Biotechnology, Chemical, and Pharmaceutical

Overview

Every biotechnology, chemical and pharmaceutical company needs a competitive advantage. BakerHostetler’s unparalleled understanding of  intellectual property (IP) allows our clients to create, expand and maintain their competitiveness by deftly guiding them through the global labyrinth of patent laws. Whether our clients need to create their own patent portfolios, license or buy patent portfolios, circumvent patents, or challenge invalid patents, our attorneys have the experience necessary for success.

We handle every type of pharmaceutical product, including small molecules, biologics and drug-device combinations. Our attorneys create, develop, overhaul, repair and maintain worldwide patent estates for new chemical entities, existing chemical entities, over-the-counter products, antibodies, proteins, vaccines, and cell and gene therapies. For due diligence – whether for Series A, B or C funding rounds; initial public offerings (IPO); or licensing – our technical mastery and legal acumen have been key in evaluating patent portfolios and providing thorough, practical advice to stakeholders.

Our team’s proficiencies in every area of the life sciences, combined with our analytical talents, have helped clients not only defend the validity of their patents but also invalidate patents that should not have been granted in the first place.

Clients trust us with patent portfolios directed at pioneering research and active pharmaceutical ingredients as well as portfolios protecting products that are subject to Abbreviated New Drug Application (ANDA) litigation, and biosimilars litigation and opposition.

We assist in securing the allowance of critical inventions that have been involved in complex, protracted prosecution. We provide patentability assessment, freedom-to-operate analysis, patent landscaping and “white-space” analysis, Orange Book listings, pre- and post-launch exclusivity counseling, and pre-litigation counseling. Our team is frequently engaged as prosecution counsel for portfolios asserted in Hatch-Waxman litigations.

Our attorneys and agents have backgrounds in the life sciences and chemical arts and hold advanced degrees in immunology, organic chemistry, genetics, biochemistry and molecular biology. Our analyses and counseling are based on substantial experience in the life sciences combined with a pragmatic understanding of business needs.

We are versed in the intricacies of marketing exclusivities and approvals. We work with our clients to develop and implement a global patent strategy that is tailored to their unique needs, helping ensure success in a competitive marketplace. Our custom software tools efficiently track and manage even the most complex global patent estates.

Select Experience

  • Johnson & Johnson has been a BakerHostetler client for more than 25 years. We handle patent prosecution matters that span a wide array of technologies, We also handle all forms of counseling related to patents and technology, including the purchase, sale and licensing of technology, as well as related mergers and acquisitions. Portfolio management includes monitoring competitor products and patents and advice regarding clearance and cohesiveness of protection, maintenance and enforcement. In addition to prosecution work, we also handle hybrid prosecution litigation that includes inter partes reviews (IPR) and reexaminations.
  • Defended an IPR filed against our client, a leading global provider of agricultural science and technology. The IPR was opposed by our team and resulted in the Patent Trial and Appeal Board (PTAB) denying the petitioner’s request. The petitioner’s request for a rehearing with the PTAB also was denied.
  • Led due diligence and preparation of the IP portion of the S1 document for an IPO that raised $182 million. BakerHostetler has been IP counsel from conceptualization to the IPO and beyond.
  • Counsel a global pharmaceutical company in all areas related to patents and technology, including the purchase, sale and licensing of technology as well as related mergers and acquisitions. Our team also manages the worldwide patent portfolio of pharmaceutical drug applications and continues to protect research and development activities and innovations derived from clinical trial activities. The products include a vaccine, numerous antibody-based cancer therapies, a neoplasm treatment and a therapy involving in vivo production of a protein used to treat ocular disorders.
  • Assisted a global pharmaceutical company in its patent portfolio strategies covering a successful oncology therapy. Our work included detailed analytical and legal work to secure additional patent protection for the product until 2033 as well as drafting applications that capture additional IP.
  • Assisting a startup pharmaceutical company in its patent exclusivity strategies for its orphan-designated clinical development candidate.
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Professionals

Name Title Office Email
Associate Cincinnati
Associate Philadelphia
Partner Philadelphia
Associate Cincinnati
Associate Philadelphia
Partner Philadelphia
Partner Washington, D.C.
Counsel Chicago
Partner Philadelphia
Partner Costa Mesa
Partner Philadelphia
Partner Philadelphia
Partner Philadelphia
Partner Philadelphia
Associate Chicago
Patent Agent Philadelphia
Partner Washington, D.C.
Partner Philadelphia
Partner Philadelphia
Patent Agent Atlanta
Patent Agent Washington, D.C.
Associate Philadelphia
Partner Denver

