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The U.S. District Court for the District of Delaware ruled in favor of Finnegan clients Cephalon Inc., Cephalon France, and Teva Santé SAS, finding valid the listed patent for the active ingredient in Cephalon’s wakefulness improving drug, Nuvigil®. Having already conceded infringement prior to trial, four generic pharmaceutical companies alleged that the listed patent, claiming a particular polymorphic form of armodafinil, was anticipated and obvious. Finding that the generic defendants failed to demonstrate inherent anticipation, Chief Judge Sleet held that the generic defendants’ experts did not show clearly and convincingly that the claimed form of armodafinil was the “necessary and inevitable result” of practicing the prior art patent. The court further held that the polymorphic form of armodafinil claimed in the patent would not have been obvious to one of ordinary skill in the art. Chief Judge Sleet enjoined the generic defendants from manufacturing, using, offering for sale, or selling their proposed armodafinil ANDA products, and further enjoined the FDA from approving the defendants’ ANDAs, before the expiration of Cephalon’s patent covering Nuvigil®.

The United States District Court for the Eastern District of Pennsylvania granted summary judgment of patent invalidity due to prior invention thereby terminating an action that Teva Pharmaceutical Industries Ltd. brought against firm clients AstraZeneca Pharmaceuticals, Inc. and several other AstraZeneca entities.  Teva alleged that its patent covered AstraZeneca’s blockbuster anti-cholesterol drug, Crestor®, and sought damages and fees.  AstraZeneca moved for summary judgment of invalidity due to its prior invention of the Crestor® formulation.  Judge William H. Yohn, Jr. found that AstraZeneca had invented first and had not abandoned, suppressed, or concealed its invention.  Accordingly, Judge Yohn invalidated all asserted claims of Teva’s patent and entered judgment in AstraZeneca’s favor.

The United States District Court for the Middle District of Florida has granted summary judgment of noninfringement in favor of Finnegan client Toyota in Solomon Technologies, Inc. v. Toyota Motor Corp. Solomon sued Toyota in the Middle District of Florida in September 2005, claiming that Toyota’s hybrid vehicles infringed U.S. Patent No. 5,067,932 ("the ’932 patent"). That case was stayed, however, after Solomon filed a related action in the International Trade Commission in January 2006.  Represented by Finnegan, Toyota showed the ITC that its accused hybrid vehicles do not infringe Solomon’s patent.  Solomon appealed to the Federal Circuit, which affirmed the ITC’s decision in Toyota’s favor. Solomon then tried to reopen the Florida case.  Toyota obtained the Court’s permission to file an early motion for summary judgment, arguing that the ITC and the Federal Circuit had already decided the issues.  The Court agreed with Toyota, holding that the doctrine of judicial estoppel precluded Solomon from raising new and inconsistent arguments in a later proceeding.  Accordingly, the district court granted Toyota’s motion for summary judgment that the accused hybrid vehicles do not infringe the ’932 patent.

The Southern District of New York (Judge Paul A. Crotty) ruled in favor of Finnegan client AbbVie, in a declaratory judgment action against its licensor The Mathilda and Terence Kennedy Institute of Rheumatology Trust (“Kennedy”). AbbVie brought this action because Kennedy claimed AbbVie would owe royalties on certain sales of its drug Humira®, despite AbbVie's assertion that the Kennedy patent at issue was invalid. Humira® is used by hundreds of thousands of patients to treat diseases such as rheumatoid arthritis and Crohn’s disease, and had revenues of more than $9 billion worldwide in 2012. After a four-day bench trial, the court held all of the claims of the Kennedy patent at issue were invalid for obviousness-type double-patenting. The court entered final judgment declaring all the claims at issue invalid, and declaring AbbVie the prevailing party and awarding costs.

The U.S. District Court in New Jersey ruled in favor of Finnegan client Otsuka Pharmaceutical Co. in its patent litigation against several companies seeking FDA approval to market generic copies of Abilify®, the sixth largest selling pharmaceutical in the United States.  The court held that the asserted patent claims covering aripiprazole, the active ingredient in Abilify®, are both valid and enforceable. The ruling maintains patent and regulatory protection for Abilify® in the United States until at least April 20, 2015.  The court also held that the proposed generics infringe the claims, and accordingly precluded the FDA from approving, and enjoined the respective companies from marketing, the generic products in the United States until at least April 20, 2015. 

The inventors of U.S. Patent No. 5,763,476 (“the ’476 patent”), assigned to Allergan/Forest Laboratories, made a startling discovery during the development of Saphris®. Saphris® contains the active ingredient asenapine, and is indicated for the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder. During the development process, the inventors discovered that asenapine administered using either a conventional oral tablet or an IV formulation had the potential to cause serious cardiotoxic side effects in subjects taking the medicine. The inventors solved this problem—which had been completely unknown in the art—using a sublingual formulation, a formulation that dissolves under the tongue that leads to the diffusion of the medicine directly through the oral mucosa and bypasses the digestive system. It was completely unexpected that a sublingual dosage form could solve the cardiotoxicity problem and even today, it is unknown exactly why.

