Overview

Generic pharmaceutical manufacturers know who to turn to when facing complex Hatch-Waxman patent litigation. As co-leader of Schiff Hardin’s Intellectual Property Group, Sailesh K. Patel also co-chairs the firm’s Pharmaceuticals and Biologics Patent Litigation Team and serves on the firm’s executive committee. Sailesh is a seasoned trial attorney. He is passionate about implementing creative and scientifically sound arguments for his clients, which has resulted in legal precedent-setting cases.

Sailesh has served as lead counsel on numerous patent infringement litigation matters. With a background in chemical and biomedical engineering, he is familiar with the language of the pharmaceutical industry. Defense against patent infringement requires subject matter experts; Sailesh is skilled at aligning the best experts to successfully defend his clients’ interests.

Sailesh is effective both in trials and in negotiating favorable settlements for his clients. There are many moving parts in patent litigation, and Sailesh is skilled at coordinating multiple parties, experts, and arguments into coherent and persuasive cases. In cases where there are multiple defendants, he represents his clients in a way that makes them stand out from the rest, leading to more favorable results. He also assists companies in Paragraph IV and Biosimilars design strategies, helping his clients protect their scientific discoveries.

He has significant experience in preparing and prosecuting patent applications in a variety of technologies beyond pharmaceuticals and biologics. Sailesh has represented clients in cases involving wind and solar technology, food processing, automotive components, and software, among other industries.

Previous Experience

Prior to joining Schiff Hardin, Mr. Patel was an associate for a prominent IP law firm.

  • Experience

    • Allergan v. Akorn (E.D. Tex. 2017) (Successfully defended Akorn at trial in the E.D. Texas invalidating Allergan’s patent covering Restasis®, a billion dollar ophthalmic product.)
    • MillerCoors v. HCL Technologies (N.D. Ill. 2018) (Representing HCL in SAP software implementation dispute)
    • Allergan v. Aurobindo Pharma (D. Del. 2018) (Lead counsel for Aurobindo in linaclotide, Linzess®, ANDA litigation)
    • The Medicines Company v. Aurobindo (D. N.J. 2017) (Lead counsel for Aurobindo in bivalirudin ANDA litigation)
    • Horizon v. Lupin (D. N.J. 2017 and Fed. Cir.) (Lead counsel for Lupin in Vimovo® ANDA litigation)
    • Mylan Institutional v. Aurobindo (E.D. Tex. 2017 and Fed. Cir.) (Lead counsel for Aurobindo in patent litigation involving isosulfan blue)
    • Eli Lilly v. Ajanta and Aurobindo (E.D. Va 2017) (Lead counsel for Aurobindo and Ajanta pharmaceuticals in litigation involving tadalafil, Cialis®)
    • The Medicines Company v. Aurobindo (D.N.J. 2017) (Lead counsel for Aurobindo in bivalirudin, Angiomax®, ANDA litigation)
    • Allergan v. Akorn (M.D.N.C. 2016 and Fed. Cir.) (Lead counsel for Akorn on bimatoprost, Latisse® and Lumigan®, ANDA litigation)
    • Depomed v. Alkem (D.N.J. 2016 and Fed. Cir.) (Represented Alkem in tapentadol, Nucynta®, ANDA litigation)
    • Pfizer v. Fresenius Kabi (D. Del. 2016) (Represented FK in tigecycline 505(b)(2) trial)
    • Otsuka v. Ajanta and Orchid (D. N.J. 2016) (Lead counsel for Ajanta and Aurobindo in aripiprazole, Abilify®, ANDA litigation)
    • Acorda Therapeutics v. Aurobindo, Accord and Alkem (D.Del. 2016) (Representing Aurobindo, Alkem and Accord in dalfampridine, Ampyra®, ANDA litigation)
    • Dexcel v. Sun (D.N.J. 2017) (Represented Sun Pharmaceuticals in omeprazole delayed release litigation)
    • Pfizer v. Aurobindo (D. N.J. 2015) (Lead counsel for Aurobindo in linezolid ANDA litigation)
    • Janssen v. Aurobindo (D. N.J. 2015) (Lead counsel for Aurobindo in galantamine ANDA litigation)
    • Forest v. Sun Pharmaceuticals (D. Del. 2014) (Lead counsel for Sun Pharmaceuticals Ltd. in ANDA litigation of the Alzheimer drug Namenda®,memantine XR).
    • AstraZeneca v. Aurobindo (D.Del. 2016 and Fed. Cir.)(Lead counsel for Aurobindo in ANDA litigation of diabetes drug Onglyza® (saxagliptin)).
    • Rosco Inc. v. Velvac Inc. (S.D.N.Y) (Lead counsel for Velvac in patent litigation involving fender mounted mirror assemblies)
    • Cephalon v. Glenmark (D. Del. 2014) (Lead counsel for Glenmark in bendamustine ANDA litigation)
    • Teva Women’s Health v. Lupin (D.N.J. 2012 and Fed. Cir.)  (Lead counsel for Lupin in ANDA litigation for birth control drugs Seasonique and Loseasonique)
    • Teva Women’s Health v. Lupin (D.N.J.) (Represented Lupin in Seasonale® ANDA litigation)
    • Warner-Chilcott v. Lupin (D.N.J.) (Represented Lupin in Loestrin and Femcon ANDA litigation)
    • Sciele Pharma v. Lupin (D.Del.) (Represented Lupin in metformin, Fortamet, ANDA litigation)
    • Shire v. Mylan (D. Del.) (Represented Mylan in lanthanum carbonate ANDA litigation)
    • Abbott Laboratories v. Mylan Inc. (N.D. Ill) (Represented Mylan in lopinavir/ritonavir ANDA litigation)
    • Kodak v. DR Systems (S.D. Cal. 2009) (Represented Kodak in patent litigation involving MRI imaging systems)
    • AstraZeneca v. Sandoz (D.N.J.) (Represented Sandoz in quetiapine ANDA litigation)
    • AstraZeneca v. Lupin (D.N.J.) (Represented Lupin in esomeprazole ANDA litigation)
    • Sepracor v. Lupin (D.N.J.) (Represented Lupin in eszopiclone ANDA litigation)
    • AstraZeneca v. Lek and Sandoz (S.D.N.Y.) (Represented Lek and Sandoz in omeprazole litigation. Obtained a finding of non-infringement opening the U.S. market for a generic version of Prilosec)
    • Schreiber Foods v. Saputo Foods (N.D. Ill) (Represented Schreiber in patent litigation involving imitation cheese)
    • Continental Can v. Orexo (N.D. Ill) (Represented Continental Can in patent litigation involving oxygen barrier films)
    • Sailesh has also handled many inter partes review petitions in the USPTO.
  • Credentials

