The U.S. Patent and Trademark Office (USPTO) is launching a special category of its Patents for Humanity Program to recognize inventions that address the COVID-19 pandemic, the agency said April 5. The new award category is intended to provide business incentives for patent applicants, holders and licensees whose inventions track, prevent, diagnose or treat COVID-19. Created in 2012, the Patents for Humanity Awards are intended to honor game-changing innovations that address long-standing development challenges. Award winners receive a certificate to accelerate USPTO processing for one eligible matter, such as a patent application or ex parte reexamination proceeding. Under the Patents for Humanity Program Improvement Act, award winners may transfer the acceleration certificates to third parties, which means they can leverage the certificate to raise funds to help transform their inventions into deliverable goods and services, according to the USPTO.
First thrombosis incident reported in Australia
Australia’s Therapeutic Goods Administration (TGA) received its first report of thrombosis and thrombocytopenia with symptom onset seven days following vaccination with Astrazeneca plc’s COVID-19 vaccine in Australia. “No cause-and-effect relationship between COVID-19 vaccination and this case (or those reported internationally) has been established at this stage,” the TGA reported April 2, adding that the benefits of vaccination continue to outweigh the risks. The agency is investigating the case with a panel of external experts and is meeting with international regulators, including the EMA and officials from the U.K.’s Medicines and Healthcare Products Regulatory Agency to discuss the rare cases of blood clots reported several days after vaccinations with the Astrazeneca vaccine.
FDA offers guidance on ANDAs during pandemic
The FDA released a new question-and-answer guidance April 5 on generic drug development, submission and assessment of abbreviated new drug applications (ANDAs), and generic marketing and exclusivity during the pandemic. The guidance provides general recommendations based on the questions the agency has received from ANDA sponsors. The policy outlined in the guidance will remain in effect only for the duration of the COVID-19 public health emergency, according to the FDA.
FDA revises Moderna EUA
The FDA revised the emergency use authorization (EUA) for Moderna Inc.’s COVID-19 vaccine to help increase the number of doses available. The first revision clarifies that currently available vials of the vaccine contain 10 to 11 doses, depending on the type of syringes and needles used to extract each dose. The second revision authorizes an additional multidose vial containing 13 to 15 doses. Because the vaccine doesn’t contain a preservative, the FDA said remaining vaccine should not be pooled from multiple vials to create a full dose.
Fed Circuit’s indefinite ruling stands
The U.S. Supreme Court denied cert April 5 to Ibsa Institut Biochimique SA v. Teva Pharmaceuticals USA Inc., making last year’s Federal Circuit decision the end of the road for Ibsa, of Lugano, Switzerland. In that decision, the U.S. Court of Appeals for the Federal Circuit made it clear that words matter in translation, as it found that patent claims to a soft gel capsule formulation protecting Ibsa’s thyroid drug, Tirosint (levothyroxine sodium), were indefinite. At question was the use of “half-liquid” in the U.S. patent as the English translation of the Italian word “semiliquido,” which was used in the Italian priority document. Affirming a lower court’s decision, the Federal Circuit agreed that “half-liquid” was not synonymous with “semi-liquid” in the U.S. claims.
BMS settles Medicaid rebate claims
Bristol Myers Squibb Co. (BMS), of New York, agreed last week to pay the U.S. and participating states a total of $75 million, plus interest, to resolve allegations raised in a whistleblower suit that it knowingly underpaid Medicaid rebates, according to the U.S. Department of Justice. Under the Medicaid rebate program, drug manufacturers are required to pay quarterly rebates to state Medicaid programs based on the average manufacturer price (AMP) of the drugs covered by the program. The whistleblower alleged that BMS underreported the AMPs for a number of its drugs by deducting service fees paid to wholesalers from the AMPs and excluding additional value it received due to price appreciation provisions in its contracts with wholesalers. BMS will pay about $41 million, plus interest, to the U.S., with the rest of the settlement going to participating states.
GAO refuses to reconsider VA challenge
The U.S. Government Accountability Office (GAO) last week denied Shertech Pharmacy Piedmont LLC’s request for a reconsideration of the company’s challenge to the terms of a Department of Veterans Affairs (VA) request for quotes for providing radiopharmaceuticals to a VA medical center in Durham, N.C. Shertech, of Kernersville, N.C., claimed that the requirement for the successful contractor to be located within 50 miles of the VA center unduly restricted competition. But the GAO agreed with the VA that the geographic requirement was “reasonably necessary” to meet the medical center’s needs.