Salmon Calcitonin 200 IU/SPRAY (Fortical): Court issued permanent injunction against Apotex

In a patent dispute between generic player Apotex and innovator Upsher-Smith Lab, the U.S. District Court for the Southern District of New York has issued permanent injunction against generic player. (as reported by innovator in press release Here )

The court has opined that the disputed patent US6440329, which was reissued after corrections by USPTO as USRE40812 is valid.

Earlier in July, 2006, Apotex filed ANDA with Para IV certification against ‘329 patent. The innovator asserted claim 19 of he ‘329 patent against Apotex. Importantly, the claim 19 was reissued as such in the reissued patent by USPTO.

USRE40812 (Assignee: Unigene Laboratories, Reissued date:June, 2009 Expiry: Feb 2, 2021): The disputed claim 19 covers a liquid pharmaceutical composition comprising about 2,200 MIC units of salmon calcitonin, about 20 mM citric acid, about 0.2% phenylethyl alcohol, about 0.5% benzyl alcohol, and about 0.1% polyoxyethylene(20) sorbitan monooleate.

The essential feature of claim 19 is the use of citric acid in Salmon Calcitonin, which enhanced shelf stability and bioaviailability of the formulation.

The Apotex challenged the said patent based on obviousness grounds. Further, Apotex asserted that the claimed formulation in RE’812 is substantially similar to M/S Novartis Pharma’s marketed formulation Miacalcin (the formulation comprises of 2200 IU/ ml 0f Salmon Calcitonin, sodium chloride as tonicity agent, nitrogen as sparging, Benzalkonium chloride as absorbtion enhancer agent, preservative and surfactant, HCl as PH adjusting agent), which was approved by USFDA on Aug 17, 1995.

Arguably, Apotex alleged that it would have been obvious for person having ordinary skilled in the art (PHOSITA) to replace Benzalkonium chloride in Miacalcin formulation by citric acid as absorption enhancing agent to devolp Fortical formulation.

Importnatly, in the prior art, there was no reference, which could suggest that Citric acid can act as absorption enhancing agent. Further, the court observed that a PHOSITA would have not motivated to select Citric acid as absorption enhancing agent.

Also, court observed that use of 0.1% polyoxyethylene(20) sorbitan monooleate and benzyl alcohal in a single nasal spray formulation is not obvious. Further, prior art teaches away from the said combination.

In the light of above evidences, court opined that the claimed invention is not obvious and denied Apotex’s summary judgment request and granted innovator’s summary judgment request and issued permanent injunction against generic player.

Innovator UPSHER SMITH got final approval from USFDA to market Salmon Calcitonin 200 IU/SPRAY (Fortical) on Aug 12, 2005