Update on US Caselaw, including Myriad and Hamilton Beach

1. Update on US Caselaw, includingMyriad and Hamilton Beach Joerg-Uwe Szipl Griffin and Szipl, P.C. _____ AIPLA IP Practice in Japan Committee Meeting with the Japan Patent Attorney’s Association Tokyo, Japan, April 8, 2014

2. Association For Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013) • Federal Circuit (689 F.3d 1303 (Fed. Cir. 2012) ruled on three types of claims: • Isolated DNA coding for BRCA polypeptide (gene claims) (valid). • Isolated DNA having a specific sequence (cDNA claims)(valid). • Isolated DNA having at least 15 nucleotides of (cDNA) sequence (probe claims) (valid). • Method of screening tumor samples requiring comparing BRCA gene from tumor sample with BRCA gene from non-tumor sample (invalid). • Method of screening potential cancer therapeutics using transformed eukaryotic host cells (valid).

3. Myriad Genetics, Inc. • Supreme Court granted review on the issue of whether the isolated DNA claims were patentable subject matter under 35 U.S.C. §101. • Court held: “Genes and the information they encode are not patent eligible under §101 simple because they have been isolated from the surrounding genetic material” • cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In this situation, a short strand of cDNA may be indistinguishable from natural DNA. • What was not decided: • Patent eligibility of method claims • Patent eligibility of probes and primers 3

4. In re BRCA1-and BRCA2-based Hereditary Cancer Test Patent Litigation, 2014 WL 931057 (D. Utah 2014) • Decision of the District Court denying plaintiff’s motion for preliminary injunction • Myriad, after the Supreme Court decision sued defendants including Ambry Genetics and sought preliminary injunction to stop them from selling tests to screen BRCA1 and BRCA2 genes • Plaintiff seeking preliminary injunction must show • Likelihood of success on the merits • Likelihood of irreparable harm • Balance of equities in movant’s favor • Injunction is in the public interest 4

5. In re BRCA1 • Plaintiffs are likely to suffer irreparable harm • Price erosion and market share. • Loss of remainder of patent term. • Defendants unlikely to pay significant damages. • Harm to Defendants (going out of business) outweighs harm outweighs harm Plaintiffs are likely to suffer without an injunction. • Public interest does not clearly favor an injunction. • Plaintiffs are not likely to succeed on the merits • Defendants have raised substantial questions concerning whether Plaintiffs’ patents claim patent eligible subject matter 5

6. In re BRCA1 • Patent’s primer claims are drawn to ineligible subject matter • Isolated DNA is patent ineligible insofar as the location and order of the nucleotides existed in nature. • That is true whether that DNA is cleaved, genomic DNA, or synthetic primers and probes with the same encoded information. • Probes and primers, although synthetically designed, are not markedly different from naturally occurring DNA. 6

7. In re BRCA1 • Plaintiffs method claims are drawn to patent ineligible subject matter • Ruling consistent with with the holding of the Federal Circuit that was not considered by the Supreme Court. • Plaintiff argued that claims apply the BRCA1 and BRCA2 genes to apply physical steps that were not well-understood, routine or conventional at the time the time the patents were filed. • Court held that the steps were conventional • Court held that the claims preempt all practical application of the discovery of the BRCA1 and BRCA2 genes, because they employ PCR, the most widely used method of gene amplification, to the scientific principle that the certain gene mutations make cancer more likely 7

8. Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296 (Fed. Cir. 2013) Court reviewed District Court denial of a preliminary injunction. Patent related to test for certain genetic mutations (e.g., Downs Syndrome) by isolating fetal DNA (cffDNA) from maternal blood serum. Claims included steps of amplifying “paternally inherited nucleic acid” and detecting the presence of such DNA. Court remanded issue of infringement in view of improper claim interpretation. Price erosion as irreparable harm was discounted by District Court. The fact that Defendant would be put out of business from injunction does not control. 8

9. Aria Diagnostics, Inc. v. Sequenom, Inc., 2013 WL 5863022 (N.D. Cal. 2013) • District Court considered cross motions for summary judgment. • Court grants summary judgment of invalidity of the claims. • The claims apply only conventional techniques to the discovery of paternally inherited cffDNA. • Even though there may be alternative ways of detecting cffDNA, these alternatives are not practical or commercially viable. • Claims covering the only commercially viable way of detecting the cffDNA carry a substantial risk of preempting all practical uses of cffDNA. 9

10. Genetic Technologies Ltd. V. Agilent Technologies, Inc., 2014 WL 941354 (N.D.Cal. 2014) Defendant seeks to dismiss complaint under Rule 12(b)(6) for failing to state a claim upon which relief could be granted. Lack of claim was based on the assertion that the claims were not directed to patent eligible subject matter. Patentee made discovery that non coding regions of DNA were correlated to mutations in the coding regions of DNA, admittedly a non patentable scientific principle. Parties dispute whether the remaining steps, i.e., using a primer pair to amplify a non-coding intron sequence amount to well-understood, routine, or conventional techniques at the time the patent was filed. 10

11. Genetic Technologies Ltd. • Federal Circuit test of whether a claim is meaningfully limited: • Preempts all applications of the natural law. • Contains only insignificant post solution activity. • Provides no real direction. • Requires a particular machine or implements a transformation of matter. • Defendant has not shown by clear and convincing evidence that the claims are directed to non-patentable subject matter. 11

12. Hamilton Beach Brands, Inc. v. Sunbeam Products, Inc., No. 2012-1581 (Fed. Cir. August 14, 2013) Invention related to a portable slow cooker pot with clips to seal the pot for transport. Issue was whether the patent was invalid for being on sale under 35 U.S.C. §102(b), more than one year before the patent was filed in the US. Defendant moved for summary judgment. Court found that Hamilton Beach’s foreign supplier offered the patented invention to HB more than one year before patent was filed. 12

13. Hamilton Beach • On sale requires • An offer, which, if accepted would create a binding contract, and • Invention was ready for patenting. • There is no “supplier exception” to the on sale bar • Purchase order (PO) was an offer that could have been legally binding. • Documents shown to potential customers at the time indicated that the invention was ready for patenting • It was irrelevant that certain problems with the claimed pot where not solved until a month after the PO. • Significantly, the patentee did not argue experimental use. 13

14. Hamilton Beach • Lessons learned from Hamilton Beach • There is no supplier exception to on sale bar. • Experimental production must be well documented • Cite Confidentiality Agreements. • Make sure no legally binding offer for commercial purposes is made before all experiments are completed. • Make sure patent applications are filed before first commercial order from suppliers. 14

15. Thank you Joerg-Uwe Szipl Griffin and Szipl, P.C. Arlington, VA, USA Szipl@Szipl.com