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Life Sciences, Biotechnology & Pharmaceutical

Miles & Stockbridge's Life Sciences, Biotechnology and Pharmaceutical Practice comprises business-minded lawyers who combine industry expertise with a sophisticated understanding of the law to help life sciences companies achieve their goals. Our service-minded team is presently comprised of litigators, business lawyers, and eight patent professionals, with the interdisciplinary capabilities needed for life science companies from the smallest start-up to the largest multi-national corporation.  Our team includes three former Examiners from the USPTO, five colleagues with Ph.D.’s, and three colleagues with Bachelor’s Degrees in biotechnology, pharmaceutical, and chemical disciplines.

Miles & Stockbridge is situated in one of the fastest growing biotechnology regions in the nation, and one that is home to major research universities, including The Johns Hopkins University and the University System of Maryland. Maryland is also home to more than 50 federal institutions, including many critical governmental entities related to the life sciences industry, such as the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the National Institute of Standards and Technology (NIST). Miles & Stockbridge started representing clients in the life sciences industry over 25 years ago and today represents dozens of life sciences companies and universities in the United States and overseas. Miles & Stockbridge has represented clients involved in pharmaceutical manufacturing, research and development, drug formulation, contract manufacturing, clinical research organizations, and universities. While Miles & Stockbridge's lawyers are based in the mid-Atlantic region, our work and resources reach across the country and around the world.

We are skilled in handling large patent portfolios with an eye to providing sophisticated legal services while still controlling cost.  We are client-focused and have deep and long-standing relationships where client input and satisfaction are among our top priorities.  Our team demonstrates is skilled at handling cases and projects throughout the life sciences space including in the fields of:

  • Agroscience/Small Molecule and Genetic Based Agro Solutions
  • Biologicals
  • Bioinformatics/ In Silico Technology
  • Biomarkers/Probes/Primers 
  • Chemical Engineering/Processes
  • Diagnostics/PCR Technology/Assays
  • Food Technology (including enzymes, proteins, fermentation, genome based technology, GMOs, and seed traits) 
  • Immunology 
  • Material Science/Polymers
  • Medical Devices/Microfluidics 
  • Molecular and Cellular Biology 
  • Natural Products/Compositions and Methods (including handling 35 U.S.C. § 101 issues)
  • Nanotechnology 
  • Neurosciences 
  • Nutraceuticals 
  • Organic Chemistry/Stereochemistry/Enantiomers/Crystalline Structures
  • Personalized Medicine/Gene Therapy 
  • Pharmacology 
  • Protein Chemistry 
  • Recombinant DNA 
  • Small Molecule Chemistry for Pharma and Agro 
  • Stem Cells and Regenerative Medicine
  • T-cells and Engineered T-cell Therapies 
  • Vaccine Technologies

Our life sciences team has specific experience in the above topics and real-world experience assisting clients not only with patent prosecution issues, but also with business and litigation issues and the particular challenges and opportunities arising from the America Invents Act (“AIA”).  We have the ability to assist clients with AIA Challenges and Proceedings.  Our team is proficient at counseling, filing, and defending against USPTO-based challenges to pending U.S. applications and/or issued patents.  Our lawyers have handled many post-grant proceedings, including inter partes matters, and we continue to represent clients in proceedings under the recently-enacted AIA provisions. We have taken these cases from start to finish, including lodging appeals to the Patent Trial & Appeal Board (PTAB). It is well-known that proceedings at the USPTO can be much cheaper and quicker to resolve than resorting to litigation in the federal district court. We assist clients with AIA proceedings designed to strengthen patent positions, including through reissue or supplemental exam, or through filing against third-party competitive patents. We are similarly well-positioned to defend patents or applications that have been challenged by Inter Partes Review, Ex Parte Reexam, Post Grant Review, Covered Business Methods, or Preissuance Submissions against pending applications.    

Our life science attorneys and patent agents also work with clients in the fields of Biologicals and Biosimilars to assess and strategically plan for market clearance and entry as follows:

  • Strategic management of IP portfolios to assess and take into account any exclusivity periods
  • PTA calculations and how to maximize patent term during prosecution 
  • Assessing trade secret coverage and strategy post-Myriad 
  • Biosimilar patent dispute resolution process 
  • Due diligence and information exchange involving biosimilar producer
  • Freedom to Operate Assessments
  • Patent Challenges of Third Party Patents using AIA procedures, including reexam, IPR, PGR, and third party submission after publication
  • Defending patent holders against AIA challenges, and reexam requests
  • Valuation of IP estates
  • Commercialization assistance and options, including licensing, joint venture agreements, and assessing possible anticompetitive issues

We also have specific and unique capabilities in the field of Personalized Medicine and Genetic Therapy options.  Our lawyers understand the real-world implications of the U.S. Supreme Court’s recently-issued Myriad decision.  Stemming from that decision, the USPTO is now trying to constrain claims directed to nucleic acids, biomarkers, and diagnostic methods.  Our team has become proficient in generating successful results for our clients on these issues. We develop and implement strategies designed to achieve broad protection and defensible coverage for claims in this space. This is especially important given that examination standards for patent applications throughout the world require businesses to have a well-planned filing and enforcement strategy in place due to the differences country-to-country.

We offer significant experience in the procurement, management, assessment, and enforcement of life science IP that impacts personalized medicine: genomics; proteomics; pharmacogenomics; pharmacology; bioinformatics; stem cells and therapies; and methods and devices adapted for such technologies. 

Personalized genetic therapy requires collaboration among licensees, patentee(s) and any number of stakeholders.  A bioinformatic company’s gene-based treatment and regime will involve criticality in patient selection for a given drug, and there will be a need to establish and work within development agreements and/or licenses with numerous entities, including those doing contract research, diagnostics, clinical testing, product development/screening, and manufacturing.
 
We have extensive experience in working with collaborators and drafting collaboration and joint venture agreements. Miles & Stockbridge also teams with life sciences companies to provide counsel and assistance in areas such as licensing and strategic collaborations; corporate formations and tax structuring; debt and equity finance; mergers and acquisitions; human resource and employment management; immigration; real estate acquisition and development; risk management and litigation.  In addition, we recognize that clients need legal advice grounded in industry experience.  Our group can provide both, and at reasonable and competitive rates.

This industry experience, combined with our technical backgrounds, enables us to understand each project and helps us develop a worldwide patent strategy for each life science patent portfolio, including managing oppositions throughout the world, AIA challenges, pre-litigation issues, licensing, and more.