An inter partes review (IPR) cannot be instituted based solely on statements made by the applicant about prior art in the specification of the challenged patent, the U.S. Patent and Trademark Office (USPTO) said in a memo of binding guidance sent Tuesday to all Patent Trial and Appeal Board (PTAB) judges. The memo reminds the judges that the America Invents Act restricts the basis of IPRs to prior art patents and printed publications. Since a patent cannot be prior art to itself, “the challenged patent itself, or any statements therein, cannot be the ‘basis’ of an IPR,” the agency explained. However, it noted, such statements “may provide evidence of the general knowledge possessed by a person of ordinary skill in the art and may be used to support an obviousness argument in conjunction with one or more prior art patents or printed publications.” In the past, according to the USPTO, some PTAB panels have used an admission in the specification of a challenged patent in instituting IPRs based on their interpretation that the admission was prior art and it was found in a patent. Such interpretations had created confusion among the various PTAB panels, the agency said.
Countering what it called a “troubling drop in routine childhood immunizations” due to COVID-19 shutdowns, the U.S. Department of Health and Human Services (HHS) amended its public health emergency declaration to increase access to those vaccines and decrease the risk of preventable disease outbreaks as children return to daycare and school. The amendment authorizes state-licensed pharmacists, and supervised, licensed pharmacy interns, to order and administer FDA-licensed vaccines to individuals ages 3 through 18. In issuing the amendment, HHS noted that “an unfortunate result” of families following lockdown orders was that many children missed routine vaccinations. “This decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by the COVID-19 pandemic,” HHS said, as it can place additional strains on the health care system, especially if avoidable outbreaks coincide with a resurgence of COVID-19.
The FDA issued a final guidance about its compliance policy for the quantity of bioavailability and bioequivalence samples that must be retained. The guidance, which will allow smaller samples to be retained, reflects technological advances in the agency’s ability to test the samples and responds to applicants and contract research organizations (CROs) that requested retention of a lower quantity of reserve samples. A reduced sample size will be less burdensome for applicants and CROs while ensuring public health, the FDA said. The agency is implementing the guidance immediately without a comment period because “prior public participation is not feasible or appropriate as public comment would not affect the specifications of FDA's testing of retention samples,” according to a notice published in the Aug. 19 Federal Register.
The U.S. Department of Justice (DoJ) filed a False Claims Act complaint against Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc., both subsidiaries of Jerusalem-based Teva Pharmaceutical Industries Ltd., alleging they illegally paid Medicare copays for Teva’s blockbuster multiple sclerosis (MS) drug, Copaxone (glatiramer acetate). DoJ alleged that from 2007 through 2015, Teva paid two foundations, the Assistance Fund and Chronic Disease Fund, with the understanding that the foundations would use the money to cover the copays of Medicare beneficiaries taking Copaxone, violating the Anti-Kickback statute. At the same time, Teva raised the U.S. price of Copaxone from about $17,000 per year to more than $73,000 per year – more than 19 times the rate of inflation. According to the complaint, Teva referred MS patients who faced Medicare copays for Copaxone to its specialty pharma vendor, Advanced Care Scripts Inc., which allegedly coordinated the referral of new patients to the foundations in batches at the same time the drug company made payments to the foundations. The timing ensured the Copaxone patients received most of the copay assistance the foundations provided with money from Teva. The two foundations and the specialty pharmacy already have agreed to settlements with the government.
Health Canada said this week that it is implementing an International Council for Harmonisation guideline, S11: Nonclinical safety testing in support of development of paediatric medicines. The guideline, which is to be implemented in the EU next month, is intended to streamline drug development while minimizing the unnecessary use of animals in nonclinical testing. It recommends standards for when nonclinical juvenile animal testing would be considered informative and necessary to support pediatric clinical trials and provides guidance on the design of that testing.
The FDA and the NIH’s National Center for Advancing Translational Sciences updated CURE ID to make it a more effective tool during the COVID-19 pandemic. The updates allow doctors to more easily report real-world experiences in treating COVID-19 patients who are unable to be enrolled in a clinical trial. An internet-based repository that lets clinicians report novel uses of existing drugs for difficult-to-treat infectious diseases through a website or mobile device, CURE ID enables the crowdsourcing of medical information to facilitate the development of new treatments for neglected diseases. The updates include a case report form tailored to COVID-19 with data fields harmonized with other real-world data and clinical trial platforms.
The U.S. Drug Enforcement Administration is finalizing its March 10, 2020, interim rule making cenobamate, including its salts, a schedule V controlled substance, according to a notice to be published in the Aug. 20 Federal Register. The FDA approved the SK Biopharmaceuticals Co. Ltd. drug, marketed as Xcopri, last November to treat partial-onset epileptic seizures in adults.
HHS said it has debarred Anil Jaiswal, a former professor in the School of Pharmacology at the University of Maryland at Baltimore, for three years following findings of misconduct in research supported by NIH grants. The misconduct included the use of manipulated images to falsely show research results in NIH grant applications and two papers. As part of a voluntary exclusion agreement, Jaiswal will ask to have the papers, published more than 15 years ago, corrected or retracted, according to a notice published in the Aug. 19 Federal Register.
The U.S. Securities Exchange Commission will hold an open meeting Sept. 16 to consider amendments to modernize Rule 14a-8, which governs the inclusion of shareholder proposals in a company's proxy statement. If approved, the amendments would mark the first change to the shareholder-proposal process in more than 35 years. The amendments "recognize the significant changes that have taken place in our markets in the decades since these regulatory requirements were last revised, including, in particular, the types and use of communications, the types and frequency of shareholder-company engagement and the substantial shift to investing through mutual funds and ETFs, rather than directly by Main Street investors," SEC Chairman Jay Clayton said last November when the amendments were introduced.