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.

• Served as counsel to Xencor Inc. in the first-ever matter before the US Patent Office Appeals Review Panel (ARP) concerning the use of means-plus-function claiming for antibody-related technologies; in a precedential opinion, the ARP held that the means-plus-function format employed by Xencor can be used to claim antibodies
• Serves as global lead technical counsel for a top 10 pharmaceutical company in defense of its flagship antibody against biosimilar entry
• Developed a patent strategy for an antibody company leveraging artificial intelligence (AI) and machine learning to make biobetters of several marketed antibodies that have yearly sales exceeding $2 billion
• Supports Boehringer Ingelheim in the creation of life cycle management strategies to protect several of its lead antibody assets
• Implemented a reissue strategy for Baxalta (now Takeda) in support of a patent litigation over recombinant proteins, which resulted in the issuance of four patents covering its competitor’s product
• Served as lead technical trial counsel for Takeda in a multi-jurisdictional patent infringement litigation involving Factor IX/IXa-activating antibodies
• Served as lead counsel for Replimune (patent owner) in post grant review (PGR) resulting in a complete victory that found all challenged claims were not invalid
• Provides strategic patent advice to Nippon Shinyaku Co. related to the protection of its antisense oligonucleotide technologies targeted the dystrophin gene
• Represented an oncolytic virus company (petitioner) as lead counsel in inter partes review (IPR) concerning a combination treatment; the IPR settled after a favorable institution decision
• Served as lead technical trial counsel for Baxalta (now Takeda) in a US International Trade Commission (ITC) dispute involving the method of manufacturing recombinant factor VIII (ADVATE), a billion-dollar pharmaceutical product; the case settled favorably after the ITC ruled in Baxalta’s favor on domestic industry on appeal
• Served as lead counsel for Kamada Ltd. (petitioner) in an inter partes review concerning recombinant protein production, which resulted in complete invalidation of all asserted claims
• Counseled NBE Therapeutics in the sale of its antibody drug conjugate (ADC)-related technology to Boehringer Ingelheim
• Prosecuted patent applications to issuance concerning methods for the manufacture and stabilization of proteins and antibodies for an industry-leading antibody company
• Represented Merck KGaA and related entities in an arbitration against NantKwest and Brink Biologics involving NK-92 cell lines; successfully moved to dismiss related district court action seeking to enjoin the arbitration.
• Served as lead technical counsel for Merck Sharp & Dohme Corp. in an arbitration against Ligand Pharmaceutical Inc. involving Verbecestat, a drug to help Alzheimer patients
• Represents an international biofuel company in all aspects of its US intellectual property (IP) strategy, including strategically drafting patent applications relating to its key business objectives.
• Defended Nippon Shinyaku Co. against several IPRs filed in connection with a patent dispute, which were ultimately dismissed by the Federal Circuit.
• Represented an industry-leading life sciences company in the development and expansion of a patent portfolio related to DNA/protein sequencing technologies
• Represented the world’s largest contract research organization in negotiation of IP license agreements and research collaboration agreements
• Developed a global tax strategy aligned with manufacturing objectives for a biosimilar manufacturer
• 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
• 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 leading consumer food product company in several aspects of its US IP strategy, including the preparation and prosecution of patent applications
• Represented an international biopharmaceutical company in the development of a biosimilar program, including performing a patent landscape analysis related to an innovator product
• 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 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