On September 23, 2020, the U.S. Food and Drug Administration (FDA) published a proposed rule amending the agency’s regulations concerning “intended uses.” While the proposed rule does not signal a fundamental change in FDA’s position that all relevant sources of evidence may be considered, it attempts to make clear what sort of evidence is not on its own sufficient to demonstrate a product’s intended use.
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The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to generic drug applications and updating the Orange Book to reflect those changes.
MAPP 5242.1 makes clear that the policies, processes and procedures for changing ownership of an application differ based on whether the change is effected by a simple transfer of ownership or whether it results from a corporate merger or acquisition.
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In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.
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On July 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance containing its current thinking, policies and recommendations relating to the manufacturing and marketing of “multiple function” device products—products comprised of at least one FDA-regulated “device” function and at least one “other function”—a function that either does not meet the definition of a “device” under the Federal Food, Drug & Cosmetic Act; that is not subject to premarket approval; or for which the FDA has expressed an intention not to enforce regulatory compliance.
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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…
On July 21, 2020, the U.S. Food & Drug Administration (FDA) issued draft guidance outlining the agency’s current thinking on the development of drugs containing cannabis or cannabis-derived compounds. The new guidance is disappointing to many in the cannabis industry because it does not provide insight into the FDA’s views on the marketing of nondrug, hemp-derived CBD products.
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On June 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures with respect to device establishments—facilities where medical devices are manufactured. The FDA’s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications between the establishment’s representative and FDA’s inspector(s) during the inspection process.
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U.S. patent law establishes requirements that inventors and applicants must satisfy to obtain a patent, which include utility, recitation of patent eligible subject matter, novelty, nonobviousness, an adequate written description, enablement and the best mode of practicing the invention. Biogen International GmbH v. Mylan Pharmaceuticals, Inc. presents an example of tensions between the nonobviousness and written description requirements.
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In response to the ongoing COVID-19 public health emergency, the United States Food and Drug Administration (FDA) issued a temporary policy related to the distribution of drug samples. Recognizing the unique challenges currently facing manufacturers that distribute drug samples as part of marketing efforts and the healthcare providers requesting those samples for patients, the FDA is temporarily easing certain requirements of the Prescription Drug Marketing Act.
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On June 4, 2020, the U.S. Food & Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products—led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health—that include both (i) drug and device; or (ii) biological product and device constituent parts. In addition, because the underlying 2017 Guidance was issued by OPD, CBER, CDER and CDRH collectively, the same principals would like apply to inspections in which CBER is the lead center.
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