Pharmaceutical Litigation

Sterne Kessler’s pharmaceutical and biopharmaceutical litigation practice integrates life science trial skills, technical depth and patent knowledge to win complex cases for clients. We represent both brand and generic pharmaceutical and biopharmaceutical companies involved in experimental and prescription drugs and biologics.

We provide early and ongoing analysis of the relevant patents, prior art and products involved. And, we formulate strong positions on invalidity, non-infringement, and claim construction at the outset of the litigation, ensuring that our tactics are focused on winning. In 2019, Managing Intellectual Property magazine presented Sterne Kessler with the “Impact Case of the Year Award” for our win in Allergan et al v Teva Pharmaceuticals USA, et al. Sterne Kessler represented client Teva and successfully invalidated all patents in suit following a bench trial.

Selecting the right counsel is critical, particularly in an IP-related case, because of the inherent complexity of the subject matter. We know that in today's competitive marketplace, it is especially difficult to navigate the demands of FDA regulation, patent validity challenges, and patent protection of small molecule and biologic drugs. Whether the challenge is gaining market access for a generic drug, maintaining exclusivity for a proprietary drug, or developing and launching a biosimilar, Sterne Kessler has the legal and technical depth to win.

Sterne Kessler’s advantage stems from its integrated trial team, which brings together a deep bench of experienced litigators, technical experts and attorneys and agents with specialized patent law knowledge that provides clients with a fully synchronized approach to their cases. Sterne Kessler professionals hold nearly 50 Ph.D.s and 30 master's degrees in substantive technical fields like organic chemistry, medicinal chemistry, biochemistry, and molecular and cell biology. Our ANDA expertise includes over 50 Paragraph IV filings and over 500 opinions. 

Pharmaceutical and ANDA Litigation

Sterne Kessler has particular depth and expertise at the interface between patent law and the FDA drug approval process. Our team excels at every phase of the Abbreviated New Drug Application (ANDA) process — assisting generic drug and branded pharmaceutical companies navigate the process to achieve their objectives.

We counsel clients in matters arising at the interface between patent law and the FDA approval process. Our practice includes:

• Patent validity & infringement analyses
• Exclusivity strategies
• Preparation of patent certifications for ANDAs and 505(b)(2) applications
• ANDA- and 505(b)(2)-related litigation
• Prepare and file patent term extension applications
• Orange Book listing strategies

We have acted as lead counsel in Hatch-Waxman cases across a wide range of therapies, including:

• Cardiovascular drugs
• Chemotherapeutics and other oncology drugs and biologics
• Respiratory disorder and asthma drugs
• Dermatological drugs
• Pain medications
• Antihistamines
• Mental disorder drugs
• Treatments in the form of patches, creams, suspensions, topicals, orals, injectables, rings, suppositories and ODTs, to name a few

Biosimilar Litigation

Sterne Kessler has one of the most experienced biotechnology practices in the United States. We have been at the forefront of the rapidly evolving biotechnology industry for more than 30 years. In addition, we have a proven track record in high-stakes Hatch-Waxman/ANDA counseling and litigation. The Biologics Price Competition and Innovation Act (BPCIA) has created a unique pathway for biosimilar drugs and Sterne Kessler is uniquely qualified to help.

• Our team represented Sandoz in Genentech, et al. v Sandoz et al. in a BPCIA case focused on the proposed launch of a biosimilar version of Rituximab (brand name Rituxan, a treatment for Non-Hodgkin’s Lymphoma). Sandoz decided “not [to] pursue its submission for biosimilar rituximab in the US … follow[ing] a request by the US Food and Drug Administration (FDA) for additional information to complement the submission.”  According to a contemporaneous press release, Sandoz was “disappointed to have to make this decision and stand[s] behind the safety, efficacy and quality of [its] medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia.”  Sterne Kessler patent litigation under the BPCIA regarding Sandoz’ U.S. regulatory application for its rituximab biosimilar.

