Tag Archives: pharmaceuticals

Juxtaposing Helsinn with Pharmaceutical Trademarks

Ryan Smith, Karen Kline

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…

 

Playing Your Cards Right: Arguments Against Obviousness Can Be Detrimental for Satisfying the Written Description Requirement

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.

To read the full text of this Duane Morris Alert, please visit the firm website.

FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP

On January 30, 2020, the U.S. Food & Drug Administration (FDA) issued a new Manual of Policies & Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.

Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it “may grant an ANDA submission either a shorter review goal date or an expedited review” if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.

View the full Alert on the Duane Morris LLP website.

Much of Oklahoma’s $572 Million Opioid Case Likely to Be Replicated Elsewhere, But Unique Cause of Action May Not

On August 26, 2019, Cleveland County, Oklahoma, District Judge Thad Balkman delivered his highly anticipated ruling in the state of Oklahoma’s lawsuit against certain pharmaceutical companies responsible for manufacturing and marketing prescription opioid medications. Because the other pharmaceutical companies named in the state’s case settled with the Attorney General’s Office earlier this year, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals remained the primary subjects of the evidence at trial and the focus of the attention surrounding Judge Balkman’s then-forthcoming ruling.

As Judge Balkman stated in the published judgment, the defendants knowingly and misleadingly marketed their highly addictive prescription opioids, and by doing so caused harm for which the state could seek redress, as their “actions annoyed, injured, or endangered the comfort, repose, health or safety of Oklahomans.”

View the full Alert on the Duane Morris LLP website.

CDER’s New MAPP on Risk-Based Site Selection Model for Routine Inspections

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.

We invite you to read the full text of this Duane Morris Alert on the firm website.