Jonathan B. Roses
(he/him/his)Overview
Jonathan B. Roses manages large US and international patent portfolios, advises clients on IP strategy, including regulatory matters related to small molecule and biologic drugs and medical devices, and represents life sciences companies in contested matters, such as post-grant and federal district court proceedings. He has a proven track record of building client relationships, teaching and mentoring junior attorneys, and providing top-notch service and results.
Jonathan counsels an array of clients, including pharmaceutical, biotech, and medical device companies focused on the areas of small molecule pharmaceuticals, pharmaceutical formulations, organic chemistry, medical devices, diagnostic methods and devices, and surgical methods. He is highly skilled in conducting and managing domestic and foreign patent prosecution and pre-litigation investigations, including worldwide freedom-to-operate, patentability, and exclusivity analyses.
Jonathan is also experienced in representing clients in federal district court litigation and in post-grant inter partes review (IPR) proceedings before the United States Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (PTAB), and foreign counterparts. He additionally provides regulatory advice and representation to clients relating to patent term extension (PTE) and Orange Book listings under the Hatch-Waxman Act, and is a frequent speaker on issues related to regulatory exclusivity and pharmaceutical patent litigation.
Jonathan is active in the Boston Intellectual Property Law Association (BIPLA), having served as co-chair of the Patent Office Practice Committee since 2017, and having authored or co-authored several response to Requests for Comments from the USPTO on behalf of the BIPLA on a range of issues. Most recently, Jonathan authored the BIPLA’s Comment on the USPTO’s May 2024 Notice of Proposed Rulemaking regarding Terminal Disclaimer practice. He has also authored or co-authored comments on subject matter eligibility, motions to amend and claim construction standards in post-grant proceedings, proposed changes to regulations promulgated under the Bayh-Dole Act, patenting artificial intelligence inventions, and expanding diversity and inclusion in the American innovation system.
Prior to joining Wolf Greenfield, Jonathan served as Counsel at an Am Law 50 law firm, where he prosecuted and managed prosecution of patent applications worldwide for domestic and foreign life sciences, universities, and consumer product clients in the chemical, pharmaceutical, biotechnology, and materials science arts. For 10 years, he represented innovator pharmaceutical companies in ANDA (Hatch-Waxman) and 505(b)(2) patent infringement litigations involving Paragraph IV challenges of Orange Book listed patents covering numerous blockbuster drugs.
Before beginning his legal career, Jonathan was a medicinal chemist at Ariad Pharmaceuticals and Millennium Pharmaceuticals (both now part of Takeda Pharmaceuticals).
Experience
- Represented Tremeau Pharmaceuticals, a clinical stage pharmaceutical company focused on commercializing non-opioid pain therapies targeting serious rare diseases, in securing new issued patents related to rofecoxib, the selective COX-2 inhibitor NSAID that was marketed as VIOXX® until its withdrawal from the market 15 years earlier over safety concerns.
- Performed due diligence for Royalty Pharma in connection with strategic funding collaboration with Cytokinetics for its specialty cardiology pipeline, affording $250 million on closing and up to a total of $575 million.
- Persuaded the PTAB to deny three inter partes review (IPR) petitions from two different petitioners at the institution stage on patents related to methods of treating facial wrinkles using animal-protein-free botulinum toxin compositions and methods of purifying a particular complex of botulinum toxin.
- Advised private equity and royalty investment firms on diligence matters related to marketed and clinical stage drugs for ALS, Parkinson’s disease psychosis, prophylactic hereditary angioedema (HAE), Rett syndrome, and cancers such as metastatic castration-resistance prostate cancer, urothelial cancers, and cholangiocarcinoma, including financings closing at over $300 million.
- Represented US subsidiary of 140-year-old global pharmaceutical company based in Japan in parallel IPR and federal district court Hatch-Waxman proceedings related to its antihyperglycemic drug used in the management of type 2 diabetes. Won in a Final Written Decision on all claims of one patent after taking deposition of defendants’ sole expert witness and presenting oral argument before the United States Patent and Trademark Office’s Patent Trial and Appeals Board. Achieved Denial of Institution for two Petitions filed on another patent related to the same drug.
- Represented global pharmaceutical company in Hatch-Waxman patent litigation related to its subsidiary’s blockbuster oncology drug. Achieved a significant victory at the Court of Appeals for the Federal Circuit when the appeals court reversed a district court finding of patent invalidity based on obviousness and remanded the case with instructions to enter judgment in favor of the client. Further representation for second wave of defendants in the United States and foreign counterpart litigation and post-grant proceedings.
- Managed a global patent portfolio and provided strategic advice on behalf of a United States-based antibiotics company. The portfolio included well over 600 matters, including nearly 200 pending applications and over 300 granted patents, and included three approved products and one clinical stage candidate.
- Provided regulatory advice related to and performed regulatory submissions to the Food and Drug Administration, including providing advice on and drafting forms for listing of patent information in the Orange Book and providing advice on, drafting, and filing Patent Term Extension applications related to both drug products and medical devices.
- Advised non-profit foundation that manages a historic house museum in Washington, DC on strategic trademark prosecution, brand building and protection, and collaboration agreements with brewers and food scientists to produce historic recreations of pre- and post-prohibition era beer offerings.
- Performed intellectual property due diligence investigations related to investments in and acquisitions by a range of domestic and foreign companies in the areas of small molecule pharmaceuticals, and software related to implementation of medical technology and healthcare administration. Analyses included freedom-to-operate, patentability, market exclusivity, and confirmation of status (such as pendency, enforceability, and ownership).
Activities
- American Chemical Society (1999-present)
- American Institute of Chemists (1999-present)
- American Bar Association, Intellectual Property Section (2007-present)
- Boston Bar Association (2007-present)
- Boston Intellectual Property Law Association (2007-present), Patent Office Practice Committee Co-Chair (2017-present)
Recognition
- Named to Boston Magazine’s Top Lawyers list (2021-2022)
- Named to the Massachusetts Super Lawyers list (2021-2024)
- Named to the list of Massachusetts Rising Stars by Super Lawyers (2015-2020)
- Harvard CopyrightX (2015)
- Boston College Law School Environmental Law Society Regulatory Skills Series (2007)
Interests
- Spending as much time as possible with my family, particularly summers in southern Maine.
- Moonlighting as a mediocre musician, playing guitar, bass, banjo, mandolin, drums, and keyboards.
- Serving as my family’s IT Help Desk when technology goes wrong.