Senator Tammy Baldwin (D-WI) sent letters this week to companies warning of improper Orange Book listings of patents for inhalers, following up on the FTC’s focus on potential anticompetitive harm of improper listings. According to Senator Baldwin’s letters, the recipients of the letters were warned by the FTC in November regarding the listing of inhaler patents, but have not removed the patents from the Orange Book. The letters follow an investigation launched earlier this month by the Senate Committee on Health, Education, Labor, and Pensions (of which Senator Baldwin is a member) into the prices of inhalers.
Coordinating IP and Regulatory Filings Can Minimize the Risk of Inequitable Conduct Before the PTO
On July 29, 2022, the U.S. Patent and Trademark Office (PTO) published a Notice on the Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board. The notice was part of the PTO’s response to President Joe Biden’s July 2021 Executive Order on Promoting Competition in the American Economy. It also answered Congress’ call for PTO action following the Federal Circuit’s September 2021 ruling that a drug formulation patent was unenforceable based on a drug manufacturer’s inconsistent disclosures to both the PTO and the FDA. In view of the notice, companies should review the interface between their IP and regulatory functions to confirm that their interoperation (or lack thereof) does not run afoul of a patent applicant’s duties of disclosure and reasonable inquiry to the PTO.
To read the full text of this Duane Morris Alert, please visit the firm website.
Silence Is Not Necessarily Golden for Negative Patent Claim Limitations
During the prosecution of a patent application before the U.S. Patent and Trademark Office, claim amendments that introduce a negative limitation―the exclusion of a particular element or feature from the scope of the claims―may be dispositive in distinguishing the instant application from the prior art and advance the application toward allowance. However, the introduction of negative limitations may raise questions and issues as to whether the claims satisfy the written description requirement under 35 USC §112(a). Recently, the U.S. Court of Appeals for the Federal Circuit elaborated upon what satisfies the written description requirement with respect to the recitation of negative claim limitations.
To read the full text of this Duane Morris Alert, please visit the firm website.
Duane Morris Life Sciences & Medical Technologies Industry Group Ranked in The Legal 500
Duane Morris’ Life Sciences and Medical Technologies Industry Group has been ranked in The Legal 500 US 2021 guide.
An excerpt from the publication:
Duane Morris LLP is recommended for its expertise in M&A, patents, and commercial licensing and collaboration agreements, acting for domestic companies in addition to a strong roster of clients in the Asia-Pacific region.
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Who Watches the Watchmen? Supreme Court to Decide Fate of Administrative Patent Judge Appointments
The Supreme Court of the United States is to decide the fate of administrative patent judges of the Patent Trial and Appeal Board, namely whether the current appointment scheme violates the Appointments Clause of the U.S. Constitution. This case, which may have broad implications on post-grant proceeding process before the USPTO, is being watched by companies around the world.
To read the full text of this Duane Morris Alert, please visit the firm website.
Forum Selection Clause Held Inapplicable for Precluding Inter Partes Review Before the Patent and Trial Appeal Board
Confidentiality agreements or nondisclosure agreements (NDAs) are generally one of the first documents that in-house counsel require teams to execute when exploring licensing and/or research opportunities with third parties. NDAs are meant to protect the confidential information of one or both parties while each party determines whether the collaboration is worth pursuing. However, in a recent case in the Southern District of New York, one party tried to invoke a forum selection clause of an NDA to prevent the other party from challenging patents using inter partes review at the USPTO’s Patent Trial and Appeal Board.
To read the full text of this Duane Morris Alert, please visit the firm website.
Juxtaposing Helsinn with Pharmaceutical Trademarks
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.
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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.