American Intellectual Property Law Association Biotechnology Committee. Biotechnology in the Courts Subcommittee Report

Transcription

1 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 Biotechnology Committee March 28, 2013 Edited By: Melanie Szweras Subcommittee Chair Bereskin & Parr LLP Nicholas Landau Subcommittee Vice Chair Bradley Arant Boult Cummings LLP C O N T R I B U T O R S Trevor J. Davies Lynn C. Tyler Michael R. Brunelle William R. Schmidt 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 Melanie Szweras at mszweras@bereskinparr.com. 1

2 CONTRIBUTORS: Trevor J. Davies is a partner at Allens Patent & Trade Mark Attorneys and leads Allens life sciences patent team. He specializes in biotechnology, pharmaceutical, food technology, agriculture, and renewable energy patents. Trevor's services include intellectual property advice, particularly drafting patent specifications and prosecuting patent applications throughout the world, patent oppositions, advising on patentability of inventions and carrying out due diligence on existing or pending patent rights. He also advises on strategies for capturing, protecting, commercializing and enforcing intellectual property rights. His wide-ranging experience and knowledge is sought by local and foreign clients in relation to Australian and foreign patent and design protection and enforcement, as well as plant breeders' rights. Trevor has a BSc(Hons) majoring in Microbiology and Biochemistry, and a PhD in Microbiology. Prior to becoming a patent attorney, Trevor was a post-doctoral research fellow at the University of Chicago, USA and University of Saarland, Germany. Lynn C. Tyler is a partner and registered patent lawyer in the Intellectual Property Department of Barnes & Thornburg LLP in Indianapolis. He concentrates his practice in litigation of intellectual property matters, representing clients at all stages of the process. Mr. Tyler is listed in Best Lawyers in America and Indiana Super Lawyers. He is the author of several published articles on issues of intellectual property or federal procedure in a variety of peer-reviewed publications. In 2010, one of his articles won the prestigious Burton Award for Legal Achievement. The first of his two articles on inequitable conduct has been cited by two Federal Circuit Judges in published opinions. Mr. Tyler graduated summa cum laude in 1981 from the University of Notre Dame and in 1984 received his J.D. magna cum laude from the University of Michigan Law School. In 2007, he received a M.S. in Biology from Purdue University (Indianapolis campus). Mr. Tyler s civic activities include being a co-founder, past president, and volunteer for the Neighborhood Christian Legal Clinic. For his work on behalf of the Clinic, he received the Indianapolis Bar Association's Pro Bono Award in 2002 and was a corecipient of the firm's inaugural Joseph A. Maley Pro Bono Award in Michael R. Brunelle is an associate in the Indianapolis, Indiana office of Barnes & Thornburg LLP, and a member of the firm s Intellectual Property Department. He concentrates his practice on intellectual property litigation. Mr. Brunelle received his B.S. in chemical engineering from Purdue University in He received his J.D. magna cum laude in 2008 from Indiana University School of Law Bloomington. During law school, Mr. Brunelle served as a managing editor of the Indiana Law Journal, as executive problem editor of the Sherman Minton Moot Court Board, and was selected for membership in the Order of the Coif. 2

3 Prior to attending law school, Mr. Brunelle worked as a process engineer at Tate & Lyle North America, a specialty starch producer in Lafayette, Indiana. Mr. Brunelle is a member of the Indiana State Bar Association, and is admitted to practice in the state of Indiana as well as the U.S. District Courts for the Northern and Southern Districts of Indiana, the Western District of Michigan, and the U.S. Court of Appeals for the Federal Circuit. William R. Schmidt is an associate at Wenderoth, Lind and Ponack in Washington, D.C. He is a member of the firm s Chemical and Biotechnology Patent Prosecution Group. Mr. Schmidt received his B.S. in Biology and M.S. in Molecular Biology from Virginia Tech. After teaching English in Japan and working in an immunology laboratory at the University of Pennsylvania Medical School, Mr. Schmidt attended Cardozo Law School and received his J.D. in Mr. Schmidt is a member of the New York Bar and registered to practice before the USPTO. 3

