Patent Litigation & Patent Prosecution
We assist life sciences clients in maximizing the value of a product or technology at every step of its life cycle. Our lawyers have, for example, worked with a large, global pharmaceutical company for more than 15 years, to successfully guide its interferon products and technology through patent procurement; interference proceedings, including a related district court action; litigation against infringers; and arbitration, thereby significantly enhancing the value of those assets to the company. We provide integrated patent/FDA advice, coordinated patent/antitrust counseling, and extensive litigation representation, including comprehensive experience with Hatch-Waxman litigation, ANDA cases, and ANDA-related issues and disputes. Our multidisciplinary team litigates patents before federal district courts across the US, as well as in the US Court of Appeals for the Federal Circuit and before the ITC. We also litigate patents in the English Patents, Intellectual Property Enterprise and appellate courts and oppositions in the European Patent Office; manage cross-border patent litigation across Europe; and participate in Japanese opposition proceedings.
With a deep technical bench, including a number of professionals with PhDs, industry experience, and longtime academic experience, our team's strong scientific and patent credentials in a broad range of relevant technologies allow us to understand our clients' technologies and businesses and to apply the right tools to meet their needs and goals.
- Boston Scientific Corporation, where our patent litigators successfully concluded one of the fiercest battles in what courts and the media dubbed the "Stent Wars," in cases where the damages sought approached or exceeded US$1 billion. Between 2007 and 2010, the Cordis division of Johnson & Johnson filed four separate cases accusing Boston Scientific's multi-billion dollar Promus® stent of infringing patents on a variety of technologies. Deploying a wide array of patent defenses, we obtained decisive victories in all four cases.
- Hologic, Inc., where our attorneys secured an important jury verdict for Hologic, the world's leading company dedicated exclusively to women's health care, in a patent infringement lawsuit that the firm had filed in a Massachusetts district court just three months earlier. The unanimous verdict found that Baltimore-based IZI Medical Products, LLC infringed two of three asserted US patent claims as a result of IZI's manufacture and sale of a radiolucent foam cushion designed to provide comfort to women during mammography.
- Novartis in patent litigation relating to a groundbreaking gene therapy product being developed with the University of Pennsylvania which uses Chimeric Antigen Receptor modified T cells (CART) to target and destroy leukemic cells. In the litigation, filed in the Eastern District of Pennsylvania, Novartis and the University of Pennsylvania asserted declaratory judgment claims that a patent owned by St. Jude Children's Research Hospital and exclusively licensed to Juno Therapeutics is invalid and would not be infringed by the CART therapy under development. The case settled before trial with the parties agreeing to a license.
- Complete Genomics in a patent infringement suit related to sequencing by ligation, securing a total victory. Plaintiff Illumina had accused the Complete Genomics Analysis Platform, including Complete Genomics' cPAL technology, of infringing the patent-in-suit and sought an injunction that would have shuttered Complete Genomics' business. We won summary judgment of invalidity as to the asserted method claims and summary judgment of non-infringement as to the asserted kit claims.
- GE subsidiaries Amersham plc and Amersham Biosciences in securing a complete victory and successfully fending off claims made by Enzo Biochem, Inc. and Enzo Life Sciences, Inc. over an eleven-year period for patent infringement, fraudulent inducement, breach of contract, unfair competition, and tortious interference. On September 21, 2012, the court granted summary judgment in favor of GE/Amersham with respect to Enzo's patent infringement claims. On October 22, 2013, the court granted GE/Amersham's motion for summary judgment as to all remaining claims.
- Hologic, Inc., where Matthew Wolf had the rare distinction of arguing a doubleheader with back-to-back cases before the US Court of Appeals for the Federal Circuit. In one courtroom, he argued an appeal on behalf of Hologic against SenoRx, Inc. and obtained a successful ruling from the Court reversing the district court's claim construction and vacating the jury's finding of invalidity.
