Do You Have the Right Scientific and Technical Support To Succeed In Biopharmaceutical Patent Litigation?

Posted by on February 9, 2018

This post was authored by David H. Schwartz, a principle at Innovative Science Solutions and Paul Fehlner, JD, PhD, founder of Life Sciences Innovation. Paul is a life sciences lawyer and biopharmaceutical consultant with a strong intellectual property focus who partners with research institutes, startups, and Fortune 500’s to help them transform basic scientific discoveries into life-changing products and services around the world. In addition to his strong technical and legal knowledge, he was responsible for Novartis Pharma’s patent litigation over the past nine years, and has firsthand litigation experience from private practice.

Successful litigation takes the right combination of trial acumen and the application of proper legal principles to the underlying facts. Law firms provide experienced trial lawyers and knowledgeable litigators, sufficient for most civil litigation cases. But not for most biopharmaceutical patent litigation.

The underlying facts in biopharmaceutical patent litigation revolve around highly technical information. Biotechnology involves complicated experiments, intricate regulatory filings, and complex biomolecules. Chemistry and pharmaceutical sciences involve byzantine synthetic pathways, intermediate molecules, and abundant analytical data. Putting together the right facts requires a deep understanding of the underlying technology. There are three areas where this is critical: evidence collection, discovery, and expert selection.

Evidence Collection: What is relevant and what does it mean? These questions apply to notebooks, internal emails, reports, and publications. If you don’t understand the evidence, how can you hope to prevail in the dispute? For example, if you need to find mechanistic or in vitro evidence to support a specific position from a lab notebook entry, you need to understand how researchers collect and record data, and how the notebook data relate to internal reports, published literature, or patent specifications that rely on the data. Compiling this type of evidence can make your case far more compelling by establishing (or refuting) an invention story, asserted timeline, or some other important fact.

Discovery: What documents support your case? What documents contradict it? If you don’t thoroughly understand the documents you are producing and receiving from the other side, how can you hope to use them effectively? These documents can include diligent reduction to practice in multiple laboratory notebooks across several years. Putting together this story can be extremely tedious, technical, and complex. You need a scientist who understands the specific technical elements and how they fit the case themes. Ideally, this should be a scientist who has been steeped in the science and “lived and breathed” documents like the ones he or she is reviewing.

Expert Selection: Recruiting the right expert team with sufficient understanding of the technology to be credible, and including individuals who are capable of communicating understandably, can be key to winning a patent lawsuit. If you lack the technical chops to effectively vet the expert, and ensure that they are strong enough to remain credible, how will you know that you don’t simply have a personable pseudo-expert who falls apart under cross-examination? Sometimes it is not even clear exactly what type of expert is needed for a given patent case. Is it necessary to have someone with an MD to offer medical insights? Is a working knowledge of the specific technology a necessary feature of the expert’s background or is a more general scientific acumen the more important feature?

In one recent patent dispute we were involved with, we recruited an individual with a specific knowledge of identifying lead compounds in a drug discovery program. This expert was able to put together a chart highlighting dozens of lead compounds from other programs, all of which made the point that our client wanted to shed light on.

Thirty years ago, addressing the underlying technology in a patent lawsuit was never in question: patent lawyers with technical backgrounds handled these matters. Since then, patent litigation has become so important that clients hire the best trial lawyers for their cases. Platoons of highly trained litigators back up these first chairs. But unless the firm has a significant intellectual property practice capable of supporting biopharmaceutical patent litigation, few if any lawyers at the firm have both the technical capability and bandwidth to properly support high stakes patent litigation. Hiring temps just removes the problem: how will the firm that itself lacks technical expertise be certain that science temps have the experience and temperament to deliver for litigation?

For the best results, incorporating the necessary and appropriate technical expertise requires working with a knowledgeable and experienced outside technical consulting firms. Best-in-class patent litigation firms routinely use outside technical consultant companies. Consulting firms like ISS provide vetted experts at the right level of experience at an acceptable cost. At ISS, senior consultants with years of experience who speak the language lead scientists in document review. They are able to winnow the panel of dozens of potential expert candidates to the key individuals who will add value and help the team prepare for trial. Litigation support consulting companies will know enough about patent litigation to provide a seamless exchange of information from the law firm to the testifying experts and back again.

Today, law firms rely on third parties for document collection and production because they cannot compete on quality and price. Virtually no law firm goes forward with litigation managing discovery entirely on its own. Similarly, retaining a technical scientific consulting firm steeped in litigation support, at an overall lower cost along with higher quality results, will be the norm for patent litigation. If your patent case depends on the right technical support, how will you know for sure that you have that support?



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