4 TABLE OF CONTENTS I. Cancer Voices v Myriad Genetics [2013] FCA 65 (15 February 2013).5 II. III. Abbott GmbH & Co., KG v. Centocor Ortho Biotech, Inc., Case No FDS (D. Mass. 2012).7 Verinata Health, Inc. and The Board of Trustees of the Leland Stanford Junior University v. Sequenom, Inc, and Sequenom Center for Molecular Medicine, LLC (Case No. 4:12-cv SI, N.D.Cal).11 4

5 Case Summaries I. Cancer Voices v Myriad Genetics [2013] FCA 65 (15 February 2013) Reported by: Trevor J. Davies, PhD In a widely-anticipated decision that has been seen as a win for biotech innovators, the Federal Court of Australia has confirmed the patentability of genetic materials in their isolated form. In 2010, Cancer Voices Australia, a national advocacy organisation, together with breast cancer survivor Yvonne D'Arcy (collectively, CVA), initiated action in the Federal Court to revoke three claims of AU , the BRCA1 patent owned by Myriad Genetics Inc and licensed exclusively to Melbourne-based company Genetic Technology Limited (collectively, Myriad). Those claims were directed to isolated nucleic acid coding for mutations in the BRCA1 gene that can be used to detect predisposition to breast and ovarian cancers. CVA contended that the claims in suit were invalid on the ground that isolated nucleic acid is not a manner of manufacture that satisfies a threshold requirement for patentability in Australia. Of note, CVA did not raise any other grounds of invalidity, nor did it seek to challenge the other 27 claims directed to diagnostic testing methods using the isolated nucleic acid. A determination whether or not a composition of matter is a "manner of manufacture" must be decided in accordance with the principles set out in the High Court's decision in the NRDC case where it was held that: 'A composition of matter may constitute patentable subject matter if it constitutes an artificial state of affairs, that has some discernible effect, and that is of utility in a field of economic endeavour'. Justice Nicholas noted that NRDC does not require the Court to ask whether a composition of matter is a 'product of nature' for the purpose of deciding whether or not it constitutes patentable subject matter. Applying NRDC, Nicholas J found that isolated nucleic acid, even if assumed to have the same chemical composition and structure as found in cells of some humans, constitutes an artificial state of affairs and therefore is patentable subject matter. Nicholas J also confirmed that the disputed claims are not directed to genetic information per se and could never be infringed by someone who merely reproduced a DNA sequence in written or digital form. Furthermore, as the claims are directed to an isolated chemical composition, naturally occurring DNA or RNA as they exist in a cell, are not within the scope of the claims. The topic of 'gene patenting' has been an ongoing subject of public debate and government inquiry, even though patents for genes per se are no longer being granted. In his decision, Nicholas J referred to the lapsing of a recent Private Members' Bill that 5

6 would have excluded from patentability 'biological materials which are identical or substantially identical to such materials as they exist in nature'. Nicholas J also noted that the Federal Government's November 2011 response to three inquiries into gene patenting had accepted an Australian Law Reform Commission recommendation that genetic materials and technologies not be excluded from patentability. Finally, his Honour noted that while some have expressed concerns that gene patents will inhibit future research and the development of new therapies, the experimental use exemption introduced by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 goes at least some way towards addressing any such concerns. On 4 March 2013, Yvonne D'Arcy filed a Notice of Appeal against the decision on a number of grounds including that the primary Judge erred in finding that isolated nucleic acid involved the creation of an "artificial state of affairs" and therefore was patentable subject matter. Cancer Voices Australia is not party to the appeal. To date, the Australian Patent Office, the Australian Law Reform Commission, the Australian Government, and a single judge the Federal Court have found that isolated biological material is patentable subject matter. We must now wait for the appeal to see what three judges of the Full Bench of the Federal Court decide. 6

