Christopher J. Betti, Ph.D.

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, artificial intelligence (AI) driven drug discovery, 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.

• Represented an oncolytic virus company (patent owner) as lead counsel in post grant review (PGR) resulting in a finding that all challenged claims were not invalid
• Represented an oncolytic virus company (petitioner) as lead counsel in inter partes review (IPR) that settled after a favorable institution decision
• 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 counsel for Baxalta in an US International Trade Commission (ITC) dispute involving the method of manufacturing recombinant factor VIII (ADVATE), a billion-dollar pharmaceutical product, and the case settled favorably after the ITC ruled in Baxalta’s favor on domestic industry on appeal
• 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
• 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 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