By James DeGiulio --
Medicis and Q-Med Settle Restylane Dispute with Genzyme
Genzyme has agreed to drop its infringement suit with Medicis regarding the cosmetic injection product Restylane in exchange for a lump sum payment from Q-Med. In October 2010, Genzyme brought suit in the U.S. District Court for the District of Massachusetts against Medicis, who licenses the product from Q-Med (see "Court Report," October 25, 2010). Genzyme claimed that importing and selling Restylane, Perlane, Restylane-L, and Perlane-L injection products infringed U.S. Patent No. 5,399,351. Genzyme alleged that Medicis also actively induced the infringement of the patent by selling these products together with instructions that advised others to infringe the '351 patent. Q-Med, as licensor, was not named as a defendant in the suit, but Q-Med elected to assume the defense of Genzyme's claim in accordance with its license agreement with Medicis.
On February 15, Q-Med announced in a press release that the parties had reached a settlement agreement, and that Genzyme agreed to dismiss the case and release Medicis and Q-Med from any liability related to the suit. Q-Med did not disclose the exact sum paid to Genzyme. However, Medicis is not required to make any payments under the terms of the settlement and none of the parties admit any liability related to the lawsuit's claims.
Sun Agrees to Briefly Stop Selling Generic Eloxatin
As Sun Pharma and Sanofi-Aventis continue to try to close their long-running battle over the cancer drug Eloxatin, Sun has agreed to temporarily halt its sales of oxaliplatin while the parties decide how to proceed with the infringement dispute that appeared to have been settled. The case has a long history. In 2007, the dispute between Sun and Sanofi-Aventis began, after Sanofi brought suit against Sun in response to Sun's ANDA filing, alleging infringement of U.S. Patent No. 5,338,874 (see "Court Report," July 30, 2007). Sanofi also filed suit against other generic drug manufacturers who filed ANDAs for generic oxaliplatin. In 2009, the parties entered into settlement negotiations, eventually agreeing to a license. Two days after Sanofi and Sun reached a settlement agreement, the District Court denied summary judgment of invalidity and granted summary judgment of noninfringement of '874 patent. A series of challenges to the original license agreement followed, eventually reaching the Federal Circuit, which vacated the settlement and remanded the case because the disputed language in the consent judgment was susceptible to two different interpretations (see "Sanofi-Aventis v. Sandoz, Inc. (Fed. Cir. 2010)"). The Federal Circuit denied Sanofi's request for reconsideration of this decision on February 7.
On February 9, Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey approved the stipulation and proposed order requiring Sun to briefly refrain from selling, attempting to sell, or offering for sale any product containing oxaliplatin until February 17. In exchange, Sanofi agreed not to seek injunctive relief against Sun or its affiliates until February 15, according to the order. The agreement was sought to facilitate further negotiation in the action. This latest agreement can be found here.
Novozymes' Biofuel Enzyme Patent Survives Danisco Invalidity Challenge
Novozymes' patent covering a modified enzyme for use in ethanol production survived an invalidity challenge in the company's patent dispute with Danisco following the denial of Danisco's motion for summary judgment ofr invalidity. In May 2010, Novozymes sued Danisco in the U.S. District Court for the Western District of Wisconsin, claiming that Danisco and its U.S. affiliates infringed U.S. Patent No. 7,713,723, covering the modified alpha-amylase enzyme (see "Court Report," May 23, 2010). Novozymes moved for a preliminary injunction in September, asking the District Court to stop Danisco and its subsidiaries from selling GC358 and the more recent GC980 enzymes. However, that bid was denied. The Court concluded that Novozymes had failed to demonstrate that it would be irreparably harmed without an injunction, and questioned whether the patent-in-suit was actually valid, criticizing its written description. Following this ruling, Danisco moved for summary judgment of invalidity of the '723 patent.
On February 4, Judge Barbara B. Crabb denied Danisco's motion for summary judgment, rejecting the argument that the patent's written description does not convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Judge Crabb ruled that Danisco had not met its burden to prove invalidity by clear and convincing evidence. However, she also stated in her opinion that lack of enablement might be a better argument for the defendants, hinting that the specification may require undue experimentation. Judge Crabb's opinion can be found here.
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