Editor: Please tell our readers about your initial interest in technology and bio-tech subjects and how this led to a career as a litigator dealing with IP cases.
Bresnick: I have always had an interest in science. I received a Bachelor of Arts degree in chemistry from Cornell University. After graduation from Cornell I worked in a biochemistry research laboratory at Boston University School of Medicine. That ultimately led me to Boston University Law School with the idea of becoming a patent attorney. Patent law was a nice mix between the two disciplines I enjoyed.
Editor: So your practice is in Weil Gotshal's litigation department where you are dealing with IP subjects?
Bresnick: That is correct. My practice is mostly litigation. But I do some IP counseling as well.
Editor: Is it possible for a patent to be challenged before it is filed with the Patent Office?
Bresnick: A patent cannot be challenged until it is issued. There is a new bill in Congress that would create an opposition proceeding in the patent context, similar to a trademark opposition proceeding, but that bill has not yet passed. For now a third party's involvement in the prosecution of another's patent application is limited to a few situations: (1) a reexamination proceeding, (2) an interference proceeding, or (3) a third party can cite prior art to the Patent Office against a pending application (35 U.S.C. Sec. 301).
Editor: What about the FDA procedure? Does that precede the application for a patent?
Bresnick: There is no statutory or other requirement for one type of application to precede the other. But regulatory personnel and patent prosecution counsel should coordinate their efforts to make sure applications are timely filed and rights are not lost .
For example, patent applications are often filed much earlier in the developmental process, and a patent could issue years before a company obtains FDA approval to sell its new pharmaceutical product. The patent law now permits for a patent owner to regain a portion of the patent term that "erodes" during the FDA approval process, but a patent holder may not necessarily regain all of the term "lost."
Also, patent prosecution counsel should coordinate with the regulatory group to make sure that clinical trials are confidential to defend against a challenge that those trials constitute "prior art."
Editor: The United States Supreme Court recently decided Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. ___, 125 S Ct. 2372 (2005). A copy of the United States Supreme Court's opinion in the Merck case can be found on the Court's website: http://a257.g.akamaitech.net/7/257/2422/13jun20051230/www.supremecourtus.gov/opinions/04pdf/03-1237.pdf in which the Court determined that the use of patented protected products owned by Integra but used in clinical trials by third parties was protected. Did this outcome serve to clarify the law?
Bresnick: Integra Lifesciences owned patents related to peptides used for cell adhesion. Merck funded the research of doctors who were working with the peptides on the development of new blood vessels from existing ones, a process known as angiogenesis. Integra filed a patent infringement suit against Merck and the doctors involved in the pre-clinical research involving the peptides. The Court determined that pre-clinical trials conducted by a company would not infringe the patent of another company when that research is solely for purposes reasonably related to the FDA approval process.
Editor: Perhaps you can provide an update on the "doctrine of equivalence" which was the subject of some ambiguity in the Festo case. 22 Festo Corp. v. Shoketsu Corp., 535 U.S. 722 (2002).
Bresnick: The doctrine continues to be developed, amplified and further refined after Festo . One of the major problems that courts, litigants and companies have struggled with is the application of the doctrine to a particular set of facts. Its application, determined on a case by case basis, has often presented challenges even with clarification from the courts as to the appropriate guidelines to apply.
One area that might help with the doctrine of equivalence is the Federal Circuit's recent decision in Phillips v. AWH Corp., 33__F.3d__, 2005 U.S. App. LEXIS 13954 (Fed. Cir. 2005). A copy of the Federal Circuit Court of Appeals' opinion in Phillips can be found on the Court's website:http//fedcir.gov/opinions/03-1269.pdf. which addressed some of the fundamental questions of claim construction. More certainty in what claim terms mean might lend itself to further certainty in the application of the doctrine of equivalence.
The Phillips decision resolved, among other things, an important conflict regarding what the primary source for interpreting claims should be. One line of cases said that extrinsic sources, such as dictionary definitions, should be the primary source. The other line of cases said that intrinsic evidence, namely as the claims, the patent specification and prosecution history - understood from the perspective of the person of "ordinary skill" in the art - should govern the meaning of claim terms.
The Court rejected undue reliance on extrinsic evidence in favor of the intrinsic evidence. Specifically, the Court held that the specification and the claims themselves - not dictionaries and other extrinsic evidence - are the primary sources for claim interpretation. This decision will hopefully help companies to direct their patent prosecution, litigation and other business efforts.
Editor: Do you expect stem cell research to revolutionize the work of chemists in the laboratory?
Bresnick: It is a revolutionary technology, and many scientists believe that there is great hope and promise in using the technology to solve debilitating diseases. In that respect it could well revolutionize the work of chemists.
Editor: There has even been an effort to patent gene sequences.
Bresnick: Yes. The Patent Office is attempting to meet the challenge of examining patent applications in this area. The website contains position papers and guidance documents that may help applicants draft and prosecute applications that relate to gene technology.
Editor: It has long been rumored that the Patent Office is understaffed and under- funded. Would you like to comment on that?
Bresnick: The Patent Office faces these criticisms and challenges from time to time.
For example, we saw this happen a few years ago with the growth of the "business method" patent. In a 1999 case, the United States Supreme Court denied certiorari and let stand the Federal Circuit Court of Appeals decision that did away with the judicially created business method exception. See State St. Bank & Trust Co. v. Signature Fin. Group, 149 F.3d 1368(Fed.Cir 1998) cert. denied, 525 U.S. 1093 (1999). After the Court formally cleared the path for business method patents, more applicants started to file applications in this area, which led to the filing of patent claims that required the use of computers and mathematical algorithms.
In response, the Patent Office set up several mechanisms to ensure that applications directed to business methods were getting appropriate scrutiny and that the examiners were properly trained to address them. The Patent Office reached out to the industry for their input and guidance and developed a series of initiatives to address the needs articulated by the affected industries. These initiatives included a second review process in which a second examiner reviews an application assigned to the business method class, and additional training for the examiners assigned to review applications in this class. Documents describing these initiatives, and other documents providing guidance in this area, are posted on the Patent Office website, http://www.uspto.gov/.
Those types of mechanisms could be implemented in other areas.
Editor: We are seeing old-line pharma companies relying heavily on biotech start-ups to provide them with a pipeline. Do you see this trend continuing?
Bresnick: I do. As long as there are ideas and companies that are willing to develop those ideas, traditional pharma companies could partner with biotech start-ups.
Editor: What do you anticipate to be the major sources of funding of biotech research in the future?
Bresnick: I see it as a blended source with continued venture capital funding, traditional pharma companies and biotech start-ups.
Editor: To summarize, are there any bright line areas of patent law which allow patentees to be on sure footing in their introduction of products into the market?
Bresnick: The Federal Circuit's decision in Phillips has resolved a fundamental conflict in the law and provided more certainty in how claims should be construed. Hopefully, this will assist companies in their business, litigation and prosecution efforts.
Editor: We appreciate your giving our readers a broad overview of developments in the patent law arena.
Published September 1, 2005.