    Education

    • Boston College Law School, J.D., 1999
    • Northwestern University, B.S., Chemical Engineering, 1996

    Bar Admissions

    • Illinois
    • U.S. Court of Appeals for the Federal Circuit
    • U.S. District Court for the Northern District of Illinois
    • U.S. District Court for the Eastern District of Michigan
    • U.S. Patent and Trademark Office

      Professional Memberships

      • American Bar Association
      • Asian American Bar Association of Chicago, Honorary Board Member
      • Indian-American Bar Association of Chicago, Advisory Council, Past President
      • North American South Asian Bar Association, Former Board of Directors, Intellectual Property Section, Former Chair
      • Intellectual Property Law Association of Chicago, Past Board of Managers

      Teaching Appointments

      • Chicago-Kent College of Law, Pharmaceutical Patent Law, Adjunct Professor
    • Insights

      TITLE
      Alert

      Pharmaceutical and Technology Industry Innovation Growth at Stake in Helsinn Healthcare v. Teva

      Today’s oral arguments in Supreme Court case Helsinn Healthcare v. Teva illustrate the power that a successful appeal could have to change a longstanding doctrine and significantly impact how businesses handle intellectual property transactions.

      News Release

      Aly and Patel Named 2018 Life Sciences Stars

      Imron Aly and Sailesh Patel have been named Life Sciences Stars in the Hatch-Waxman Patent Litigation Practice Area by LMG Life Sciences in its 2018 guide.

      News Release

      61 Schiff Attorneys Named to 2019 Best Lawyers in America List and Six Recognized as “Lawyer of the Year”

      Schiff Hardin is pleased to announce that 61 attorneys have been included in the 2019 edition of The Best Lawyers in America, as well as six who were named a “Lawyer of the Year” in their respective areas of practice.

      In The News
      Event

      2018: A Year of Change for Post Issuance Proceedings

      4th Annual IP Strategy Summit: Chicago

      Location:
      Chicago, Ill.
      In The News
      News Release

      Schiff Hardin Recognized Among Managing Intellectual Property IP Stars

      Schiff Hardin has been ranked as ‘Recommended’ by Managing Intellectual Property magazine in the Illinois IP Stars Patent Contentious category.

