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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

FDA Is Evolving on Qualifications for 'New Chemical Entity'

The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity. Originally published in the Intellectual Property and Life Sciences sections of...more

FDA's 'Active Moiety' Interpretation of the Three-Year Clinical Investigation Exclusivity

The court found that a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity. In Otsuka Pharmaceutical Co. v. Burwell, the U.S. District Court for the District of...more

Post-Grant Challenges in Life Sciences: 2015 in Review

The prevalence of inter partes reviews (and post-grant reviews to come) forces practitioners to consider the strong likelihood that patents covering commercial products will face post-grant challenges. Originally...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Analysis of Inter Partes Review and Post-Grant Review in the Life Sciences Industry Through First Quarter 2015

The recently established inter partes review (IPR) and post-grant review (PGR) of the America Invents Act have been in the spotlight lately, especially now that the life sciences industry has begun to utilize these...more

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