By Suresh Pillai --
Par Files Amended Complaint in Nascobal® Suit
Par Pharmaceuticals filed an amended complaint against Fleming & Co. Pharmaceuticals, alleging patent and trademark infringement and unfair competition over Par's prescription nasal spray, Nascobal®. The patent-in-suit, U.S. Patent No. 7,404,489, covers Par's spray-based vitamin B-12 product that was designed as an alternative to monthly injections for the treatment of vitamin B-12 deficiencies.
In its complaint, filed in the U.S. District Court for the Southern District of California, Par claims that Fleming's sale of CaloMist® to distributors and users, and the marketing of the spray to California physicians, intentionally traded on the goodwill Par had built up among California consumers of Nascobal®.
Among the relief requested, Par has asked the District Court for a permanent injunction barring Fleming from infringing the '489 patent, treble damages for infringement and for Lanham Act violations, punitive damages, pre- and post-judgment interest, and attorneys' fees.
AstraZeneca Granted Permanent Injunction in Pulmicort® Case
One month after granting AstraZeneca a temporary restraining order (see "Biotech/Pharma Docket," May 5, 2009), the U.S. District Court for the District of New Jersey has permanently enjoined Apotex from launching a generic version of Pulmicort Respules®, a pediatric asthma treatment. This action is the latest in AstraZeneca's fight to protect its rights in the patents-in-suit, U.S. Patent Nos. 7,524,834, 6,598,603, and 6,899,099, key patents in AstraZeneca's Pulmicort® patent portfolio. AstraZeneca filed its suit against Apotex on March 31, one day after Apotex had received FDA approval to manufacture and market a generic version of Pulmicort® Respules. Because Apotex indicated its intent to market and manufacture its generic 
version prior to the expiration of AstraZeneca's patents (2018 with pediatric exclusivity extending until 2019), AstraZeneca filed suit.
AstraZeneca's suit against Apotex is merely the latest in a series of lawsuits designed to protect its intellectual property rights covering Pulmicort®. AstraZeneca has previously filed suit against Teva and only resolved the conflict upon reaching a licensing agreement with Teva. Under the settlement with Teva, Teva acknowledged the validity and enforceability of the '603 and '099 patents and agreed to pay a significant royalty on sales of its generic version as well as damages connected with Teva's launch of its generic version of Pulmicort® following FDA approval. In exchange, AstraZeneca granted Teva an exclusive license to make and market a generic version of Pulmicort®. In the face of the permanent injunction, it is likely that Apotex will seek a similar deal with AstraZeneca.
Abbott Denied Summary Judgment in Attempt to Invalidate Humira® Patents
The U.S. District Court for the Eastern District of Texas denied Abbott Laboratories' motion for summary judgment seeking invalidation, on the ground of anticipation, of two patents connected to the Abbott drug Humira®. Although Abbott lost the summary judgment motion, Abbott did prevail in its demand to have the priority dates for the patents-in-suit established as February 4, 1994. This decision is the latest in Centocor, Inc.'s suit against Abbott, alleging that the Abbott drug Humira® violates two patents owned by Centocor, Inc (see "Court Report," April 23, 2007). The patents-in-suit, U.S. Patent Nos. 7,070,775 and 7,276,239, cover recombinant A2-specific TNFα-specific antibodies. Humira® is widely used in the treatment of various forms of arthritis and recently received FDA approval to be used in the treatment of Crohn's disease.
The prosecution history of the patents-in-suit consisted of the filing of 14 patent applications over 15 years. As part of its demand, Abbott included as evidence five additions to the specification as evidence of Centocor's acquiescence of the filing date of February 4, 1994. Although the District Court estopped the plaintiffs from gaining benefit of the earlier filing date, the Court did not go so far as to invalidate the patents themselves, holding that questions of anticipation that could invalidate patents were matters of fact and not law.
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