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Patent Applications United States Patent and Trademark Office Pharmaceutical Industry

Fish & Richardson

Preparing Your Company for Hatch-Waxman

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The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Provides Guidance on What Claims Can Properly Serve As Obviousness-Type Double Patenting References

In a precedential decision issued on August 13, 2024, the U.S. Court of Appeals for the Federal Circuit held that a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued,...more

Lathrop GPM

Broad Biotech Patent Claims-the Saga Continues

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There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...more

Goodwin

USPTO Emphasizes Searches of FDA Databases for Pharmaceutical Patent Applications

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In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more

American Conference Institute (ACI)

[Event] 20th Paragraph IV Disputes - April 25th - 26th, New York, NY

Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...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

Goodwin

USPTO Announces Cancer Moonshot Expedited Examination Program

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​​​​​​​The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, “Cancer Moonshot Expedited Examination Pilot Program” (the “Cancer Moonshot Program”)...more

Goodwin

USPTO and FDA Continue to Focus on Patent Quality in the Pharmaceutical Industry

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​​​​​​​After a recent reminder from the U.S. Patent and Trademark Office (USPTO) regarding the duties of disclosure and reasonable inquiry during examination of a patent application and a Request for Comments (RFC) on the...more

AEON Law

Patent Poetry: Dispute over COVID Vaccine Shows Importance of Inventorship

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Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...more

Proskauer - Life Sciences

Update on Artificial Intelligence: USPTO Urges Federal Circuit to Affirm Decision That AI Cannot Qualify as an “Inventor”

In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

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As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Proskauer - Life Sciences

Juno v. Kite: Written Description and Claiming Antibodies and Chimeric Antigen Receptors—Lessons for Patent Prosecutors

The recently reversed jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno...more

Proskauer - Life Sciences

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

American Conference Institute (ACI)

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

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

Proskauer - Life Sciences

Update on Artificial Intelligence: Court Rules that AI Cannot Qualify As “Inventor”

Striking a blow to patent applicants seeking to assert inventorship by artificial intelligence (“AI”) systems, the U.S. District Court for the Eastern District of Virginia ruled on September 3, 2021 that an AI machine cannot...more

Knobbe Martens

Is your funded medical device startup actually a “large entity” according to the USPTO?

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The U.S. Patent and Trademark Office (USPTO) allows a patent applicant to pay reduced fees if it qualifies as a “small entity.”  Many types of filing fees are reduced by 50%.  These savings can be important for companies on a...more

Troutman Pepper

Enforcing IP in a Pandemic: Considerations, Risks, Strategies

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Moderna, a biotechnology company that is currently advancing a leading COVID-19 vaccine candidate, recently stated that it would not enforce its vaccine patents during the current health crisis. In light of this...more

Dorsey & Whitney LLP

USPTO Defers Provisional Filing Fees For COVID-19 Technologies, But Beware Of Early Publication

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The USPTO has announced yet another COVID-19 pilot program, which began on September 17, 2020. Under this new pilot, the USPTO allows applicants to defer the application fee for any provisional patent application directed to...more

Fox Rothschild LLP

Expedited TM Review For Covid-19 Products/Services

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Last month, the United States Patent and Trademark Office’s (USPTO) began an initiative to expedite the review of, and waive the fees related to, trademark applications for marks used to identify qualifying Covid-19 products...more

Goodwin

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

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Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

Foley & Lardner LLP

Federal Circuit, USPTO Clarify Subject Matter Eligibility for Methods of Treatment

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On June 7, 2018, the USPTO issued new guidance in the form of a memorandum regarding the patentability of methods of treatment. This memorandum, issued in response to the Federal Circuit’s holding in Vanda Pharmaceuticals...more

Foley & Lardner LLP

USPTO Withdraws Newly Characterized Antigen Test For Written Description Of Antibodies

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The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the...more

Patterson Belknap Webb & Tyler LLP

USPTO Adopts Amgen v. Sanofi, Excises “Newly Characterized Antigen” Test from its Written Description Guidance for Antibody Claims

Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...more

McDonnell Boehnen Hulbert & Berghoff LLP

Bioquark Seeks to Reverse Brain Death

Last year, two biotech companies announced that they had received institutional review board (IRB) approval for a study focused on the clinical intervention of brain death in humans. The study, entitled "Non-randomized,...more

Ward and Smith, P.A.

New Patent Office Initiative Provides a Boost to Cancer Immunotherapy Patent Applications

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On June 29, 2016, the United States Patent and Trademark Office (USPTO) announced that it is implementing a pilot program to more quickly review patent applications related to treating cancer using immunotherapy. This...more

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