Posts Tagged: "pharmaceutical patents"

On October 7, the Federal Trade Commission (FTC) sent letters to 10 pharmaceutical companies notifying them of the agency’s intent to challenge allegedly improper patent listings in the U.S. Food and Drug Administration’s (FDA) Orange Book. While the FTC argues that improperly listed patents can delay consumer access to affordable generics, some have questioned whether the FTC’s regulatory action could slow the development of new treatments, which would in turn delay access to new generics.

Twenty-five intellectual property luminaries sent a letter today to several members of Congress asking them to beware of misleading and inaccurate assertions by “activists and academics” that government price controls on drugs will lead to lower costs for consumers. The letter was sent to Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA), Chairman and Ranking Member, respectively, of the Senate Committee on Health, Education, Labor & Pensions; and Representatives Jason Smith (R-MO) and Richard Neal (D-MA), Chairman and Ranking Member, respectively, of the House Committee on Ways and Means.

It is not news that cannabis-based medicines have been used for millennia around the world in the treatment of conditions and diseases such as chronic pain; epilepsy; neuropsychiatric disorders; nausea and vomiting related to chemotherapy; symptoms associated with autistic spectrum disorder; amyotrophic lateral sclerosis; rheumatoid arthritis, among others. However, this topic has been the subject of recent discussions due to the progressive dissemination of scientific data proving the efficacy and safety of their uses. New scientific research and clinical studies are expected, not to mention the revision/alteration of legislation in some countries so that the cultivation, production, commercialization and use of cannabis-based medicines becomes more viable and comprehensive.

The Council for Innovation Promotion (C4IP) on Monday held a webinar featuring some big names in the IP world to clear up what the organization characterizes as misguided views on the use of Title 28 of the U.S. Code, Section 1498(a). The event was prompted in part by a recent U.S. government statement of interest filed in a patent infringement suit against Moderna, Inc.’s COVID-19 vaccine. That statement argued that Moderna should be released from infringement liability under the terms of a government contract that “authorize[d] and consent[ed] to all use and manufacture” of any U.S. patented invention.

A bipartisan group of congress members sent a letter to U.S. Patent and Trademark Office Director Kathi Vidal late last week urging her to implement some of the proposals outlined in her October 2022 Request for Comments on Robust and Reliable Patents in order to address problems around drug pricing. The letter was sent by Representatives Jodey Arrington (R-TX), Lloyd Doggett (D-TX), Michael Burgess (R-TX), Ann McLane Kuster (D-NH), and Darrell Issa (R-CA). They specifically expressed concerns about the practice of “patent thicketing” and gave the example of two separate patents granted for a rheumatoid arthritis biological drug by the same company, where the difference in the claims was seemingly minor. The letter cites to a video titled “The Case for Patent Reform,” featuring Senior Vice President and Head of Legal & Intellectual Property Biosimilars at Fresenius Kabi, for this reference.

Today, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) published a Patient Access Report profiling the many ways in which drug pricing controls, often enacted in the name of ensuring widespread access to low-cost medicines, actually result in less access to innovative medicines that are more widely available in free markets. The GIPC’s report comes at a time during which the Biden Administration has taken recent action on drug pricing provisions included in the Inflation Reduction Act passed into law last August, which could have deleterious effects on patient access in the United States.

On February 24, the U.S. Patent and Trademark Office (USPTO) issued a notice in the Federal Register indicating that the nation’s patent agency was reopening the comment period related to its request for comments (RFC) on collaboration initiatives with the U.S. Food & Drug Administration (FDA). Previously closed on February 6, the comment period on USPTO-FDA collaboration initiatives is now extended until March 10. The reason stated in the Federal Register notice for reopening and extending this comment period is to “ensure that all stakeholders have a sufficient opportunity to submit comments on the questions presented” in the agency’s RFC on ways that the two agencies could cooperate to improve market entry of generic drugs and biosimilars, and to reduce the number of patent grants related to certain drugs. The reopening of the comment period comes a few weeks after the USPTO also reopened and extended the deadline for responding to the agency’s RFC on ensuring robust and reliable patent rights. As reported at that time, while it’s understandable that the agency is interested in hearing from as many stakeholders as possible, some have said the extensions are creating uncertainty as to which stakeholders are being given more time to prepare their full comments for submission.

