Joseph M. O'Malley, Jr. is a partner in the Intellectual Property practice at Paul Hastings. He has extensive patent litigation experience across a broad range of technologies, including chemicals and pharmaceuticals. Mr. O'Malley has served as lead trial counsel for many branded pharmaceutical clients including Pfizer, Merck, Abbott, Eisai, Sunovion (formerly Sepracor), and Takeda (formerly Nycomed), and has prevailed at trial and appeal in billion-dollar-a-year Hatch-Waxman Act pharmaceutical patent litigations.
Accolades and Recognitions
Recognized in Best Lawyers in America, 25th Edition
Recognized by the National Law Journal in 2017 as an IP Trailblazer
Winner of Law360 MVP award for Life Sciences
Recognized by respected publications, including Chambers, The Legal 500, Intellectual Property Magazine, Benchmark Litigation, IAM Patent 1000, LMG Life Sciences and by Managing Intellectual Property IP Stars
Finalist, Lawyer of the Year Award, Intellectual Property Magazine
Ranked, Chambers Global 2015 and 2016, USA, Intellectually Property: Patent
Chambers USA (2015) says Mr. O'Malley "takes the helm on pharmaceutical cases on behalf of the leading names in the field." The publication has referred to him as "the complete package" and cites his "winning combination" of a "tremendous work ethic, personable demeanor and litigation skills." Chambers USA (2016) recognizes him as a "good strategist," "charismatic" and a "subject matter expert." Sources also reserve praise for his "calm and unflappable demeanor" and business-focused approach. Chambers USA (2017) says the "excellent" Joseph O'Malley is highly rated for his work on complex IP issues in the life sciences space, where interviewees describe him as "a good strategic thinker." Sources say: "He is good at getting the big picture of litigations, including the business and political aspects."
IAM Patent 1000 ranks Mr. O'Malley in the Gold band noting him as a "true leader" in the space, and recognizing his work on the most high-profile, big-ticket work from the most demanding of clients. According to the publication, Mr. O'Malley "has driven the firm to huge success and is everything customers seek in a pharmaceutical patent litigator." The publication cites his "immense courtroom experience" that "shows each time he steps up to the plate" and has noted the "complex scenarios" he has handled "requiring creative strategies." According to IAM Patent 1000 (2015): such is his standing among peers, he is hailed as "a great credit to the legal profession." In IAM Patent 1000 (2016): "O'Malley is a challenging guy to litigate against - he is very comfortable in court and in command of all the issues at all times. He has amazing attention to detail and comes prepared with very effective game plans." One highly ranked peer reported: "I have never seen anybody better than Joe in settling difficult conflicts on a win-win basis."
LMG Life Sciences has recognized Mr. O'Malley among its "US Life Sciences Stars" and notes he is a "preeminent litigator in the industry."
National Litigation Star, Benchmark Litigation
Recipient, Burton Award for Legal Achievement
Altana Pharma, AG, et. al. v. Teva Pharmaceuticals USA, Inc. et. al., D.N.J. - Mr. O'Malley was co-lead trial counsel in this Hatch-Waxman Act litigation representing Pfizer (Wyeth) and Takeda in connection with the patent protecting the companies' $2 billion-dollar-per-year Protonix® (pantoprazole) acid reflux medication. In April 2010, Mr. O'Malley, along with co-counsel, won the jury trial in favor of Wyeth and Altana, finding the patent covering Protonix® to be valid and rejecting generic drug manufacturers' obviousness and obviousness-type double patenting defenses.
Dey, L.P., et al v. Sunovion Inc., S.D.N.Y (2009-2012) - In March of 2012, Paul Hastings secured a summary judgment ruling, on behalf of defendant Sunovion, that five of the seven patents asserted against Sunovion's Brovana® product were invalid under 35 U.S.C. 102(b) due to Sunovion's public use of the claimed subject matter during a clinical trial. The Court also held on summary judgment that plaintiffs were precluded from obtaining any damages for infringement of the two remaining patents which may have occurred during the four and a half years prior to the issuance of reexamination certificates for those patents. Following that summary judgment decision, and a later pre-trial claim construction decision in which the Court adopted every one of our client's proposed definitions, the case settled on confidential terms. Portions of the case are being appealed by plaintiffs Dey and Mylan.
