Melanie R. Rupert is a partner in the Life Sciences IP practice in the New York office of Paul Hastings. Ms. Rupert’s practice focuses on patent litigation matters, with an emphasis on the biotechnology, pharmaceutical, and medical device industries. She has more than two decades of experience in the life sciences space, including significant experience leading Hatch-Waxman cases on behalf of innovator drug companies.
She has represented some of the world’s leading life sciences companies in high-stakes patent challenges to their blockbuster products, including antidepressants, antibiotics, antipsychotics, anti-epileptics, treatments for cancer, treatments for Alzheimer’s disease, treatments for high cholesterol, and treatments for insomnia. In addition, Ms. Rupert guides clients on strategic matters related to patent portfolio development and management, pre-suit analysis, post-grant review challenges, and ex-U.S. opposition proceedings. She also works closely with clients in due diligence analysis related to both company and product-based asset acquisitions.
Ms. Rupert frequently speaks and writes about current issues in the life sciences industry. She is recognized by leading directories, including Chambers USA, which states, "She is phenomenal and is a really tough opponent; her depth of knowledge and skill is second to none." She was also named as an “IP Life Science Star” by LMG, one of the “Top 250 Women in IP” by Managing Intellectual Property, listed in the Legal 500 and Euromoney’s Women in Business Law Expert Guide.
Ms. Rupert also has significant involvement in both internal and external initiatives aimed at improving gender diversity and inclusion in the legal profession. She holds several leadership roles at Paul Hastings, including serving as the global co-chair of talent development and as an elected member of the partner compensation committee. She also serves as an adjunct professor at New York University School of Law, where she teaches a course on life sciences patent law each spring.
- Recognized in Chambers USA, Intellectual Property: Patent (2022)
- Recognized in IAM Patent 1000, Patent Litigation (2022)
- Recognized as a Leading Practitioner for Life Sciences by Expert Guides: Women in Business Law (2022)
- Women in Business Law Awards – Shortlisted to the Life Sciences Lawyer of the Year category (2022)
- Named one of the "Top 250 Women in IP" by Managing Intellectual Property
- Recipient of the Paul Grossman Award in 2013, which is awarded to one Paul Hastings partner annually for excellence in training, mentoring, and guiding the professional development of associates
- New York University School of Law, J.D., 2001
- Cornell University, B.S. in Biological Sciences, Concentration in Molecular & Cell Biology, 1998 (Howard Hughes Undergraduate Scholar)
Significant recent representative matters:
- Presently represents Allergan in a patent infringement matter against Revance, regarding Allergan’s innovations in its Botox® franchise for animal protein-free formulations and processes utilizing botulinum neurotoxin A.
- Presently represents Eisai and Merck jointly against two generic challenges to Lenvima® (lenvatinib), an innovative treatment for cancer that blocks signals that allow cancer cells to survive and multiply.
- Presently represents Helsinn against a generic challenge to Akenzyo® (fosnetupitant/palonosetron), an innovative intravenous treatment for chemotherapy-induced nausea and vomiting.
- Successfully represented Eisai in connection with numerous generic challenges to Belviq® (lorcaserin), an innovative treatment for weight loss. Shortly before trial, generics Lupin and Teva stipulated to infringement of the patent-in-suit covering the active ingredient. Soon after the infringement stipulation was filed, a consent judgment was filed pursuant to a settlement agreement very favorable to the client.
- Successfully represented Merck in connection with a generic challenge to Entereg® (alvimopan), an innovative treatment used for post-operative ileus (“POI”). Following a favorable claim construction ruling, Teva stipulated that its proposed generic product would infringe the sole patent at issue. Teva agreed to settle the case with a consent judgment reflecting a complete victory for Merck.
- Successfully represented Eisai in connection with numerous generics challenges to Banzel® (rufinamide), an innovative treatment for a rare and devastating form of childhood epilepsy. Favorable settlements were reached with the generics in each of these cases.
- Successfully defended Covidien, a leading medical device manufacturer, against claims of patent infringement related to its cuffed endotracheal tubes, including successfully opposing a preliminary injunction.
- Presently represents a number of branded pharmaceutical companies in pre-suit diligence in anticipation of patent challenges to their key products, which includes portfolio counseling and strategy.
