By Donald Zuhn —
After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants. In previous posts, we counted down stories #20 to #16, stories #15 to #11, and stories #10 to #6, and today we count down the top five stories of 2015. As with our other lists (2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2015" on January 21, 2016 from 10:00 am to 11:15 am (CT). Details regarding the webinar, which will focus on a handful of the most important stories, can be found here.
5. Federal Circuit Decides Akamai v. Limelight on Remand
Nearly ten years ago, Akamai Technologies, Inc. sued Limelight Networks, Inc. in the U.S. District Court for the District of Massachusetts, alleging infringement of U.S. Patent No. 6,108,703. The claimed invention of the '703 patent is directed to delivering electronic data using a content delivery network (CDN), the CDN purporting to facilitate faster delivery of the data by separating the content of a website onto multiple servers. The content that requires greater network capacity (such as photos and videos) can be assigned to servers (be "tagged") that provide this content at faster speeds. Limelight operates a CDN, with Limelight carrying out three of the four claimed steps (i.e., distributing, resolving, and returning) and contractually requiring its customers to carry out the fourth claim step (i.e., tagging). At trial, the District Court granted Limelight's motion for judgment of non-infringement as a matter of law (in view of the Federal Circuit's decision in Muniauction, Inc. v. Thomson Corp., where the Court held that direct infringement of a claimed method requires that a single entity perform every step of the claim (the single entity rule), which requirement could be satisfied if the steps of the claimed method are performed by multiple parties provided that a single defendant exercises "control or direction" over the entire process). On appeal, a Federal Circuit panel affirmed, but the en banc Court reversed and remanded for further proceedings. In a June 2014 appeal, the Supreme Court reversed the Federal Circuit finding that Limelight had infringed the '703 patent, holding that a defendant is not liable for inducing infringement under 35 U.S.C. § 271(b) when no one party has directly infringed the patent under § 271(a). In June of 2015, the Federal Circuit, hearing Akamai on remand, decided that "because Limelight . . . did not perform all of the steps of the asserted method claims . . . and because the record contains no basis on which to impose liability on Limelight for the actions of its customers who carried out the other steps, Limelight has not directly infringed the '703 patent under § 271(a)." In dissent, Judge Moore opined that the single entity rule "is a recent judicial creation inconsistent with statute, common law, and common sense." In August, the en banc Court decided that there was substantial evidence to support the jury finding that Limelight directly infringed the '703 patent, and therefore the Court reversed the District Court's grant of Limelight's motion for judgment of non-infringement as a matter of law. The en banc opinion signals a move away from the restrictive Muniauction joint infringement framework to something that resembles a "totality of the circumstances" test. However, the en banc decision is not the end of the line for the parties, since the en banc Court noted that there were remaining issues in both the appeal and cross-appeal. Another trip back to the Supreme Court for Akamai may be in the offing.
For information regarding this and other related topics, please see:
• "Eli Lilly and Company v. Teva Parenteral Medicines, Inc. (S.D. Ind. 2015)," September 1, 2015
• "Federal Circuit Delivers En Banc Opinion in Akamai v. Limelight," August 13, 2015
• "Akamai Technologies, Inc. v. Limelight Networks, Inc. (Fed. Cir. 2015)," June 21, 2015
4. Hi-Tech Fallout from Alice Corp. v. CLS Bank Int'l
As the fallout from the Supreme Court's Alice Corp. v. CLS Bank Int'l case makes its way through the federal courts and the U.S. Patent and Trademark Office, applicants and patentees continue to struggle with the implications of the decision. Alice provided a two-part test for patent-eligibility under 35 U.S.C. § 101, requiring that one first determine whether the claim at issue is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to something more than the judicial exclusion. Notably, generic computer implementation of an otherwise abstract process does not qualify as "something more." Notoriously unclear and difficult to apply in practice, when employed by courts, the Alice test has resulted in the vast majority of claims under review being found patent-ineligible under § 101. Similar statistics are the case for the Patent Trial and Appeal Board (PTAB). As a result, any court or PTAB decisions finding that claims meet the requirements of Alice are useful clues for applicants and patentees. For instance, drawing analogies between one's claims that those that a judicial body has found patent-eligible can be persuasive to patent examiners in the USPTO, as well as to other judicial bodies. In addition, since late last year, a theme of many 35 U.S.C. § 101 disputes has been whether claims under review are more like those in Ultramercial Inc. v. Hulu LLC or DDR Holdings, LLC v. Hotels.com. In Ultramercial, the Federal Circuit held that claiming a disembodied method that merely uses general-purpose technology (i.e., the Internet) fails to meet the requirements of § 101, while in DDR Holdings, the Court stated that claims that are necessarily rooted in computer technology (e.g., one that changes the technology itself rather than just using it) are patent-eligible. Patentees attempt to draw analogies between their claims and those of DDR, while defendants attempt the same with those of Ultramercial.
