Pharmaceuticals

Big Protection for Small Molecule Companies

New therapies developed in research institutes need protections and financing. “Big Pharma” is constantly in search of new therapies for their product pipelines. Mintz meets the needs of researchers and big pharma through a cross-disciplinary approach to the industry. Colleges and universities, entrepreneurs, venture capital firms, and private and public companies, alike, look to Mintz to provide a wide spectrum of support to help them achieve their financial and business goals.

Hatch-Waxman Victory for Kowa Pharmaceuticals and Nissan Chemical

For Kowa Pharmaceuticals and Nissan Chemical, Mintz sued nine generic drug makers that had filed Abbreviated New Drug Applications (ANDA) with the FDA. The court upheld the validity and infringement of all asserted claims in two patents for the cholesterol drug Livalo®.

Mintz Guides Spero to Follow-On Offering

In July 2018 Mintz represented Spero Therapeutics, a multi-asset clinical stage biopharmaceutical company, in its underwritten public offering. The offering included 3,780,000 shares of its common stock and 2,220 shares of its non-voting Series A Convertible Preferred Stock, with the gross proceeds to Spero being $75M prior to the deduction of any underwriting discounts and commissions.

Mintz Guides Company Through Clinical Trials Program

Mintz serves as general counsel to a privately held pharmaceutical R&D company focused on inflammatory, metabolic, and affective disorders. Mintz handles the company’s corporate, transactional, and IP work, including supporting the company’s preclinical and clinical research program.

Our Approach

We know the challenges faced by researchers, developers, manufacturers, and distributors of pharmaceuticals. And we collaborate across practice areas to serve your legal and business needs.

While our intellectual property team helps innovators generate and defend patent and trademark protections, our transactional professionals focus on private and public financings, negotiating collaborative license and development agreements, monetizing royalty streams, acquisitions, and the providing of essential day-to-day guidance for public companies. Then, there are our health law professionals who help clients navigate complex government regulations related to clinical trials, pricing, reimbursement, labeling, and more. Too, we are also adept at handling the unique employment and real estate issues facing pharmaceutical companies and research institutions.

In short, whatever the need, we have a team who has handled it for a client like you and who can handle it for you.

Protecting Pharma Innovators

Mintz's IP litigation team is focused on defending the hard-earned exclusive patent rights of research-driven pharmaceutical companies. Our team achieved some important early victories in Hatch-Waxman litigation. We prevailed in one of the first post-KSR ANDA trials, which resulted in the Federal Circuit’s authoritative pronouncement on the law of chemical obviousness — and raised the bar for ANDA plaintiffs.

FDA Regulatory: Life Cycle Services

Approval pathways
Product development
Clinical research
Advertising and promotion
Compliance and enforcement
FDA interactions and disputes
Corporate transactions
Commercial relationships

Royalty Monetization

Our team has handled dozens of royalty monetization transactions. We utilize structures and terms that help our clients most effectively achieve their goals for engaging in these transactions. No two deals are the same. We're familiar with and have used different transaction terms and structures (including synthetic structures), and will discuss options with you to determine what will work best in your circumstances.