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United States Patent and Trademark Office › Biologics › Food and Drug Administration (FDA)

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

MoFo Life Sciences

Patent Term Extension For Medical Devices

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Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could...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

Axinn, Veltrop & Harkrider LLP

Are Drugmakers Gaming the Patent System?

Axinn, Veltrop & Harkrider LLP on

We all know that policymakers are increasingly focused on lowering drug costs. From the Inflation Reductions Act's Medicare price negotiations (aka price controls) to the recent proposals directed at pharmacy benefit managers...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

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

American Conference Institute (ACI) on

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

Goodwin

USPTO Publishes Notice Calling Out Pharmaceutical Industry

Goodwin on

President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

American Conference Institute (ACI) on

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

MoFo Life Sciences

Patent Term Extension For Biologics

MoFo Life Sciences on

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S....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

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

American Conference Institute (ACI) on

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Goodwin

FDA’s Woodcock Reviews Patents Practices as a Way to Effect Drug Pricing

Goodwin on

On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more

Mintz - Intellectual Property Viewpoints

PTAB statistics show interesting trends for Orange Book and biologic patents in AIA proceedings

Mintz - Intellectual Property Viewpoints on

The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends...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

Patterson Belknap Webb & Tyler LLP

The 2019 U.S. Federal Government Shutdown and its Potential Impact on Biologics

Patterson Belknap Webb & Tyler LLP on

On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day. If the shutdown continues through the weekend, it will be the longest federal government shutdown in U.S....more

Troutman Pepper Locke

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

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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

Patterson Belknap Webb & Tyler LLP

The Federal Circuit’s First Application of the AIA’s On-Sale Bar: Implications for Bio/Pharma

Patterson Belknap Webb & Tyler LLP on

When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner...more

Troutman Pepper Locke

Patent Term Extension for Drugs Not Limited to New Chemical Entities

Troutman Pepper Locke on

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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