Overview

Dr. Heidi Berven is a seasoned attorney with more than 10 years of experience. As patent counsel for both large and small companies, she honed her skills in drafting and prosecuting chemistry and pharmaceutical patent applications and in providing IP support for negotiations ranging from single-compound licensing transactions to whole company acquisitions. Her practice routinely includes:

  • Patent preparation and prosecution in the U.S. and globally
  • Life cycle management of global patent portfolios
  • Competitor intelligence
  • IP support for licensing negotiations
  • Freedom-to-operate and patentability reviews
  • Orange Book listings for approved pharmaceutical products
  • Patent Term Adjustment maximization by action before the USPTO and federal courts

Services

Practice Areas

Experience

Representative Matters

  • Assisted local counsel in defending patent covering Phase III pharmaceutical product in Opposition in Europe
  • Assisted local counsel in combating nullity action relating to patent covering billion dollar statin in South America
  • Assisted local counsel in appeal of insufficiency of disclosure rejection of pharmaceutical composition of matter patent application by Chinese Patent Office to Intermediate Court   
  • Provided IP/due diligence support for compound/project in-licensing and out-licensing efforts
  • Provided IP/due diligence support for acquisition by tender offer of Praecis Pharmaceuticals by GlaxoSmithKline
  • Served as patent counsel in antibacterial and cancer therapeutic areas and served as site patent team leader for antibacterial therapeutic area
  • Served as patent counsel for clinical project management teams across organizations (site-site, company-company, and company-foundation)
  • Advised management team on patent-critical issues
  • Reviewed patent information for SEC filings for truth and accuracy
  • Oversaw drafting and negotiation of various technology-related transactional matters, including confidentiality agreements, material transfer agreements, sponsored research agreements, research collaborations, and CRO agreements
  • Created IP education programs for scientists and routinely visited laboratories to meet with scientists  
  • Managed and controlled costs of outside counsel
  • Performed exit interviews for departing employees
  • Devised and implemented team-based approach to accelerate patent application drafting process
  • Drafted 100+ patent applications in the chemical and pharmaceutical arts
  • Prepared and/or prosecuted the following selected patents:
    • 8,513,266 Methods of treating cancer using pyridopyrimidinone inhibitors of PI3K alpha

    • 8,507,687 Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid

    • 8,497,284 C-Met modulators and method of use

    • 8,481,001 Combination therapies comprising quinoxaline inhibitors of P13K-alpha for use in the treatment of cancer

    • 8,476,298 C-Met modulators and method of use

    • 8,415,387 Modulators of ATP-binding cassette transporters

    • 8,399,615 Processes and intermediates

    • 8,383,858 Processes and intermediates for preparing steric compounds
    • 8,378,124 Preparation of protected alpha-keto beta-amino esters and amides
    • 8,362,002 Azetidines as MEK inhibitors for the treatment of proliferative diseases
    • 8,293,929 Processes and intermediates
    • 8,247,408 Pyridopyrimidinone inhibitors of PI3K.alpha. for the treatment of cancer
    • 8,236,815 Ion channel modulators and methods of uses
    • 8,178,532 c-Met modulators and method of use
    • 8,101,622 Pyridopyrimidinone inhibitors of PI3Kα and mTOR
    • 8,067,436 c-Met modulators and methods of use
    • 8,044,062 Substituted pyrido[2,3-d]pyrimidin-7(8H)-one inhibitors of phospatidylinositol 3-kinase alpha
    • 7,989,622 Phosphatidylinositol 3-kinase inhibitors and methods of their use
    • 7,977,345 c-MET modulators and method of use
    • 7,834,200 Processes and intermediates
    • 7,786,308 Muscarinic modulators
    • 7,786,141 Dihydrospiroindene modulators of muscarinic receptors
    • 7,786,107 Modulators of muscarinic receptors
    • 7,776,905 Modulators of ATP-binding cassette transporters
    • 7,776,887 Processes and intermediates
    • 7,767,680 Ion channel modulators and methods of use
    • 7,071,339 Process for preparing functionalized gamma-butyrolactones from mucohalic acid
    • 6,924,377 Process for preparing highly functionalized gamma-butyrolactams and gamma-amino acids
    • 6,916,805 Quinoxalinones as serine protease inhibitors
    • 6,864,259 Antibacterial agents
    • 6,825,199 7-Substituted quinazolin-2,4-diones useful as antibacterial agents
    • 6,777,560 Process for preparing 5-(4-fluorophenyl)-1-[2-((2R,4R)-4-hydroxy-6-oxo-tetrahydro-pyran-2-yl)ethyl]-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxylic acid phenylamide
    • 6,716,842 Antidiabetic agents
    • 6,602,886 3-Alkyl-3-phenyl-piperidines
    • 6,528,510 HIV protease inhibitors
    • 6,512,006 HIV protease inhibitors
    • 6,509,335 Benzoxazinoes/benzothiazinones as serine protease inhibitors
    • 6,492,410 Combinations of protein farnesyltransferase and HMG CoA reductase inhibitors and their use to treat cancer
    • 6,440,997 E-2-(3,4-Dichlorocinnamyl)-1-cyclopropylmethylpiperidine, and its antidiarrhoeal use
    • 6,433,213 Process for the synthesis of 1,3-diols
    • 6,417,196 Stabilization of quinapril using magnesium oxide
    • 6,362,181 Isoquinolones
    • 6,340,758 Conformationally semi-constrained quinoxaline 2,3-diones as neuroprotective agents
    • 6,331,538 7-Substituted quinazolin-2,4-diones useful as antibacterial agents

