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We Received a Patent Term Extension - Now What?

This is the final article in our five-part series on PTE. Obtaining a patent term extension (PTE) is extremely valuable to an innovator. By design, PTE extends the patent term to recoup time lost to the rigorous...more

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

How to Obtain Multiple Patent Term Extensions for a Single Product

This is the second article in our five-part series on PTE. Everywhere you look, patent term extension (PTE) is described using the “Rule of Ones:” one patent, one product, one PTE. However, the Rule of Ones does not...more

Patent Term Extension for Drugs Not Limited to New Chemical Entities

Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more

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