Quinn emanuel trial lawyers

Life Science: Pharmaceutical Patent Litigation
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Quinn Emanuel is made up of trial lawyers.  We pride ourselves on knowing how to set up complex cases to win.  Our lawyers also know the science.  Almost 50 of us have degrees in biological or chemical life sciences disciplines, many of us with PhDs or other advanced degrees.  Quinn Emanuel’s life sciences attorneys represent pharmaceutical, biotechnology, medical device, and other life sciences companies from around the world. 

Quinn Emanuel’s life sciences attorneys have litigated over 200 ANDA cases, and various branded vs. branded matters and pharmaceutical licensing disputes.  Our cases have involved diverse subject matter such as new chemical entities, methods of use, crystalline structures, restricted-distribution systems, and new formulations of existing compounds.  These same attorneys also have experience advising pharmaceutical companies on pre-regulatory approval activities, FDA regulations, and patent prosecution strategies which allow the companies to develop the strongest patent portfolio to assert during litigation. 

Our life sciences practice also has considerable experience in IPRs and other post-grant proceedings acting primarily on behalf of patent owners, and has handled concurrent post-grant reviews and litigations.  Our practice is based on an inter-disciplinary model that allows us to become fully familiar with our clients’ businesses and to represent our clients in a wide variety of disputes, including: Intellectual Property, Antitrust, Product Liability, Government Investigations, Off-label Promotion, and Appeals.

Our practice and our attorneys have been recognized as the best in the field.  Below are some of our recent recognitions. 

  • The Firm was named to Law360’s 2017 “Practice Groups of the Year” in the area of Intellectual Property.
  • Our Life Sciences practice was top ranked nationwide in 2016 by Managing Intellectual Property.
  • The Firm was highly ranked by LMG Life Sciences 2017 in the areas of General Patent Litigation and Hatch-Waxman Patent Litigation with Peter Armenio, Nick Cerrito and Eric Stops named as Patent Stars.
  • Our Life Sciences practice and was ranked by Managing IP as a top firm in US in the categories of Bio/Life Sciences in 2016.
  • The Firm was named a Client Service Leader by BTI Consulting Group in BTI Client Service A-Team 2017 and was named a 2016 ‘Most Recommended Law Firm’ by BTI Consulting Group for the third year in a row.
  • Peter Armenio, Victoria Maroulis, and Ray Nimrod were named “IP Patent Stars” by Managing Intellectual Property in 2017.
  • Nick Cerrito, has been voted by his peers as a Best Lawyer in America since 2010 and by his clients as a BTI Consulting “Client Service All Star”.
  • Victoria Maroulis was named one of the most influential women in IP Law by Law360 in 2015.
  • Nick Cerrito, Peter Armenio, and Robert Wilson were listed by Best Lawyers in America 2017 in the practice areas of Intellectual Property Litigation Patent Litigation and Patent Law.
  • Peter Armenio and Ray Nimrod were recognized by Intellectual Asset Management’s (IAM) Patent 1000 – The World’s Leading Patent Professionals in 2016.
  • Peter Armenio and Ray Nimrod were ranked as Patent stars in New York by Managing Intellectual Property in 2017.
  • Peter Armenio, Sandra Bresnick, Ray Nimrod, Evangeline Shih, and Matt Traupman were named as New York Metro Super Lawyers in 2016 for Intellectual Property Litigation.
  • Andrew Chalson was named as a Law360 Life Science Rising Star in 2016.
  • Nick Cerrito and Peter Armenio were listed as “2016 Best Lawyers in America” by Best Lawyers 2016 in Intellectual Property Litigation, Patent Litigation and Patent Law.

Representative Clients:

  • Adapt Pharma, Inc.
  • Avanir Pharmaceuticals, Inc.
  • Celgene Corporation
  • Concert Pharmaceuticals, Inc.
  • Dexcel Pharma
  • Forest Laboratories
  • Gilead Sciences Inc.
  • Jazz Pharmaceuticals
  • Johnson & Johnson
  • Keryx Biopharmaceuticals, Inc.
  • Lundbeck
  • Merck & Co., Inc.
  • Vivus. Inc.

