David Gindler

David Gindler leads Orrick’s Life Sciences Sector. An experienced trial attorney, he focuses on intellectual property litigation and licensing, with a strong emphasis on trials of high-stakes patent and trade secret disputes in the life sciences field. David’s exceptional record has earned him repeat honors by Chambers USA. He has been Chambers-ranked for 15 years and is currently ranked Band 2 for Life Sciences: IP/Patent Litigation in both the USA Nationwide and California editions.

• Engagements

  Select prior experience includes:

  • Genentech and Hoffmann-La Roche Inc. v. Sandoz and Lek. Currently representing Genentech and Hoffmann-La Roche in a non-ANDA patent infringement lawsuit filed in the US District Court for the District of New Jersey against Sandoz and Lek relating to defendants' generic version of Genentech's product Esbriet, a blockbuster treatment for idiopathic pulmonary fibrosis. Defeated Sandoz's motion to transfer the case to Delaware, where prior ANDA litigation took place. The case is now proceeding to discovery.
  • Confidential International Arbitration. Currently representing a leading biotechnology company in an arbitration pending in the International Court of Arbitration of the International Chamber of Commerce filed by a large multinational pharmaceutical company. The case involves claims for breach of a license and collaboration agreement between the parties. The claimant has valued the case at more than $500 million.
  • Novartis v. Genentech. Currently representing Genentech in a dispute with Novartis in which Novartis seeks to avoid paying royalties owed on its drugs Cosentyx and Ilaris under a patent license agreement based on product manufactured and imported into the United States before, but sold after, expiry of the licensed patents. Novartis also sought to recoup more than $200 million in royalty payments it made under the licensed patents for the drug Cosentyx, claiming it did not need the license because its product did not practice the licensed patents. On May 2, 2023, the US District Court for the Northern District of California granted Genentech’s motion to dismiss all of Novartis’ claims seeking a refund of the $200 million in royalties paid on Cosentyx. The Court also refused Novartis’ request for leave to amend its complaint, finding that any amendment would be futile. The case has now been remanded to California Superior Court, where the only remaining dispute is whether Novartis is obligated to pay royalties to Genentech for product made and imported into the United States before, but sold after, expiry of the licensed patents.
  • PDL BioPharma v. Eli Lilly and Co. Currently representing PDL BioPharma in a lawsuit filed in the US District Court for the Southern District of Indiana alleging anticipatory breach of contract and seeking a declaratory judgment relating to PDL's rights under a Development and License Agreement with Lilly. The lawsuit seeks to adjudicate PDL's right to receive royalties on donanemab, a treatment for Alzheimer's Disease awaiting FDA approval, based on Lilly's use of PDL's licensed intellectual property relating to the humanization of chimeric antibodies.
  • Genentech and Biogen v. Celltrion and Teva; Genentech and Biogen v. Sandoz; Genentech and Biogen v. Fresenius Kabi and Doctor Reddy's Laboratories. Represented Genentech and Biogen in patent litigation under the BPCIA against multiple competitors relating to the blockbuster drug, Rituxan. The lawsuits against Celltrion and Fresenius were settled on favorable terms. The lawsuit against Sandoz was dismissed after it withdrew its request for FDA approval of its aBLA. In addition to multiple district court litigations, David defended Genentech and Biogen against 25 IPR petitions at the PTAB and secured 16 non-institution decisions, four adverse judgments against petitioners (who abandoned the proceeding), and three final written decisions rejecting the attack on all claims.
  • Boehringer Ingelheim v. Genentech and Biogen; Celltrion v. Genentech and Biogen; Pfizer v. Genentech and Biogen; and Sandoz v. Genentech and Biogen. Defended Genentech and Biogen in connection with 25 IPR petitions in the PTAB for multiple patents relating to methods of using Rituxan. Secured 16 non-institution decisions, 4 adverse judgments against petitioners (who abandoned the proceeding), and 3 final written decisions rejecting the attack on all claims. Only 2 of the 25 proceedings resulted in loss of patent claims in final written decisions. The petitioners are competitors who filed, or planned to file, applications with the FDA to market biosimilar versions of rituximab under the Biologics Price Competition and Innovation Act.
  • Miltenyi Biomedicine v. University of Pennsylvania and Novartis.  Represented Miltenyi Biomedicine as petitioner in two IPR proceedings before the Patent Trial and Appeal Board (PTAB) against the University of Pennsylvania (as patent owner) and Novartis (as exclusive licensee). The patents that Miltenyi sought to invalidate relate to anti-CD19 CAR T-cell therapy for the treatment of blood cancers. After receiving institution decisions, the parties reached a mutually acceptable license agreement, which was Miltenyi’s goal from the outset. Miltenyi Biomedicine is part of the Miltenyi global biotechnology family of companies and is seeking to launch its first therapeutic product: a next-generation CAR T-cell therapy to treat patients with lymphoma.
  • Altela v. Skysong Innovations. Secured a complete victory for Skysong Innovations, which manages the intellectual property of Arizona State University ("ASU"). In this arbitration, claimant Altela alleged that Skysong wrongfully terminated Altela's license agreement covering groundbreaking water reclamation technology from ASU, resulting in the complete loss of Altela's business and over $40 million in damages. A three-person arbitration panel unanimously rejected all of Altela's claims, finding that Skysong properly terminated the license agreement for non-payment of royalties and failure to provide quarterly royalty reports. The panel awarded Skysong its unpaid royalties from Altela, along with all of Skysong's attorneys' fees.
