IP and Technology Transactions

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On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration asserts that its departure is guided, at least in part, by the goal “to get as many safe and effective vaccines to as many people as fast as possible.”[1] That goal, however, is unlikely to be affected by such a waiver in the short term due to uncertainty in World Trade Organization (“WTO”) politics, ongoing shortages on raw materials and equipment, and lag-time in retrofitting potential manufacturers.
Continue Reading Waiver Of Intellectual Property Protections For COVID-19 Vaccine Unlikely To Have Meaningful Impact In Short Term

While the legal landscape continues to evolve in the cannabis industry, making entry into the space a potentially risky proposition,  the passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”) can be a real game changer in attracting mainstream companies to the industry.

According to the Farm Bill, hemp is now exempt from the Federal Controlled Substance Act (“CSA”), theoretically making all hemp-derived cannabidiol (CBD) products, and all commercially available products derived from hemp, legal in all 50 states. 
Continue Reading The Farm Bill’s Impact on Hemp and CBD – and How Some States are Reacting

In our previous blog post of November 11, 2014, we noted that Celltrion had filed a declaratory judgment action against Kennedy Trust for Rheumatology Research for invalidity of certain patents covering methods of treating rheumatoid arthritis.  Celltrion Healthcare Co. v. Kennedy Trust for Rheumatology Research, Case No. 1:14-cv-02256-PAC (S.D.N.Y. 2014).  Unlike the other cases in which the biosimilar applicants challenged patents owned by reference product sponsors, this case involved a biosimilar applicants’ challenge to a patent that was not owned by the reference product sponsor (Janssen Biotech, Inc.), but by a licensor (Kennedy Trust for Rheumatology Research).  Janssen had a non-exclusive license to the Kennedy Trust patents in suit and Celltrion had voluntarily dismissed its declaratory judgment action of patent invalidity against Janssen on October 23, 2014.
Continue Reading Update: Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions Before Bringing Suit

In our blog post of November 18, 2013 (“No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Before Biosimilars Application is Filed”), we discussed the decision of the U.S. District Court for the Northern District of California holding that a biosimilars applicant could not avoid the Biologics Price Competition and Innovation Act (“BPCIA”) patent exchange process by filing a patent declaratory judgment prior to filing its 351(k) biosimilar application.  That case – Sandoz, Inc. v. Amgen Inc. – is on appeal to U.S. Court of Appeals for the Federal Circuit.  (Appeal docketed as No. 14-1693, Fed. Cir., December 13, 2013).  While that case, involving Amgen’s ENBREL® product, will decide the issue of whether BCPIA patent process can be avoided by filing a declaratory judgment prior to filing of the 351(k) application, another dispute has arisen between Sandoz and Amgen as to whether the patent and application certification and exchange process in Section 351(l)(2) of the Public Health Service Act is mandatory or permissive.
Continue Reading Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions Before Bringing Suit

Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may harm competition or competitors.  The Supreme Court has recognized an exception to this immunity for “sham litigation,” which it has defined as litigation that is “objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits,” and is motivated by a desire “to interfere directly with the business relationships of a competitor.”  (Prof’l Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49, 60-61 (1993)).
Continue Reading Sham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?

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 Department of Justice under the Hart-Scott-Rodino Premerger Notification requirements as asset transfers/acquisitions.  See 78 Fed. Reg. 68705, et seq.  While exclusive licenses of any patent regardless of industry have always been subject to reporting under the Premerger Notification rules as asset transfers/acquisitions, assuming they met the monetary thresholds for reporting, the FTC, adopted new rules specifically targeting exclusive licenses of patents of pharmaceutical companies.
Continue Reading FTC Targets Reporting of Licensing of Pharmaceutical Patents With Special Rules for Premerger Notification: What You Need to Know

The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) by obtaining a declaratory judgment of patent invalidity before even submitting a biosimilars application.  See Sandoz Inc. v. Amgen Inc., Civil No. 13-2894 MMC, _____ USLW _____ (N.D. Cal. 2013).
Continue Reading No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Action Before Biosimilars Application Is Filed

On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation. In FTC v. Actavis, 570 U.S. 756 (2013), the Federal Trade Commission (“FTC”) prevailed when the Supreme Court held in a 5-to-3 decision [1] that reverse payment settlements in Hatch-Waxman cases are subject to antitrust scrutiny, resolving a circuit split and impassioned debate among antitrust lawyers. This is only the second antitrust case in 20 years where the enforcers have prevailed. The Court, however, rejected the FTC’s position that reverse-payment settlements were presumptively illegal, ruling that they are subject to scrutiny under the rule of reason.
Continue Reading FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?

On August 13, 2012, the Federal Trade Commission (“FTC”) proposed amendments to the Premerger Notification Rules issued under the Hart Scott Rodino Antitrust Improvements Act of 1976 (the “HSR Act”). The proposed amendments would expand when a transfer of exclusive rights to a patent in the pharmaceutical industry is potentially reportable under the HSR Act.Continue Reading FTC Proposes Amendments to the Premerger Notification Rules to Expand the Reportability of Transfers of Exclusive Patent Rights in the Pharmaceutical Industry

Clinical trials are the lifeblood of biotech. Finding the right service providers (CROs, safety, IVRS, consultants, contract manufacturers and many others), as well as the right clinical investigators and sites, results in a complex web of legal obligations and potential liabilities. Limitation of liability clauses can reduce a party’s exposure if a contractual obligation is breached. More often, limitations of liability provisions are used to shift risk to the sponsor of the clinical trial. But, if your contracts are well negotiated and drafted, the risks can be carefully and fairly allocated between the parties in a balanced and reasonable manner. Because of the complexity of the legal relationships and liabilities found in clinical trials, this article is limited to a brief description of limitation of liability clauses, and their general strengths and weaknesses.
 Continue Reading Limiting Liability in Clinical Trials: Non-Lawyers, Lawyers Beware