News & Analysis as of

United States Patent and Trademark Office › Biologics › FDA Approval

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

American Conference Institute (ACI) on

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

American Conference Institute (ACI) on

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

Fish & Richardson

Biologics and Biosimilars Landscape: IP, Policy, and Market Developments

Fish & Richardson on

In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

American Conference Institute (ACI) on

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: The USPTO's COVID-19 Prioritized Examination Pilot Program

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

On May 14, 2020, the United States Patent and Trademark Office (USPTO) began accepting requests for prioritized examination of up to 500 patent applications without requiring payment of certain fees associated with...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Announces COVID-19 Prioritized Examination Pilot Program

McDonnell Boehnen Hulbert & Berghoff LLP on

Earlier this month, the U.S. Patent and Trademark Office announced that it would be implementing a COVID-19 Prioritized Examination Pilot Program, in which applicants that qualify for small or micro entity status will be...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

Herbert Smith Freehills Kramer on

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Troutman Pepper Locke

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

Troutman Pepper Locke on

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

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