Eversheds Sutherland (US) LLP

From patent applications to litigation, Eversheds 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. Eversheds 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. Eversheds 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. Eversheds Sutherland is effectively positioned to litigate all manner of complaints including litigation under Paragraph IV.

Why Eversheds Sutherland
Teamwork. Eversheds 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
• Packaging
• Alternative indications
• Transdermal and other drug delivery devices

Take Action
Eversheds 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.

Selected Experience

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 those cases where our client was threatened by the patent holder, we defended it in vigorous litigation to demonstrate invalidity or non-infringement of the patents.

Sutherland wins on summary judgment for technology transfer organization.   
Sutherland won on summary judgment for a technology transfer organization in litigation of disputes over ownership, monetization and licensing of pharmaceutical patents.

Sutherland wins Paragraph IV patent challenge.
Sutherland won a verdict of non-infringement in a district court case for a reformulated generic pharmaceutical composition.
 

§  “Diversity at Sutherland Asbill & Brennan LLP” to “Diversity at Eversheds Sutherland (US) LLP”

§  “Diversity” section:

o   The firm’s emphasis on diversity is reflected in numerous ways throughout the firm, such as the manner in which we recruit lawyers and other employees, our work-life policies and our professional service efforts. We have been recognized for our achievements in diversity.  More importantly, we understand the significant role a diverse community plays in the firm's growth and development.

§  “Our Awards and Recognitions” section:

o   Eversheds Sutherland (US) LLP continues to be recognized for its efforts to promote diversity in the workplace and in the legal profession. In 2016 we were named a “Best Place to Work for LGBT Equality,” having earned a perfect 100 score on the Human Rights Campaign’s Corporate Equality Index, and we also were ranked a Top 100 Firm for Minority Attorneys by Law360. In addition, the firm was awarded the Gold Standard Certification for the fifth consecutive year by the Women in Law Empowerment Forum.

§  “Our Commitment” section:

o   Eversheds Sutherland (US) LLP is committed to promoting diversity within the firm and in the legal profession.  We believe that diverse skills, knowledge and viewpoints make us a stronger, more productive law firm.  We hire and promote qualified lawyers and other professionals regardless of race, color, national origin, religion, disability, gender, gender identity or sexual orientation.  We understand that diversity enhances our value to clients by allowing us to staff our client teams with professionals who possess broad experiences and a spectrum of perspectives.

o   Eversheds Sutherland (US) LLP has a cross-office Diversity Committee with responsibility for supporting and enhancing our firm culture.  Our committee has helped coordinate and lead a number of efforts to advance diversity within our firm and the community. Affinity groups at the firm serve as support networks for attorneys of color; women lawyers; and gay, lesbian, bisexual and transgender attorneys.

o   We are committed to working with our clients as they pursue the common goal of a professional workplace where opportunity is available to all.