Documents recently filed in the Mylan vs. Galderma patent litigation reveal that Mylan Pharmaceuticals continues to argue that it should be allowed to manufacture generic Oracea. This ongoing battle is known as the “Oracea Patent Litigation”.

If you are interested to see how generic pharma takes on big pharma to get a bite of the rosacea prescription market, read on!

This legal battle has been ongoing for several years. Rosacea News covered Galderma’s legal proceedings against Mylan in March 2009. Mylan has filed  for and as we now know, received approval for an Abbreviated New Drug Application (ANDA) for Doxycycline Delayed-release (DR) Capsules USP, 40 mg. This filing was challenged in court by Galderma.

Mylan are now seeking to prove that a particular patent 7,749,532, is invalid and thus their application to manufacture generic Oracea should proceed as it won’t violate this invalid patent.

We can learn a few interesting facts from court documents filed by Mylan Pharmaceuticals.

• Patent 7,749,532, also known as the Chang Patent, is assigned to Supernus Pharmaceuticals and contains terms relating to Oracea such as “an immediate release (IR) portion comprising a drug, wherein the drug consists of about 30 mg doxycycline; (ii) a delayed release (DR) portion comprising a drug, wherein the drug consists of about 10 mg doxycycline”. Galderma has licensed this patent from Supernus and is paying license fees (so far $2m has been disclosed) based on the sales of Oracea.
• Mylan wants the Chang patent (only  issued on July 6, 2010) to be declared invalid so that Galderma cannot use it to stop them releasing generic Oracea.
• Mylan first applied to be allowed to manufacture Generic Oracea in October 2008.
• Galderma has listed patents 7,211,267, 5,789,395 and 5,919,775 (Ashley and Amin patents) as proscriptive to their drug Oracea. Mylan says that these patents are “later-listed” compared to their application for an abbreviated new drug application.
• Galderma says that their sales of Oracea would be “devastated” if a generic version was to become available.
• In November 2009 the FDA denied Galderma’s request to stop Mylan’s Abbreviated New Drug Application saying that Oracea is an old antibiotic.
• Galderma are concerned that if it leaks out that Mylan is about to release Generic Oracea it will seriously affect the market in the period until the court case is finally settled.
• Mylan has received final approval from the FDA for generic Oracea.
• The next court date in this process is February 14-18, 2011.

So What Does This All Mean?

Speculation earlier in the year suggested that Generic Oracea may become available as soon as the first quarter of 2011. That speculation continues to look possible if the February 2011 trial proves successful for Mylan. Great news for everyone who thinks that Oracea is too expensive.

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