By James DeGiulio --
Abbott Fails to Stay Patent Dispute with Wyeth over Stents
Despite pending reexaminations over the patents-in-suit, Abbott Laboratories was unsuccessful in its attempt to stay litigation with Wyeth over patents for drug-coated stents. On September 22, 2009, Wyeth filed suit against Abbott in the U.S. District Court for the District of New Jersey, accusing the defendants of infringement by selling certain drug-eluting coronary stents. According to the complaint, Wyeth claimed that Abbott's Xience V stent infringed U.S. Patent No. 7,591,844, which issued that same day. Boston Scientific, a licensee of Abbott's stent, is also accused of infringement. The plaintiffs sought a permanent injunction, damages, and attorneys' fees. On April 15, 2010, Boston Scientific requested an inter partes reexamination of all 24 claims of the '844 patent, alleging that the claims are invalid as obvious in light of a number of prior art references that had not been disclosed during prosecution. In July, Wyeth amended the complaint by adding U.S. Patent No. 6,746,773 to the infringement counts. Abbott then asked the USPTO for an inter partes reexamination of all remaining claims in the '733 patent. Both requests for reexamination were granted, and Abbott moved to stay the case while the USPTO reexamined both patents at issue in the case.
On February 1st, Judge Joel A. Pisano denied the defendants' motion to stay proceedings in the suit. Judge Pisano applied the three-part test for deciding whether to stay a case: (1) whether a stay would unduly prejudice or present a clear tactical disadvantage to the non-moving party; (2) whether a stay will simplify the issues in question and trial of the case; and (3) whether discovery is complete and whether a trial date has been set. The judge ruled that putting the litigation on hold for the six years the reexamination is likely to take will subject plaintiffs to continuing sales and market loss. Although he acknowledged that reexaminations resulting in cancelled claims would simplify the issues in the case, Judge Pisano found that the case was moving along at an appropriate pace, noting that litigation has been pending for over a year, discovery is underway and claim construction proceedings will take place in the coming months. Judge Pisano's opinion can be found here.
Roxane Sanctioned in Asacol Patent Dispute with Medeva
Roxane Laboratories was hit with sanctions when Medeva successfully argued that Roxane Laboratories concealed a batch of its generic drug in a patent suit over the colitis drug Asacol. In October 2007, Medeva filed suit in the U.S. District Court for the District of New Jersey alleging that Roxane infringed U.S. Patent No. 5,541,170 by filing an ANDA for a generic version of Asacol (see "Court Report," November 4, 2007). The infringement issue is whether Roxane's proposed generic product releases its entire dose of mesalamine to the right side of the colon as claimed in the '170 patent. After discovery, Medeva filed a motion for sanctions, claiming that Roxane was responsible for spoliation of evidence by destroying highly relevant documents and manufacturing a "secret batch" of its generic product in November 2008 in order to conduct testing in humans. The District Court heard oral argument on the motion on November 23, 2010.
On January 28, Magistrate Judge Tonianne Bongiovanni granted Medema's motion to impose sanctions for Roxane's impermissible concealment of a batch of its generic product, but denied the plaintiffs' motion to impose sanctions for Roxane's alleged destruction of documents. Plaintiffs had requested information regarding all samples of Roxane's mesalamine product, but Roxane did not reference the concealed lot in its discovery responses and did not state it was withholding information based on the attorney-client privilege or the work product doctrine. The judge thus found no justification for Roxane's failure to include information on this drug batch. However, Judge Bongiovanni did not agree with the plaintiffs that Roxane's alleged destruction of documents warranted sanction, noting that Roxane had produced high-quality documents thus far in the litigation, and had adhered to a policy that required the company to retain technical information, such as laboratory notebooks, for a minimum of 20 years. Judge Bongiovanni said Roxane must now pay Medeva's expert costs related to its expedited testing of the concealed batch, along with attorneys' fees incurred in arguing its motion over the batch. Judge Bongiovanni's opinion can be found here.
Watson Settles with Promote Innovation in Androderm False Marking Suit
Watson Pharmaceuticals has settled with Promote Innovation over a false marking suit concerning its Androderm testosterone treatment, agreeing to stop using packaging for the product that was allegedly marked with expired patents. Promote Innovation first brought suit in the U.S. District Court for the Eastern District of Texas in August 2010, arguing that Watson had been marking Androderm products with four expired patents: U.S. Patent Nos. 4,849,224; 4,855,294; 4,863,970; and 4,983,395 (see "Court Report," August 23, 2010) The complaint accused Watson of wrongfully and illegally advertising a patent monopoly, alleging that Watson's marketing materials give the false impression that the patents for Androderm are still in effect and not in the public domain. Promote claimed that Watson benefited from this false marking by increasing its market power or commercial success, while consumers were harmed by preventing other companies from developing rival products. Promote further claimed that Watson's actions harmed the U.S. government by stifling competition and violating the spirit of U.S. patent law.
On February 1st, Judge T. John Ward ratified a stipulated dismissal between Watson and Promote Innovation. The order calls for Watson and any companies selling its Androderm products to stop using the labels, packaging, and other materials. However, Watson is granted reasonable time to sell inventory that was manufactured on or before the date of the order. Each company is to pay its own attorneys' fees and costs, but other terms of the settlement were not disclosed. Judge Ward's order can be found here.