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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

Developing, Disclosing, and Patenting Technology During National Emergencies

National emergencies, like the one COVID-19 has triggered in the United States, spur technological development, as concerned researchers look for ways to repurpose existing technology or develop new technology to help. ...more

Pioneer Drug Maker Throws First Punch At Pharmacy Outsourcing Facilities (503b)

Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more

DTC Compounded Medications: A Treatment Option for a System in Need?

We have all been there: An advertisement on television or a pop-up on Facebook beckons us to try the latest “visit-free,” “delivered to your door” treatment for a medical condition. Originally published in Dermatology Times...more

How to Use Patents to Maximize Value for Your Venture

In this follow up to last month’s topic on intellectual property and technology transfer, we will extend our discussion on ownership to patents. Originally published in DermatologyTimes....more

NIH May Own Gilead's Blockbuster Hepatitis Drug Due to Misstep

Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more

Aligning a Product's Marketing, Regulatory and IP Plans

Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD). Originally published in Law360 - September 8, 2017....more

Deuterated Drugs Are New Chemical Entities

FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more

Supreme Court Affords Greater Leeway to Biosimilars in the 'Patent Dance'

In a recent ruling, the U.S. Supreme Court clarified what happens when biosimilar applicants do not follow the regulatory framework for disputes with reference product sponsors — a process known as the “patent dance.” Since...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

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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