Posts Tagged: "Food and Drug Administraiton"

The contentious issues surrounding Right to Repair are getting super-heated as the U.S. Copyright Office concludes its triennial rulemaking review of exemptions to section 1201 of the Digital Millennium Copyright Act (DMCA). Exemptions granted would be in force for three years beginning October 2024.  When is an exemption not an exemption? When it’s an exemption from common sense.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Monday issued a precedential decision affirming a district court’s mixed ruling in a patent infringement case involving two patents owned by United Therapeutics on the pulmonary hypertension drug, Tyvaso.
U.S. Patent 10,716,793 and U.S. Patent 9,593,066 cover methods of treating pulmonary hypertension and pharmaceutical compositions comprising treprostinil—Tyvaso is an inhaled solution formulation of treprostinil. United Therapeutics also owns a new drug application (NDA) for Tyvaso, No. 022387.

The U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) today jointly held an all-day listening session featuring speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies who weighed in on the relationship between patents and affordable access to medicines. The session was announced via a Federal Register Notice and request for comments on the subject, published on November 7, 2022, stemming from a joint July 2022 announcement that the two agencies plan 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.”

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.

On Friday, April 1, Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to once again voice his concerns about several sources advancing data on the effects of pharmaceutical patents on drug pricing. Tillis is specifically troubled that the data seems to be based on opaque methodologies and to contain inaccurate or incomplete information that may mislead policymakers. In a previous letter to these organizations, he requested the agencies conduct an independent assessment of the accuracy and reliability of those sources. In the present letter, Tillis again highlights his concern about work from the Initiative for Medicines, Access & Knowledge (I-MAK). He had previously written to Tahir Amin, Co-Founder and Co-Executive Director of I-MAK, requesting that I-MAK provide a detailed explanation of its methods to allow others to check the accuracy of I-MAK’s patent data and to assess the credibility of its other assertions.

Just over one week ago, Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University published a Policy Memo with the Hudson Institute charging that some of the key data relied upon in the heated debate over the effects of pharmaceutical patents on drug pricing and access may be faulty. Now, Senator Thom Tillis (R-NC) has written letters to the key organization providing that data, the Initiative for Medicines, Access & Knowledge (I-MAK), as well as the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), expressing concern about the findings of Mossoff’s memo and requesting more information from I-MAK about its methodology.

The U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) recently released an update to its Orange Book patent and biologic patent study, examining post-grant petitions filed against Orange Book patents and biologic patents between September 16, 2012, and June 30, 2021. The PTAB classified a petition as challenging an Orange Book-listed patent by comparing the petition’s filing date with data from the U.S. Food and Drug Administration’s (FDA’s) electronic Orange Book indicating when the patent was listed. The PTAB manually identified biologic patents as any patent potentially covering a Purple Book-listed product and any non-Orange Book-listed patent directed to treating a disease or condition.

Almost a third of the recently signed $8.3 billion bill to fund the United States response to the coronavirus outbreak is devoted directly to vaccine research and development. And while the realities of drug development and FDA approval mean it is unlikely any vaccine will be available before next year, the government has numerous tools at its disposal in seeking to reduce the strain on the nation’s health care system. As many as nine different pharmaceutical companies worldwide are rushing to develop a safe and effective vaccine. Some are using traditional vaccine methods, including testing previously developed vaccines for other viruses. Others are using new technology to address the outbreak. The rush to find and deploy a coronavirus vaccine raises several interesting legal and regulatory issues, including balancing speed with efficacy, understanding ownership, and vaccine costs.

The U.S. Court of Appeals for the Federal Circuit recently affirmed the Patent Trial and Appeal Board’s (PTAB’s) decision upholding the patentability of Eli Lilly & Co.’s patent claims directed to reducing toxicity of a chemotherapy agent. In so holding, the Federal Circuit cited the Food and Drug Administration’s (FDA’s) skepticism of the efficacy of the methods as evidence supporting non-obviousness. See Neptune Generics, LLC v. Eli Lilly & Co., Nos. 2018-1288, 2018-1290, 2019 U.S. App. LEXIS 12492 (Fed. Cir. Apr. 26, 2019) (Before Moore, Wallach, and Hughes, J.) (Opinion for the Court, Moore, J.) Neptune Generics, LLC, Fresenius Kabi USA, LLC, and Mylan Laboratories Ltd. (collectively, the Petitioners) filed three petitions for inter partes review (IPR) against claims 1-22 of U.S. Patent No. 7,772,209 (the ?209 patent) owned by Eli Lilly & Co. The ?209 patent generally relates to methods of administering folic acid and a methylmalonic acid (MMA) lowering agent, such as vitamin B12, before administering pemetrexed disodium, a chemotherapy agent, to reduce the toxic effects of pemetrexed. The Board found that the ?209 patent was not unpatentable as obvious because it was not known in the art to pretreat pemetrexed with vitamin B12 along with folic acid and the skepticism of others, specifically the FDA, supported a conclusion of non-obviousness. The Federal Circuit found that substantial evidence supported the PTAB’s findings and affirmed.

High prescription drug prices and their impact on costs borne by the government in Medicaid, Medicare Part D and other federal programs, is a front burner topic in Washington. The President has committed to reducing the price of prescription drugs, and pressured drug companies to hold the line. The Department of Health and Human Services (HHS) has proposed two regulatory initiatives—price disclosure in drug advertising and foreclosing rebates from manufacturers to pharmacy benefits managers (PBMs)—aimed at pushing prices down. Some Democrats have urged more sweeping actions, such as having the government negotiate Medicare drug pricing as a single buyer or regulating drug prices by reference to an international index based on government-negotiated drug prices abroad. These proposals cannot solve the drug pricing problem. The Administration’s proposals merely tweak the status quo and put no effective restraint on new drug prices. Jawboning by the Executive has had a minimal impact. Disclosure of manufacturers’ list prices, unless accompanied by numerous and inherently confusing caveats highlighting the difference between those prices and the co-pay an insured consumer must bear at retail, is potentially misleading and, in any event, has no direct impact on prices. Eliminating rebates, as HHS’s rulemaking acknowledged, will inevitably raise health insurance costs now partly paid for by rebates while manufacturers’ pricing power remains unabated. The Democrats’ call for government power buying or price regulation would impact drug prices but also require politically sensitive government determinations about the “worth” of prescription drugs to patients—a significant step on the road to government-allocated health care. 

This week in Other Barks & Bites: The United Nations highlights the importance of women in innovation on International Women’s Day; Comments due today on USPTO Section 101 Guidance; FDA Commissioner Scott Gottlieb resigns; a Senate bill with six bipartisan co-sponsors would increase requirements on patent disclosures for biologics; USPTO Director Iancu speaks out on Alice; Apple announces its intention to increase its presence in San Diego while its patent battle with Qualcomm heats up; Chinese copyright registrations increased by double digit percentage points in 2018; Stanley Black & Decker faces off against Sears in a trademark infringement battle over branding for Craftsman tools; Amazon announces that it will close dozens of pop-up stores in the U.S.; and Democrats from both houses of Congress introduce a new net neutrality bill.