By James DeGiulio --
Teva's Patents Covering Copaxone Upheld in Infringement Suit
Mylan failed in its efforts to dismiss Teva's patent suit over the multiple-sclerosis drug Copaxone when the patents directed to the active pharmaceutical ingredient (API) in the drug, glatiramer acetate, were upheld as valid. In September 2008, Teva brought suit in the Southern District of New York against Sandoz, and in 2009 against Mylan, after both companies filed Abbreviated New Drug Applications (ANDAs) for Copaxone (see "Court Report," September 7, 2008 and November 8, 2009). Teva asserted four patents in its infringement suits: U.S. Patent Nos. 7,199,098, 6,939,539, 6,054,430, and 6,620,847. Among other defenses, Mylan and Sandoz argued that the patents were invalid. The defendants argued during claim construction that the claims were indefinite because the molecular weight of the compound was not described sufficiently, and both defendants moved for summary judgment on this issue. Sandoz' motion was denied, while Mylan's motion was pending. In October 2010, Teva attempted to force the defendants to provide advance notice of their intent to launch the generic. This attempt was not successful. On July 5, the District Court again denied Teva's request for an order directing the generic drug makers to provide the Court and Teva with 10 days notice prior to the launch of their generic Copaxone products, ruling that the defendants "are under no legal obligation" to provide such notice. The trial was scheduled to begin today.
On August 29, Judge Barbara S. Jones issued a Memorandum and Order denying Mylan's summary judgment motion that the patents are invalid under 35 U.S.C. § 112 for not explicitly defining the molecular weight of the glatiramer acetate. Mylan's main objection was that the definition focused on how the chemical compound is made. The defendants also argued that the term "molecular weight" as it is used in the asserted patents was merely a "random amino acid composition" because it was made up of molecules with average molecular weights. Judge Jones rejected this definition, adopting Teva's claim that the "copolymer-1" that makes up the drug is a mixture of molecules, all with different molecular weights. The parties also disputed the term "average molecular weight," which Sandoz and Mylan asserted as subject to several interpretations, thus rendering term invalid. However, Judge Jones noted that Teva had successfully argued during the prosecution of the patent that a person of ordinary skill would understand its meaning. This was found to produce a presumption that the description complies with the provisions of 35 U.S.C. § 112.
Mylan Found to Infringe One of Galderma's Oracea Patents
Mylan was found to infringe one of five patents asserted against it, but managed to invalidate two of the five patents, in Galderma's suit against the generic drug maker for infringement of patents directed to the rosacea drug Oracea. On October 19, 2010, Galderma filed suit in the District of Delaware, asserting that Mylan's ANDA infringed U.S. Patent Nos. 5,789,395, 5,919,775, 7,211,267, 7,232,572, and 7,749,532, which are directed to a once-daily administration of doxycycline for the treatment of acne rosacea. Galderma launched two suits, which were later consolidated. Mylan answered by asserting that the patents were invalid and unenforceable, and that its product did not infringe any of the claims of the five patents. Mylan's ANDA was approved in July 2010, and Galderma quickly secured a preliminary injunction against Mylan, blocking the company from entering the market with its generic Oracea product.
On August 26, Judge Leonard P. Stark, in a detailed Opinion, determined that Galderma had proved by a preponderance of the evidence that Mylan's proposed generic rosacea drug infringed all of the asserted claims of the '532 patent (the "Chang" patent), which is not set to expire until on December 19, 2027. The Chang patent, which was upheld in the face of anticipation, obviousness, inventorship, and written description challenges, covers the formulation for Oracea. Judge Stark also ruled that Galderma had failed to prove that Mylan had infringed any claims of the other four patents, and that Mylan successfully demonstrated that the '395 and '775 patents were invalid. These patents were invalidated due to inherent anticipation, where the prior art disclosed the use of a high dose of tetracycline to treat periodontitis or rheumatoid arthritis, diseases with similar properties as rosacea.
Despite finding that Mylan's proposed product would infringe the Chang patent, Judge Stark declined to adopt the remedy suggested by Galderma, which was to convert the preliminary injunction in place into a permanent injunction. Further, Galderma requested to change the effective date of FDA approval of Mylan's ANDA to a date no earlier than the expiration of the latest asserted, valid patent. Judge Stark stated that while Galderma is entitled to some relief, neither party had prevailed in the entirety of its positions. He also said it was noteable that the only patent Mylan was found to have infringed issued well after the company filed its ANDA. As such, he said he would require the parties to submit briefs addressing the appropriate remedy and would leave the preliminary injunction in place for now.
Shire Avoids Dismissal in Patent Suit over Generic Intuniv
Impax and Watson were unsuccessful in their attempt to dismiss a patent infringement suit brought by Shire over a generic version of Shire's ADHD drug Intuniv. On December 2, 2010, Shire and the inventors brought suit in the Northern District of California for patent infringement and a declaratory judgment against defendants Impax and Watson (see "Court Report," December 12, 2010). Impax and Watson had both filed ANDAs for a generic form of guanfacine hydrochloride extended release tablets, and Shire asserted that this filing infringed U.S. Patent Nos. 5,854,290, 6,287,599, and 6,811,794. Plaintiffs moved to dismiss all of defendants' counterclaims under Rule 12(b)(6) and to strike all their affirmative defenses 
under Rule 12(f). Following Shire's motions, the defendants countered with a motion to dismiss the suit. Impax and Watson argued that their answers to Shire's complaint are pleaded in the same fashion as the complaint itself. Following this logic, defendants concluded that if the District Court dismissed their counterclaims and defenses, it should dismiss the complaint as well.
On August 29, in an Order Denying Motions to Dismiss, Judge Richard Seeborg denied both plaintiffs' and defendants' motions. Judge Seeborg noted that there would be little benefit in requiring parties to replead their claims and counterclaims with additional factual allegations. Shire has been aggressively litigating its patent rights to Intuniv over the past year, having also brought suit against Mylan and Sandoz in West Virginia and Colorado federal court, respectively.
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