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Rare Disease: Sustained Progress in Development Regardless of the Pandemic

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Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020.

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We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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Rare Disease: Sustained Progress in Development Regardless of the Pandemic

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Catherine Polizzi, known as a pioneer in Patent Prosecution + Strategy law, is a deeply experienced lawyer who is highly regarded by clients and competitors alike. Her intellectual versatility combined with incisive, pragmatic counseling and business acumen is the hallmark of her practice. Catherine has the unique experience of working with both startups and emerging companies as well as well‑known, established global companies through the challenging process of obtaining patents and provides strategic, effective portfolio counseling and management, as well as strategic advice surrounding freedom of operation and other forms of IP assessment. She develops valuable, strategic portfolios around breakthrough therapies in a variety of areas, including cancer, cancer immunotherapy, autoimmune diseases, inflammatory diseases, infectious diseases, cardiovascular diseases, metabolic disorders, and neurodegenerative diseases such as Alzheimer’s disease.She also has significant experience in a wide spectrum of technology areas, including biologics such as antibodies and polypeptides; nucleic acids; precision medicine including precision oncology; diagnostics; cell therapy including T cell and NK cell technologies, such as chimeric antigen receptors; drug formulation technologies; drug delivery technologies such as nanotechnologies; therapeutic and prophylactic vaccines; microfluidics; drug screening systems; AI solutions for life sciences including drug discovery and development platforms; polynucleotide therapeutics such as siRNA; amplification and detection technologies; genetic screening; sequencing technologies including next-generation sequencing; regenerative medicine; spectroscopy; surgical imaging technologies; and organic chemistry including small molecule drugs.Catherine’s unique background, ability to integrate IP with a given business model to translate into meaningful valuation, risk assessment and advice, and highly effective communication skills in critical settings, such as R&D, all phases of product development, and investment contexts, enable her to provide effective, creative solutions to the significant challenges often faced by clients. Catherine is an acquisition and value enhancement driver as well, a critical conduit for companies as they grow from startup through IPO, exit, and beyond.IP Leadership for Transactions, Financings, and Acquisitions. Catherine’s practice also includes due diligence evaluation and counseling in the context of venture investment assessments and in connection with public and private financing, spin‑offs, partnerships, and mergers and acquisitions, where her IP strategies have helped drive the value of multibillion-dollar deals.Strategist in Legal Challenges and a Key Member of Litigation Teams. In addition to helping create value and commercialize her clients’ technologies, Catherine devises strategies and defenses to fortify their patents in the event of legal challenges by competitors. She renders advice on all aspects of patent positioning, including opinions on patentability, validity, freedom of operation, infringement, and competitor IP evaluation. She also works in the area of third-party challenges, such as inter partes review (IPR) and oppositions.A Recognized Leader. Catherine formerly served as the chair of the firm’s Patent Prosecution & Counseling Group and co-chair of the firm’s Intellectual Property Group. Chambers USA noted that Catherine “maintains a strong reputation for her capabilities advising biotechnology clients on portfolio management and other IP matters,” while clients note that she is “a great strategic thinker, great at flagging the high-level questions and brings a good business perspective” and praise her for “bring[ing] a good business perspective to IP efforts which is not always evident with other IP attorneys.” Catherine has also received many awards and accolades throughout her career, including the following:<ul><li>Ranked in four different Chambers categories for IP and Life Sciences 2011–2025</li><li>Recognized as a Hall of Fame lawyer by LMG Life Sciences for Patent Prosecution and Patent Strategy & Management since 2018</li><li>Recognized as Patent Star by Managing IP for 2025</li><li>Recommended as a leading lawyer by The Legal 500 U.S. for 2012–2024</li><li>Recognized among World’s Leading Patent Practitioners by IAM Patent 1000 for 2014–2024</li><li>Recognized as a Best Lawyer in Biotechnology and Life Sciences by Best Lawyers for 2023 and 2024</li><li>Selected as one of the Top 100 Intellectual Property Lawyers in California by The Daily Journal for 2009–2022</li></ul><h4>Representative Experience</h4><ul><li>Genentech, the world’s first and most successful biotechnology company, has relied on Catherine’s strategic patent counseling and prosecution services for its most difficult and challenging patent matters for nearly 15 years. Her work involves developing overall patent strategy, patent application drafting, and prosecution for key technologies. Her high-value work for Genentech also includes strategic assessment of key and novel technologies, as well as patent litigation support and advisement.</li><li>10x Genomics, a biotechnology company developing forefront gene sequencing technology used in scientific research, turns to Catherine to serve as lead patent counsel related to in situ and spatial assay platforms for cellular and subcellular identification of cell and biomarker diversity in tissues, including gene expression, gene sequencing, RNA profiling, and related reagents, panels, hardware, and software analysis tools.</li><li>Codexis, a biotechnology company that specializes in enzyme engineering, focusing on improving sustainability and cost-efficiency of manufacturing in the pharmaceutical industry, including in the manufacture of oligonucleotides and small molecule drugs, relies on Catherine for developing Codexis’s complex IP strategy. She has provided critical advice in management of their intellectual property portfolio, including strategic consideration of patent application filings, and patent risks to their planned commercial operations, including freedom to operate.