American Intellectual Property Law Association
Biotechnology Committee
Biotechnology in the Courts Subcommittee
Report
Summaries of Recent Decisions of Interest to the Biotechnology Community
Prepared for the AIPLA Spring Meeting
May 6-8, 2010
New York, New York
Edited By:
Lisa Tyner
Subcommittee Chair
Baker Botts, L.L.P.
E-mail:
Larissa Piccardo
Subcommittee Co-Chair
Baker Botts, L.L.P.
E-mail:
C O N T R I B U T O R S
Roy Roberts
Travis D. Boone
Mark V. Polyakov
Georgianna Witt Braden
The AIPLA Biotechnology in the Courts Subcommittee Report is a forum for members of the subcommittee to present summaries and commentary on recent judicial decisions of interest to the biotechnology community. Any view of a contributor expressed in a summary should be understood to reflect only the present consideration and views of the contributor, and should not be attributed to the AIPLA or any of its committees, the contributor’s firm, employer, or past or present clients, to other contributors, or to the editor. To request an electronic copy of the Report, or if you are interested in summarizing a case for a future edition, please contact Lisa Tyner at or Larissa Piccardo at .
CONTRIBUTORS:
Roy Roberts and Travis D. Boone are associates in the Alexandria Office of Buchanan Ingersoll & Rooney PC.
Roy's practice focuses on foreign and domestic patent prosecution and client counseling, primarily in the life sciences area. Prior to working at Buchanan, he was an associate at Griffin & Szipl, PC. Roy obtained his doctorate from Stony Brook University where he studied Molecular and Cellular Pharmacology, and later did postdoctoral research at Memorial Sloan-Kettering Cancer Center. He can be contacted at .
Travis's practice focuses on prosecution and opinion work in a range of technologies including chemistry, pharmaceuticals, biotechnology, surgical/medical/cosmetic/hygiene products, textile/building/construction products and nanotechnology. He has experience preparing due diligence, patentability, validity and infringement opinions and prosecuting domestic and foreign patent applications in these areas. He may be contacted at .
Mark V. Polyakov is an associate at Wood Phillips, an intellectual property law firm in Chicago. Mark focuses on pharmaceutical and biotechnology technologies, and in particular, early stage life science companies. He is experienced with many aspects of domestic and foreign patent prosecution and opinion work. Mark has also provided clients with strategic advice regarding intellectual property matters. Previously, Mark worked as an intellectual property associate at Athersys, a biotechnology company in Cleveland, Ohio. Mark is a member of the American Intellectual Property Law Association, American Bar Association, Chicago Bar Association, Illinois State Bar Association, and Intellectual Property Law Association of Chicago. He is an author of several legal publications on intellectual property matters. His most recent article, Mark Polyakov & Eugene Goryunov, (Non)obviousness of Claims to Genetic Sequences: Finding the Middle Ground, has been published in the February 2010 issue of Santa Clara Computer and High Technology Law Journal. Mark may be contacted at .
Georgianna Witt Braden is a senior associate in the Houston office of Howrey LLP. Her practice focuses on patent litigation, including matters involving the infringement, validity, and enforceability of patents. Dr. Braden has experience preparing due diligence, patentability, validity and infringement opinions and prosecuting domestic and foreign patent applications in the areas of genetics and molecular biology. She has experience litigating matters relating to biotechnology and biochemistry, including genetically engineered plants, point mutations of recombinant DNA, and electrophoresis separation assay procedures. In addition, Dr. Braden has litigated cases involvingmedical instruments related to heart catheters and thermal cycle machines. Prior to studying law at the University of Houston Law Center, Dr. Braden earned a doctorate in molecular genetics. Her graduate research involved the study of homocysteine regulation of gene expression in the migrating neural crest cells of the chick embryo, with specific emphasis on the over expression of the pax-3 gene and its inhibition of apoptosis in the neural tube. She may be contacted at .
TABLE OF CONTENTS
I. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., No. 2008-1248, (Fed. Cir. March 22, 2010)……….4
II. Vanderbilt University v. ICOS Corporation, No. 2009-1258 (Fed. Cir. April 7, 2010)………8
III. Association for Molecular Pathology et al., v. USPTO, et al., Civil Action No. 09-cv-4515, (S.D.N.Y. March 29, 2010)………11
Case Summaries
I. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., No. 2008-1248, (Fed. Cir. March 22, 2010)
Reported by: Roy Roberts, PhD and Travis D. Boone
Summary
The full bench of the Federal Circuit has reaffirmed existing law that 35 U.S.C. § 112 has a separate written description requirement, apart from the enablement requirement. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., No. 2008-1248, slip op. (Fed. Cir. March 22, 2010). The court noted that "a separate requirement to describe one's invention is basic to patent law." Ariad, at 12. In rejecting Ariad's argument, it stated that "[c]laims define and circumscribe, the written description discloses and teaches." Ariad, at 15.
Procedure
Ariad Pharmaceuticals, Inc. ("Ariad") sued Eli Lilly & Co. ("Lilly"), alleging infringement of U.S. Patent No. 6,410,516 ("the '516 patent"). Following a jury trial wherein none of the asserted claims were found invalid, Lilly moved for judgment as a matter of law, which was denied. On appeal, a panel of the Federal Circuit reversed the denial and held Ariad's claims invalid for lack of written description. Ariad's petition for rehearing en banc was granted.
Decision
The Written Description Requirement Generally
The court began by considering various sources of law including the statutory language of 35 U.S.C. § 112 itself, Supreme Court precedent, as well as the decisions of its predecessor Court of Customs and Patent Appeals, and its own prior decisions. It then reached its conclusion that a written description requirement exists in the statute, separate from the enablement requirement. Ariad, at 23. The court stated that the written description requirement extends beyond a priority context, such as in questions of new matter or whether claims are supported by a parent application, and is a requirement that even originally-filed claims must satisfy. Ariad, at 22.