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Recent Representations Print

  • Alvogen Pine Brook LLC v. Celgene Corp., No. IPR2018-01714 at Paper 7 (Patent Trial Appeal Board). We represented Celgene Corporation in connection with a petition seeking Inter Partes Review of Celgene’s U.S. Patent No. 7,968,569 that was filed by Alvogen Pine Brook and Lotus Pharmaceuticals. Quoting liberally from our preliminary response, the Patent Trial and Appeals Board denied institution, soundly rejecting Alvogen’s position on the merits and upholding the validity of Celgene’s patent, which covers methods of using Celgene’s Revlimid drug product for the treatment of multiple myeloma. The patent expires in October of 2023.
  • Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC, No. 13-cv-391(D.N.J.). We represented Jazz in a Hatch-Waxman patent litigation involving Jazz’s Xyrem® (sodium oxybate) drug product, which is indicated to cataplexy and excessive daytime sleepiness in narcolepsy patients. The case began in 2010 with one generic filer and five patents-in-suit. By October 2018, there were nine generic filers and nearly 20 patents-in-suit. The settlement permits entry of generic sodium oxybate before the Jazz’s last-to-expire patent-in-suit, but generic entry will not occur until January 2023, with an authorized generic from which Jazz will receive a royalty. Generic entry will be allowed after the term of the authorized generic expires which may occur from July 2023 to January 2028 depending on whether various options are exercised by the parties.
  • Apotex Inc. et al. v. Celgene Corp., No. IPR2018-00685 (Patent Trial and Appeal Board). We won a complete victory for our client Celgene Corporation in an inter partes review challenging U.S. Patent No. 8,741,929, which expires in 2028. The patent covers methods of using Celgene’s Revlimid drug product for the treatment of mantle cell lymphoma (“MCL”), a deadly and hard-to-treat blood cancer. Apotex is seeking to market a generic version of Revlimid with a label indication for MCL. The PTAB rejected Apotex’s positions in their entirety, upholding the validity of the ’929 patent.
  • Apotex Inc. et al. v. Abraxis BioScience, Nos. IPR2018-00151, IPR2018-00152, & IPR2018-00153; Cipla Ltd. v. Abraxis BioScience, Nos. IPR2018-00162, IPR2018-00163, & IPR2018-00164 (Patent Trial Appeal Board). QE won three complete victories for our clients Celgene Corporation and Abraxis BioScience, LLC, in inter partes reviews challenging U.S. Patent Nos. 7,820,788, 7,923,536, and 8,138,229.  These patents cover aspects of Celgene’s Abraxane drug product, which is approved to treat metastatic breast cancer and other aggressive cancers.  Inter partes review of all three of these patents had previously been instituted based on identical prior art, arguments, and expert testimony in a related case that had settled.  We prevailed in these IPRs by obtaining key admissions from the opposing parties’ expert during his deposition.  The PTAB relied on these fatal admissions in denying institution of each IPR, despite having previously instituted on the same grounds.  We had previously successfully defended against another IPR covering an unrelated patent related to Abraxane, U.S. Patent No. 8,853,260.
  • Avanir Pharm. v. Actavis S. Atl., LLC, 36 F. Supp. 3d 475, 487, 506 (D. Del.), aff’d, Avanir Pharm. v. Par Pharm., Inc., 612 F.App’x 613 (Fed. Cir. 2015).  We represented Avanir in a five-defendant Hatch-Waxman patent infringement case involving client Avanir’s core patents, which protect its Nuedexta® (dextromethorphan/ quinidine) drug product.  Nuedexta® is FDA-approved for the treatment of pseudobulbar affect or PBA.  PBA results in episodes of uncontrollable crying or laughing that are often sudden and not congruent with the affected patient’s internal emotions.  The case began in July 2011 when Avanir received its first notice that a generic manufacturer had submitted an application to the FDA to market a generic version of Nuedexta®.  Four other generics followed suit.  Only two generics remained, however, when the case proceeded to trial—three settled just days before.  Trial was conducted for six days in September and October, 2013, in front of Judge Leonard Stark in the District of Delaware.  Post-trial briefing was conducted over October and November 2013, with supplemental briefing ordered in February 2014.  Judge Stark’s ruling finally issued on April 30, 2014.  In that ruling, Judge Stark found Avanir’s core patents valid and infringed.  One defendant appealed.  The Federal Circuit held oral argument August 7, 2015.  The next business day, the Federal Circuit issued a Rule 36 affirmance of the District Court’s decision on August 10, 2015, thereby ensuring patent protection for Nuedexta® until August 2026.
