By Suresh Pillai --
Resolution Announced in Johnson & Johnson Razadyne® ER Patent Litigation
Johnson & Johnson units Janssen LP, Janssen Pharmaceutica NV, and Ortho-McNeil Neurologics have stipulated to a dismissal with prejudice of all claims of patent infringement against KV Pharmaceutical Co., Barr Pharmaceuticals Inc., and Sandoz Inc. with respect to a generic version of Razadyne® ER. The dispute stemmed from ANDA filings made in 2005 by KV, Barr, and Sandoz seeking approval to market generic Razadyne®. The Johnson & Johnson units filed suit in the U.S. District Court for the District of New Jersey (see "Court Report," June 22, 2008), alleging that the generic companies were infringing U.S. Patent No. 7,160,559.
Under an agreement between the parties, all three generic companies are allowed to market generic versions of galatamine hydrobromide extended-release capsules, the subject of their current ANDAs. Although the Johnson & Johnson units stipulated to the dismissals with prejudice, the generic companies reserved the right to pursue invalidity counterclaims or defenses in any future actions between the parties that involve the '559 patent.
In a separate Razadyne® case (see "Court Report," August 17, 2008), the U.S. District Court for the District of Delaware invalidated Johnson & Johnson's U.S. Patent No. 4,663,318 for lack of enablement. That case is currently on appeal before the Court of Appeals for the Federal Circuit. The settlement with respect to the '559 patent does not affect that appeal.
AstraZeneca Seeks a TRO to Stop Launch of Generic Pulmicort®
AstraZeneca filed a motion for interim relief with the U.S. District Court for the District of New Jersey, seeking a temporary restraining order to keep Canadian generic manufacturer Apotex from launching a generic version of Pulmicort®, a children's asthma medication. In its motion, AstraZeneca stated that relief was necessary until its current patent infringement suit against Apotex involving the drug has been resolved. The two patents in suit, U.S. Patent Nos. 6,598,603 and 6,899,099, cover the method for treating respiratory disease in children between the ages of 12 months and 8 years. AstraZeneca originally filed suit on March 31, 2009, upon Apotex's announced intention to market a generic version of AstraZeneca's Pulmicort® Resulpules on the heels of the FDA's grant of Apotex' ANDA. The trial is scheduled to begin on April 16.
Biovail Files Counterclaims for Invalidity in Seroquel® IP Dispute
In its latest action against AstraZeneca, Biovail has filed counterclaims in the U.S. District Court for the District of New Jersey asking the Court to invalidate or rule unenforceable AstraZeneca's U.S. Patent Nos. 4,879,288 and 5,948,437. The '288 and '437 patents cover Seroquel® XR, which is used to treat schizophrenia and bipolar disorder, and which is AstraZeneca's best selling drug. As a basis for its filing, Biovail alleges that AstraZeneca engaged in inequitable conduct during prosecution of the '288 and '437 patents, an allegation that also has been made in other Seroquel® XR suits. While acknowledging that applicants have been found to have withheld non-material information from the U.S. Patent and Trademark Office, Biovail notes that those cases have been appealed to the Court of Appeals for the Federal Circuit and that Biovail is merely seeking to preserve its rights until the appellate court has considered the matter. In its motion, Biovail also argues that both patents are invalid and/or that Biovail did not infringe the patents.
The litigation stems from a suit AstraZeneca filed against Biovail and two subsidiaries in February (see "Court Report," March 8, 2009). In its initial filing, AstraZeneca alleged that in submitting an ANDA seeking FDA approval to market a generic version of quetiapine fumarate, Biovail infringed upon AstraZeneca's patents. AstraZeneca is asserting both direct infringement and inducement of infringement, and is seeking a declaratory judgment that both patents are valid and infringed. In addition, AstraZeneca is seeking an order that the ANDA not become effective until after the patents' dates of expiry, and that the Court issue a permanent injunction against Biovail, as well as costs and treble damages.
Additional Disclaimer: MBHB represents Biovail in
the above case. To the
extent that this post contains any
opinions, the opinions would be of Dr. Pillai and not Biovail or MBHB.
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