Galderma suing Mylan Pharmaceuticals over Oracea

Galderma, the makers of Oracea are suing Mylan Pharmaceuticals for allegedly infringing 4 patents related to their sub-antimicrobiotic dose doxycycline product Oracea.

State University of New York, Galderma Sue Mylan

March 20 (Bloomberg) — The State University of New York, Galderma Laboratories LP and New York University sued generic- drug maker Mylan Pharmaceuticals Inc. for allegedly infringing four patents for the drug Oracea, used to treat skin blemishes.

“Mylan was aware of the existence” of the patents, and the patent-holders “will be irreparably harmed” unless stopped by a judge, the plaintiffs said in a complaint filed yesterday in federal court in Wilmington, Delaware.

The Bloomberg release specifically mentions the following patents:

  • 7,211,267: Methods of treating acne
  • 7,232,572: A method of treating rosacea in a human in need thereof comprising administering to said human a tetracycline compound in an amount that is effective to treat rosacea, but has substantially no antibiotic activity.
  • 5,919,775: Method for inhibiting expression of inducible nitric oxide synthase with tetracycline
  • 5,789,395: Method of using tetracycline compounds for inhibition of endogenous nitric oxide production

We also know that Collagenex holds up to 6 patents relating to Oracea. One of these patents, which was highlighted by Rosacea News in May 2006, covers treating ocular and facial rosacea at the same time with one treatment.

The market for rosacea treatments is certainly worth fighting for. The current value of rosacea prescriptions is greater than $500m a year. Galderma is well positioned to take advantage of this market, and the even bigger dermatology market with their rosacea products such as Metrogel, Oracea, the upcoming Sansrosa as well as the Cetaphil range.

Update: some more information has surfaced on the details of the claim

SUNY, NYU, Galderma Sue Generics Firm Mylan for Allegedly Infringing Rosacea Rx IP

The suit alleges that Mylan Pharmaceuticals, a business unit of Mylan Laboratories, recently filed an abbreviated new drug application with the US Food and Drug Administration for a generic doxycycline delayed-release capsule.

Though the date of the filing is not clear, the plaintiffs received notification of Mylan’s ANDA on or about Feb. 4 of this year, and said that Mylan claimed in its ANDA that specific claims of the four patents were invalid and would not be infringed by manufacture or sale of the generic product.

Consequently, SUNY, NYU, and Galderma filed their suit, claiming that Mylan’s ANDA filing and allegations within that filing constituted infringement of the patents; and that they would be irreparably harmed if Mylan were allowed to manufacture or sell the generic product. Moreover, the plaintiffs alleged in their complaint that Mylan’s actions are "an exceptional case … because Mylan was aware of the existence of the [patents] at the time of the submission of [the] ANDA."

The oldest of the four patents, No. ‘395, was filed on Aug. 30, 1996, and thus would be set to expire on Aug. 30, 2016; while the youngest, No. ‘267, was filed on Feb. 18, 2005, and thus would expire on Feb. 18, 2025, barring any extensions.

… according to Collagenex’s 2007 financial results, released in March of last year just before the Galderma acquisition closed, Oracea had $52.5 million in net sales in 2007.

And some interesting snippets from Mylan Confirms Four First-to-File Challenges

Mylan Pharmaceuticals was sued by Galderma Laboratories Inc., Galderma Laboratories LP, The Research Foundation of the State University of New York and New York University in the U.S. District Court of Delaware in connection with the ANDA filing for Doxycycline Delayed-release (DR) Capsules USP, 40 mg.

Doxycycline DR Capsules are the generic version of Galderma’s adult rosacea treatment Oracea Capsules, which had approximately $82 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health

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

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