News & Analysis as of

Patents FDA Approval Patent Applications

Rothwell, Figg, Ernst & Manbeck, P.C.

Key Patent Considerations for Antibody Drug Conjugates (ADCs)

In 1910, German scientist Paul Ehrlich introduced a groundbreaking concept to the world: chemical compounds could be engineered to interact with unique receptors on disease-causing cells while avoiding interaction with...more

Robins Kaplan LLP

ANDA Approvals - Fall 2024

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 18th, 2:00 pm PDT

Smart & Biggar on

Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 12th, 12:00 pm GMT

Smart & Biggar on

Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...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

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

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

MarkIt to Market® – March 2022: Watching the Pot™

Easing Barriers to Medical Marijuana Research May Unlock a New Wave of Innovation; Biopharma Tactics Should Inform Strategic Patent Protection - While more than two thirds of U.S. states and the District of Columbia have...more

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

MarkIt to Market® – March 2022

Thank you for reading the March 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss copyright registration eligibility in relation to non-human authorship and new legislation surrounding...more

Knobbe Martens

Federal Circuit Review - September 2021

Knobbe Martens on

Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more

Fox Rothschild LLP

USPTO Launches COVID-19 Prioritized Patent Application Examination Pilot

Fox Rothschild LLP on

After offering to expedite review of trademark applications for COVID-19 products and services, the USPTO has now launched a prioritized examination pilot program for certain patent applications “that claim products or...more

Sheppard Mullin Richter & Hampton LLP

USPTO Announces a New Initiative to Expedite Examination of COVID-19 Related Patent Applications

The USPTO has authorized an initiative to prioritize examination of patent applications having COVID-19 uses that would require FDA approval. A pilot program only for small and micro entities has been implemented effective...more

Mintz

COVID-19: Prioritized Patent Application Examination and Patents 4 Partnerships

Mintz on

The United States Patent and Trademark Office (USPTO) has recently launched two new initiatives to support COVID-19 innovations: 1) a COVID-19 Prioritized Examination Pilot Program, and 2) Patents 4 Partnerships that provides...more

Smart & Biggar

Rx IP Update - February 2019

Smart & Biggar on

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Hogan Lovells

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents,...

Hogan Lovells on

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...more

Foley & Lardner LLP

Orange Book Listing Creates Injury To Support Standing To Appeal IPR Decision

Foley & Lardner LLP on

Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and...more

Foley & Lardner LLP

The Hobson's Choice Of The Hatch-Waxman Integrity Act

Foley & Lardner LLP on

As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more

Knobbe Martens

Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc.

Knobbe Martens on

Federal Circuit Summary - Before Wallach, O’Malley, and Schall. Appeal from the Patent Trial and Appeal Board. Summary: PGR petitioner has standing to appeal PTAB decision, where petitioner intended to file an ANDA for...more

Miles & Stockbridge P.C.

Teaming Up to Cure Cancer "Patents 4 Patients" – Fast Track Review

The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more

Sheppard Mullin Richter & Hampton LLP

PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications...more

McDonnell Boehnen Hulbert & Berghoff LLP

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

Foley Hoag LLP

A Fractured Federal Circuit Panel Interprets The Biosimilars Patent Resolution Procedures

Foley Hoag LLP on

On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more

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