Michael Shuster
Protecting Early Stage Technology
Michael Shuster, a partner at Fenwick & West known for innovative patent prosecution and solutions, spoke on protecting early stage technology. He began his discussion by noting several recently issued cases that make protection of early stage technology a difficult task.
As background, Shuster explained that early stage technology is often developed at universities and research institutes that don't have the ability to carry the technology beyond the very early stages. In order to get this technology into a commercial embodiment, partnering with a biotech or pharma company is required. A central question in these arrangements is, "How do you allocate the rewards among early stage developers (universities or research institutes) and their collaborators (biotech or pharma companies) in terms of allocating patent protection that recognizes the relative contributions of those two players?"
The practical implications of the recent cases is that there has been increased focus on the written description requirement, which has raised the bar with regards to getting effective patent coverage on early stage technology. The goal of the written description is to clearly convey that the applicant has invented the subject matter that is claimed. Traditionally, written description outside of biotech always was relied upon for the purposes of avoiding overreaching by the applicant.
A Federal Circuit decision from 1997, Regents of the University of California v. Eli Lilly., 119 F.3d 1559, 43 USPQ2d (BNA) 1398 (Fed. Cir. 1997), cert. denied 523 US 1069 (1998) has changed written description away from the traditional purposes, and elevated it to more of a super enablement requirement that is particular to biotech. To satisfy written description, the specification must describe the claimed invention in sufficient detail to allow a person of ordinary skill to reasonably conclude that the inventor had possession of the invention. The specification can describe the invention in two alternate ways: 1) actual reduction to practice, a description of work that's actually done; or 2) constructive reduction to practice, a description of work that you would carry out to teach how to make the invention. This new change in written description, begun by Lily, has imposed upon biotech a de facto requirement for actual reduction to practice.
Two other important cases, Enzo Biochem, Inc. v. Gen-Probe Inc. 285 F.3d 1013, 62 USPQ2d (BNA) 1289 (Fed. Cir. 2003, vacated by 296 F.3d 1316 (Fed. Cir. 2002) and University of Rochester v GD Searle & Co., 249 F. Supp. 2d 216, 68 U.S.P.Q.2D (BNA) 1424 (WDNY 2003), have further impacted written description for early stage technology. Enzo involved the satisfaction of actual reduction to practice for biological inventions by a deposit of biological materials in a depository. Rochester held that method of treatement claims based on discovery of a biological pathway do not provide an effective strategy for early stage developers to protect their investment in the absence of disclosed compound that modulates the pathway.
In the wake of these legal developments, Shuster was able to impart several practical strategies for protecting early stage technology. First, if you have novel targets, claim composition of matter for those targets. Second, to the extent that you first discover the function of a gene product, or its involvement in disease, assay claims are going to be very useful for capturing some value. Finally, a method of treatment claim, without an actual working compound, is not likely to be afforded patent protection at this time.Lynn Pasahow
Recent Cases And Analysis
Lynn Pasahow, a distinguished partner at Fenwick & West, presented an update on biotech patent litigation with a special focus on selected recent cases. His presentation was framed within the following parameters: "Consider what happens when you're not in the position of the University of Rochester, and did not conduct the initial research on a product. What if you're the company that completes the invention? After the initial research from another gets into the public realm, what can you patent?"
Much of Pasahow's discussion revolved around this question and the concept of "inherent anticipation." A fundamental notion of patent law is that you cannot patent something that either existed before, or was published in a way that would have enabled someone to do it before. Sometimes what was described or done before included a feature that nobody knew about at the time. Having figured out this additional feature, can one patent it? The general answer is no. Pasahow explains that if the feature was inherently expressed in what was done or described in the past, it existed and was anticipated.
In one recent case, In re Cruciferous Sprout Litigation, a company patented one of the beneficial ingredients in brussel sprouts. The Federal Circuit held the patent invalid, noting that people have been eating sprouts for a long time, and the discovery of one of the ingredients that makes them good for you does not allow the patenting of sprouts with that ingredient. "While this seems like a trivial point, in terms of what the biotech industry does, it is actually a very fundamental point. Much of what biotech patents is natural ingredients or functions, and this case makes clear, there are limits on the breadth of those patents."
In light of this and other recent Federal Circuit cases on this issue, Pasahow noted that, "Inherent anticipation is going to be an increasingly fascinating and fertile field of litigation in the biotech space as we continue to get patents on things that our bodies have done for ever." Figuring out the rules that apply is going to occupy some considerable time in the Federal Circuit.
Pasahow next addressed two new developments relating to the patent statutes. The first development concerns a 1984 statutory exemption from patent infringement covering the preparation of data for an FDA application. The underlying reason for the statute was to allow generic drug manufacturers to get a head start before a patent expires, and get their FDA application in order. Congress believed this would allow the approval of the drug to be in place at the same time that the patent expired, and the generic drugs could launch immediately.
Interpreting the language of the exemption, in Integra Lifesciences I, Ltd. v. Merck KGaA, the Federal Circuit concluded that the pre-clinical identification and development of drug candidates are not acts reasonably related to the development and submission of information under the FDA laws, and therefore are not exempt from patent infringement. "As a practical matter," Pasahow stated, "this reaffirms the notion that companies can make research tools that the drug industry is going to use and they will be able to get patent royalties on them."
Pasahow concluded the presentation by outlining a second recent statutory development: the clarification of the patent statute that makes acts of importing the fruits of patent infringement done abroad an infringement of U.S. patent laws. In Bayer AG v. Housey Pharmaceuticals, Inc., the Court helped define what can and cannot be imported. It held the patent statutes do not cover the generation of knowledge in infringement of a U.S. patent abroad, and subsequent use of that knowledge in the U.S.. Instead, the Federal Circuit held, the law only applies to the making of a physical compound and bringing the it into the U.S, resolving an issue that has generated a great deal of debate in recent years.