Category Archives: Life Sciences Agreements

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Patent Related Changes To Bayh-Dole Act Regulations

Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that date. In this article, we focus on the most significant patent-related changes.… Continue reading this entry

Don't Blame Patents For High Drug Prices

Before his recent arrest, Martin Shkreli, the former CEO of Turing Pharmaceuticals, gained notoriety for increasing the price of the AIDS drug Daraprim® (pyrimethamine) from about $13.50 to about $750 per pill. He also was reported to be considering a similar price hike for benznidazole, for which his new company, KaloBios Pharmaceuticals, was going to seek … Continue reading this entry

Sequenom Deal May Avoid Federal Circuit Decision

Less than a month after their case was argued at the Federal Circuit, Illumina Inc. and Sequenom Inc. have announced a deal to settle their patent infringement litigation. While I haven’t seen an order dismissing the case, that is a likely next step. … Continue reading this entry

Federal Circuit Jurisdiction Over Patent Contract Disputes

In a precedential order issued in Jang v. Boston Scientific Corp., the Federal Circuit held that it has jurisdiction over the parties’ patent-related contract dispute under Gunn v. Minton even though the patents at issue have been invalidated. Despite having found Federal Circuit jurisdiction, the court denied the parties’ petition for permission to bring an … Continue reading this entry

Federal Circuit Refuses To Find Implied License For Endo Opana Patents

In Endo Pharmaceuticals, Inc. v. Actavis, Inc., the Federal Circuit reversed the district court’s decision denying Endo’s motion for summary judgment of infringement based on an implied license. The Federal Circuit found that Roxane and Actavis did not have an express or implied license to practice the Endo Opana patents at issue, even though they … Continue reading this entry

New FTC Rules For Exclusive Pharmaceutical Patent Licenses

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

Negotiate in Good Faith or Pay 50% of Your Profits; PharmAthene v. SIGA Technologies

On September 22, 2011, the Delaware Chancery Court awarded PharmAthene, Inc. a 50 percent share of profits above a certain threshold amount from sales of SIGA Technology Inc.’s pharmaceutical product known as ST-246, due to SIGA’s failure to negotiate in good faith for the grant of a license to PharmAthene. The outcome of this case … Continue reading this entry

IPOs, Acquisitions, "Bare-Knuckle Tactics" and More: A Recent Panel Discussion

On May 10th, at Foley & Lardner LLP's 2011 Boston Life Sciences conference, I participated on a panel entitled "Match Making: Identifying Partners, Creative Collaborations and Long Term Outcomes." Mike Morency, Ph.D., an Intellectual Property partner in Foley's Boston office moderated the discussion among John A. Delyani, Ph.D., M.B.A., Head, Therapeutic Areas for Strategic Alliances at the Novartis Institute of BioMedical Research, Gerry Brunk, Managing Director at Lumira Capital, and me. … Continue reading this entry

This Bag Ain't Big Enough for the Two of Us

On May 16th, Amylin Pharmaceuticals announced that it had filed a lawsuit against Eli Lilly alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of BYETTA® (exenatide) injection, a first line treatment for type 2 diabetes. In September 2002, Amylin and Lilly entered into a Collaboration Agreement, U.S. Co-promotion Agreement and several related agreements for the development and commercialization of BYETTA...Since the complaint was filed under seal, we do not know Amylin's specific arguments as to how Lilly breached the agreements with Amylin. These agreements have been publicly filed with the SEC (see [here] for the Co-Promotion Agreement and [here] for the Collaboration Agreement), so a review of some of the provisions may shed some light on the possible arguments by each party. … Continue reading this entry

Licensees Obtaining Data from Other Licensees

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

Stand-Off On Diligence Provisions: Depomed and Abbott Terminate License Agreement

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

Collaboration & License Agreement Review: Elagolix

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