  • PDL BioPharma v. Merck. Secured a $19.5 million lump-sum payment from Merck to settle PDL BioPharma's lawsuit filed in the US District Court for the District of New Jersey alleging that Merck's manufacture of its cancer drug Keytruda infringed a foundational patent relating to the humanization of recombinant antibodies. The case was settled little more than one year after it was filed following the claim construction hearing.
  • Ariosa Diagnostics v. Sequenom. Secured a complete victory for Ariosa Diagnostics in a declaratory judgment action filed in the US District Court for the Northern District of California against Sequenom. Defeated Sequenom's initial effort to secure a preliminary injunction to enjoin Ariosa from selling its Harmony Prenatal Test (an affordable, highly accurate, non-invasive blood test to assess the risk of fetal chromosomal abnormalities). Prevailed on an early summary judgment motion that invalidated Sequenom's patent for failing to claim patent-eligible subject matter. The decision was affirmed by the US Court of Appeals for the Federal Circuit in a closely watched appeal.
  • Koninklijke Philips N.V. et al. v. ZOLL Medical Corp. Defeated a $217 million damages claim in the US District Court for the District of Massachusetts for ZOLL's infringement of defibrillator technology patents and secured jury verdict of no willful infringement. Retained for the damages phase of the litigation after ZOLL was found to infringe in an earlier liability trial handled by another law firm. Initially secured multiple appellate victories for ZOLL on the liability verdict, including overturning the jury verdict that several asserted patent claims were not invalid as anticipated. On remand, when Philips sought $217 million on its infringement claims against ZOLL, and ZOLL sought $3.3 million on its infringement counterclaims against Philips, the jury awarded $10.4 million to Philips and $3.3 million to ZOLL, resulting in a net verdict of $7.1 million to Philips.
  • Koninklijke Philips N.V. et al. v. ZOLL Lifecor Corp. Obtained a favorable outcome for ZOLL Lifecor in a patent infringement case pending in the US District Court for the Western District of Pennsylvania involving external defibrillator technology. Won an important Daubert motion excluding critical parts of the opinion of Philips's damages expert. The case settled after the court refused to allow Philips to offer a supplemental opinion on damages and the related victory discussed above at the damages trial for ZOLL Medical.
  • PDL BioPharma v. Genentech and F Hoffmann-La Roche. Represented PDL BioPharma in a Nevada state court action alleging breach of a 2003 settlement agreement that, among other things, barred Genentech from challenging the validity of PDL patent rights. After extensive discovery and motion practice, the case was stayed pending Genentech and Roche's interlocutory appeal to the Nevada Supreme Court of a trial court order granting PDL's motion to compel them to produce critical documents withheld on grounds of privilege. The case settled during the appeal, with Genentech entering into amended license agreements with PDL. Details about the financial terms of the settlement can be found in PDL's public disclosures.
  • Medlmmune v. Genentech and City of Hope; Centocor, Inc. v. Genentech and City of Hope; Bristol Myers Squibb v. Genentech and City of Hope. Represented City of Hope in a series of declaratory judgment actions attacking a family of patents co-owned by Genentech and City of Hope (referred to as the "Cabilly patents") that cover fundamental processes relating to recombinant antibodies. All cases were resolved on favorable terms, with no findings of invalidity, unenforceability or noninfringement. After nearly 15 years of continuous litigation challenges, the Cabilly patents expired in 2018 without any court or tribunal finding any claim invalid, not patentable, or unenforceable.
  • Alnylam Pharmaceuticals et al. v. Whitehead Institute for BioMedical Research et al. Represented Alnylam and Max Planck Institute in a complex patent dispute in the US District Court for the District of Massachusetts concerning rights to fundamental technology covered in two patent families in the field of RNA interference. Successfully resolved the case on favorable terms through a creative settlement that used co-ownership rights and other cooperative mechanisms to overcome USPTO rejections in both patent application families.
  • University of Utah v. Alnylam Pharmaceuticals, et al. Secured a complete victory on summary judgment for Alnylam, Max Planck Institute, Whitehead Institute and Massachusetts Institute of Technology in a lawsuit in the US District Court for the District of Massachusetts alleging that a University of Utah professor should have been included as an inventor on patents in the field of RNA interference co-owned by defendants.
  • Aon Corporation v. Guy Carpenter & Company. Represented Aon Corporation, one of the world's largest insurance and financial services companies, in a declaratory judgment action filed in the US District Court for the Southern District of New York relating to a competitor's patent in connection with graphical representations of insured risks and related weather and catastrophe data. Successfully negotiated a settlement of the litigation significantly in advance of trial.
  • CooperVision v. CIBA Vision. Represented CooperVision in multiple lawsuits in multiple forums (the US District Court for the District of Delaware and the US District Court for the Eastern District of Texas) in actions involving cross-allegations of infringement of patents relating to certain core technologies used in contact lenses. CooperVision successfully resolved the case through an innovative cross-licensing arrangement.
  • Data Treasury Corporation v. NCR Corporation. Represented NCR in a patent infringement suit filed in the US District Court for the Eastern District of Texas relating to electronic processing of financial transactions. Achieved very early settlement on favorable terms, while multiple defendants in related cases involving the same patents reportedly paid eight-figure settlements.