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ODP Should Not Nullify PTA

The long and arduous path of prosecution begins with the filing of a parent patent application. Several years later, the applicant files a first continuation application. A few more years pass after which the applicant files...more

Obviousness-Type Double Patenting Just Became Less of a Problem for Innovators

The Federal Circuit recently issued a pair of decisions concerning the Gilead doctrine, which allowed later-issuing patents to be obviousness-type double patenting (ODP) references against earlier-issuing patents....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

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