By Suresh Pillai --
AstraZeneca Secures Temporary Restraining Order in PULMICORT® Case
Last week, the U.S. District Court for the District of New Jersey barred Apotex from launching a generic version of PULMICORT® by granting AstraZeneca's requested temporary restraining order (see "Biotech/Pharma Docket," April 15, 2009). The TRO will remain in effect at least until April 27, 2009 when the Court is scheduled to hold a hearing to determine whether or not the injunction should continue.
The grant of the TRO is the latest round in litigation initiated by AstraZeneca in defense of its PULMICORT®-related intellectual property. The original suit stemmed from the FDA’s March 30, 2009 approval of Apotex’s ANDA application for the marketing and manufacturing of a generic version of PULMICORT®. AstraZeneca filed suit upon Apotex's indication of intent to market its generic version prior to the expiration of AstraZeneca's patents (scheduled to expire in 2018 with pediatric exclusivity following in 2019).
Settlement Announced in Vanos® Patent Suit
Last week, Medicis Pharmaceutical Corp., the owner of patents covering the dermatitis steroid skin cream Vanos®, announced the settlement of its patent dispute with Perrigo Corp. Medicis filed the suit in the U.S. District Court for the Western District of Michigan in June 2008 (see "Court Report," June 15, 2008), following Perrigo’s ANDA filing seeking to market a generic version of Vanos®. As part of the ANDA, Perrigo asserted that the Vanos® patents were invalid and unenforceable. The Medicis suit addressed patent infringement for two patents-in-suit, U.S. Patent Nos. 6,765,001 and 7,220,424. Medicis claimed that were Perrigo allowed to market a generic version of Vanos®, both patents would be infringed.
Under the terms of the agreement, Perrigo can commence marketing its generic version of Vanos® on December 13, 2013 and will, in return, pay royalties to Medicis based on sales. Medicis also agreed to make an initial $3 million payment, to be followed by a payment of up to $5 million, at certain achievement milestones as the drug progresses through the hurdles of regulatory approval, commercialization, and development. Medicis has also agreed to pay royalties to Perrigo based on sales of the drug. This agreement also terminates the lawsuit.
Ivax Fails in Effort Invalidate Detrol® Patent
The U.S. District Court for the District of New Jersey has ruled that the patents underlying Pfizer Inc.'s bladder control drug, Detrol®, are valid and enforceable. Ivax Pharmaceuticals, a Teva subsidiary currently embroiled in a patent dispute with Pfizer over Detrol®, had filed a motion for reconsideration regarding its efforts to have Pfizer's U.S. Patent No. 5,382,600 ruled unenforceable due to Pfizer's alleged inequitable conduct before the U.S. Patent and Trademark Office during prosecution of the patent. Pfizer originally filed this case in January 2007 (see "Court Report," February 25, 2007) after Ivax filed an ANDA with the FDA seeking approval to market a generic version of Detrol® prior to the 2012 expiration of the '600 patent.
In its complaint, Ivax claimed that Pfizer had knowledge of errors in statements made by one of the co-inventors during prosecution, and in spite of this knowledge, failed to correct these errors. Ivax alleged that Pfizer's knowledge of the errors and failure to cure them constituted inequitable conduct.
The District Court, however, disagreed with Ivax's assertion. The Court stated that while errors in the declaration could be considered relevant, the errors in this case were not so serious as to undermine the validity of the inventor's declaration. Though the USPTO originally rejected all claims on obviousness grounds and only reversed based in part on the information from the disputed declaration, the Court concluded that the declaration, as a whole, could not be considered a misstatement or invalid.
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