7 II. Abbott GmbH & Co., KG v. Centocor Ortho Biotech, Inc., Case No FDS (D. Mass. 2012) Summary Reported by: Lynn C. Tyler and Michael R. Brunelle We previously reported on the ongoing battle between various Abbott (n/k/a AbbVie) entities and certain Johnson & Johnson affiliates (including Centocor, which is now Janssen Biotech, Inc., Janssen ) over an antibody to the cytokine IL-12. When functioning properly, IL-12 assists the immune system by binding receptors on the surfaces of certain cells as part of the body s inflammation response to infection. Thus, antibodies against IL-12 can be effective treatments. The patents-in-suit, Abbott s U.S. Patent No. 6,914,128 and U.S. Patent No. 7,504,485, cover antibodies designed to target IL-12. Janssen s accused product, STELARA, contains an antibody that also targets human IL-12. The case went to trial in September 2012 on Janssen s anticipation, enablement, obviousness, and written description defenses. The jury returned a verdict in favor of Janssen on the issues of written description, enablement, and obviousness. The jury ruled in favor of Abbott on the issue of anticipation. After receiving the jury s verdict, Abbott filed a renewed motion for judgment as a matter of law on all three bases that the jury had found in favor of Janssen. In March 2012, the district court denied Abbotts motion on all three bases. A summary of this latest decision follows. Invention Abbott s 128 and 485 patent include claims to antibodies to IL-12 and IL-23. Claim 29 of the 128 patent, which was found to be infringed as a matter of law, reads: 29. A neutralizing isolated human antibody, or antigen-binding portion thereof that binds to human IL-12 and disassociates from human IL-12 with a K off rate constant of s -1 or less, as determined by surface plasmon resonance. Claims 1 and 11 of the 485 patent read: 1. A pharmaceutical composition comprising an isolated human antibody, or antigen-binding portion thereof, which is capable of binding to an epitope of the p40 subunit of IL-12, and further comprising an additional agent. 7

8 11. The composition of any one of claims 1-4, wherein the antibody, or the antigen binding portion thereof, dissociates from the p40 subunit of IL-12 with a K d of or less or a K off of s -1 or less, as determined by surface plasmon resonance. Decision Written Description In a case such as this, to satisfy the written description requirement the specification must disclose either a representative number of species falling within the scope of the genus or structural features common to members of the genus so that one of skill in the art can visualize or recognize the members of the genus. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc). At trial, Janssen argued that the specification only disclosed antibodies that were closely-related structurally and did not disclose the full scope of the genus, in part pointing to differences in the structure of STELARA, which at least by the time of trial was an undisputed member of the genus. Abbott raised two primary relevancy-based challenges to the evidence presented by Janssen on the issue of written description. First, Abbott argued that Janssen s evidence that the disclosed antibodies were not representative of other members of the genus (e.g., STELARA ) based on structural differences between STELARA and the disclosed antibodies was irrelevant because the patent claims are functional, not structural. The district court found this unpersuasive, noting trial testimony concerning the ways in which antibody structures could affect function. The court further found that the jury s decision was reasonable based on direct testimony from both parties that the disclosed antibodies were not representative of the entire genus. Second, Abbott argued that Janssen s evidence comparing the differences between the accused STELARA product and the disclosed antibodies had no bearing on the issue of written description. Instead Abbott argued that the jury could only consider whether the patent discloses species that are representative of the genus, not of the allegedly infringing product. The district court rejected this argument as well. Because the parties did not contest that STELARA was the only known antibody in the genus other than those disclosed in the patent, the district court found it permissible for Janssen to describe to the jury a fuller picture of the variety in the claimed genus. Interestingly, Abbott also argued that the visualize or recognize portion of the test quoted above applies only to the structural features requirement, not the representative number of species requirement, and that Janssen s case had improperly conflated the two. The district court disagreed based on its reading of Ariad. The court stated that the disclosure of a representative number of species renders a genus recognizable by distinguishing the genus from other materials. The court also found that in Carnegie-Mellon Univ. v. Hoffman-LaRoche, Inc., 541 F.3d 1115 (Fed. Cir. 2008), the 8