• Our team has represented Amgen in a number of Patent Trial and Appeal Board (PTAB) cases directly related to biosimilar launches and litigation. That work has included three cases (all pending) representing Amgen as petitioner (Amgen, Inc. v Alexion Pharmaceuticals) and three cases representing Amgen and Immunex as patent owners (Sanofi-Aventis, et al. v Immunex, et al.) – pending Federal Circuit appeals.
• Similarly, our team represented Bristol Myers Squibb in a series of Inter Partes Reviews (IPRs) related to Merck’s Keytruda (Merck Sharpe & Dohme Corp. v Ono Pharmaceutical Co. Ltd.). The four IPRs (against two patents) were part of a larger patent litigation between the companies pertaining to Keytruda. Bristol-Myers Squibb and Ono, who discovered and developed the PD-1 antibody Opdivo (nivolumab), had asserted in litigation that Merck’s sale of Keytruda infringed the companies’ patents relating to the use of PD-1 antibodies to treat cancer in the U.S., Europe (United Kingdom, Netherlands, France, Germany, Ireland, Spain and Switzerland), Australia, and Japan. As part of the agreement, Merck made an initial payment of $625 million to Bristol-Myers Squibb and Ono. Merck is also obligated to pay ongoing royalties on global sales of Keytruda through 2026.

This Unique Pathway Requires Unique Attorneys - The abbreviated approval pathway for biosimilars in the United States is fundamentally distinct from the Hatch-Waxman pathway for generic small-molecule drugs. Companies anticipating biosimilar competition for their key products or contemplating bringing a biosimilar challenge require an IP legal team that understands the nuances and the issues that can arise with each. Our knowledge of biotech patent law and years of experience dealing with the patent issues involved in Hatch-Waxman/ANDA matters combine to create a team of professionals that can tackle the most sophisticated IP issues faced by those in this emerging industry, whether they are innovators or biosimilar challengers.

• Our team of professionals is both legally adept and technically astute. Most have earned an advanced technical degree (more than 50 have a Ph.D.) and significant industry or academic experience.
• We are experienced biotech advisors, having represented companies through the years that have been positioned at the cutting edge of technologies like genomics, bioinformatics, vaccines, nanomedicine, and pharmacogenomics.
• We are recognized leaders in IP issues relating to therapeutic antibodies, which now make up the fastest-growing segment of the pharmaceutical industry.
• We have assembled a deep bench of experienced litigators, technical experts, and attorneys and agents with extensive experience representing both brand and generic pharmaceutical companies in blockbuster ANDA matters.
  • Our body of ANDA work comprises more than 50 Paragraph IV filings and over 500 opinions.
  • We have translated that extensive ANDA experience to navigating the BPCIA, and particularly the litigation options available under that regime.
• We are the clear leaders in life sciences and biotechnology PTAB litigation.
• Our professionals are trained to evaluate complex intellectual property issues in the context of the business environment to ensure alignment with your strategic goals.

Medical Device Cases

In addition to leading pharmaceutical and biologic cases in district courts, at the USITC, and at the PTAB, Sterne Kessler has also taken a leading role in a number of medical device cases. That work includes both district court and PTAB representation for both standalone devices (see Nevro v Boston Scientific as an examples – nearly 20 IPRs as both petitioners and patent owners), DNA sequencing technology (see 10X Genomics v University of Chicago – cases overtaken by the US Supreme Court’s decisions regarding patentable subject matter), and drug delivery devices (often, though not always, associated with a related ANDA case).

Competitor Disputes

In addition to helping clients navigate pathways related to bringing generic and biosimilar drugs to market, Sterne Kessler also assists competitors in the pharmaceutical and biopharmaceutical industries achieve positive resolution when dispute arise between competitors. Competitor work spans a wide range of disputes including:

• Licensing and other contract disputes involving IP in the life sciences;

• Inventorship disputes, including interferences between competing teams of inventors;
• Contesting patent validity at the USPTO’s Patent Trial and Appeal Board (PTAB) – both via Inter Partes Review (IPR) and Post Grant Review (PGR)