Tag Archives: patents

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.

COVID-19 Therapies: Protecting Against Government Intrusion

As the COVID-19 pandemic continues to disrupt our lives, wreak havoc on our economy and force millions to social distance, shelter at home or even quarantine, scientists across the globe have turned their focus and expertise to developing new treatments and vaccines aimed at containing the effects of this virus.

The need for this life-saving work has never been more apparent or more urgent. We owe them a sincere debt of gratitude as our lives may literally depend on their success. And as the hard work of these scientists starts to bear fruit, the demand for these treatments will be so urgent and of such magnitude that no single company will likely be able to scale up, manufacture and distribute the treatment to all those in need.

The U.S. government has several options at its disposal to intervene―if necessary―to ensure a low priced treatment is rapidly made available to those in need.

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

Numerical Ranges: More Than Just Endpoints in Patent Process

On February 11 and 12, 2020, the United States Patent and Trademark Office held a series of webinars covering the interpretation of ranges during the prosecution of patent applications. The following is a brief report and summary of the covered material.

Numerical ranges provide more than just two particular endpoints for a set of data within patent applications. The interpretation of a claimed numerical range when compared with disclosed numerical ranges in the prior art, assuming the claimed invention recites the other limitations of the prior art, can form the basis for an anticipation rejection based on 35 U.S.C. § 102, an obviousness rejection under 35 U.S.C. § 103, or an alternative grounds rejection under both 35 U.S.C. §§ 102/103.

View the full Alert on the Duane Morris LLP website.

What Competitors Don’t Know Can Hurt You: SCOTUS Rules Secret Sales Can Trigger On-Sale Bar Under AIA

The Supreme Court of the United States recently affirmed the decision of the U.S. Court of Appeals for the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals, 855 F.3d 1356 (2017), which invalidated a patent-in-suit under the post-AIA on-sale bar. The question presented, answered by the Court in the affirmative, was “[w]hether, under the Leahy-Smith America Invents Act [AIA], an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.”

Justice Thomas, writing for the Court, concluded that the “on sale” provision in §102(a)(1) of the AIA was a re-enactment of the “on sale” bar provision in the pre-AIA patent statute that did not alter its meaning or interpretation, despite the inclusion of the phrase “or otherwise available to the public” in post-AIA §102(a)(1). Thus, based on the Federal Circuit’s “settled precedent,” and consistent with the Supreme Court’s decision in Pfaff v. Wells Electronics, 525 U.S. 55 (1998), the Court held that “a commercial sale to a third party who is required to keep the invention confidential may place the invention ‘on sale’ under [the AIA].” Details of the ruling and some takeaways for companies entering into licenses and supply agreements are discussed below.

Read the full Duane Morris Alert.

COMMINGLED INTELLECTUAL PROPERTY–LIKE PEANUT BUTTER AND JELLY?

By Jennifer A. Kearns, John M. Neclerio and Vicki G. Norton

Who doesn’t like the favorite sandwich of childhood – peanut butter and jelly? The two substances blend and meld together, creating a delectable gooey, messy, sticky and sweet treat.

In the life sciences, commingled intellectual property can also create “gooey,” messy and sticky problems for companies. Unfortunately, there’s nothing sweet about commingled IP and the complications that can arise from it, and you can be sure that an experience arising from claims of commingled IP will leave a sour taste in your mouth.  Here we discuss proactive or preventative steps that companies can take to reduce the risk of commingling IP.

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