Finnegan represented Allergan/Forest in its Hatch-Waxman litigation in the District of Delaware, filed against generic pharmaceutical defendants that sought to make generic versions of Saphris®. The four defendants that proceeded to trial conceded infringement of certain claims of the ’476 patent. Following a two week trial, the district court held the asserted claims valid, rejecting defendants contentions that they were obvious in view of the prior art and were not enabled or adequately described by the specification. It has been established precedent for decades that the discovery of an unknown problem can itself be patentable, and the district court determined that the inventors discovered an unobvious solution to an unknown problem, namely that oral and IV administered asenapine could cause serious cardiotoxic side effects. The district court further explained “[t]he sublingual solution to the cardiotoxicity problem was not ‘predictable’ or ‘expected’. . . . There were numerous other formulations that could have been experimented with to try to solve the problem, but no reasonable expectation that any of them would have.” The district court further disagreed with defendants’ assertions that there was other motivation to make a sublingual asenapine tablet, stating that “skilled artisans reviewing the publications of the publically reported clinical studies would have understood that orally administered asenapine was safe, bioavailable, and clinically effective even at relatively low doses. . . . There was nothing in the prior art that would have indicated that the oral tablet had problems, such that skilled artisans would have been motivated to invest the resources necessary to completely change the route of administration.” As such, “[t]he court discerns no motivation from the record evidence to use a sublingual formulation—a formulation that had never before been used for an antipsychotic drug.”

The district court ordered the Food and Drug Administration (FDA) not to approve the defendants’ Abbreviated New Drug Application (ANDA) for generic asenapine until after the expiration of the ’476 patent.

The District of Delaware ruled in favor of Finnegan client Forest Laboratories in a Hatch-Waxman litigation against generic pharmaceutical defendant Mylan, Inc. The suit involved Savella®, a medicine containing the active ingredient milnacipran, which is used for the treatment of fibromyalgia. The court held the asserted claims of all three patents litigated at trial valid and infringed, denying defendants claims that the patents were obvious and anticipated by prior art. In the words of the court, "[a]t best, the teaching of the art was and is multidirectional, with no clear motivation to pursue milnacipran as an effective treatment for fibromyalgia. Notably, there were no FDA-approved treatments for fibromyalgia at the time of the patents-in-suit. Consequently, the inventors' development of treating fibromyalgia with milnacipran was the antithesis of anticipation and obviousness as discussed in more detail below." The court entered final judgment and ordered the FDA not to approve Mylan’s Abbreviated New Drug Application (ANDA) for generic milnacipran until after the expiration of the last Forest patent litigated at trial.

The district of Delaware (Judge Stark) ruled in favor of firm client Galderma Laboratories, L.P., in a Hatch-Waxman litigation against generic defendant Tolmar, Inc., on September 11, 2012. (CA-No. 10-45-LPS). The drug involved was Differin® Gel 0.3%, an acne medicine containing the active ingredient adapalene 0.3%. The court held the claims of all four patents litigated at trial valid, enforceable, and infringed. In the words of the Court, “[t]rial was devoted almost entirely to Tolmar’s challenges to the validity and enforceability of Galderma’s patents-in-suit. Tolmar has failed to meet its burden on any of these contentions.” The court entered final judgment on September 24, 2012, (1) ordering the FDA not to approval Tolmar’s ANDA for generic adapalene 0.3% until after the expiration of the patents litigated at trial (March 12, 2023), including any periods of regulatory exclusivity, and (2) enjoining Tolmar from marketing a generic adapalene 0.3% product during the term of the litigated patents.

Intertrust Technologies is a leading developer of digital rights management (DRM) solutions and trusted computing technologies that enable Internet trust between people and allow for data privacy and digital security among a wide variety of devices and services. Finnegan prosecutes and manages Intertrust’s entire patent portfolio. We also advise on portfolio development as well as enforcement and defensive strategies for its patents relating to content protection, digital security, data privacy, trusted computing, and rights management—all of which are key components of a connected environment in the 21st century.

The U.S. Court of Appeals for the Federal Circuit found in favor of Finnegan client DuPont, affirming a district court’s grant of JMOL that plaintiff Novozymes’s patent failed to comply with the written description requirement of 35 U.S.C. § 112 and was thus invalid as a matter of law. Novozymes filed a patent application that disclosed vast numbers of prophetic alpha-amylase proteins without any guidance pointing to which of the proteins actually had advantageous properties. Then, some ten years later, in a continuation application, Novozymes claimed a very particular protein with certain properties that was not in any way highlighted in the original application. The Federal Circuit held that the original application did not describe the variants later claimed in the issued patent, noting in its decision that a patent “is not a reward for the search, but compensation for its successful conclusion.”

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