For information regarding this and other related topics, please see:
• "01 Communique Laboratory, Inc. vs. Citrix Systems, Inc. (N.D. Ohio 2015)," December 30, 2015
• "Vehicle Intelligence and Safety LLC v. Mercedes-Benz USA, LLC (Fed. Cir. 2015)," December 29, 2015
• "'Software' Claims Reciting No Structural Components and Having Questionable Novelty Struck Down under 35 U.S.C. § 101," November 23, 2015
• "MacroPoint, LLC v. FourKites, Inc. (N.D. Ohio 2015)," November 10, 2015
• "PTAB Issues Questionable 101 Decision," October 26, 2015
• "PTAB Finds Two Sets of Claims to Be Not Abstract," September 24, 2015
• "Versata Development Group, Inc. v. SAP America, Inc. (Fed. Cir. 2015)," July 15, 2015
• "Internet Patents Corp. v. Active Network, Inc. (Fed Cir. 2015)," June 23, 2015
• "OIP Technologies, Inc. v. Amazon.com, Inc. (Fed. Cir. 2015)," June 12, 2015
• "Ultramercial v. WildTangent — Petition for Writ of Certiorari," June 3, 2015
• "Allvoice Developments US, LLC v. Microsoft Corp. (Fed. Cir. 2015)," May 15, 2015
• "Ultramercial Requests En Banc Review," January 19, 2015
3. Federal Circuit Decides Amgen v. Sandoz
In July, the Federal Circuit, in a seriously fractured decision, construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) in Amgen v. Sandoz. In doing so, the Court limited the information available to biologic drug makers regarding a competitor's application for a biosimilar product (adopting Sandoz's argument). On the other hand, the decision extended the statutory exclusivity period enjoyed by innovator biologic drug makers relating to when the biosimilar applicant can enter the marketplace (as Amgen argued). In October, the Federal Circuit denied petitions for rehearing and rehearing en banc filed by both parties. Amgen had petitioned for rehearing on the panel's decision that the District Court correctly determined that the provisions of the BPCIA requiring disclosure to the reference product sponsor of a biosimilar applicant's application and relevant manufacturing information was optional rather than mandatory. Sandoz petitioned for rehearing on the panel's decision that the District Court had erred in deciding that the 180-day notice of commercial marketing for the biosimilar product could not be given to the reference product sponsor prior to FDA approval of their biosimilar application.
For information regarding this and other related topics, please see:
• "Federal Circuit Denies En Banc Petition in Amgen v. Sandoz," October 16, 2015
• "Amgen v. Sandoz Update — En Banc Rehearing Petitions Filed," September 10, 2015
• " Federal Circuit Lifts Injunction Against Sandoz," September 2, 2015
• ""Don't Stop the Dance"[*] — The Dissents-in-Part from Amgen v. Sandoz," July 23, 2015
• "Amgen v. Sandoz (Fed. Cir. 2015)," July 22, 2015
• "Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)," July 21, 2015
• "Amgen v. Sandoz — Federal Circuit Oral Argument," June 7, 2015
• "Amgen Wins Injunction against Neupogen® Biosimilar Pending Appeal," May 6, 2015
• "Amgen v. Sandoz Update — Amgen's Continuing Efforts to Obtain Preliminary Injunction," April 28, 2015
• "Amgen v. Sandoz Update — BIO Files an Amicus Brief at the Federal Circuit," April 21, 2015
• "Amgen Receives No Help from the FDA — A Biosimilar Update," April 15, 2015
• "The Tyranny of the Judiciary," March 23, 2015
• "Gotta Dance? Apparently Not — A Biosimilar Update," March 19, 2015
2. USPTO Expands on Subject Matter Eligibility Guidance
In December 2014, the U.S. Patent and Trademark Office published Interim Guidance regarding the examination of claims for subject matter eligibility under 35 U.S.C. § 101. Early last year, the USPTO provided a promised set of examples of patent-eligible and patent-ineligible claims relating to the abstract idea exception to 35 U.S.C. § 101, in light of Alice Corp. v. CLS Bank. Some of the new examples are hypothetical claims designed to illustrate the contours of § 101. The USPTO also kicked off 2015 by holding a forum on the Office's Alexandria campus, where Office representatives discussed the Interim Guidance and received additional input from the public regarding that guidance. In July, the Office updated its subject matter eligibility guidance, with the update providing recommendations and resources for examiners in addition to those in the Interim Guidance. In the update, the Office also addressed several broad themes from comments it received on the Interim Guidance. The update did not, however, provide any materials related to interpreting the metes and bounds of § 101 with regard to natural products or diagnostic methods.