Yesterday, February 1, was the deadline for submissions to the U.S. Patent and Trademark Office (USPTO) on its call for responses to a number of questions purportedly aimed at making U.S. patents more “robust and reliable.” But many commenters have weighed in to question why the Office is relying on data driven by advocacy groups to explore potentially major adjustments to the U.S. patent system when, as the expert agency on patents, it has not yet undertaken a data-driven study itself to confirm the need for such changes. The key data being questioned is that of  the Initiative for Medicines, Access & Knowledge (I-MAK), an advocacy organization that has become a “principal, go-to source” for data on the number of patents and patent applications covering pharmaceutical innovations. Some of the questions raised in the USPTO’s Request for Comments (RFC) seem to be based on many of the premises of the I-MAK data.

Healthcare costs in the United States continue to rise, placing an ever-increasing burden on patients and government payer programs. Popular discourse blames patented drugs as the culprit for these rising costs. In a move that previously would have been unthinkable, policymakers have even called upon the Department of Health and Human Services to exercise a mechanism known as Bayh-Dole “march-in” rights, to break the patents on drugs that the private sector has spent billions developing, in order to lower their prices. But this fixation on patents as a major driver of America’s medical spend is misplaced.

On August 19, British brand name pharmaceutical firm GlaxoSmithKline (GSK) filed a brief with the U.S. Supreme Court opposing a petition for writ of certiorari filed by generic drugmaker Teva Pharmaceuticals. Teva’s petition appeals a decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) reinstating a jury verdict that found Teva liable for inducing infringement of GSK’s patents covering the heart failure treatment, Coreg. GSK’s brief argues that the Federal Circuit properly applied the law on induced infringement and that the “skinny label” arguments raised by Teva’s petition only affect 30% of the damages awarded by the jury in the case.

In its third precedential patent decision this week, the U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed a district court’s finding that Eagle Pharmaceuticals, Inc.’s abbreviated new drug application (ANDA) does not infringe two patents owned by Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Company, LLC (collectively, Par). The CAFC also affirmed the district court’s denial of declaratory judgment that the sale of the proposed generic product would infringe.

Late last week, United States Patent and Trademark Office (USPTO) Director Kathi Vidal announced in a blog post that the agency had issued a notice in the Federal Register, which was published on Friday, to clarify the duties of disclosure and reasonable inquiry for pharmaceutical patent applicants, as well as parties to Patent Trial and Appeal Board (PTAB) proceedings. The notice was specifically targeted to parties proceeding before both the USPTO and Food and Drug Administration (FDA) and was issued in response to urging by Senators to establish interagency communications aimed in part at eliminating so-called drug patent thickets.

Earlier today, the U.S. Senate Committee on the Judiciary convened a brief executive business meeting to discuss a series of judicial nominees selected by the Biden Administration, as well as a pair of proposed bills. One of those bills, the Interagency Patent Coordination and Improvement Act of 2022, follows various efforts to limit certain patent rights in the pharmaceutical industry and was passed favorably out of the Committee via voice vote toward a full vote on the Senate floor.

The U.S. Patent and Trademark Office (USPTO) yesterday announced in a joint blog post with the Food and Drug Administration (FDA) that the Office plans to execute a number of initiatives aimed at lowering drug prices, as directed in July 2021 by President Joe Biden’s “Executive Order on Promoting Competition in the American Economy.” The announcement came via a blog post jointly authored by USPTO Director Kathi Vidal and Food and Drug Administration (FDA) Commissioner Robert M. Califf. Biden’s Executive Order in part encouraged curbing some pharmaceutical companies’ practices, such as so-called pay-for-delay settlement agreements between brand pharmaceutical companies and generics manufacturers. The Order called for the USPTO and the FDA “to leverage [their] collective expertise in promoting innovation, competition, and the approval and regulation of safe and effective drugs to help provide relief to American families at the pharmacy.”