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The US Court of Appeals for the Federal Circuit has issued a precedential decision in a case involving Merck’s reissued patent, entitled “To Full Patent-Term Extension”. The case centers around Aurobindo’s bid to invalidate a reissued patent that shields Merck & Co’s Bridion (Sugammadex) injectable. Specifically, Aurobindo argued that the patent-term extension granted to Merck did not comply with the requirements of the Hatch-Waxman Act, which allows for a five-year extension of the patent term for certain patents that include a patent term extension.
The crux of the case is the interpretation of the language “the patent” in the context of patent-term extensions for reissued patents. The Federal Circuit held that the language “the patent” in the context of patent-term extensions for reissued patents refers not to the original patent, but rather to the reissued patent itself. This determination is precedential, meaning that it sets a legal precedent for future cases.
The court’s ruling is significant, as it clarifies the scope of patent-term extensions for reissued patents, which are often seen as a way to obtain market exclusivity for innovative medical treatments. In this case, the ruling is a win for Merck, as it allows the company to retain its exclusivity period for Bridion, a medication used to reverse the effects of over-sedation during anesthesia. The ruling also sets a precedent for future cases involving reissued patents and patent-term extensions.
The implications of this decision are far-reaching, as it provides guidance to patent owners, generic drug manufacturers, and the pharmaceutical industry at large. The ruling demonstrates the importance of careful drafting and clarification of legal language, as even seemingly simple phrases like “the patent” can have significant consequences in court. With this decision, the Federal Circuit has provided much-needed clarity in a complex area of patent law, and its impact will be felt for years to come.