API and IP Newsletter
Contents
ANDAs approved in April 2023
We follow generic FDA approvals every month, especially small molecules ie ANDAs.
In April about 83 ANDAs were approved and out of which about 10 were tentative approvals.
Some of our observations are as below.
General information
Challenges of manufacturing eye care medicines in India
Shortage of Skilled Labour: The Indian pharmaceutical industry faces a shortage of skilled labour, which hampers the manufacturing process. To overcome this challenge, the industry needs to invest in training and development programs to upskill the existing workforce and attract new talent to the industry.
Lack of Adequate Infrastructure: Though initiatives and efforts by the government are driving the growth of the sector, the Indian pharmaceutical industry still lacks adequate infrastructure, which makes it difficult to manufacture high-quality eye care medicines.
News here.
Dual draft guidance outline FDA vision for paediatric drug development, exclusivity
The FDA says these new draft guidance “revise and replace” a 2005 draft guidance, How to Comply with the Pediatric Research Equity Act. The agency notes, however, that the new draft documents do not replace “any other pediatric guidance already published.”
“The substantial lag between approval of a drug for adult use and the approval in children,” Lynne Yao, director of the Division of Pediatrics and Maternal Health, said in a statement.
News here
Intellectual Property
GSK vs Teva on Skinny label or label cave out issue
Section viii carve-outs
What are Section viii carve-outs in the US?
The statute (21 U.S.C. § 355(j)(2)(A)(viii)) allows the generic sponsor to remove or “carve out” the protected indication or other protected condition of use from the product labelling, and submit a “section viii” statement explaining that the applicant does not seek approval for the protected use
Though the statue looks simply the issues related to section viii carve-outs remain unresolved in the context of small molecules.
This is the case of Carvedilol and GSK’s patent # `000 reissued in 2008, related to the treatment of congestive heart failure post-myocardial infarction using carvedilol.
In the lower court, Teva argued that it could not be found to have induced infringement because the patented use was carved out on the skinny label.
The lower Court held that GSK failed to prove Teva caused the direct infringement.
GSK appealed. On appeal, GSK argued that Teva promotes its generic product as being the same as the branded product.
In October 2021, a three-judge CAFC panel decided in favour of GSK and impose a $235 mio penalty on Teva.
Decision here.
The petition was filed at Supreme Court. In the US, the Supreme Court in general takes up very few cases on petition. In March 2023, Biden Government’s solicitor general Elizabeth Prelogar requested Supreme Court justice that the case is a suitable vehicle to address the larger existential question for the industry over skinny labels.
The issue to be addressed by Supreme Court was, whether a generic drug manufacturer's FDA-approved label that carves out all of the languages the brand manufacturer has identified as covering its patented uses can be held liable on a theory that its label still intentionally encourages the infringement of those carved-out uses.
However, in spite of intervention from the US Government on 15 May Supreme Court denied Teva’s petition.
This is not good for Teva. With the denial, Teva will continue to owe a $235 million pay-out to GSK which was imposed after the CAFC ruling in October 2021 which stated Teva persuaded doctors to prescribe its generic version Coreg (Carvedilol).
Decision here.
