For those following the saga of the possible availability of Generic Oracea in the future, another twist today. Two of the patents that were previously ruled invalid and thus unable to protect Galderma’s product, have now been ruled no longer invalid.
This legal ruling will no doubt embolden Galderma that their profitable product Oracea can continue as an exclusive low-dose doxycycline treatment for the symptoms of rosacea.
Today’s result flies in the face of recent news that Lupin Pharmaceuticals was close to making Generic Oracea available, having been granted tentative FDA approval. Galderma will now have potentially 2 more patents at their disposal to mount a challenge to Lupin.
The saga will continue as these patents have not been ruled to be valid and protective, but the previous designation of invalid has been set aside. Don’t you just love how these things work!?
Be ready for this battle to take several years to resolve.
Law360, New York (August 07, 2013, 5:48 PM ET) — By Alex Lawson
The Federal Circuit on Wednesday vacated a district court’s finding that two patents held by Galderma Laboratories Inc. for rosacea drug Oracea were invalid, ruling that the district judge did not adequately examine certain claims in light of prior art presented by generics manufacturer Mylan Pharmaceuticals Inc.
The three-judge panel said the district took too narrow a view in invalidating U.S. Patent Numbers 5,789,395 and 5,919,775, known as the Amin patents, which cover the use of certain antibiotics known as tetracyclines to inhibit nitrus oxide production and prevent rosacea.
The panel was careful not to rule on the merits of the invalidity ruling in light of the dependent claims but merely vacated the ruling and sent it back to the district court for full consideration.
[Update] for an exhaustive summary of the relevance of this ruling see the following article . Note the important summary.
August 08, 2013, By Andrew Williams
The result was somewhat academic, in part because the Plaintiffs also asserted a later-expiring patent [i.e. the Chang patent (ed)] that had been found by the lower court to be valid and infringed by Mylan.
The Federal Circuit affirmed the remainder of the lower court’s findings, with the result being that the FDA will not be able to approve Mylan’s ANDA until the expiration of the infringed patent, which currently will occur on December 19, 2027.”
So we are not going to see Generic Oracea for many years.