Sunovion Inc. v. Teva Pharmaceuticals USA Inc. et. al., D.N.J. (2009 to present) - Mr. O'Malley was lead trial counsel on Sunovion's behalf in one of the largest Hatch-Waxman Act cases ever filed, with 22 generic defendants. At issue were the patents protecting Sunovion's Lunesta® (eszopiclone) sleeping agent. Lunesta® is Sunovion's largest-selling drug product. In June 2010, Paul Hastings secured, on Sunovion's behalf, a dismissal of inequitable conduct claims in a twenty two-defendant Hatch-Waxman litigation relating to Sunovion's popular sleep aid Lunesta®. Judge Cavanaugh of the District of New Jersey issued one of the first post-Exergen Corp. v. Wal-Mart Store decisions dismissing a generic drug manufacturer's inequitable-conduct defenses for failure to satisfy the "stringent pleading standard." In April 2013, all defendants admitted that Sunovion's patent is valid, obviating the need for a validity trial. In a September 2013 ruling in favor of Sunovion, the Federal Circuit reversed the district court's entry of summary judgment in favor of Dr. Reddy's Laboratories, which had been granted in January 2013. This reversal effectively prevented Dr. Reddy's from entering the market with its generic Lunesta® product immediately upon approval, destroying the branded market for Sunovion's largest drug product. The decision also makes new law, namely, that if a generic's application to the FDA permits infringement, then it infringes as a matter of law, notwithstanding other evidence of noninfringement, in this case, a sworn Certification by Dr. Reddy's, filed with the District Court, promising not to infringe.
Merck & Co., Inc. v. Sandoz Inc., D.N.J. (2009 to present) - Mr. O'Malley is currently co-lead trial counsel with his Partner, Bruce Wexler, in this Hatch-Waxman Act litigation protecting patents covering Merck's Emend® (aprepitant) drug product.
Eisai Co., Ltd. and Eisai Inc. v. Teva Pharmaceuticals USA Inc., Dr. Reddy's Laboratories and Mylan Laboratories, S.D.N.Y. - Mr. O'Malley was lead trial counsel on behalf of Eisai from 2004 through 2008 during the successful summary judgment proceedings and bench trial involving Eisai's patent covering the company's billion-dollar-a-year acid reflux and ulcer medication, Aciphex® (rabeprazole). As a result of those summary judgment proceedings and trial, Eisai's patent was held valid, enforceable and infringed. The drug product represented 40% of the company's revenues at the time of trial and the patent life extended to 2013, resulting in several billions of dollars to the company being at stake. Mr. O'Malley also successfully argued the appeal to the Court of Appeals for the Federal Circuit resulting in affirmance of those trial court rulings. The Federal Circuit decision from that case has become an important weapon to branded pharmaceutical companies seeking to protect their basic composition-of- matter patents against unenforceability challenges, and against obviousness challenges following the Supreme Court's decision in KSR.
Eisai Co., Ltd. v. Teva Pharmaceuticals USA, Inc., D.N.J. - Mr. O'Malley represents Eisai Co., Ltd. regarding the company's two billion-dollar-a-year Alzheimer's drug, Aricept® (donepizil hydrochloride). The generic drug maker charged that Eisai's patent should be held unenforceable because Eisai had failed to disclose an allegedly related copending patent application of Eisai's. In 2008, the U.S. District Court for the District of New Jersey granted Eisai's motion for a preliminary injunction, finding that Eisai's patent was valid and infringed and that Teva's remaining defense of patent unenforceability lacked substantial merit. At the time, the preliminary injunction was only the fourth preliminary injunction ever granted by the District of New Jersey on behalf of branded pharmaceutical companies.