Prior Experience

  • Concert Pharmaceuticals, Senior Director, Lexington, MA
  • EPIX Pharmaceuticals, Executive Director, Patent Counsel, Lexington, MA
  • Praecis Pharmaceuticals, Senior Patent Counsel, Waltham MA
  • AstraZeneca, Patent Attorney, Waltham, MA
  • Pfizer, Inc., Patent Attorney, Ann Arbor, MI
  • Schwegman, Lundberg, Woessner & Kluth, Associate Attorney, Minneapolis, MN
  • University of Iowa College of Law; Law, Health Policy and Disability Center; Post-Doctoral Research Fellow

Credentials

Education

Admissions

Court Admissions

Recognition

Awards

IAM Patent 1000: The World’s Leading Patent Professionals, Recognized as one of the World’s Leading Patent Practitioners, 2023-2024

Managing Intellectual Property IP STARS, Recognized as a Patent Star, 2024

LMG Life Sciences

  • Recognized practitioner for Patent Prosecution, Patent Strategy & Management - 2022

News & Insights

Events

  • Webinar | | | Speaker
  • Potential Rule Changes at the USPTO: Implications for European Practitioners
    Event | Montreux, Switzerland | October 23-25, 2008 | | Presenter
  • Regulatory Updates
    Event | Philadelphia, PA | May 28-30, 2008 | | Facilitator for round table discussion
  • Overcoming the Challenges Posed By Proposed Changes to Markush (Alternatives) Practice
    Event | Philadelphia, PA | May 28-30, 2008 | | Presenter
  • Effectively Maintaining Patent Protection and Enforcement in Light of Upcoming Regulations
    Event | Philadelphia, PA | May 28-30, 2008 | | Panelist

Publications

  • Patenting Non-Naturally Occurring Fragrance Compounds
    Publication | Perfumer & Flavorist |
  • Publication |
  • Celebrating the First Anniversary of “First to File” in the United States: Are Your Internal Procedures and Third-Party Agreements Ready for the Party?
    Publication | Today’s General Counsel |
  • Recent Developments in the Law of Joint Inventorship
    Publication | Developing a Patent Strategy, Aspatore: Inside the Minds |
  • Comparative effectiveness research has implications for medical device and pharmaceutical patenting
    Publication | Michigan Lawyers Weekly, Volume 24, No. 35, Page 2 |
  • Publication | LabWork, Powered by MiBiz |
  • The Face of the Patent is not the 'Whole Story’: Determining Effective Life of a Pharmaceutical Patent in the United States
    Publication | World Patent Information, 26, 4 |
  • Metal-mediated Allylation of Mucohalic Acids: Facile Formation of y-allylic a, β-unsaturated Butyrolactones
    Publication | Tet. Lett., 44, 5579 |
  • Unanticipated Economic Gains and the ADA: Assistive Technology Patent Trends
    Publication | Peter D. Blanck, (ed.) Northwestern University Press |
  • Evidence of Disability After Daubert v. Dow
    Publication | Psychology, Public Policy and Law, 5, 1 |
  • Assistive Technology Patenting Trends and the Americans with Disabilities Act
    Publication | Behavioral Sciences and the Law, 17, 47 |
  • The Economics of the Americans with Disabilities Act, Part II
    Publication | Notre Dame Journal of Philosophy, Public Policy, and Law, 12, 9 |
  • Vinylcyclopentane Synthesis via Phenylthio Radical Catalyzed Alkenylation of Vinylcyclopropanes: Preparative and Mechanistic Studies
    Publication | J. Organic Chemistry, 58, 6851 |
  • 2,2-Dihalovinylcyclopropanes as Highly Diastereoselective Three-Atom Addends in Phenylthio Radical Mediated Vinylcyclopentane Synthesis
    Publication | J. American Chemical Society, 115, 11364 |
  • Regioselective Thiopyran Formation upon Cyclization of 2- ThiyI-6-heptenyl Radicals
    Publication | Synthetic Letters, 827 |
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