The court noted that claims covering multiple embodiments or species ("genus" claims) can lack written description if the specification does not disclose representative species or structural features common to the genus. Ariad, at 21. According to the court, this is an especially acute problem for functional claims that may simply claim a desired result, and may do so without describing species that achieve that result. Ariad, at 20.
The previous Eli Lilly decision was referred to by the court in describing the issues relating to the written description requirement. Ariad, at 21 (citing Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)). According to the court,
we held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus (emphasis added).
Ariad, at 21 (citing Eli Lilly, at 1568-69) (emphasis added).
Continuing, the court explained that adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Ariad, at 21 (citing Eli Lilly, at 1568). It also stated that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. Ariad, at 21 (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002)). The court declared that "merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Ariad, at 21. Beyond citing its prior decisions, the court provided little additional guidance to applicants seeking to ensure that their claims are supported by adequate written description.
The court did admit that the phrase "possession of the invention" was not very enlightening, and that "possession in the disclosure" is a more complete standard. Ariad, at 24. Accordingly, an "actual possession" or reduction to practice outside the specification is not enough to satisfy the written description requirement. Ariad, at 25. Further, the court held that reduction to practice is neither necessary nor sufficient. Ariad, at 25. The court did provide that the existence of working examples in the specification, or at least prophetic examples (i.e., a "thought experiment" that has not been performed) can be sufficient in establishing that written description support exists. Ariad, at 35. The court also stated that "a description that merely renders the invention obvious does not satisfy the requirement." Ariad, at 25.
For functional claims, the court asserted that the "written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts." Ariad, at 27.
From this perspective, the court is not kind to basic research conducted by universities and institutions, even if that research is groundbreaking or necessary to the later patentable inventions of others. Ariad, at 28. The court acknowledged that universities may not have the resources or inclination to work out the practical end points of all such research, such as identifying target compounds. Ariad, at 28. Nonetheless, the court declared that the difficulty in obtaining patents to basic research is intentional, noting that patents are not awarded for theories, but are compensation for bringing research to a successful conclusion. Ariad, at 28. It also referred to the notion that the requirement ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time. Ariad, at 28.
The Issues in This Case
Turning to the specific facts of Ariad, the court evaluated whether Ariad adequately described some way of performing the claimed methods.
An exemplary claim at issue in Ariad's '516 patent is claim 80, rewritten below to include the claims from which it depends:
80. [A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-κB-mediated intracellular signaling, the method comprising altering NF-κB activity in the cells such that NF-κB-mediated effects of external influences are modified, wherein NF-κB activity in the cell is reduced] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.
The parties agreed that the specification of the '516 patent suggested the use of the three classes of molecules to achieve NF-κB reduction: specific inhibitors, dominantly interfering molecules, and decoy molecules. The court discussed each of the three disclosed classes of molecules used to achieve NF-κB reduction in the patent, and how the disclosure of such does not sufficiently describe the claimed invention, in that the specification did not "demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-κB activity so as to 'satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.'" Ariad, at 28 (citing Capon v. Esshar, 418 F.3d 1349, 1357 (Fed. Cir. 2005)).
Specific inhibitors block NF-κB binding to DNA in the nucleus. The court held that nearly all of Ariad’s evidence regarding the disclosure of such a molecule, I-κB, relies upon Figure 43 of the ‘516 patent, which was not disclosed until after the 1989 priority date. The court discounted expert witness testimony that I-κB existed in 1989 and that one could isolate natural I-κB, stating that "a vague functional description and an invitation for further research does not constitute written disclosure of a specific inhibitor. . . . And it certainly does not constitute written disclosure of a method for reducing NF-κB activity using I-κB." Ariad, at 33-34.
The specification described dominantly interfering molecules as truncated forms of NF-κB that would retain the DNA binding domain, but lack the RNA polymerase activating domain. However, not only did the specification provide no example of molecules in this class, but it also acknowledged that dominantly interfering molecules can work only if the DNA binding domain and the DNA polymerase domain of NF-κB are distinct regions in the NF-κB molecule. The court concluded that because the inventors (who had discovered NF-κB) did not know if this were true at the relevant time, "one of ordinary skill in the art was at best equally ignorant." Ariad, at 34. Thus, the court dismissed the dominantly interfering molecules as merely a wish or plan for future research, and therefore without adequate written description support. Ariad, at 34-35. The court considered it irrelevant that this teaching was later actually practiced. Ariad, at 35.
Decoy molecules mimic a gene target of NF-κB so that NF-κB binds the decoy instead of its natural target. Unlike the other two classes of molecules, the specification of the '516 patent proposed example structures of decoy molecules: it included a table of sequences recognized by NF-κB and a consensus sequence of the binding site (i.e., a common pattern among the sequences recognized by NF-κB). Nonetheless, the court found the disclosure as a whole insufficient. Ariad, at 35. While the specification stated that NF-κB "would bind the decoy" to result in the desired negative regulation, the court was troubled by the lack of a "descriptive link between the table of decoy molecules and reducing NF-κB activity." Ariad, at 35-36. The court also noted that what descriptive support existed in the specification could not "bear the weight of the vast scope of these generic claims." Ariad, at 37.
In view of the above, it appears that Ariad failed to properly describe the invention due to a lack of working examples demonstrating inhibition of NF-κB activity, or otherwise providing a descriptive link between certain disclosed molecules and the claimed functional activity.