For information regarding this and other related topics, please see:
• "Comments on the USPTO's Subject Matter Eligibility Guidance — BSA," November 5, 2015
• "Comments on the USPTO's Subject Matter Eligibility Guidance — The ABA," November 3, 2015
• "July 2015 Update on Subject Matter Eligibility," August 25, 2015
• "Biotech-specific Subject Matter Eligibility Materials Delayed," July 30, 2015
• "New Update on Subject Matter Eligibility to be Published on July 30th," July 29, 2015
• "Interim Guidance Status Check," June 15, 2015
• "A Modest Proposal (or Two)," April 22, 2015
• "Microorganisms, Funk Brothers, Chakrabarty and TRIPS," April 7, 2015
• "USPTO Holds Forum on Interim Guidance — Part III," February 19, 2015
• "USPTO Holds Forum on Interim Guidance — Part II," February 18, 2015
• "USPTO Holds Forum on Interim Guidance — Part I," February 3, 2015
• "USPTO Issues Post-Alice Abstract Idea Examples," January 28, 2015
1. Federal Circuit Decides Ariosa v. Sequenom and Denies Rehearing En Banc
In June, the Federal Circuit decided Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the District Court's decision granting Ariosa's summary judgment motion for invalidity on the grounds that the claims of of U.S. Patent No. 6,258,540 were patent ineligible. Although the Federal Circuit appreciated that the inventors had found cell-free fetal DNA (cffDNA) in maternal plasma or serum "that other researchers had previously discarded as medical waste," the panel stated that "[a]pplying a combination of known laboratory techniques to their discovery," the inventors "implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender." In affirming the District Court decision, the opinion concluded that "[t]he method . . . begins and ends with a natural phenomenon," and "[t]hus, the claims are directed to matter that is naturally occurring." Judge Linn noted in his concurring opinion, which in a rational world would have been a dissent, that he joined the majority "only because [he is] bound by the sweeping language of the test set out in Mayo Collaborative Services v. Prometheus Laboratories, Inc." Sequenom responded to the decision by filing a petition for rehearing en banc in August, arguing that the panel's decision was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013, and that the panel's decision poses a threat to patent protection in multiple fields of invention. However, despite the filing of twelve amicus curiae briefs in support of Sequenom's petition, the Federal Circuit declined to rehear en banc the panel decision in December. The patent community now awaits the deadline for petitioning for certiorari.
For information regarding this and other related topics, please see:
• "Ariosa v Sequenom — A Path to the Supreme Court?" December 14, 2015
• "Federal Circuit Denies Rehearing En Banc in Ariosa v. Sequenom," December 2, 2015
• "Natera Responds to Sequenom's Petition for Rehearing En Banc," October 25, 2015
• "Ariosa Diagnostics Responds to Sequenom's Petition for Rehearing En Banc," October 21, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: JYANT Technologies, Inc.," September 29, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: NYIPLA," September 28, 2015
• "On Ariosa and Natural Products," September 27, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Novartis AG," September 23, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Paul Gilbert Cole," September 22, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Bioindustry Association," September 20, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: WARF, Marshfield Clinic, and MCIS, Inc.," September 17, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA," September 16, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.," September 15, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics V Sequenom and Isis Innovation — A European View," July 2, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)," June 22, 2015
The fourth annual Naples Patent Experts Conference will be held on February 8-9, 2016 at the Naples Beach Hotel & Golf Club in Naples, FL. The conference, which is presented by the University of Akron School of Law, will feature presentations on current significant topics by leading jurists, scholars, and practitioners from the United States and abroad. The conference will offer presentations on the following topics:
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