News & Analysis as of

The Complexities of the USPTO Proposed Attributable Ownership Rules

The USPTO proposed attributable ownership rules would require the public disclosure of the “attributable owner” of patent applications and patents. As discussed in this article, the proposed definition of “attributable owner”...more

FTC Continues Aggressive Posture On Reverse Payment Settlement Agreements With Reference To Disgorgement

In two recent statements, the FTC reaffirmed its intention aggressively to pursue reverse-payment patent settlement agreements in the pharmaceutical industry. ...more

FTC Targets Reporting of Licensing of Pharmaceutical Patents With Special Rules for Premerger Notification: What You Need to Know

On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the...more

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

Senate Legislation Update -- The Commerce Committee Gets in the Act

Last Thursday, Sen. McCaskill, along with Sen. Rockefeller, introduced the "Transparency in Assertion of Patents Act" (S. 2049). Of course, several other bills are currently pending in the Senate that have been introduced by...more

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more

"Antitrust and Competition: Nonmerger Enforcement Activity Heats Up on Both Sides of the Atlantic"

U.S. and European antitrust agencies had similar enforcement priorities last year, a trend we expect to continue in 2014. Nonmerger enforcement will continue to focus on intellectual property, financial services and...more

FTC Hit with Lawsuit by Target of its Fraudulent Patent Enforcement Investigation

On January 13, 2014, MPHJ Technology Investment LLC (MPHJ) filed a seven-count complaint against the Federal Trade Commission (FTC) alleging various constitutional and other violations, including violations of MPHJ’s First...more

"Antitrust and Competition: Surveying Global M&A Enforcement Trends"

US: Agencies Continue Aggressive Enforcement - Despite changes in leadership at the U.S. Department of Justice’s (DOJ) Antitrust Division and the Federal Trade Commission (FTC) (collectively, the Agencies) in 2013, the...more

Top Stories of 2013: #4 to #6

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

New FTC Rule Means More Exclusive Patent Rights Transfers Must Be Reported

The FTC has expanded the types of exclusive patent transfers that may be reportable under the HSR Act. Effective December 16, 2013, the FTC will consider patent transfers to be exclusive and potentially subject to the HSR Act...more

Give It Back! Disgorgement – Another FTC Arrow against Reverse-Payment Settlements that Delay Generic Entry

If the uncertainty that the Supreme Court’s Actavis decision injected into the world of reverse-payment settlement litigation wasn’t enough to get your attention, then the FTC’s recent effort to obtain disgorgement from...more

Global Connection - November 2013: Entering the U.S. Franchise Market: a Summary of Legal Considerations

Franchisors that have developed successful programs in their home countries will frequently consider expansion opportunities in other countries. In the past, the U.S. was not necessarily an attractive venue in light of the...more

FTC Expands Scope of Hart-Scott-Rodino Reporting Rules for Pharmaceutical Patent Rights Transfers

The Federal Trade Commission has broadened the rules dictating when pharmaceutical companies must report a transfer of exclusive patent rights to the U.S. Department of Justice and FTC for antitrust review and approval. Under...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

Patent Reform Update: Leahy Introduces Senate Bill, Goodlatte Circulates House Manager’s Amendment

Significant congressional activity took place on November 18, 2013, bringing patent reform several steps closer to enactment. While final passage remains too early to predict (and no single bill has yet been voted out of...more

Pay-for-delay to Stay FTC’s Top Priority

In a recent interview, Federal Trade Commission (FTC) Bureau of Competition chairwoman Deborah Feinstein announced that targeting pay-for-delay arrangements by pharmaceutical companies would continue as a top priority for the...more

Antitrust agencies amend premerger notification rules to clarify reporting of certain acquisitions of exclusive patent rights in...

The US Federal Trade Commission, with the concurrence of the Antitrust Division of the US Department of Justice, has amended the premerger notification rules to clarify when a transfer of exclusive rights to a patent or part...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

FTC Expands the Scope of Pharmaceutical Licensing Transactions That Will Be Subject to Premerger Review

The Federal Trade Commission (FTC) recently announced that it has finalized amendments to the premerger notification rules (HSR Rules) that provide a framework for determining when a transaction involving the transfer of...more

FTC Broadens Notification Requirements for Transfers of Pharmaceutical Patent Rights

The Federal Trade Commission (FTC) has revised the rule for determining when a transfer of exclusive rights to a patent in the pharmaceutical industry (including biologics and medicine manufacturing) results in a potentially...more

FTC Expands Reporting Requirements For Transfers Of Pharmaceutical Patent Rights

The U.S. Federal Trade Commission (“FTC”) issued final changes to the premerger notification rules that affect whether pharmaceutical companies must report certain proposed acquisitions of exclusive patent rights to the FTC...more

FTC Orders Greater HSR Reporting of Patent Licenses in the Pharmaceutical Sector

Background. One item on the negotiation checklist for patent licenses in the pharmaceutical sector is compliance with the U.S. Hart-Scott-Rodino (“HSR”) Premerger Notification Rules. The HSR rules require that certain patent...more

HSR Act Rules Expand For Pharmaceutical Licensing Agreements

Rules from the Federal Trade Commission include new requirements for reporting pharmaceutical patent transfers. On November 6, the Federal Trade Commission (FTC) released finalized amendments to the premerger...more

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