Katherine M. Kowalchyk, Ph.D.

Partner
Minneapolis
3200 IDS Center, 80 South Eighth Street
Minneapolis, MN 55402
D: 612.371.5311
Contact My Assistant
Denise Chamberlin
D: 612.336.4692

Education

University of Minnesota
J.D., magna cum laude, 1991
Ph.D., Microbiology, 1984

University of Wisconsin
B.A., Bacteriology, with distinction, Phi Beta Kappa, 1977

Bar and Court Admissions

U.S. Patent and Trademark Office, 1992
Minnesota State Bar, 1991

Professional Affiliations

Minnesota State Bar Association
Minnesota Intellectual Property Law Association
    Co-Chair of the Women in Intellectual Property Law Committee
American Intellectual property Law Education Foundation
    Secretary to the Board

Publications & Speaking

CASRIP Patent & IP Law Summer Institute, University of Washington School of Law, July 2015

CASRIP Biotech and Pharma Licensing, University of Washington School of Law, July 30, 2014

Myriad Decision May Invalidate Many Patents, co-authored  with Marianne R. Timm-Schreiber, Ajay Singh, and Gary Myles, Today’s General Counsel, December/January 2014

The M&G Edge Association for Molecular Pathology v. Myriad Genetics, Inc.: Isolated, Naturally Occurring DNAs are Patent Ineligible Products of Nature, June 19, 2013

Biosimilars: Impact of Differences with Hatch Waxman, Pharmaceutical Patent Analyst, vol.2:29-37, January 2013

CASRIP Strategic Licensing of Biotechnological and Pharmaceutical Inventions, University of Washington School of Law, August 1, 2012

The American Invents Act Playbook; CLE for EPPIC March 22, 2012

The Risky Business of Biosimilars: Managing Legal and Scientific Uncertainty, 10th Annual Biosimilars America conference, March 14, 2012

Claims to Isolated DNA [Genes?] are Patentable…For Now, ABA Roundtable Feb. 8, 2012

Prometheus v Mayo, Diagnostic Method Claiming Strategies spoke at New York Licensing Group, January 2012

American Invents Act 2011 presentation to the MN Association of Paralegals, Nov. 9, 2011

Center for Advanced Study and Research on Intellectual Property (CASRIP) presentation on Biotechnology and Pharmaceutical Licensing, July 2011

AIPLA Women in IP networking dinner-panel discussion on networking and business development skills for women in conjunction with a talk by Patricia Gillete regarding advancement of women in the field entitled Is it really about the Shoes?, May 4, 2011

Practical Patent Licensing in view of Current Case Law, Women in Intellectual Property Law CLE, October 26, 2010

Biosimilars Current Framework and Future directions, Chemical Committee of Minnesota Intellectual Property Law Association, CLE, October 21, 2010

Biosimilars: Recently Enacted Legislation for an Approval Pathway, The M&G Edge, April 2010

Are Genes Patentable? ABA Roundtable Discussion, February 2010

Wyeth v. Kappos: The New Calculation for Patent Term Adjustment, published in Lexis Nexis Research Solutions, February 2010

Biosimilars, presented to FDA group of MSBA, February 2010

The Promise of Personalized Medicine, Life Science Alley, January 13, 2010

Personalized Medicine: Paradigm Shift in the Pharma Business, IP Value in the Life Science Industries, Intellectual Asset Management, Supplement, 2006

Continuous Capture and Assessment of Intellectual Property, Inside the Minds: Winning Legal Strategies for Biotech Companies, 2005

Recent Patent Cases Affect the Validity and Scope of Biotechnology Patents, BioPharm International 16:58, 2003

As intellectual property plays a larger role in today's business landscape, Katherine understands that her clients need more than just patent applications. She helps them consider how a single application fits in with the rest of their portfolio and what kind of value it will bring to the company at a strategic and tactical level.

Katherine concentrates her practice in intellectual property law, with a particular emphasis in biotechnology. She is experienced in patentability assessment, strategic filing, and coordinated prosecution of worldwide patent applications, including prior art management, PTO examiner interviews, appeals, and oppositions. She also handles licensing transactions, intellectual property due diligence for technology and licensing transactions, mergers and acquisitions, product launches, and public offerings, including freedom-to-operate, landscape, infringement, and validity analysis and opinions. She has experience in post grant review of patents including inter partes reexamination and oppositions. She is a certified mediator.

Katherine provides strategic patent portfolio management for clients in the biotechnology, pharmaceutical, chemical, and medical device industries. She also counsels clients on developments in the law related to biologic molecules, including proposed regulation of biosimilars (follow-on biologics), patentable subject matter as it relates to gene patents and diagnostic methods, and licensing.

A wealth of technical experience in the chemical and biotechnology arts allows Katherine to quickly understand complex technologies and interact with scientists and inventors in order to prepare the best intellectual property strategies. Her experience includes plant and animal genetics, immunology, cell growth and metabolism and receptor/ligand function, humanized antibody and antibody fragment design function, therapeutics and screening systems, genetic profiling, diagnostic and prognostic nucleic acid signature systems, hybrid and transgenic plants for food and consumer products, the interface of biomedical data and software platforms, organic and small molecule therapeutics, and nanoscale devices.

Katherine is a frequent contributor to the legal community, and writes and speaks on intellectual property issues in the life sciences as detailed below. She participates in firm management by chairing the diversity committee and serving on the conflicts committee at Merchant & Gould. She serves on the Board of the American Intellectual Property Law Education Foundation, a nonprofit dedicated to increasing the diversity of attorneys practicing intellectual property law.

Her volunteer work is both local and  international. She has signed up as a volunteer attorney for the U.S. Patent and Trademark Office Pro Bono Pilot Program. She has a passion for working with national and international nonprofits directed toward improving the health and welfare of women and children in the developing world.
 

Quoted

Endo's law suit against Impax for crush-proof Opana unlikely to reach settlement before May FDA ruling,  Financial Times, February 25, 2013