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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.  Fifty-five 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 300 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 recognitions from the past few years.

  • The firm received top ranking in the 2022 ANDA Litigation Intelligence Report, which reviews the top-performing and most active law firms for ANDA / Hatch - Waxman Cases, for ANDA with an overall performance of 100%. The report also ranked the firm first in plaintiff performance with a score of 100%.
  • The firm has been ranked in 8 jurisdictions with 21 individual attorneys recognized for 2022 by IAM Patent 1000: The World’s Leading Patent Professionals.
  • The firm was ranked as Band 1 by Chambers USA 2021 for Intellectual Property nationwide.
  • The firm was highly ranked by Managing Intellectual Property for our Patent and Life Science practices in the United States in 2016-2021.
  • The firm was named to Law360’s 2020 “Practice Groups of the Year” in the area of Intellectual Property.
  • The firm was awarded the LMG Life Sciences Awards - Patent Impact Cases of the Year award for its work in the CRISPR-Cas9 patent disputes (2019).
  • 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.
  • Ray Nimrod and Matthew Robson were named Litigators of the Week by the American Lawyer in 2022 for the firm’s victory regarding CRISPR-Cas9 genome editing patents.
  • Nick Cerrito, Victoria Maroulis, and Robert Wilson were listed as “Best Lawyers in America” by Best Lawyers 2016-2022 in the practice areas of Intellectual Property Litigation Patent Litigation and Patent Law.
  • Victoria Maroulis has been recognized by Managing IP in the 2021/22 edition of IP STARS ‘Top 250 Women in IP’.
  • Managing Intellectual Property consistently names our partners as “IP Patent Stars”, including Nick Cerrito, Victoria Maroulis, and Ray Nimrod.
  • Ray Nimrod was awarded the LMG Life Science Award as General Patent Litigator of the Year – New York for 2019.
  • Matthew Robson was named as a Law 360 Life Science Rising Star in 2019.
  • Nick Cerrito, consistently 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”.

Representative Life Science Clients

  • AbCellera Biologics Inc.
  • Avanir Pharmaceuticals, Inc.
  • Bristol Myers Squibb Co.
  • Celgene Corporation
  • Chiesi Pharmaceuticals
  • Corcept Therapeutics, Inc.
  • Dexcel Pharma
  • Gilead Sciences Inc.
  • Incyte Corporation
  • Jazz Pharmaceuticals
  • Johnson & Johnson
  • Lundbeck
  • Merck & Co., Inc.
  • Rigel Pharmaceuticals
  • Sarepta Therapeutics
  • Takeda Pharmaceuticals
  • TherapeuticsMD
  • Vivus. Inc.

