News & Analysis as of

HSR Act Allows Pharmaceutical Licensing Transactions To Be Subject to Unique Reporting Requirements, FTC Tells Court

The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...more

In Defense of Patenting

Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more

Licence To Pill: Exclusive Or Not? Bristol-Myers Squibb Company v Apotex Pty Ltd

The Federal Court of Australia held that Bristol-Myers Squibb Company (BMS) is not the exclusive licensee of a patent relating to aripiprazole under the terms of the licence granted to it by Otsuka Pharmaceutical Co Ltd...more

Planes, trains and Over-the-Counter pills

This Reed Smith client alert looks at the recent amendments to the Human Medicines Regulations 2012, which came into force in November 2013....more

New FTC Rules for Exclusive Pharmaceutical Patent Licenses

The Federal Trade Commission (FTC) has issued final rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) relating to the transfer of exclusive patent rights in the pharmaceutical industry. These new...more

FTC Announces Amendments to Hart-Scott-Rodino Rules Regarding Pharmaceutical Patent Licenses

The Federal Trade Commission (FTC) has announced revisions to the rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) that will apply to certain transactions involving the transfer of patent rights in...more

FTC Finalizes Amendments To HSR Rules Regarding Transfer Of Exclusive Patent Rights In The Pharmaceutical Industry

The Federal Trade Commission (FTC) has finalized certain amendments to the Hart-Scott-Rodino (HSR) premerger notification regulations clarifying the scope of reportable transactions involving transfers of patent rights in the...more

Medicis Pharma. Corp. v. Anacor Pharma., Inc., C.A. No. 8095-VCP (Del. Ch. Aug. 12, 2013) (Parsons, V.C.)

In this opinion, the Court of Chancery denied the defendant’s motion to dismiss the plaintiff’s complaint for specific performance of a license agreement, holding that the plaintiff’s claims were not subject to mandatory...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses

To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more

China Life Sciences - January 2013

In This Issue: Investor Q&A; Key Regulatory Issues for Strategic Life Sciences Partnerships in China; Compulsory Patent Licensing in China; and New Developments on the “Patentable Subject Matter” Requirement of U.S....more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

Doing Business in Canada: Technology

Many Canadian businesses are involved in researching and developing cutting-edge technology in a number of areas including: information technology, high-tech, life sciences, pharmaceuticals, clean technology, environmental...more

FTC Sights Set on Pharma Deals – Calls for Additional Hart-Scott-Rodino Reporting

The Federal Trade Commission has proposed expanding Hart-Scott-Rodino reporting and waiting period obligations for certain pharmaceutical, biologics and medicine manufacturing licenses. The new rules are subject to public...more

Yet Another Turn of the Screw: The FTC Again Targets Pharmaceutical Industry, This Time Through the HSR Act

Fresh from its victory in the Third Circuit on “pay-for-delay” deals involving brand name and generic pharmaceutical companies, the Federal Trade Commission (“FTC”) has announced yet another initiative aimed at the...more

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