Experience

  • Representing Johnson & Johnson in various sophisticated intellectual property matters, and have done so for more than 25 years. In a more recent engagement, developed patent portfolio for a drug treatment now approved by the Food and Drug Administration (FDA), with work involving managing the worldwide patent portfolio directed at the drug treatment as well as expanding the patent portfolio to protect continued research and development activities and innovations derived from various clinical trial activities. Work closely with in-house counsel to align the patent strategy with FDA approval and labeling activities, advise concerning Orange Book listings, and consider life cycle management in order to enhance and strengthen the exclusivity position for the drug treatment. Assess and enhance existing and pending patent claims in view of potential challenges.
  • Devising exclusivity strategies for J&J’s darunavir patent portfolio. Protect combination products and drug regimens in view of law’s inherent bias against such subject matter. Analyzed patent applications and clinical data in order to present sophisticated legal arguments for patentability to both patent examiners and Board of Appeal judges.
  • Representing Teva Pharmaceuticals in its exclusivity strategies for its TREANDA and BENDEKA products.
  • Representing Teva Pharmaceuticals in its exclusivity strategies and patent portfolio development for its AUSTEDO product.
  • Representing Tyra Pharmaceuticals in patent portfolio creation strategies. Tyra’s 2021 IPO raised over $170 million.
  • Representing Prelude Therapeutics in patent exclusivity strategies and patent portfolio development, which led to a successful IPO. BakerHostetler has been IP counsel from conceptualization to the IPO and beyond.
  • Providing counsel since 2005 to DePuy Synthes, a major medical device company that was acquired by J&J, in all aspects of their patent prosecution needs. We handle patents across a wide range of medical device technologies, such as trauma bone plate technology, spinal implants and craniofacial devices. We have also successfully defended DePuy Synthes in an IPR relating to dynamic spinal rods, which led to a favorable settlement in an underlying patent infringement action.
  • Representing Teleflex Incorporated, a manufacturer providing medical devices used in critical care and surgery, since 2004. We handle all patent and trademark prosecution matters for the client across almost 30 divisions of the company, spanning a wide array of technologies, including medical and surgical devices, in the vascular, respiratory, cardiac and anesthesia areas.
  • Defending an IPR that was filed against our client resulting in the Patent Trial and Appeal Board (PTAB) denial of the petitioner’s request. The petitioner’s request for a rehearing with the PTAB was also denied.
  • Counseling Dicerna in its licensing of Tekmira's proprietary lipid nanoparticle technology for delivery of one of its RNAi candidates, with potential for $24.5 million in milestones in addition to ongoing royalties.
  • Representing RoundTable Healthcare Partners regarding IP aspects in various pharmaceutical and medical device acquisitions, including its sale of CorePharma LLC and other companies to Impax Laboratories Inc. for $700 million and of Aspen Surgical Products Holdings Inc. to Hill-Rom Holdings Inc. for $400 million.
  • Representing a biopharmaceutical company in negotiation of several multiyear supply agreements with a contract manufacturer.
  • Advised GlaxoSmithKline plc regarding the IP aspects of its sale of a hepatitis C treatment candidate to Janssen Pharmaceuticals.
  • Serving as lead corporate and acquisitions counsel to an Indian pharmaceutical company in connection with acquisitions of U.S. pharmaceutical distribution and manufacturing businesses.