Recent Representations

  • Natera, Inc. v. NeoGenomics Laboratories, Inc., 1:23-cv-629 (M.D.N.C.): We represent Natera as plaintiff in a highly contentious patent infringement case in the Middle District of North Carolina against defendant NeoGenomics Laboratories regarding NeoGenomics’ cancer diagnostic test, RaDaR. Within four months of filing suit we obtained a preliminary injunction enjoining all making, use, sale, or offers to sell RaDaR, effective immediately. This is the first time a medical diagnostic has ever been enjoined through a preliminary injunction.
  • Chiesi USA, Inc. et al. vs. Aurobindo Pharma USA, Inc. et al., C.A. No. 3:19-cv-18756 (D. N.J.): Quinn Emanuel obtained a complete trial victory in a patent litigation for Chiesi USA, Inc. (“Chiesi”) against generic manufacturer Aurobindo. The case arose from Aurobindo’s filing of an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Chiesi’s Cleviprex® (clevidipine) injectable product. Chiesi asserted that Aurobindo’s ANDA infringed several of its US patents, and  Aurobindo counterclaimed for declaratory judgments of non-infringement, invalidity, and unenforceability of the patents-in-suit.  After a 7 day bench trial, Chiesi prevailed on all issues including, patent infringement, no invalidity and no unenforceability. The decision means that Aurobindo cannot launch its generic product until the patents-in-suit expire in October 2031.
  • The Regents of the University of California, et al. v. The Broad Institute, Inc., et al., Patent Interference No. 106,115 (Patent Trial and Appeal Board): The firm achieved a major victory for The Broad Institute, Inc. (“Broad”) against the University of California, University of Vienna, and Emmanuelle Charpentier (“CVC”) when the PTAB issued an opinion and judgment confirming Broad’s entitlement to foundational patents on the use of CRISPR-Cas9 in eukaryotic cells (including humans and plants).  The PTAB further found CVC’s claims to the same invention unpatentable.  CVC scientists Jennifer Doudna and Emmanuel Charpentier were awarded the Nobel Prize for CRISPR-Cas9, and CVC contended that they were entitled to patents covering eukaryotic uses.  The PTAB disagreed, and found in favor of our client. The CRISPR-Cas9 technology at issue has been described in the press as potentially worth billions.  This victory was widely covered in the press, including by the Wall Street Journal, Time Magazine, Science, The Boston Globe, Bloomberg, Barron’s and many others.  
  • Celgene Corp. v Hetero Labs Ltd., et al., 17-3387 (D.N.J.): The firm recently settled an eight-generic challenge to Celgene’s (now BMS’s) blockbuster cancer treatment, Pomalyst® (pomalidomide). The product is used for a variety of cancer treatments and has sales in excess of $3 billion per year. Due the firm’s efforts, Pomalyst® will remain patent protected until 2026.
  • PureWick Corp. v. Sage Products LLP, 19-1508-MN (D. Del.): We represented PureWick Corp. in a patent case involving External Urinary Catheters. On April 1, 2022, a jury returned a verdict finding that the defendant, Sage Products LLC, willfully infringed two PureWick patents by making and selling Sage’s PrimaFit female external urine collection device, and infringed a third PureWick patent by making and selling Sage’s PrimoFit male external urine collection device.  The jury awarded PureWick $26.2 million in lost profits from Sage’s sales of the PrimaFit and an additional $1.8 million based on a 6.5% reasonable royalty on Sage’s sales of the PrimoFit.  
  • BlephEx, LLC v. Myco Industries, Inc. et al., 19-13089 (ED MI): We obtained a preliminary injunction on behalf of our medical device client BlephEx in its ongoing patent litigation against Myco Industries. BlephEx’s device and Myco’s accused device compete in the ophthalmic market for dry eye treatment devices.  In 2020, Eastern District of Michigan court granted BlephEx’s Motion for Preliminary Injunction against Myco and Mr. Choate.  In February 2022, we obtained a further victory for BlephEx when the Federal Circuit unanimously affirmed the grant of a preliminary injunction.  The parties settled soon after, with our client’s adversary agreeing to entry of a permanent injunction against any further sales of the accused product in the US and payment of damages to our client.
  • Wilson Wolf Manufacturing Corp. v. Sarepta Therapeutics, Case No. 19-cv-02316-RGA (D. Del.):  We represent Sarepta in a patent litigation filed by Wilson Wolf Manufacturing Corp. alleging that Sarepta’s SRP-9001 gene therapy candidate is manufactured using certain devices and methods that infringe one or more claims of three patents assigned to Wilson Wolf.
  • Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc., 21-1360 (Fed. Cir.): We secured a Final Written Decision before the Patent Trial and Appeal Board (“PTAB”) that an Orange Book-listed patent owned by firm client Corcept Therapeutics and covering methods of co-administering its drug Korlym® with another class of drugs known as CYP3A inhibitors is not invalid as obvious. Following its defeat before the PTAB, the petitioner appealed to the Federal Circuit.  There, we secured a unanimous panel decision upholding the validity of Corcept’s patent based preliminarily on admissions that Teva’s expert had made during the PGR.  This victory was of tremendous importance to our client, as the patent-in-suit does not expire until 2039 and will protect the Korlym® product well into the future. 
  • 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.
  • Theravance Biopharma US, Inc., et al. v. Junning Lee, No. 17-cv-05044-VC (N.D. Cal.): QE represented biopharmaceutical company Theravance Biopharma US, Inc. and certain of its affiliates against its former Senior Vice President of Technical Operations, Junning Lee. Prior to his resignation in February 2017, Lee downloaded hundreds of thousands of confidential, proprietary, and trade secret documents from Theravance’s servers, then attempted to cover his tracks when Theravance discovered the downloading.  We asserted claims for trade secret misappropriation under state and federal law, as well as claims for breach of contract and breach of Lee’s fiduciary duty and duty of loyalty.  The court (Judge Vince Chhabria in the Northern District of California) granted our motion for preliminary injunction with only minor modification, ordering Lee to return dozens of devices, to provide access to his email accounts, and to identify any third parties who might have received Theravance data.  Theravance was not required to post a bond.
  • Merck Sharp & Dohme B.V. v. Warner Chilcott Company, LLC, et al., No 2016-2583 (Fed. Cir.): QE achieved a significant appellate victory for our long-time client Merck (US) in connection with its NuvaRing® contraceptive product. On October 19, 2017, the United States Court of Appeals for the Federal Circuit reversed the district court’s finding that Merck’s patent covering NuvaRing® was obvious.  The decision prevents generic competition for NuvaRing® until after the patent expires.
  • 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.): QE 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. 10-5197 (SDW) (LDW) (D.N.J.): QE 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 was by far the largest deal in Celgene’s history, and it provided certainty on their highest selling product, which had been in limbo since this litigation began in 2010.  That certainty has allowed Celgene to continue its pioneering efforts to prolong the lives of cancer patients.  Bristol Myers Squibb Company acquired Celgene in 2019.  The Firm continued to represent Celgene in more than fifteen Hatch-Waxman patent cases involving generic challenges to Revlimid®, and has since favorably settled all of those cases in a manner that preserves the terms of the original 2015 Natco settlement.
  • 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.): QE 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.): QE 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: QE 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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