Last week the United States Court of Appeals for the Federal Circuit issued a decision in the latest appeal in the Apple/Samsung epic patent battle. See Apple, Inc. v. Samsung Electronics Co. (Fed. Cir., August 23, 2013). In this situation the parties really were not fighting against each other; instead finding themselves arguing on the same side against the decision of the district court to allow sensitive information to be publicly available.
On August 9, 2012, Judge Lucy Koh of the United States District Court for the Northern District of California issued a decision that denied in part the parties’ motion to seal certain filings. In general, Judge Koh sealed information about the parties’ production and supply capacities, confidential source code, third-party market research reports, and the pricing terms of licensing agreements. However, Judge Koh ordered unsealed documents disclosing the parties’ product-specific profits, profit margins, unit sales, revenues, and costs, as well as Apple’s own proprietary market research reports and customer surveys and the non-price terms of licensing agreements.
In her ruling Judge Koh ordered the parties to take an immediate appeal to the Federal Circuit, which occurred on August 13, 2012. The Federal Circuit consolidated the appeal by Apple and the appeal by Samsung, designating Apple as the appellant and Samsung as the cross-appellant. On August 15, 2012, the district court granted a stay pending the final resolution, thus the August 9, 2012 order that sensitive financial information would be made publicly available has been stayed pending disposition of the appeal.
In the immortal words of baseball great Yogi Berra, “It’s déjà vu all over again”. A little more than a year after they previously heard AMP v. USPTO, the CAFC panel of Judges Lourie, Bryson and Moore have once again taken up the question of whether isolated DNA and related methods are patent eligible subject matter under 35 U.S.C. §101.
To recap, last year, the same panel ruled that the composition claims reciting isolated DNA were patent eligible, with Judges Lourie and Moore supporting patent eligibility and Judge Bryson dissenting. All three Judges also agreed method claims involving “analyzing” or “comparing” DNA were not patent eligible. Lastly, all three Judges agreed that a screening claim (claim 20 of the ‘282 patent) was patent eligible. For a full discussion of last year’s decision (in English and Japanese), please click here. After the decision, AMP appealed to the Supreme Court, who later vacated the CAFC decision and remanded the case to the CAFC for further consideration in view of their Mayo decision (English summary;Japanese summary).
The July 29, 2011 Federal Circuit decision in Assoc. for Molecular Pathology et al. v. U.S.P.T.O. and Myriad Genetics has been eagerly awaited by the biotechnology community and by persons concerned with the ethical implications of DNA technology. Although a significant part of the decision involved standing to sue, I will only discuss the scientific portions of the decision that deals with the very real ethical question of whether human genes and/or gene sequences should be patented.
The decision in Myriad was written by Judge Alan Lourie with concurrences-in-part by Judges Moore and Bryson. Judge Bryson also filed a dissent-in-part. Judge Lourie, who has a Ph.D. in chemistry, is well suited to understand all the issues associated with genetic sequence cases and has written some key biotechnology decisions, such as the Regents of the University of California v. Eli Lilly, 119 F.3d 1559 (Fed. Cir. 1997) (Cloned human insulin product did not infringe patented rat insulin.) and In re Deuel , 51 F.3d 1552 (Fed. Cir. 1995) (Settled an issue of obviousness between genetic sequences). Judge Bryson was also part of the Lily decision.
In CyberSource Corporations v. Retail Decisions, Inc., Judge Dyk (joined by Judges Bryson and Prost) ruled that a method and system for detecting credit card fraud in Internet transactions was patent-ineligible under 35 U.S.C. §101. But in Ultramercial, LLC v. Hulu, LLC, Chief Judge Rader (joined by Judges Lourie and O’Malley) just ruled that a claimed method for monetizing and distributing copyrighted products over the Internet was patent-eligible. In fact, our good Chief Judge has “thrown down the gauntlet” at his Federal Circuit colleagues by stating “breadth and lack of specificity does not render the claimed subject matter impermissibly abstract.” Wow! That “judicial donnybrook” I mentioned in my recent article on the remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC (see CAFC on Patent-Eligibility: A Firestorm of Opinions in Classen ) on what the standard is (or should be) for patent-eligibility under 35 U.S.C. §101 has now broken out.