9 Federal Circuit considered structure in the context of the representative species requirement. Enablement The parties did not contest that the patents enabled the disclosed antibodies, and thus Abbott s enablement argument again tested whether the district court believed the jury could have reasonably determined that the disclosed species were not representative of the entire genus. At trial, Janssen presented uncontested evidence that the patents described the use of a particular phage-display library, which was only able to create antibodies with VH1, VH3, and VH4 heavy chains. STELARA, with a VH5 heavy chain, could not be created from that library. Finding that the jury reasonably concluded that the entire genus included the STELARA antibody, the district court affirmed the jury s finding that part of the genus, and thus the full scope of the claims, was not enabled. Indeed, as noted above, STELARA was found to infringe as a matter of law, and thus was a member of the genus. Because the jury accepted that STELARA was not enabled, it seems to follow that the full scope of the claims was enabled. Obviousness Finally, the district court affirmed the jury s obviousness finding. The district court found that there was clear and convincing evidence of a need to create a human, neutralizing, high-affinity antibody to IL-12; that there was a small number of identifiable solutions to create antibodies to human antigens (e.g., phage display and transgenic mice); and that there was market pressure to create human antibodies, as opposed to humanized, chimeric, or mouse antibodies, as fully human antibodies were more likely to be successfully marketed. Finally, the district court found that Janssen presented sufficient evidence that there was a reasonable expectation of success of making the IL-12 antibody using transgenic mice, and because the obviousness of any single method renders the claim obvious the court found that it did not need to evaluate the expectation of success using phage display. Thus, the court concluded that the claimed invention was obvious to try. Commentary In our earlier summary following the trial, we noted that Abbott would face an uphill battle on appeal given that the jury found against it on three separate defenses. In evaluating Abbott s post-judgment motion for judgment as a matter of law, the district court similarly stated that Abbott faces an uphill battle, quoting Monteagudo v. Asociacion de Empleados del Estado Libre Asociado de P.R., 554 F.3d 164, 170 (1 st Cir. 2009). Of course, this is in large part due to the substantial deference given to a jury s verdict and the related standards of review. The verdict will continue to receive substantial deference on appeal. We also noted that Abbott had prevailed over Janssen (Centocor) before the BPAI in an interference involving Abbott s 128 patent and a Janssen application. Janssen 9

10 challenged the result in an action under 35 U.S.C. 146 and it still appears that the parties stipulated to the use of the same evidentiary record and that the district court has yet to decide the matter. At least for now, the case remains a representative species of the genus of high profile biotech cases, such as University of Rochester v. Searle, Ariad v. Eli Lilly, and of course Centocor v. Abbott, in which the claims were found invalid based on 112 grounds. These outcomes show the difficult balance patent lawyers must strike between doing their best to ensure that their client is the first to file an application and waiting to ensure there is an adequate disclosure. If the application is filed too late, the client may not get a patent at all. If the application is filed too soon, the client may get a patent but it may only provide an opportunity to spend millions in litigation just to have the patent declared invalid. The next time you hear someone complain that lawyers are overpaid, point to this as an example of the difficult judgments they have to make and the risks to which they are exposed! 10

