Bio Filter Option

Christopher J. Betti, Ph.D.

Partner

christopher.betti@morganlewis.com

Chicago Phone +1.312.324.1449 Fax +1.312.324.1001

110 North Wacker Drive//Chicago, IL 60606-1511//United States

A registered patent lawyer, Christopher J. Betti, Ph.D., concentrates his practice on biotechnology and pharmaceutical patent matters with an emphasis on biologics-related patent prosecution and patent litigation. Christopher also devotes a significant portion of his practice to product life-cycle management, intellectual property portfolio management, pre-litigation counseling, due diligence analysis associated with venture capital financing and public offerings, and opinions and strategic advice relating to complex patentability, patent validity, infringement, and freedom-to-operate issues.

Additionally, Christopher regularly counsels innovators and biosimilar applicants in all matters related to the Biologics Price Competition and Innovation Act. He provides US Food and Drug Administration regulatory advice relating to biologics and pharmaceuticals, including advice concerning Orange Book patent listings and patent term extensions. Christopher also assists clients in developing pre-ANDA litigation strategies and defending generic pharmaceutical companies in ANDA litigations.

Christopher represents technology companies in trials before US district courts and in Section 337 investigations in the US International Trade Commission, providing advice and strategic direction for various post grant matters. He also regularly drafts and negotiates intellectual property (IP) license agreements, sponsored research agreements, research collaboration agreements, and joint development agreements. Additionally, Christopher counsels biotechnology and pharmaceutical companies in the commercialization, enforcement, life-cycle management, and monetization of their IP.

Although Christopher’s work spans a multitude of technologies, he has industry recognized capabilities in both antibodies and cell culture related technologies. Other technologies with which he has experience include molecular diagnostics, biosimilars/follow-on biologics, DNA/protein sequencing, gene editing, recombinant DNA and genetic engineering, pharmaceutical formulations, optoelectronic readers, bioinformatics, biologics, small molecules, genomics, food chemistry, medical solutions, metabolic engineering, medical packaging technology, medical devices, diagnostic systems, antibody mimetics, display- and array-based technologies, RNAi, and stem cells.

Prior to joining Morgan Lewis, Christopher was a partner in another international law firm, where he led its biosimilars practice. As a graduate student at Loyola University Chicago Stritch School of Medicine, he initiated and developed studies establishing that DNA repair operating in conjunction with cell death leads to the formation of chromosome translocations and ultimately cancer. His research further outlined a strategy to combat therapy-induced leukemia. Christopher’s doctoral and postdoctoral research led to the publication of numerous peer-reviewed journal articles, and his findings have been presented both nationally and internationally.

Selected Representations

  • Provides strategic patent advice to a global company related to its antisense oligonucleotide technologies.
  • Counseled company with antibody drug conjugate (ADC) related technology in its sale to a top 20 pharmaceutical company.
  • Representing a leading provider of hemophilia products in a multi-jurisdictional patent infringement litigation involving Factor IX/IXa activating antibodies.
  • Served as trial counsel in a Section 337 investigation involving recombinant factor VIII proteins in the International Trade Commission.
  • Represented a Fortune 100 company in an arbitration involving natural killer related cell lines.
  • Served as lead counsel for a petitioner in an inter partes review resulting in complete invalidation of all asserted claims (IPR2014-00899).
  • Developed an international patent prosecution strategy for technologies based on metabolic engineering.
  • Drafted and filed several petitions for inter partes review for a major pharmaceutical company.
  • Represents the world’s largest contract research organization in negotiation of IP license agreements and research collaboration agreements.
  • Drafted and prosecuted patent applications related to methods for the manufacture and stabilization of proteins and antibodies for an industry-leading antibody company.
  • Developed a global tax strategy aligned with manufacturing objectives for a biosimilar manufacturer.
  • Reviews 351K applications for a biosimilar manufacturers.
  • Reviewed and negotiated biologics manufacturing agreements and commercial license agreements for a biosimilars manufacturer.
  • Conducted numerous freedom-to-operate analyses related to several branded biologics and related manufacturing and purification methods for several biosimilar manufacturers.
  • Assisted a biosimilar manufacturer in implementing best practices for handling potential patent litigation related to the filing of a 351k application.
  • Manages the international patent portfolio for a privately held molecular diagnostics company.
  • Provides strategic advice pertaining to the prosecution of a platform technology for a privately held biotechnology company.
  • Represents a publicly traded biopharmaceutical company in several aspects of their IP strategy, including managing a global patent portfolio relating to a prescription omega-3 fatty acid program.
  • Represents a biotechnology company in the development and commercialization of therapeutic and diagnostic products.
  • Represents a leading consumer food product company in several aspects of its US IP strategy, including the preparation and prosecution of patent applications.
  • Represents an international biofuel company in all aspects of its US IP strategy, including strategically drafting patent applications relating to its business objectives.
  • Represented an international biopharmaceutical company in the development of a biosimilar program, including performing a patent landscape analysis related to an innovator product.
  • Represented an industry-leading life sciences company in the development and expansion of patent portfolio related to DNA/protein sequencing technologies.
  • Provides strategic advice to a global consumer food and beverage company related to freedom-to-operate and patentability matters.
  • Represented a venture capital group, including conducting several IP due diligence analyses associated with financing and public offerings for privately held biotech companies.
  • Rendered strategic advice and opinions relating to patentability, patent validity, infringement, and freedom to operate for an independent inventor.
  • Represented a food product company in the procurement of several US patents related to novel probiotics for use in food compositions.
  • Rendered noninfringement and freedom-to-operate opinions for a pioneering stem cell company related to a high-profile litigation.
  • Represented a university in securing patent protection for groundbreaking RNAi technologies that was the subject matter of 2006 Nobel Prize in Medicine.

