Fennec announced that the US Patent & Trademark Office will issue U.S. Patent 10,596,190 to Pedmark. The patent is titled “Method for Reducing Ototoxicity in Pediatric Patients Receiving Platinum-Based Chemotherapy.” The patent can be found here.
The patent covers Fennec’s Pedmark to reduce the ototoxic effects of cisplatin in pediatric patients, particularly in the age group of five years or younger.
What does this mean?
Short answer: Pedmark’s life could be extended by an extra ~10 years to 2037.
Long answer: In the US, term of patents are 20 years from filing date. Fennec’s above patent was filed on November 29, 2017. Therefore, the patent expires November 29, 2037. Prior to this patent, Fennec only had 7.5 years of market exclusivity (upon approval) from the FDA’s Orphan Drug designation. This would have given Fennec coverage until the end of 2027, assuming approval mid-2020. With the active patent, protection could be extended by an extra ~10 years to November 29, 2037.
Important Note: Fennec’s patent is eligble to be included in the FDA's Orange Book upon Pedmark approval.
What is an FDA Orange Book Eligible Patent?
The FDA’s Orange Book lists approved drugs and each patent that is protecting the drug, including expiry of the patent. The Orange Book is critical in determining when generic drugs can enter a market.
In order for a generic drug to apply & win approval, the generic manufacturer must certify that:
- the NDA holder has not submitted patent information to the FDA for listing in the Orange Book;
- the patent has expired;
- the date the patent will expire; or
- the patent is invalid or will not be infringed by the generic drug
The above certifications provide protection to the approved brand name manufacturer (Fennec in our case). Filing a generic application in spite of the above certifications is an act of patent infringement, which would grant Fennec the ability to sue a generic drug applicant before the generic drug is marketed. This would result in litigation between the brand name manufacturer/ generic manufacturer. Litigations will put a 30 month stay on the generic application and, generally, end up in a settlement between both parties (ex.Ironwood’s Linzess).
Bottom Line: We will have to wait and see if/when Pedmark is approved to find out if today’s patent is included in the FDA’s Orange Book. We believe it will be included, which will discourage generic companies from filing ANDAs (generic version of NDA) as far out as 2037. Fennec becomes a much more attractive takeout target with Pedmark’s extended life.
PropThink contributors are LONG FENC
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