The U.S. House Blue Dog Coalition called on Congress to put partisanship aside and pass seven prescription drug pricing bills as standalone legislation that could pass in both the Democrat-controlled House and the Republican-controlled Senate. “In this time of hyper-partisanship, the only way we can fully address real issues impacting the American people is to identify commonsense, bipartisan solutions that can be implemented into law,” said Rep. Tom O’Halleran (D-Ariz.), the coalition’s policy co-chair. A House caucus made up of 26 Democrats, the coalition is pushing for the standalone passage of the CREATES Act, which would make it easier for would-be competitors to get samples of a reference drug; the Protecting Consumer Access to Generic Drugs Act, which prohibits pay-for-delay settlements; the Public Disclosure of Drug Discounts Act that would require pharmacy benefit managers to report their aggregate rebates, discounts and other price concessions for prescription drugs to a public website; the Purple Book Continuity Act, intended to make the FDA’s listing of approved biologics similar to that of the Orange Book by requiring it to be searchable and include relevant patents; the Orange Book Transparency Act, which requires the FDA listing of small-molecule drugs be kept up-to-date with patents removed promptly after they’ve been invalidated by a court or a Patent Trial and Appeal Board; the Payment Commission Data Act, which would give access to drug pricing and rebate data to the independent Medicare and Medicaid commissions to help Congress better understand the true costs of prescription drugs to consumers and taxpayers; and the BLOCKING Act, which is intended to prevent the long-term “parking” of the 180-day first generic exclusivity to delay competition. Over Republican objection, the House bundled several of the bills with partisan measures when it brought them to the floor for a vote earlier this year. The Senate is including many of the bills in a bipartisan package handled by three committees. (See BioWorld, May 24, 2019.)
The word “essentially” played a big role in a precedential, partly split opinion the U.S. Court of Appeals for the Federal Circuit handed down Thursday in Horizon Pharma USA Inc. v. Actavis Laboratories UT Inc. The majority of the appellate panel affirmed a lower court’s decision that several claims in method-of-use patents protecting Horizon’s osteoarthritis drug. Pennsaid 2% (diclofenac sodium topical solution). were indefinite and that Actavis did not induce infringement of a method patent with its labeling instructions. In her partial dissent, Judge Pauline Newman took issue with the majority’s finding of indefiniteness, which it based on the use of the clause “consisting essentially of” in some of the claims. Writing for the majority, Judge Jimmie Reyna said that in the context of the claims, “the inclusion of ‘essentially’ would allow the patentee to assert its claim against products containing ingredients nowhere listed in the patent claim.” Newman aragued that the distinction the majority made between “consisting of” and “consisting essentially of” was contrary to precedent and would cast “countless patents into uncertainty.” The majority tried to limit the impact saying, “To be clear, we do not hold today that so long as there is any ambiguity in the patent’s description of the basic and novel properties of its invention, no matter how marginal, the phrase ‘consisting essentially of’ would be considered indefinite. Nor are we requiring that the patent owner draft claims to an untenable level of specificity. We conclude only that, on these particular facts, the district court did not err in determining that the phrase ‘consisting essentially of’ was indefinite in light of the indefinite scope of the invention’s basic and novel property.” Newman also disagreed with the majority ruling that “there can be no liability for induced infringement because some patients may not follow the label instructions. . . . Patients may not always comply with instructions. However, this does not insulate the provider from infringement liability.” The panel was in agreement in affirming the district court’s finding that claim 12 of the ’913 patent was nonobvious and its order enjoining Actavis from marketing a generic until the’913 patent expires in 2027.
The FDA’s Office of Pediatric Therapeutics will hold a public workshop at the agency’s Silver Springs, Md., campus Nov. 12 to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases. Specific topics will include patients’ opinions on current trial endpoints, potential areas of innovation, and ways to create processes to include pediatric patients and their caregivers as collaborators in endpoint development in the early stages of medical product development. “While there is increased emphasis on incorporating the patient voice in rare disease drug development activities, there is an increased need for pediatric patient-specific engagement efforts,” the FDA said in a notice published in Thursday’s Federal Register.
India’s Central Drugs Standard Control Organisation (CDSCO) issued a draft question-and-answer document explaining its requirements for the import and registration of biopharmaceuticals. Responding to frequently asked questions on the subject, the draft defines terms and explains the procedures for getting a registration certificate and an import license. It also lays out the various fees involved. It can take up to 45 days to get an import license once a complete application has been received, CDSCO said, and up to nine months for a registration certificate.