Awards and Affiliations

Life Sciences Star, Intellectual Property, LMG Life Sciences (2020, 2021)

Shortlisted, Patent Strategy & Management Attorney of the Year – Midwest, LMG Life Sciences (2020, 2021)

Member, Practice Group of the Year, Intellectual Property, Law360 (2019)

Member, Litigation Department of the Year–Intellectual Property, The American Lawyer (2019)

Member, American Intellectual Property Law Association (AIPLA) Biotechnology Committee

Board of Directors, Illinois Biotechnology Industry Organization (2013–2015)

Admissions

  • Illinois
  • US Patent and Trademark Office
  • US Court of Appeals for the Federal Circuit

Education

  • Loyola University Chicago School of Law, 2005, J.D.
  • Loyola University Chicago, 2002, Ph.D., Molecular Biology, Cum Laude
  • Benedictine University, 1996, B.S., Magna Cum Laude

Sectors

  • Life Sciences

Services

  • Intellectual Property Litigation

Regions

  • North America

Events

9/28/2021 - How and When to Tell Your Story: Public Disclosure Considerations for Listed Life Sciences Companies
3/12/2019 - Functional Claiming of Antibodies: Legal Challenges and Patent Strategies
10/10/2017 - Biologics: Shifting Patent Estates and the Legal Challenges Keeping You Up at Night

News

5/20/2022 - Skilled in the Art, Law.com
9/29/2021 - Morgan Lewis Recognized in LMG Life Sciences 2021 Americas Awards
8/2/2021 - LMG Life Sciences Awards: 2021 Americas Shortlists Announced, LMG Life Sciences
4/27/2021 - Toothful or Toothless? Biden's Biosimilar Bills Under the Microscope, The Center for Biosimilars
9/26/2019 - Morgan Lewis Named ‘Powerhouse’ Firm in Ninth Annual BTI Litigation Outlook
5/10/2019 - FDA Eases Way for Gold-Standard Biosimilars, Law360
4/2/2019 - Morgan Lewis Earns Top Rankings in Patexia Patent Prosecution Analysis
12/12/2017 - Morgan Lewis Advises Repros Therapeutics in Sale to Allergan
1/17/2017 - 3 Takeaways As FDA Dishes On Interchangeable Biosimilars, Law360
2/26/2016 - Morgan Lewis Expands IP Team with Four New Chicago-Based Partners

Publications

April 2022 - Blockbuster Biologics Review | Issue 15
2018–2022 - Blockbuster Biologics Review
3/3/2022 - PTAB Issues Decision Awarding Priority of Invention of CRISPR Gene Editing Patents to Broad Institute
December 2021 - Blockbuster Biologics Review | Issue 14
August 2021 - Blockbuster Biologics Review | Issue 13
April 2021 - Blockbuster Biologics Review | Issue 12
3/5/2021 - Declaratory Judgments Unavoidable for Biosimilar Applicants, Law360
2/17/2021 - The BPCIA and Declaratory Judgment: The Real Dance Partners?, Biosimilar Development
February 2021 - Blockbuster Biologics Review | Issue 11
2/18/2020 - Fed. Circ. Instructive on Transitional Phrases in Patent Claims, Law360
1/15/2020 - Federal Circuit: Inherency in an Obviousness Analysis
1/13/2020 - Federal Circuit: Open Transitional Phrases and Markush Groups in Pharmaceutical Claims
12/24/2019 - Federal Circuit: Finding the Safe Harbor in Drug Development’s Choppy Waters
November/December 2019 - Pharmaceutical Litigation, IP Litigator
10/14/2019 - Federal Circuit: ‘Consisting Essentially of’ Risks Indefiniteness and No Intent from ANDA Label’s Permissive Use
8/13/2019 - Patent Opportunities In FDA Bispecific Antibody Guidance, Law360
4/2/2019 - What’s In a Name? FDA Proposes Updates to Its Biosimilar Naming Policy
3/18/2019 - LawFlash: What’s in a Name? FDA Proposes Updates to Its Biosimilar Naming Policy
3/8/2019 - FDA Sings the Orange Book Blues to Announce a Potential New Patent Listing Approach
12/8/2018 - Experience with Generics Guides FDA Biosimilars Policy
September 2018 - Life Sciences International Review Q3 | 2018
8/9/2018 - FDA Biosimilars Plan Draws From Experience With Generics, Law360
1/9/2018 - Amgen Moves to Dismiss Genentech’s Misrepresentation Claim
10/26/2017 - Lawsuits Filed on the Same Day Regarding Amgen’s Avastin® Biosimilar
6/14/2017 - Humira Patents Invalidated in Inter Partes Reviews
7/6/2016 - Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval
5/27/2015 - FDA Biosimilar Policy: More Questions, More Answers, Law360
5/12/2015 - FDA Biosimilar Policy: 3 Documents, 1 Key Theme, Law360
9/22/2014 - Purple Is The New Orange: A New Book On Biosimilars, Law360