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Patent Litigation - Abbreviated New Drug Application (ANDA) Litigation

In this ANDA case, our client, Elan Corporation PLC, filed suit to prevent infringement of its patent directed to naproxen formulations for once-daily oral administration. The district court held Elan’s patent claims invalid in view of Elan’s offer to license technology directed generally to the joint R&D of such pharmaceutical products. The Federal Circuit vacated the district court’s holding and remanded the case so that Elan could pursue its claims on the merits.
The U.S. District Court for the District of Delaware ruled in favor of Finnegan client AstraZeneca AB, finding that the listed patent for the active ingredient, saxagliptin, in AstraZeneca’s type II diabetes drugs Onglyza® and Kombiglyze® was valid and infringed. Having conceded infringement prior to trial, 11 generic pharmaceutical companies alleged that claims directed to the compound saxagliptin were invalid as obvious. Finding that the generic defendants failed to establish by clear and convincing evidence that the asserted claims would have been obvious at the time the patent application was filed, the presiding judge held that defendants’ alleged motivations were “at odds with the teachings of the prior art” and appeared to be “the product of a classic hindsight analysis.” The generic defendants are enjoined from making, using, offering for sale, selling, or importing into the United States their proposed generic saxagliptin products before the expiration of AstraZeneca’s patent.
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 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.
In an important victory for firm client, Eli Lilly and Company, the Southern District of Indiana rejected claims by Teva Pharmaceuticals USA, Inc. alleging that all of Lilly’s patents covering Lilly’s blockbuster drug for the treatment of postmenopausal osteoporosis, Evista®, are invalid.  The court granted a permanent injunction preventing Teva from marketing its generic version of Evista® before the expiration of four of Lilly’s patents covering Evista®, the last of which expires in 2014.  Teva appealed the decision, and in September 2010, the Federal Circuit ruled in favor of Lilly, affirming the validity of Lilly’s patents for Evista®. Chief Judge Rader, writing for a unanimous panel, held that there was no evidence that "would teach, suggest or motivate or supply any common sense reason" for a person to arrive at Lilly’s invention.  The Federal Circuit further affirmed that the patents were enabled, observing that the initiation of a human clinical trial presumptively establishes the credibility of the asserted utility.
The U.S. Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of enablement/utility of Finnegan client, Eli Lilly and Company’s method of use patent on Strattera® and upheld the court’s rulings of validity on other grounds and the judgment of infringement in a case involving numerous generic drug manufacturers. The Federal Circuit’s ruling in Lilly’s favor provides protection for Lilly’s Strattera® franchise through May 2017.
Finnegan represented GlaxoSmithKline (“GSK”) in various patent infringement litigations protecting GSK’s Paxil® antidepressant drug against many generic drug manufacturers that filed ANDA suits seeking to sell generic versions of the drug. Finnegan worked with GSK’s antitrust counsel to settle multiple litigations and minimize their antitrust risk. After one of those settlements, the generic drug manufacturer’s API supplier brought an antitrust suit challenging the settlement. Finnegan worked with GSK’s antitrust counsel to successfully defeat the antitrust claim in a motion to dismiss strongly upholding the right of patent owners to settle ANDA litigations. Finnegan also worked with GSK’s antitrust counsel in defending related class action antitrust suits brought by other litigants based on patent infringement litigations.
Andrx Pharmaceuticals, Inc. (“Andrx”) filed suit against Finnegan client Elan Corporation PLC, alleging that Elan violated the federal antitrust Sherman Act and various Florida antitrust statutes by entering into a settlement agreement in an Abbreviated New Drug Application (“ANDA”) patent infringement litigation that Elan brought against another company, and by initiating an ANDA litigation against Andrx relating to the same patent. Finnegan obtained judgment on the pleadings in Elan’s favor on all issues at the outset of the case. The U.S. Court of Appeals for the Eleventh Circuit affirmed the majority of the holdings, including that the Noerr-Pennington doctrine shielded Elan from Andrx’s patent misuse claims relating to Elan’s assertion of its patent against Andrx. The Eleventh Circuit remanded the settlement agreement holding for further proceedings. Andrx ultimately agreed to dismiss the claim.
The United States District Court for the District of Delaware ruled in favor of firm clients AstraZeneca and Shionogi Pharmaceuticals, finding that the FDA Orange Book listed patent for the active ingredient in their blockbuster anti-cholesterol drug, Crestor®, is valid and enforceable—preserving market exclusivity for Crestor® into 2016.  The patent was challenged in these Abbreviated New Drug Application litigations by eight generic pharmaceutical companies.  Judge Farnan ruled that the novel rosuvastatin inventions claimed in the patent would not have been obvious to one of ordinary skill in the art.  Judge Farnan further found that the failure to submit certain prior art during the prosecution of the patent application was not the result of an intent to deceive the United States Patent and Trademark Office.  Instead, Judge Farnan credited AstraZeneca and Shionogi’s witnesses and evidence that innocent mistakes resulted in the non-submission of the prior art and ruled that the patent is enforceable.
This ANDA case involved Zenith and two other generic drug manufacturers that attempted to invalidate Lilly's patent and thereby open the market for generic sales. The lengthy trial involved complex technical and legal issues. Lilly prevailed in the district court on all issues, protecting its exclusive marketing rights and a large revenue stream. The Federal Circuit later affirmed the lower court’s decision, which upheld Lilly's patent on its blockbuster drug.