News & Analysis as of

Patents PHRMA

Dechert LLP

Initiatives to Increase Communication Between the USPTO and the FDA Concerning Pharmaceutical Patent Applications

Dechert LLP on

President Biden, in July 2021, issued an Executive Order (“E.O.”) observing that “too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and...more

Foley & Lardner LLP

USPTO-FDA Listening Session — Voices from Patient and Patent Advocates

Foley & Lardner LLP on

On January 19, 2023, the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) held a “listening session” focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's...more

Kramer Levin Naftalis & Frankel LLP

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more

Fish & Richardson

Mayo at Five: Eligibility of Diagnostic Method Claims

Fish & Richardson on

Just over five years ago, the Supreme Court began reshaping the concept of patent-eligible subject matter in the life sciences with its decision in Mayo v Prometheus. Decisions following Mayo – from the Supreme Court to the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more

McDonnell Boehnen Hulbert & Berghoff LLP

No Rehearing En Banc for In re Cuozzo Speed Technologies -- PTAB Update

Earlier this week, the Federal Circuit issued an order denying a petition for rehearing en banc in the In re Cuozzo Speed Technologies, LLC case. As we have previously reported, this case was the first appeal of the first...more

Kelley Drye & Warren LLP

Expanded FTC Premerger Notification Rules Specific to the Pharmaceutical Industry are Upheld by the D.C. Circuit

The D.C. Circuit recently affirmed a lower court’s decision upholding regulations adopted by the Federal Trade Commission (FTC) requiring a Hart Scott Rodino (HSR) Act premerger notification filing for transfers of patent...more

Goodwin

Federal Appeals Court Upholds FTC HSR Rule on Pharma Patent Licenses

Goodwin on

Background – the HSR Act: Under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act), acquisitions of voting securities, assets and other commercial interests which exceed certain monetary thresholds...more

Mintz - Intellectual Property Viewpoints

D.C. Circuit Affirms: FTC Can Change HSR Rules Targeted at Pharmaceutical Patents

In a confluence of IP and antitrust law, a three judge panel for the D.C. Circuit recently affirmed a lower court decision upholding the Federal Trade Commission’s (“FTC”) 2013 modification of regulations under the Hart Scott...more

Foley & Lardner LLP

District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers

Foley & Lardner LLP on

A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We...more

Polsinelli

Recent 340B Orphan Drug Decision May Have Widespread Implications

Polsinelli on

In This Issue: - Orphan Drug Rule Background - PhRMA Sues to Block the Orphan Drug Rule - District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule - Implications on the “Mega-Reg” ...more

McDermott Will & Emery

FTC’s Reporting Rule for Pharmaceutical Patent Transfers Upheld

On May 30, 2014, the U.S. District Court for the District of Columbia ruled in favor of the Federal Trade Commission (FTC) in a dispute with the Pharmaceutical Research and Manufacturers of America (PhRMA) regarding the...more

Wilson Sonsini Goodrich & Rosati

District Court Upholds HSR Rulemaking on Pharmaceutical Patent Licensing Transactions

The transfer of certain patent rights in the pharmaceutical industry will remain subject to the premerger notification rules under the Hart-Scott-Rodino Act (HSR Act) after a federal judge rejected a challenge brought by the...more

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