- Elan Pharmaceuticals as lead counsel in defending a patent infringement suit involving patents related to a genetic mutation for early onset Alzheimer's Disease. We obtained summary judgment in Elan's favor and dismissal with prejudice against Alzheimer's Institute of America based on its lack of standing to assert the patents-in-suit. Most recently, we also prevailed in demonstrating that it was an "exceptional case" and secured a fee award of US$3.4 million on behalf of our client.
- Boston Scientific Corporation, where the US Court of Appeals for the Federal Circuit lifted a trial court's preliminary injunction in a patent infringement suit that had prevented the firm's client, Boston Scientific Corporation, from selling its popular Guidezilla catheter. The court's ruling came just one week after oral argument before a three judge panel.
Our life sciences practitioners have literally written the book on Abbreviated New Drug Application (ANDA) patent litigation. As authors of Pharmaceutical and Biotech Patent Law (Practicing Law Institute) and the ABA's Patent Litigation Strategies Handbook chapter on Hatch-Waxman litigation, Arnold & Porter's patent lawyers are at the cutting edge when it comes to litigating Hatch-Waxman suits against generic infringers and counseling on life cycle management. We have litigated some of the most significant Hatch-Waxman cases and have extensive experience in the complex interaction between patent and FDA regulatory issues. Our clients have entrusted us with the defending against generic challenges to products such as Viagra®, Celebrex®, Allegra®, Gleevec®, Diflucan®, Ampyra®, and Treanda®. In addition to trying ANDA patent cases, our team has been involved in the negotiation and drafting of many tactical settlements, and routinely advises on the antitrust issues arising from settling ANDA patent litigation between pioneer pharmaceutical manufacturers and generics.
- Pfizer in its worldwide enforcement of patents covering its blockbuster drug Viagra®. Most significantly, after assisting Pfizer through a lengthy reexamination proceeding, we succeeded in preserving Pfizer's still ongoing exclusivity for Viagra, defeating a challenge by Teva Pharmaceuticals which sought FDA approval to sell a generic version of the drug. After a twelve-day bench trial, the US District Court for the Eastern District of Virginia ruled that Pfizer's patent claiming use of the drug to treat erectile dysfunction would be infringed by Teva's proposed copy. The court rejected Teva's arguments that Pfizer's patent is invalid and unenforceable. The case settled on appeal to the Federal Circuit. We also represented Pfizer in additional ANDA litigations concerning Viagra brought in the US District Court for the Southern District of New York. Those cases likewise settled. Our outstanding work on Viagra was recognized by The American Lawyer, which recognized Aaron Stiefel and Daniel DiNapoli as "Litigators of the Month."
- Novartis in multiple Hatch-Waxman actions concerning Novartis' flagship Gleevec® drug product used to treat chronic myelogenous leukemia (CML). Gleevec, which specifically targets an enzyme in CML cells, was one of the fastest drug products approved by the FDA, and has been the subject of a large number of ANDAs.
- Acorda Therapeutics in multiple Hatch-Waxman actions pending in Delaware regarding Acorda's flagship product, Ampyra®, the only product that is FDA-approved to improve walking in multiple sclerosis patients. In highly publicized motion practice, we succeeded in defeating a motion by Mylan to dismiss the case for lack of personal jurisdiction based on a 2014 US Supreme Court decision which had narrowed the scope of the doctrine of general jurisdiction which, to that point, had typically been the jurisdictional basis for Hatch-Waxman cases. Mylan had aimed to limit all of its Hatch-Waxman litigation to its home state of West Virginia. The Federal Circuit has since affirmed the decision. The Acorda case is also noteworthy because Acorda was the first target of Kyle Bass, and his so-called Coalition for Affordable Drugs. We are co-lead counsel on the IPR proceedings which are proceeding in parallel with the litigation.
- Cephalon, Inc. in a Hatch-Waxman case involving a generic version of Cephalon's liquid Treanda® injection product. Treanda is FDA-approved to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma.
- Aventis in Hatch-Waxman actions brought in the District of New Jersey concerning Allegra®. We served as lead trial counsel in a seven-day bench trial in 2011 against Dr. Reddy's Laboratories and others before then Chief Judge Garrett Brown. Cases settled favorably after trial.