Kevin Buckley: Biotech Patent Attorney

Biotech, Pharmaceutical, and Medical Device Law

I am a San Diego intellectual property and transactional attorney handling patent, commercial, and regulatory issues that are part of the biopharmaceutical, small molecule pharmaceutical, and in vitro diagnostics commercialization processes. As a lawyer in a technology focused law firm -- Torrey Pines Law Group, PC -- I focus on commercializing technologies internationally. I have been listed in The Best Lawyers in America┬« for many years in the field of Biotechnology Law. My full professional biography is available at Torrey Pines Law Group.

I have over 15 years experience building Fortune 500® and other entrepreneurial client businesses. My law practice includes developing and implementing commercialization strategies for biotechnology, biopharmaceutical, small molecule pharmaceutical and convergence technology innovations (technologies at the intersection of biotech, software, hardware, and informatics). This often includes patent preparation and prosecution, technology transfer, intellectual property licensing, conducting competitive intelligence and freedom-to-operate analysis, opinion drafting, business formation and corporate governance, forming institutional collaborations, intellectual property valuation, pharmaceutical life-cycle management, and conducting due diligence for private investments.

I am a registered patent attorney with the U.S. Patent and Trademark Office (USPTO) and admitted to practice law in Pennsylvania and Missouri. I have experience with matters pending before the USPTO, Board of Patent Appeals and Interferences (now the Patent Trial Appeal Board (PTAB)), and procedures related to the Patent Cooperation Treaty (PCT), World Intellectual Property Organization (WIPO), General Agreement on Tariffs and Trade (GATT), and the Paris Convention.

Legal Expertise

  • International patent issues including patent preparation, patent prosecution, patent term extension (PTE), patent term adjustment (PTA), and intellectual property due diligence in business transactions
  • Intellectual property aspects of regulatory compliance involving FDA, USDA (APHIS), and EPA regulatory issues, Investigational New Drug applications (IND), New Drug Applications (NDA), Hatch-Waxman, Abbreviated New Drug Applications (ANDA), Abbreviated New Animal Drug Applications (ANADA), 505(b)(2), 510(k), pre-market approval (PMA), Orange Book listings, safe harbor, market exclusivity, data exclusivity, Phase I, Phase II, Phase IIa, Phase IIb, Phase III clinical trials, and drug master files (DMF)
  • Patent licensing and technology transfer, including acquiring and securitizing intellectual property rights (IPR) in intangible assets such as trade secrets, know how and government licenses -- the licensed patents and technologies have involved international issues regulated by the International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR)
  • Strategic consultations including patent validity, patent invalidity, patent infringement, patent non-infringement, patent clearance and freedom-to-operate (FTO) opinion drafting
  • Complex litigation including patent infringement, copyright infringement, and trademark infringement litigation

Life sciences innovations I have been involved with include small molecule pharmaceuticals, biopharmaceuticals, biological drugs and therapeutics, medical devices, in vitro diagnostics (IVD), companion diagnostics, personalized medicine, pharmacogenomics, stem cells including induced pluripotent stem cells (iPS cells), therapeutic cloning, RNA interference (RNAi), siRNA, shRNA, miRNA, vaccines, monoclonal antibodies, antibody fragments, ribozymes, antisense polynucleotides, enzymes, catalysts, non-naturally occurring polynucleotides and polypeptides, detection and screening assays, bioinformatics, structural proteomics, three-dimensional molecular modeling and drug design, transgenic plants, transgenic animals, and microorganism and cell culture.

Life Sciences Background

Before becoming a lawyer, I was a biochemist in both academics and industry. I attended the University of California, San Diego where I was a Research Scholar and received a B.S. in Biochemistry/Chemistry with a minor degree in Economics. While conducting research in the laboratory of Dr. Dennis Carson, head of the UCSD Cancer Center, I investigated the role of novel purine nucleoside analogs in autoimmune diseases and cytokine mediated cell responses including apoptosis, rheumatoid arthritis, AIDS and cancers. I then pursued my interests in the biotech industry where I investigated ribonucleic acid (RNA)-based therapeutics for treating viral infections.