In Ultramercial, the patentee (Ultramercial) asserted that U.S. Pat. No. 7,346,545 (the ‘545 patent) was infringed by Hulu, LLC (“Hulu”), YouTube, LLC (“YouTube”), and WildTangent, Inc. (“WildTangent”). The ‘545 patent,relates to a method for distributing copyrighted products (e.g., songs, movies, books, etc.) over the Internet for free in exchange for viewing an advertisement with the advertiser paying for the copyrighted content. What is interesting in this case is that Claim 1 of the ‘545 patent that is allegedly infringed by Hulu, YouTube, and WildTangent recites a method having not one, not two, but eleven total steps. (Side note: One might wonder how anyone can infringe an eleven step method.) WildTangent’s motion to dismiss for failure to state a claim was granted by the district court based on the claimed method being patent-ineligible under 35 U.S.C. § 101. (Hulu and YouTube were dismissed from the case apparently for other reasons.)
Structure of a DNA double helix,
Fig. 1 from the CAFC majority opinion.
After much anticipation, the United States Court of Appeals for the Federal Circuit earlier today issued a decision in Association for Molecular Pathology v. Myriad Genetics. The decision on first glance will seem to be a split decision, particularly by Federal Circuit standards. The majority opinion was written by Judge Lourie, Judge Moore wrote a concurring opinion and Judge Bryson concurred in part and dissented in part. Having said that, the outcome largely seems to be what was predicted by the patent community. On the major substantive issue — are isolated DNA molecules patent eligible subject matter — the Federal Circuit reversed the decision of the district court and ruled that isolated DNA molecules do constituted patent eligible subject matter. The Federal Circuit also ruled that methods relating to the screening for potential cancer therapeutics are, likewise, patent eligible subject matter. All three Judges also found the “comparing” and “analyzing” claims to be ineligible for patent protection because they were not transformative, and thus were merely abstract mental steps.
Earlier today the United States Supreme Court granted certiorari in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which sets up another foray into the patent eligible subject matter waters for the Supreme Court in the October 2011 term. This appeal by Mayo will challenge the December 17, 2010 decision of the United States Court of Appeals for the Federal Circuit, one of the first patentable subject matter cases for the Federal Circuit in the wake of the Supreme Court’s decision in Bilski v. Kappos. In fact, this case was returned from the Supreme Court to the Federal Circuit for further consideration in light of the Supreme Court ruling in Bilski v. Kappos.
On April 4, 2011, the United States Court of Appeals for the Federal Circuit heard oral arguments in the case dubbed Association for Molecular Pathology v. United States Patent and Trademark Office. This case has been commonly referred to here and elsewhere as either the ACLU case or the Myriad Genetics case. Myriad Genetics is the patent holder on various innovations relating to isolated DNA comprising an altered BRCA1 DNA and various methods of screening for cancer built upon various observations of the altered BRCA1 DNA. The patents challenged are U.S. Patent Nos. 5,747,282, 5,837,492, 6,593,473, 5,709,999, 5,710,001, 5,753,441 and 6,033,857.
Essentially, the American Civil Liberties Union (ACLU), along with researchers, competitors of Myriad Genetics and consumers filed a lawsuit challenging the constitutionality of gene patents and argued that gene patents should not be granted because patenting a gene is the same as patenting something that exists in nature. While this argument did succeed at the District Court, it won’t succeed at the Federal Circuit. The District Court Judge fundamentally based his ruling on the fact that, as he understood it, Supreme Court precedent “establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter.” First, this is truly an oversimplification of the purification issue and, second, it demonstrates an acute lack of understanding of the science involved.
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