Step backwards for Generic Oracea. Invalid patents are back

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.

Fed. Circ. Revives Galderma’s Patents On Rosacea Drug

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.

The patents-in-suit are U.S. Patent Numbers 5,789,395; 5,919,775; 7,211,267; 7,232,572; and 7,749,532.

[Update] for an exhaustive summary of the relevance of this ruling see the following article . Note the important summary.

Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2013)

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.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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1 Reader Comment

  1. KRC says:

    I just today went out and purchased a bottle of Afrin. As typical I began to flush after my evening meal. I tried the Afrin applied topically and experienced absolutely no improvement with redness. I was hoping it would work for the portability factor. I was hoping that if I am out at a restaurant or visiting it would have been convenient to keep in my handbag. It does nothing to help me.That is my bad news.
    My good news is that apparently what does help is simple green tea. This has proven to be helpful for both redness and the neurogenic burn that I experience. The tea takes about ten minutes to work, but soaking a cloth in strongly brewed tea kept in my fridge is the only thing that seems to alleviate my redness and burn. I followup w. a little Jojoba oil as recommended by another poster and that seems to bring relief- albiet redness and burn. I just purchased a green tea soap, but too early to tell. This pretty much aligns with what others have said – expect to play trial and error and expect to pay mucho bucks trying different products and product combinations. I have to come up with a way to keep tea in my handbag. Containorizing is the main issue, which shouldn’t be too hard to work out.

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