Practice/Industry Group Overview
From patent applications to litigation, Sutherland provides comprehensive IP counsel to generic and specialty pharmaceutical companies.
The generic and specialty pharmaceutical industry growth is fueled by an increasing demand for affordable medicines. Sutherland’s IP attorneys have been integrating legal strategy with the commercial interests of our pharmaceutical clients for more than three decades. Our ability to effectively counsel in product pipeline clearance strategies, prosecute patents and defend against patent challenges enables clients to effectively develop their intellectual property portfolios. We work closely with our clients to help achieve their business goals by developing aggressive Hatch-Waxman Abbreviated New Drug Application (ANDA) and Section 502(b)(2) filing strategies. Our attorneys' advanced technical educations constantly prove their value when advising clients in the highly technical field of pharmaceuticals.
Patent prosecution and opinion work form the foundation for successful product commercialization in the pharmaceutical industry. Pharmaceutical companies research and develop improved production processes, new formulations, or new uses of products designed to avoid infringing FDA Orange Book-listed patents. Sutherland's lawyers work to ensure that these innovations receive the best possible legal protection, help clients build robust portfolios through IP-driven transactions and assist clients in meeting financial goals through licensing and other monetization strategies.
Litigation in the pharmaceutical industry is increasing as more drugs come off patent protection and generic drugs are being developed. Under U.S. Food and Drug Administration procedures for filing abbreviated new drug applications (ANDAs), certification of non-infringement or invalidity must be made with respect to patents listed in the Orange Book. The Hatch-Waxman framework is extremely technical and high-stakes for all parties involved. Sutherland is effectively positioned to litigate all manner of complaints including litigation under Paragraph IV.
Teamwork. Sutherland's IP prosecutors and our litigators work in concert to identify potential invalidity and infringement scenarios efficiently, and advocate them effectively. Moreover, we consider our clients’ scientific and commercial goals in developing IP strategies.
Technical Knowledge. Our attorneys are solid in the sciences. Many have advanced degrees in chemistry, pharmacology, biotechnology, molecular biology, medicine, biological sciences, and chemical engineering. Some worked as engineers and scientists before embarking on legal careers. Most of our IP attorneys are registered to practice before the U.S. Patent and Trademark Office. We understand our clients’ highly technical innovations and provide comprehensive legal advice.
Analytical Ability. Patent prosecution and opinion work are the foundation of our pharmaceutical practice. Our attorneys know and understand a vast array of technologies, including small molecule and biosimilar products; synthesis and polymorph purification; oral dosage and injectable formulations; packaging; alternative indications and transdermal and other drug delivery devices.
Litigation Experience. Our team is experienced in the litigation unique to the pharmaceutical business. The Hatch-Waxman framework encourages litigation and globalization complicates it. We believe pharmaceutical litigation will increase and our reputation as formidable litigators benefits our clients.
Depth of Practice. We help our clients maximize the monetary value of their pharmaceutical products. Our clients benefit not only from our pharmaceutical attorneys' legal experience and technical knowledge but also from the advice of lawyers on our tax, finance and corporate teams.
Nuts and Bolts
Our services for generic and specialty pharmaceutical clients include:
- Litigating Hatch-Waxman and other pharmaceutical patent matters, including litigation arising from:
- Paragraph IV certifications
- International Trade Commission (ITC) complaints
- Prosecuting patent applications for our specialty pharmaceutical clients
- Preparing product clearance and freedom-to-operate opinions that address patent infringement, validity and enforceability
- Drafting ANDA Paragraph IV Notices, detailed statements and offers of confidential access
- Conducting intellectual property due diligence in connection with mergers and acquisitions
- Planning for the expansion of pharmaceutical, biosimilars and biobetters product pipelines, including antibodies
- Counseling clients on FDA regulatory matters
- Analyzing FDA Orange Book exclusivity issues
- Landscaping third-party patent portfolios
- Developing strategies for product design-arounds
- Engaging experts for testifying and counseling
We have experience with a vast array of technologies, including:
- Small molecule and biologics products
- Synthesis and polymorph purification
- Oral dosage and injectable formulations
- Alternative indications
- Transdermal and other drug delivery devices
Sutherland clients benefit from a business-friendly approach to pharmaceutical issues that combines prosecution and litigation advice to meet our clients' scientific and commercial goals.
Sutherland represents a global generic pharmaceutical company seeking to enter the U.S. market with new products.
We represented a worldwide generic pharmaceutical company seeking to enter the U.S. market with new products. In cases where our client was threatened by the patent holder, we litigate vigorously to demonstrate invalidity or noninfringement of the patents.
Sutherland wins on summary judgment for technology transfer organization.
Sutherland's client, a technology transfer organization, won a summary judgment in litigation over several disputes.
Sutherland wins Paragraph IV patent challenge.
Sutherland's client wins in Paragraph IV patent challenge litigation.