      In The News

      Patel Featured on BPCIA Litigation to Watch

      The Center for Biosimilars

      Event

      Other Publications

      • “The Supreme Court's Mayo v. Prometheus Decision: The Implications for Biotechnology,” (co-author) The National Law Review (Mar. 23, 2012)
      • “There Is No Orange Book: The Coming Wave of Biological Therapeutics,” (co-author) Oxford University Journal of Intellectual Property Law & Practice (2011)
      • “Inequitable Conduct: Therasense En Banc,” SpicyIP Blog, (India) (Mar. 27, 2011)
      • “Northern Ill.’s New Local Patent Rules,” Law360 (Nov. 6, 2009)
      • “Federal Circuit Review of Markman Issues (2002),” Litigation Committee, Intellectual Property Law Association of Chicago (IPLAC) (Dec. 2003)
      • “Federal Circuit Review of Markman Issues (2001),” Litigation Committee, Intellectual Property Law Association of Chicago (IPLAC) (Dec. 2002)

      Speeches & Presentations

      Sailesh is a regular presenter and faculty member on intellectual property issues. Recent presentations include:

      • “2018: A Year of Change for Post Issuance Proceedings,” 4th Annual IP Strategy Summit: Chicago, Chicago, Ill. (Jun. 5, 2018)
      • “The On-Sale Bar and its implications in Hatch-Waxman Litigation,” Pharma IPR conference, Mumbai, India (Mar. 2018)
      • “A View from the Bench: The Federal Judges Speak on Paragraph IV Litigation,” (moderator) Paragraph IV Disputes Master Symposium – ACI’s Hatch-Waxman Series, Chicago, Ill. (Oct. 3, 2017)
      • “The State of the Asian American Attorney in Chicago Law Firms,” (panelist) The Chicago Committee, Chicago, Ill. (Jun. 3, 2015)
      • “Takeaways from High-Profile Biosimilar Court Cases,” Business of Biosimilars Conference, Boston, Mass. (Oct. 21, 2014)
      • “Perils of the Safe Harbor: Understanding How the Resetting of the Boundaries of 271(e)(1) in the Aftermath of Classen and Momenta Is Impacting Paragraph IV Litigation Strategies,” American Conference Institute, New York, N.Y. (Apr. 29, 2014)
      • “Cost-Effective Litigation Management Strategies for Paragraph IV Litigation,” Pharma IP and Regulatory Conference, Mumbai, India (Feb. 26, 2014)
      • “Formulating Assertions and Defenses in View of New Substantive and Procedural Developments in the Federal Courts and PTO,” Paragraph IV Disputes Master Symposium, American Conference Institute, Chicago, Ill. (Oct. 3, 2013)
      • “Freedom to Operate Issues and Patent Litigation Considerations for Biosimilars,” Second International Conference on Biowaivers and Biosimilars, Raleigh, N.C. (Sep. 23, 2013)
      • “Breaking Developments in Hatch-Waxman Litigation: Paragraph IV Disputes and Beyond,” Legal and Regulatory Summit on Generic Drugs, New York, N.Y. (Jul. 17, 2013)
      • “Antitrust Concerns in Settlement of Paragraph IV Litigation,” Pharma IP and Regulatory Conference, Mumbai, India (Apr. 10, 2013)
      • “Evaluating the Patentability Standards in the Pharmaceutical Industry to Mitigate the Risks Involved in Product Launches in Analyzing Freedom-to-Operate Issues,” Pharma IPR Conference, Mumbai, India (Feb. 1, 2012)
      • “A Glimpse of the Future – US Biosimilars Litigation Considerations,” Biopractice.com webinar (Dec. 15, 2011)
      • “Alleging and Defending Against Inequitable Conduct in a Paragraph IV Case: Legal and Ethical Considerations,” Paragraph IV Disputes, American Conference Institute, New York, NY (May 4, 2011)
      • “IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trade Dress, and More,” Paragraph IV Disputes, American Conference Institute, New York, NY (May 2, 2011)
      • “The Scientist: Discussing the ‘Invention’ History With an Eye Towards Distinguishing the Innovative Nature of the Generic Product and Proving Invalidity,” Paragraph IV On Trial, American Conference Institute, New York, NY (Nov. 13, 2009)

    Product Liability and Mass Torts Blog

    FDA Issues Final Guidance on Biosimilars

    Shortly after approving the first biosimilar under the abbreviated approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the FDA has recently issued 3 final guidances regarding biosimilars. Biological products, or “biologics,” are pharmaceutical products created from biological sources. Unlike chemically synthesized pharmaceuticals, biologics are isolated from natural sources, and... Continue Reading

    VISIT THE BLOG

    Clients Rely on Aly and Patel as Strategic Advisers to Bring Generic Drugs to Market

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    Aly and Patel are Strategic, Must-Have Advisers Who Bring Generic Drugs to Market Copy: Intellectual Property Practice Group Co-Leaders Imron Aly and Sailesh Patel were featured in Leading Lawyers Magazine—2018 Business Edition for their successful track record in challenging giant pharmaceutical companies to bring generic drugs to the marketplace. MORE