Recognition

  • Chambers USA
    • Intellectual Property ‒ Ohio (2011 to 2021)
    • Intellectual Property ‒ Georgia (2017 to 2021)
    • Intellectual Property ‒ Pennsylvania (2007 to 2021)
    • Intellectual Property: Litigation ‒ District of Columbia (2015 to 2021)
    • Intellectual Property: Patent Prosecution ‒ District of Columbia (2015 to 2021)
    • Intellectual Property: Trademark, Copyright & Trade Secrets ‒ New York (2014 to 2021)
  • The Legal 500 United States
    • Intellectual Property – Copyright (2015 to 2021)
    • Intellectual Property – Patent Litigation: Full Coverage (2015 to 2020)
    • Intellectual Property – Patents: Prosecution (Including Re-Examination and Post-Grant Proceedings) (2015 to 2021)
    • Intellectual Property – Trade Secrets (Litigation and Non-Contentious Matters) (2017 to 2021)
    • Intellectual Property – Trademarks: Non-Contentious (Including Prosecution, Portfolio Management and Licensing) (2019 to 2021)
  • Daily Report Intellectual Property Litigation Department of the Year (2017)
  • IAM Patent 1000 ‒ DC Metro Area (2015 to 2020); Georgia (2019, 2021); Illinois (2019, 2021); Pennsylvania (2015 to 2021); Washington (2015 to 2021)
  • WTR 1000 – The World's Leading Trademark Professionals ‒ Firm and attorney rankings (2013 to 2021)
  • U.S. News – Best Lawyers “Best Law Firms”
    • Copyright Law: National (2012 to 2021); Atlanta (2019 to 2021); New York (2018 to 2021); Philadelphia (2014 to 2021)
    • Intellectual Property Law – Orlando (2011 to 2020)
    • Litigation – Intellectual Property: National (2012 to 2021); Atlanta (2021); Chicago (2019 to 2021); Cincinnati (2012 to 2021); Cleveland (2012 to 2021); Columbus (2017 to 2020); Dallas/Fort Worth (2021); Houston (2018 to 2020); New York (2012 to 2021); Costa Mesa (2013 to 2021); Orlando (2012 to 2021); Philadelphia (2014 to 2021); Washington, D.C. (2017 to 2020)
    • Litigation – Patent: National (2014 to 2021); Chicago (2019 to 2021); Cincinnati (2012 to 2021); Cleveland (2014 to 2021); Houston (2018, 2019); Philadelphia (2014 to 2021); Washington, D.C. (2014 to 2020)
    • Patent Law: National (2012 to 2021); Atlanta (2016 to 2021); Chicago (2020, 2021); Cincinnati (2012 to 2021); Colorado (2021); Philadelphia (2014 to 2021); Seattle (2017 to 2021); Washington, D.C. (2013 to 2020)
    • Trademark Law: National (2015 to 2021); Cleveland (2017 to 2021); New York (2017 to 2020); Philadelphia (2014 to 2021); Washington, D.C. (2017 to 2020)
  • Recognized as one of the top law firms for client service, BakerHostetler was named to the 2020 BTI Client Service 30 for the sixth consecutive year.

Blog

In The Blogs

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IP Intelligence: Insight on Intellectual Property
A Recent Entrance to Copyright Protection: Can AI Qualify as an Author Under U.S. Copyright Law?
By Cory N. Barnes
June 10, 2022
Should copyright protection be given for AI-generated inventions? Stephen Thaler, the president and CEO of Imagination Engines, thinks so. The Complaint In 2018, Thaler filed an application to register a copyright for an AI-generated work...
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IP Intelligence: Insight on Intellectual Property
Federal Circuit Hears Case on Whether an AI-Generated Invention Is Patentable
By Alaina J. Lakawicz
June 7, 2022
On June 6, the U.S. Court of Appeals for the Federal Circuit held oral argument on the issue of whether an invention generated by artificial intelligence (AI) is patentable. The Patent Applications As described in a companion article...
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IP Intelligence: Insight on Intellectual Property
New Lower Trademark Examination Evidentiary Standard for Genericness Refusals at the USPTO
By Megan Mischler, Deborah A. Wilcox
June 2, 2022
The United States Patent and Trademark Office recently issued an Examination Guide clarifying the standard for refusing trademark applications on genericness grounds. Like other substantive refusals, to establish a prima facie case of...
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IP Intelligence: Insight on Intellectual Property
Decentralized Domains: Metaverse Land Grab
By Lisa Bollinger Gehman, Kevin M. Wallace, Deborah A. Wilcox
June 1, 2022
As the metaverse continues to become a more established marketplace, and consumers become more familiar with non-fungible tokens (NFTs), NFT marketplaces, decentralized domains, bitcoin, crypto wallets and the blockchain, it is no surprise...
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IP Intelligence: Insight on Intellectual Property
The Federal Circuit Provides Insight on Experimental Use and On-Sale Bar
By John S. Hilten
May 9, 2022
On April 29, 2022, the Court of Appeals for the Federal Circuit issued an opinion for Sunoco Partners Marketing & Terminals L.P. v. U.S. Venture, Inc., U.S. Oil Co., Inc. (2022 WL 1275697).This case touched on a number of issues, including...
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