Co-authored by Benjamin R. Dryden. 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 FTC rules go into effect on December 16, 2013. Importantly, these rules clarify when transfers of rights … Continue reading this entry
Tags: Antitrust, Exclusive License, Federal Trade Commission (FTC), Hart-Scott-Rodino (HSR), License
Last year, on November 23, 2011, the USPTO announced that it was considering collecting information on patent ownership and requiring disclosure of patent ownership information throughout the patent application process. Although written comments were due by January 23, 2011, the USPTO has not issued any response to public comments. Instead, in a Federal Register Notice issued November … Continue reading this entry
Tags: Exclusive License, License, Necessary Party, Ownership, Real Party In Interest (RPI)
As of January 1, 2012, PCT applicants can request that the International Bureau (IB) publish information indicating that their applications are available for licensing. WIPO will make the information available on its PATENTSCOPE website, but it will not be published with the PCT application itself. According to the announcement in the December 2011 PCT Newsletter, the … Continue reading this entry
Tags: License, Licensing Availability Request, Licensing Indication, PCT, WIPO
When a drug candidate is licensed to different licensees in different territories, the ability of each licensee to obtain marketing approval for the product may depend on access to data generated by the other. While license agreements do not always address this issue, there are some terms that can be useful in this type of situation. Case Study … Continue reading this entry
Tags: Access, Amgen, Arqule, Clinical Trial, Daiichi Sankyo, Data, FDA, License, Phase III, Regulatory Approval, Right of Reference, Territory
On March 16, 2011, Depomed, Inc. disclosed in an SEC filing that it entered into a Settlement Agreement with Abbott Laboratories to terminate an exclusive license agreement between the parties relating to Depomed's gabapentin product. I have been paying close attention to this situation because it involved a potential dispute between the parties as to the meaning of diligence provisions in the license agreement.
… Continue reading this entry
Tags: Abbott, Depomed, Diligence, DM-1796, Gabapentin, Gralise, License, Settlement, Termination
On June 15, 2010, Neurocrine Biosciences, Inc. and Abbott International Luxembourg S.à r.l entered into a $575 million collaboration deal for the development and commercialization of elagolix, Neurocrine’s novel, first-in-class oral gonadotropin-releasing hormone (GnRH) antagonist for the treatment of endometriosis-related pain and uterine fibroids. The collaboration agreement was filed by Neurocrine with the U.S. Securities and Exchange … Continue reading this entry
Tags: $575 Million, Abbott, Elagolix, License, Neurocrine
Posted in Antitrust; Life Sciences Agreements
Posted in USPTO Proposed Rule Changes