  • Celgene Corp. v. Natco Pharma Ltd., et al., No. 14-3126 (SDW)(LDW) (D.N.J.).  We represented Celgene in a Hatch-Waxman patent infringement case involving client Celgene’s Revlimid® (lenalidomide) drug product, which is indicated to treat multiple myeloma and other types of cancer.  QE filed the case in 2010 with ten patents-in-suit.  By the time the case settled in December 2015, there were over 20 patents-in-suit covering all aspects of Revlimid®, including the compound itself, formulations, crystal forms, methods of use, and the restricted distribution system.  After more than five years of litigation and the submission of expert reports, we obtained a favorable settlement for Celgene that does not permit full generic entry until after all but one of the Revlimid® patents have expired in 2026.  This settlement is hugely important for Celgene.  Revlimid® currently sells $6 billion per year and the deal ensures tens of billions of dollars in revenues before Celgene’s Revlimid® patents expire in 2027.  This is by far the largest deal in Celgene’s 20-year history, and it provides certainty on their highest selling product, which had been in limbo since this litigation began in 2010.  That certainty will allow Celgene to continue its pioneering efforts to prolong the lives of cancer patients.
  • Merck Sharp & Dohme Corp. v. Xellia Pharmaceuticals, ApS et al., No. 14-cv-199 (D. Del.) and Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, No. 14-cv-4989 (D.N.J.).  We represented Merck Sharp & Dohme Corp. in two Hatch-Waxman infringement involving client Merck’s CANCIDAS® product, which is indicated for the treatment of Candidemia and other Candida infections including intra-abdominal abscesses, peritonitis, and pleural space infections.  In the first case, QE was retained to take over as lead trial counsel approximately six weeks before the start of trial.  In June 2015, QE won a finding of infringement after a two-week bench trial before Judge Richard Andrews.  We also represented Merck in connection with the first defendant’s appeal of the district court’s decision (Appeal No. 2105-1905 (Fed. Cir.).  The case settled favorably for Merck following the appellate oral argument.  In the second case, we won a favorable claim construction ruling that defeated the second defendant’s primary non-infringement argument and then proceeded to a two-week bench trial in November 2016 on issues of infringement and invalidity.  The case settled favorably for Merck one day after closing arguments during which the judge pointedly questioned the soundness of the defendant’s theories of non-infringement and invalidity. 
  • Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc.; Civ. Nos. 10-6108 (D.N.J.), 15-1360 (D.N.J.), & 16-4971 (D.N.J.).  We represented Jazz in a Hatch-Waxman patent litigation involving Jazz’s Xyrem® (sodium oxybate) drug product, which is indicated to cataplexy and excessive daytime sleepiness in narcolepsy patients.  The cases started in 2010 with five patents-in-suit.  By April 2017, there were nearly 20 patents-in-suit.  The case settled favorably for Jazz after the close of expert discovery.  The settlement permits entry of generic sodium oxybate before the Jazz’s last-to-expire patent-in-suit, but generic entry will not occur until January 2023, with an authorized generic from which Jazz will receive a royalty.  Generic entry will be allowed after the term of the authorized generic expires which may occur from July 2023 to January 2028 depending on whether various options are exercised by the parties.
  • Petition for Inter Partes Review by Coalition for Affordable Drugs VI LLC; PTAB-IPR2015-01169. We represented Celgene Corporation in an inter partes review (IPR) regarding Celgene’s Revlimid® (lenalidomide) drug product, which is indicated to treat certain cancers.  The patent at issue covered the active ingredient in Revlimid®.  November 2015, the PTAB denied institution of the IPR.  The petition was filed by hedge fund manager Kyle Bass and patent troll Erich Spangenberg, who have been filing IPRs against pharmaceutical companies in an attempt to drive down their stock prices and profit on short positions taken in advance of filing.  This was a huge win and the importance to Celgene cannot be overstated (at the very least, it provides patent certainty and exclusivity in a growing $5-billion per year market until late 2019).
  • Par Pharmaceutical Inc. et al. v. Jazz Pharmaceuticals Inc., case numbers CBM2014-00149; CBM2014-00150; CBM2014-00151; and CBM2014-00153.  We secured a Decision Not to Institute Covered Business Method (“CBM”) Review of four patents for firm client Jazz Pharmaceuticals in the first-ever CBM attack in the pharmaceutical industry.  The PTO denied the CBMs, holding that Jazz’s patents did not claim a “financial product or service” and, therefore, were not “covered business method patents” eligible for review.  This is only the second time the PTO has denied institution of CBM review on these grounds, and the first time the PTO has found that the Patent Owner affirmatively showed its claims did not encompass a “financial product or service.”  The PTO has been liberal in its interpretation of what is included in a “financial product or service.”  The patents here cover methods of safely distributing the drug Xyrem to patients while preventing abuse and diversion of the drug.  The generic pharmaceutical petitioners alleged Jazz’s patents cover a financial product or service because they cover Jazz’s sale of its drug Xyrem, and because the claims have certain steps such as checking for cash payments and a patient’s insurance coverage.  We convinced the PTO that sales were not encompassed by Jazz’s patents’ claims, and that the claims as a whole are directed to safely controlling access to dangerous pharmaceutical drugs, not anything financial in nature.

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