- 2022 IAM Patent 1000 Ranks More Than 20 Paul Hastings’ Intellectual Property Lawyers Across Seven Jurisdictions - July 6th, 2022
- Two Paul Hastings Partners Shortlisted for 2022 Euromoney Women in Business Law Americas Lawyer of the Year Awards - May 2nd, 2022
- Benchmark Litigation Distinguishes Paul Hastings’ IP Practice with Top-Tier National Ranking - October 14th, 2020
- On the Heels of an IP Practice Group of the Year Award, Paul Hastings’ IP Attorneys Earn Top Rankings by LMG Life Sciences - October 1st, 2020
- Paul Hastings’ IP Litigation Practice Recognized as an IP Powerhouse with 25 Rankings by IAM Patent 1000 and Legal 500 US - June 12th, 2020
- Paul Hastings Soars in 2011 Edition of Legal 500 US - June 1st, 2011
- Paul Hastings Recognized as US Post-Grant and Japan Foreign Patent Firm of the Year by IAM - September 27th, 2022
- 20 Paul Hastings Lawyers Ranked in 2022 IAM Patent 1000 - July 6th, 2022
- Paul Hastings IP Practice Recognized by Chambers USA 2022 - June 1st, 2022
- Recognized as LMG Life Sciences Stars for 2020 - October 1st, 2020
- Recognized by Managing IP as the Life Sciences IP Litigation Firm of the Year - April 5th, 2019
- Recognized as Post-Grant Firm of the Year by IAM Magazine - January 30th, 2019
- Recognized among ManagingIP's "Top 250 Women in IP" - September 30th, 2014
- Recognized among ManagingIP's "IP Stars" - April 29th, 2014
- Nominated for the Legal Media Group's LMG Life Science Awards - August 12th, 2013
- Recognized as IP Pharma Team of the Year by Intellectual Property Magazine - November 30th, 2010
- Considerations for Innovator Drug Companies Regarding China’s Drug Patent Linkage System - 中国将施行药品专利链接制度——创新药企应如何应变 - December 1st, 2020
- Takeaways from China’s Proposed Regulation to Implement a Drug Patent Linkage System - October 5th, 2020
- China’s Proposals to Provide a Patent Linkage System and Patent Term Extensions – Considerations for Drug Companies - July 27th, 2020
- What Drug Companies Should Be Thinking About After the U.S. - China Trade Deal - January 23rd, 2020
- Keeping It Done When It’s Over: New Rules for Submitting Generic/Biosimilar Settlements to DOJ and FTC - August 12th, 2019
- Federal Circuit Issues Expansive Ruling in Upholding Jurisdiction over Mylan in Delaware - March 18th, 2016
- District of Delaware Finds Specific Jurisdiction Exists Over an ANDA Filer in the Context of a Hatch-Waxman Case - November 6th, 2014
- FDA Issues Draft Guidance on Reference Product Exclusivity for Biologics - August 7th, 2014
- District of New Jersey Prevents Generic Challenger from Using Claim Construction as a Backdoor to Introduce Barred Invalidity Defense - June 16th, 2014
- Limitation on Future Patent Protection for Biosimilars? - August 6th, 2012
- A Sign of Future Biosimilars Litigation? - November 21st, 2011
Engagement & Publications
Ms. Rupert frequently speaks and writes about current patent issues. Recent representative publications and engagements include:
- Panelist, "Tips and Tactics for Protecting Life Sciences Innovations in the Current Legal Climate," American Bar Association's Landslide Webinar (August 22, 2017)
- Panelist, "Year in Review: 2016-2017 Updates in Hatch-Waxman Law," ACI's Women Leaders in Life Sciences Law (July 20, 2017)
- "Managing the Complexities of Hatch-Waxman Pharmaceutical Litigation" in "Behind the Minds: Recent Trends in Patent Infringement Lawsuits" (Book Chapter, March 2014)
- Member of the Board of Directors and pro bono counsel to the Little Baby Face Foundation, a 501(c)(3) charitable organization that provides reconstructive surgeries by top surgeons to children in financial need who are born with congenital facial deformities
- Member of the State Bar of New York, the United States Court of Appeals for the Federal Circuit, the United States District Courts for the Southern and Eastern Districts of New York, the Eastern District of Michigan, and the Eastern District of Wisconsin