In the recent opinion of Amarin Pharma v. Hikma Pharms. U.S., the District Court of Delaware dismissed Amarin’s complaint against Hikma for induced infringement of three patents when Hikma used a skinny label to carve out a patented indication. However, the court held that Amarin sufficiently pled to proceed with the complaint against an insurer, Health Net, for induced infringement.
To read the full text of this Duane Morris Alert, please visit the firm website.
Pharmacy benefit managers (PBMs) play a significant role in U.S. drug pricing, yet their existence is little known to those outside of the pharmaceutical and insurance arenas. In an effort to modify one of the largest drivers in increasing drug costs―rebates paid to PBMs by drug manufacturers―the U.S. Department of Health and Human Services on November 20, 2020, published three final rules that, most notably, declared that these rebates are no longer protected by the safe harbors to the anti-kickback statute.
To read the full text of this Duane Morris Alert, please visit the firm website.
On November 16, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Fraud Alert addressing speaker programs presented by pharmaceutical and medical device companies. Such programs, at which companies may pay physicians or other health care professionals (HCPs) for speeches or presentations about drugs and devices in addition to providing remuneration to attendees, are frequently sponsored by pharmaceutical and device companies seeking to provide education regarding their products. Highlighting what it called “inherent fraud and abuse risks,” OIG’s Special Fraud Alert expressed concerns surrounding the offer or payment of remuneration from pharmaceutical and device companies to physicians or other HCPs associated with such programs.
To read the full text of this Duane Morris Alert, please visit the firm website.
Duane Morris LLP
Pharmaceutical branded drug developers interested in obtaining trademark protection should take note of the Supreme Court holding in Helsinn v. Teva that patent eligibility can be defeated by a private sale of a pharmaceutical drug from a manufacturer to a drug distributor (Helsinn Healthcare S.A., v. Teva Pharmaceuticals USA, INC. (139 S.Ct. 628 (2019)). Trademark protection via registration is often sought for branded pharmaceutical drugs when seeking to establish a market for new pharmaceutical therapies.
Trademarks for pharmaceutical drugs are subject to the requirements of two entities – the U.S. Patent and Trademark Office (“USPTO”) trademark requirements when seeking trademark registration and those of the Office of Postmarketing Drug Risk Assessment (“OPDRA”). The OPDRA, a sub-group of the Center for Drug Evaluation Research (“CDER”) of the U.S. Federal Drug Administration reviews and either approves or rejects new drug trademarks (also known as proprietary names) before they can be marketed. The OPDRA’s requirements for a pharmaceutical trademark are separate and distinct from those of the USPTO, and are not so impacted by the Helsinn decision as are those of the USPTO.
One of the USPTO requirements for issuance of a trademark registration is the use in commerce of the mark. An applicant must, at time of applying for registration or within a certain time thereafter, prove that the mark is used in commerce. A trademark registration for a pharmaceutical drug will therefore require use in commerce of the pharmaceutical drug, but oftentimes an application for trademark registration will be submitted well in advance of a market launch. Such a requirement can be met by certain pre-market activities, such as, inter alia, by use of the drug in clinical studies, in distribution to clinical sites in preparation for a clinical trial, or even pre-approval sales to a distributor. Distribution or sales, unfortunately, may present a risk to the patentability of the pharmaceutical compound or uses thereof discovered after the date of the transaction.
Enter Helsinn v. Teva
Over 18 months ago, the Supreme Court held that “an inventor’s sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art under § 102(a).” The subject sale consisted of two agreements: a license agreement and a supply and purchase agreement. Such commercial transactions could pose a bar to patent applications filed more than a year after the date of the agreements (e.g., for claims directed to effects observed in clinical trials, to dosages, or to combination therapies). For additional details on Helsinn, see our earlier blog on this topic here.
The Helsinn ruling that a secret sale can qualify as a prior sale for purposes of patent law is in tension with the USPTO’s acceptance of trademark specimens from pre-clinical or clinical trials to satisfy the “use in commerce” requirement for trademark protection. A pharmaceutical trademark applicant may face the challenge of avoiding Helsinn while also trying to rely on specimens used in commerce to obtain trademark registration. Should the deciding court find that the trademark standard for “use in commerce” equates to a patent “sale” or “public use”, said use in commerce could potentially defeat patentability. Pharmaceutical companies would face the dilemma: patent or trademark?
However, there may be another method of satisfying the trademark requirements while avoiding patentability-defeating sales or disclosures. The term “use in commerce” for trademark requirements, includes use in connection with “goods [which] are sold OR TRANSPORTED in commerce” (emphasis added).[1] Activities classified from the trademark perspective as “transported in commerce” which do not qualify as an “on-sale” patent bar might therefore be an elegant solution to the dilemma. Of course, facts matter…
It is instructive to pharmaceutical drug manufacturers seeking patent and trademark protection to be aware of the relative timing for applying for pharmaceutical drug trademarks, distributing samples for, and conducting clinical trials, and applying for patents directed to claims identified during the clinical trials. As a takeaway, a trademark applicant may want to (1) evidence the transport of a sample containing packaging bearing the mark across state lines to satisfy the trademark use in commerce requirements, and (2) file a U.S. patent application before commercial activity begins for satisfying trademark registration requirements.
[1] Section 45 of the Trademark Act, 15 U.S.C. §1127, defines “commerce” as “all commerce which may lawfully be regulated by Congress.” Section 45 defines “use in commerce” as follows:
The term “use in commerce” means the bona fide use of a mark in the ordinary course of trade, and not made merely to reserve a right in a mark. For purposes of this Act, a mark shall be deemed to be in use in commerce–
(1) on goods when—
(A) it is placed in any manner on the goods or their containers or the displays associated therewith or on the tags or labels affixed thereto, or if the nature of the goods makes such placement impracticable, then on documents associated with the goods or their sale, and
(B) the goods are sold or transported in commerce, and…
Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate. The Food and Drug Administration (FDA) considers data integrity to be critical throughout the current good manufacturing practice (CGMP) to ensure product quality and public safety. In response to an increased number of data integrity violations, which have led to warning letters, import alerts and consent decrees, the FDA published a draft guidance on Data Integrity and Compliance with CGMP on April 14, 2016. After considering comments to the draft guidance, the FDA has now issued its Final Guidance on Data Integrity and Compliance with Drug CGMP on December 12, 2018. The Final Guidance is in a Q&A format and provides detailed instructions to the industry that reflects the FDA’s current thinking on data integrity.
