court specialize in these complex cases and review them in a uniform manner. However, in the subsequent years, concern has arisen over the Federal Circuit's interpretations of the law. For example, some argue that the Federal Circuit has lowered the "obviousness" standard for what can be given a patent -- beyond what the Supreme Court ruled.
Now comes a new patent case where the Supreme Court has overturned a Federal Circuit decision.
From LegalTimes.com - Supreme Court Allows Patented Compounds in Drug Companies' Research:
In a closely watched patent case, the Supreme Court on Monday gave drug companies broad leeway to use other companies' patented compounds in their own research, even at the earliest stages of new drug development.
The unanimous ruling in Merck KGaA v. Integra Life Sciences overturned a decision by the U.S. Court of Appeals for the Federal Circuit that had jolted the drug industry with a narrow interpretation of when companies can use rival patents in drug research. Monday's high court ruling means companies can begin developing competing drugs and generics earlier in the life of a competitor's patent, enabling them to jump into the market as soon as a rival patent expires.
But, as the Wall Street Journal story "Drug Makers Win Big Patent Victory" points out, the ruling is limited:
The High Court's ruling set aside a lower court ruling that had interpreted the patent exemption more narrowly. The Supreme Court didn't rule on the specific facts of the case, which was remanded back to the lower court.
Though unanimous, the court's decision doesn't necessarily signal a change in the drift of intellectual-property law, since the Merck case concerned not the validity of the law but rather its interpretation. The court sided squarely with the government's understanding of the Drug Price Competition and Patent Term Restoration Act, which was introduced so that generic-drug makers wouldn't have to wait until the expiration of patents before conducting FDA-related research.
It remains to be seen if the Supreme Court's ruling will, in the long run, change the Federal Circuit's interpretation of patent law. The ruling clearly does not obviate the need for reforming the patent system - it might be seen as one small step along that path.
Posted by Ken Jarboe at June 14, 2005 8:08 AM
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