11 III. Verinata Health, Inc. and The Board of Trustees of the Leland Stanford Junior University v. Sequenom, Inc, and Sequenom Center for Molecular Medicine, LLC (Case No. 4:12-cv SI, N.D.Cal) Reported by: William R. Schmidt Summary Verinata Health and Stanford University filed suit on February 22, 2012 in the Northern District of California seeking a declaratory judgment that Verinata s prenatal diagnostic test using cell-free DNA sequencing technologies do not infringe Sequenom s 6,258,540 patent ( 540 patent). Verinata Health and Stanford University further alleged that the 540 patent is invalid, and that Sequenom s prenatal diagnostic test using cellfree DNA sequencing technologies infringes Stanford s 8,008,018 ( 018 patent), 7,888,017 ( 017 patent), and 8,195,415 ( 415 patent) patents. Sequenom counterclaimed alleging that Verinata s prenatal diagnostic test using cell-free DNA sequencing technologies infringes Sequenom s 540 patent, that Sequenom s prenatal diagnostic test using cell-free DNA sequencing technologies does not infringe Stanford s 018, 017, and 415 patents, and that the 018, 017, and 415 patents are invalid. This case is currently pending. Background Both the genetic tests offered by Verinata and Sequenom are based on the discovery that maternal blood of a pregnant woman contains a significant fraction of cellfree fetal DNA. This DNA can be isolated and analyzed to screen for fetal abnormalities without performance of invasive sampling techniques carrying a risk of miscarriage. Verinata is the exclusive licensee of Stanford University s 018, 017, and 415 patents. Verinata markets verifi TM, a non-invasive prenatal test that detects fetal chromosomal abnormalities (extra, missing or malformed chromosomes) from a pregnant mother s blood using DNA sequencing technologies. Such test can be used to detect birth defects such as Down s syndrome. Verinata was acquired in February 2013 by Illumina, Inc. Sequenom is the exclusive licensee of the 540 patent from Isis Innovation Ltd. Sequenom markets MaterniT21 tm, also a non-invasive prenatal test that detects fetal chromosomal abnormalities from a pregnant mother s blood using DNA sequencing technologies. Verinata alleges in its complaint that Sequenom s lawyers sent them a letter in 2010 indicating that genetic testing using cell-free nucleic acids from a pregnant mother s blood sample to screen for genetic disorders infringes the 540 patent. Verinata also alleges that Sequenom has made numerous public statements, some of which were directed at Verinata, indicating that performing genetic screening of fetal DNA using cell-free nucleic acids from a mother s blood sample infringe the 540 patent. 11

12 In a separate case, Sequenom is also suing Ariosa Diagnostics for infringement of the 540 patent for marketing a non-invasive prenatal test that detects fetal chromosomal abnormalities from a pregnant mother s blood using DNA sequencing technologies. Discussion This case has not yet been argued. However, during litigation the validity of both Verinata s and Sequenom s patents may be challenged under the Supreme Court s recent decision in Prometheus Laboratories v. Mayo Labs, 566 U.S. (2012). In brief, the Prometheus decision found that method claims directed towards natural laws that merely provide directions to apply the natural law are not patent eligible subject matter under 35 USC 101. In fact, this issue is currently being litigated with regard to claim 1 of the 540 patent in Sequenom v. Ariosa Diagnostics Inc. (Case No. 12-cv-0189, S.D. Cal.). Claim 1 of the 540 patent recites: 1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample. In the Ariosa case, Sequenom was denied a preliminary injunction in the District court to stop Ariosa from marketing its cell-free prenatal gene diagnostic test. In her decision denying the injunction, Judge Ilston indicated that it preliminarily seemed that the discovery of cell-free fetal DNA in a pregnant mother s blood was the discovery of a law of nature and that the steps recited in claim 1 were merely routine and known in the art. Thus, the Judge questioned whether claim 1 was patent eligible under 35 USC 101. At least some of the claims in the patents licensed to Verinata are not as broad as claim 1 of the 540 patent. For instance, claim 1 of the 018 patent recites obtaining a mixture of fetal and maternal DNA genomic DNA from a maternal tissue sample and conducting massively parallel DNA sequencing of DNA fragments from the mixture. Thus, a court decision in Verinata v. Sequenom indicating which of the claims of the four patents involved comply with current 35 US 101 natural law jurisprudence, may provide at least some clarity on the patent eligibility of diagnostic method claims. Stay tuned. 12