Wading into a long-running disagreement over the inventorship of patent claims involving low-dose administration of antidiuretic desmopressin, the U.S. Court of Appeals for the Federal Circuit chided a lower court Nov. 10 for abusing its discretion in granting Allergan Inc.’s request for summary judgment of equitable estoppel by failing to consider all the relevant evidence regarding the actions of both parties.
The appellate court vacated the judgment in Ferring v. Allergan and sent the case back to the U.S. District Court for the Southern District of New York for a do-over.
“Where the matter adjudged is a quintessentially fact-laden one, such as the equitable matter at issue here, it is especially important that we guard against a rush to judgment,” the Federal Circuit said in its precedential opinion. “We conclude that such a rush to judgment happened here.”
Ferring Pharmaceuticals Inc., of Parsippany, N.J., first filed its complaint in 2012 and then amended it a year later, seeking a correction in inventorship to patents granted to Seymour Fein that stemmed from his work, as a consultant, on a desmopressin project at Ferring in the late 1990s/early 2000s. Meanwhile, Fein had assigned his patents to Allergan in 2010 in a $43 million deal. Allergan countersued against Ferring and then requested summary judgment in 2015.
The district court granted the summary judgment, saying that Ferring’s long silence on Fein’s patents after a spate of correspondence in 2004 precluded the company’s right to assert its claims. However, the appeals court noted that the correspondence indicated Fein would be seeking patents on low-dose sublingual use of desmopressin; his patent claims didn’t recite sublingual administration.
In deciding the appeal, the Fed Circuit noted that it rejected Ferring’s “bright-line rule that equitable estoppel cannot apply whenever the scope of the issued patent is different than what the parties discussed in communications leading to the allegedly misleading conduct.” Differences in the scope of the claims may be relevant, it said, but “their mere existence does not render pre-issuance conduct or communications irrelevant.”
The appeals court agreed with Ferring that the company’s silence didn’t necessarily lead to estoppel. The Fed Circuit also agreed that “the district court erred by ignoring evidence that Fein intentionally and deliberately copied Ferring’s CS009 clinical study protocol for use in his own clinical studies.” That is one of the issues the court should consider on remand, the appellate court said.
CDC updates vaccine guidance
In a Nov. 9 update to its COVID-19 vaccine guidance, the U.S. CDC said its Advisory Committee on Immunization Practices (ACIP) will quickly hold a public meeting to review all the data when the FDA authorizes or licenses a SARS-CoV-2 vaccine.
Based on the data, ACIP will vote on whether to recommend the vaccine and advise on who should receive the vaccine. The ACIP recommendations must be approved by the CDC director before becoming official policy, according to the agency.
As a result of the work ACIP already has done, it is considering four groups to possibly recommend as the first to get the vaccine when supplies will be limited – health care workers, workers in essential and critical industries, people at high risk for severe COVID-19 illness due to underlying medical conditions and those who are 65 or older.
In making its final recommendations for a specific vaccine, ACIP will be driven by the goals of decreasing death and serious disease as much as possible, preserving the functioning of society, reducing the extra burden the coronavirus is having on people already facing disparities, and increasing the chance for everyone to enjoy health and well-being, according to the guidance.
Russia launches doctor-driven shortage reporting service
The Russian Ministry of Health launched a new online service to better track shortages of drugs, devices and personal protective equipment needed in treating COVID-19 cases.
Part of the State Services portal, the new site will allow doctors to submit proposals for organizing COVID-19 care, as well as comments on the lack or shortage of medical products and equipment, procedures for vaccinating medical personnel and problems with providing routine care.
The information collected will be sent to the head of the regional health management body for prompt resolution, according to the ministry.
MHRA reviewing acne drug risks
In its review of the risks and benefits of acne drug isotretinoin, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) is calling for information about the possible association between the drug and psychiatric or sexual disorders.
Marketed in the U.K. as Roaccutane, Reticutan and Rizuderm, isotretinoin is a retinoid used to treat severe forms of acne that have not responded to other therapies.
The MHRA said it will “work with patients and their families, as well as health care professionals and organizations, to ensure everyone has an opportunity to contribute to the review.” Noting the sensitivity of the issue, the agency said it would keep the information confidential.
While the MHRA is particularly interested in hearing from U.K. patients and families of their experience with the drug, it said it welcomes comments from people outside the U.K. as well.
After reviewing all the available evidence regarding isotretinoin, an expert working group will advise the MHRA on whether it should take additional regulatory action, which could include improving the risk information given to patients when they’re prescribed isotretinoin.