</li><li>Juno Therapeutics has relied on Catherine for patent strategy and prosecution from its very beginning. Juno is one of the best-funded startups in biotechnology history. It went on to become a publicly traded company in 2014 and ultimately was acquired by Celgene in 2018 for $9 billion; the strength of the patent portfolio that Catherine crafted helped drive the valuation for the deal. She led the IP team on the acquisition.</li><li>Celgene calls on Catherine for its patent strategy, drafting, and IP due diligence matters. She worked with Abraxis BioScience for many years in a similar capacity to help develop their IP position for the highly successful cancer drug, Abraxane. Catherine then counseled the company through its $2.9 billion acquisition by Celgene Corporation, including providing significant IP strategy and due diligence counseling. This IP platform was a major component of the valuation of the company.</li><li>Dewpoint Therapeutics engaged Catherine to lead its patent strategy from the very beginning. Dewpoint is on the cutting edge of drug discovery, with technology relating to condensate biology, a new and paradigm‑shift area of drug development. Catherine led the IP strategy and due diligence for its partnership with Bayer to research new treatments for cardiovascular and gynecological diseases. The work that Dewpoint is doing is seen as a significant move forward in the biopharma industry and opens the door to many potential new discoveries in biology through biomolecular condensates. For example, in January 2021, Dewpoint teamed up with Pfizer to develop new treatments for a rare kind of muscular dystrophy. In July 2020, Dewpoint announced its collaboration with Merck to evaluate a novel approach for the treatment of HIV.</li><li>Frontier Medicines, a clinical-stage precision medicine company advancing treatments for genetically defined patient populations in oncology and immunology, has entrusted all aspects of patent strategy and portfolio development for its pipeline of small molecule therapeutics to Catherine.</li><li>Insitro, a multibillion-dollar startup pharmaceutical drug company, turned to Catherine to develop its global IP strategy. The company is at the forefront of advancing AI and data-driven drug discovery and development, and trusted Catherine to manage the company’s portfolio.</li><li>Sonoma Biotherapeutics, a clinical-stage biopharmaceutical company that is developing cell therapies that use engineered regulatory T cell therapies to treat serious autoimmune and inflammatory diseases, called on Catherine to direct its patent strategy and development.</li><li>Additional representative clients include clinical-stage and startup companies, such Aimmune Therapeutics, Alpine Immune Sciences, Botanical Solution, Cartography Biosciences, CohBar, Corner Therapeutics, Cytokinetics, Dynavax Technologies, Enveda Therapeutics, Frazier Life Sciences, GOA Therapeutics, Immunome, Indapta Therapeutics, Larkspur Biosciences, Lyndra Therapeutics, Maze Therapeutics, Myst Therapeutics, Nanoprobes, Ollin Biosciences, Passkey Therapeutics, Prelude Therapeutics, Sana Biotechnology, Sangamo Therapeutics, Seagen (formerly Seattle Genetics), Sirenas, Syntis Bio, Tacit Therapeutics, TARIS Biomedical, The Immune Co., Turnstone Biologics, and Volastra Therapeutics.</li></ul><h5>Aided by Catherine’s leadership and guidance developing IP protection for high-value technology, the following companies were involved in the following high-value transactions:</h5><ul><li>The $4.9 billion cash acquisition of client Alpine Immune Science by Vertex Pharmaceuticals.</li><li>Alpine Immune Sciences’ $48 million Series A financing and subsequent $90 million merger with Nivalis Therapeutics, resulting in a publicly traded company, as well as Alpine Immune Sciences’ $91 million private placement.</li><li>The $2.6 billion acquisition of client Aimmune Therapeutics by Nestlé Health Science.</li><li>The $74 billion acquisition of Celgene Corporation by Bristol Myers Squibb (BMS).</li><li>The $1.1 billion development collaboration with BMS on behalf of Volastra Therapeutics, which was recognized as one of the most promising early-stage biotechnology companies in the industry by Fierce Biotech’s 2022 Fierce 15, to discover, develop, and commercialize new oncology medicines.</li><li>Celgene Corporation’s $9 billion acquisition of client Juno Therapeutics and earlier $2.9 billion acquisition of client Abraxis BioScience.</li><li>Dewpoint Therapeutics’ $239 million collaboration with Pfizer for the development of new treatments for a rare kind of muscular dystrophy, the $305 million collaboration with Merck on a novel approach for the treatment of HIV, and the up-to-$100 million partnership with Bayer to research new treatments for cardiovascular and gynecological diseases.</li><li>Dewpoint Therapeutics’ partnership with Mitsubishi Tanabe Pharma Corporation, with a deal value up to $480 million and $150 million Series C financing, $77 million Series B financing, and $60 million Series A financing.</li><li>Enveda Therapeutics Inc.’s $130 million raised in Series C financing.</li><li>Frontier Medicines’ $55 million collaboration with AbbVie to develop molecules against hard-to-drug targets.</li><li>Frontier Medicines’ $80 million Series C financing, $88.5 million Series B financing, and Series A Preferred Stock financing of $67 million.</li><li>Indapta Therapeutics’ $22.5 million financing to advance clinical trials of innovative cancer and autoimmune treatments and $50 million Series A financing.</li><li>Johnson & Johnson’s acquisition of TARIS Biomedical, with a focus on transforming the treatment of bladder cancer.</li><li>Lyndra Therapeutics’ $60.5 million Series C financing and $55 million Series B financing.</li><li>Myriad Genetics’ $375 million acquisition of Counsyl, Inc.</li><li>Syntis Bio’s $33 million Series A financing.</li><li>Sonoma Biotherapeutics’ collaboration with Regeneron worth over $100 million.</li><li>The $14 billion acquisition of client Medivation by Pfizer, as well as the previous $225 million Pfizer investment in Medivation.</li><li>The $43 billion acquisition of client Seagen by Pfizer.</li><li>Turnstone Biologics’ acquisition of Myst Therapeutics.</li></ul>