Biovail Labs. Int'l SRL v. Andrx Pharms., LLC and Andrx Corp., D. Del. - Mr. O'Malley was lead trial counsel on behalf of Biovail and its marketing partner Abbott Laboratories regarding their successful antihypertensive medication, Cardizem® LA. The case went to trial on November 13, 2007 in the U.S. District Court for the District of Delaware before Chief Judge Gregory M. Sleet. The parties settled the case after presentation of our clients' case-in-chief, which included the testimony of one of our experts who presented the results of elaborate testing, which demonstrated that the generic product fell within the asserted patent claims after it is ingested ("in vivo"). In order to even permit his clients to get past summary judgment, Mr. O'Malley had to convince the Delaware Court to disregard a prior Markman decision and affirmed non-infringement ruling from the District of Florida and the Federal Circuit that rejected an in vivo claim construction of the same patent claims. The Florida case involved the same parties (though different counsel) and a product that was alleged by defendants to be the same as was at issue in the Delaware case.
Warner-Lambert Company v. Teva Pharmaceuticals Inc., D.N.J. - Mr. O'Malley was lead trial counsel on behalf of Pfizer (Warner-Lambert Company) during a successful bench trial involving Teva's claims that Pfizer's patent was invalid for lack of enablement. In its November 2007 decision, the District Court found that Pfizer's formulation patent covering its cardiovascular drug Accupril® was not invalid for lack of enablement, despite the breadth of the claims. In obtaining this successful trial decision, the Paul Hastings team was able to distinguish a previous decision by the same District Court Judge, which held a pharmaceutical formulation patent of similar breadth to be invalid for lack of enablement. With that trial decision, all issues of infringement, enforceability and validity were decided in Pfizer's favor in the case after eight years of litigation. The case then settled while the appeal of the enablement ruling was pending.
Pfizer, Inc. and Warner-Lambert Company v. Ranbaxy Pharmaceuticals and Teva Pharmaceuticals, D.N.J. - Mr. O'Malley was lead trial counsel on behalf of Pfizer bringing a successful preliminary injunction motion in 2005 against generics Teva and Ranbaxy, halting sales of their generic quinapril product. Mr. O'Malley also successfully argued the affirmance of that preliminary injunction to the Court of Appeals for the Federal Circuit. The case then settled prior to trial. This injunction has been widely hailed as the first preliminary injunction to be obtained against a generic that had already entered the market. In order to obtain the injunction, Mr. O'Malley had to convince the District Court and the Court of Appeals to accept a claim construction that he had expressly advocated against in a prior litigation in front of the same District Court Judge. Mr. O'Malley's rare success in convincing the same Judge to accept the opposite claim construction to that he had previously, successfully advocated was featured in the June 2005 issue of The American Lawyer.
Warner-Lambert Company v. Teva Pharmaceuticals Inc., D.N.J. - Mr. O'Malley was lead trial counsel on behalf of Pfizer (Warner-Lambert) during a successful bench trial in which Senior Judge Debevoise of the District of New Jersey found that Pfizer's patent covering its highly successful Accupril® product was both valid and enforceable. The court had previously granted summary judgment of infringement in Pfizer's favor. Mr. O'Malley also argued the successful appeal to the Federal Circuit that resulted in the affirmance of these trial rulings on behalf of Pfizer.
Kos Pharmaceuticals v. Barr Laboratories Inc., S.D.N.Y. - Mr. O'Malley was lead trial counsel on behalf of Kos in this Hatch-Waxman Act litigation that covered the company's franchise Niaspan® product. In what was truly a bet-your-company case, the patents at issue in the litigation protected products accounting for 80% of the company's revenues. In the face of a threatened launch by the generic, a preliminary injunction motion was brought to halt the launch. The generic tabled its launch plans in view of the motion, and the case settled on terms favorable to our client Kos on the eve of the Court announcing its preliminary injunction decision.
Rutgers University School of Law Camden, J.D., 1992 (with honors)
Rutgers University, B.S., 1982 (with highest honors; member, Tau Beta Pi, National Engineering Honor Society)
Widely quoted and published on a variety of topics relating to pharmaceutical patent litigation
Authored articles in both the mainstream media and in trade journals
Recently appeared on Bloomberg TV to discuss the growing trend of at-risk launches by generic pharmaceutical makers
Prior to law school, Mr. O'Malley worked for seven years as a chemical engineer in DuPont's engineering department, where he supervised the design and construction of new chemical and pharmaceutical processing facilities.
Currently on the Industrial Advisory Board of Rutgers College of Engineering