After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories. For 2016, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants. Today, we count down stories #20 to #16, and then in the coming week, we will work our way towards the top stories of 2016. As with our other lists (2015, 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 2016" on January 18, 2017 from 10:00 am to 11:15 am (CT). Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.
20. Mailing of Corrected Restriction Requirement Did Not Reset PTA Clock
In February, the Federal Circuit affirmed the finding by the District Court for the Eastern District of Virginia that the U.S. Patent and Trademark Office properly calculated the Patent Term Adjustment of Pfizer's U.S. Patent No. 8,153,768. In calculating the PTA, the USPTO denied Pfizer 197 days between the time the Examiner issued a first restriction requirement and then, after the applicant noted that the Examiner had omitted claims 75, 76, and 103-106, issued a corrected restriction requirement. Noting that the applicant "could have taken direction for the[] classification [of the six omitted claims] from the fact that their respective independent claims were each included in the initial restriction requirement," the panel majority sided with the District Court and USPTO. Writing in dissent, Judge Newman countered that "[t]he panel majority erroneously holds that term adjustment is not available because the applicant, not the PTO, spotted the PTO's error," stating that "[w]hether the examiner's actions 'were outside the normal 'give-and-take process' of patent prosecution,' should not turn on who recognized the error."
For information regarding this and other related topics, please see:
• "Pfizer, Inc. v. Lee (Fed. Cir. 2016)," February 15, 2016
19. USPTO Continues Efforts to Enhance Patent Quality
In 2015, the U.S. Patent and Trademark Office announced the launch of a comprehensive and enhanced patent quality initiative, indicating that its efforts would be aimed at improving patent operations and procedures, enhancing the customer experience, and improving existing quality metrics. In 2016, the Office continued its efforts to improve patent quality through the Office's Enhanced Patent Quality Initiative. In response to an invitation to stakeholders to submit patent quality-related topics that could be used as case studies, the Office selected six topics for the case study pilot program in May. In April, the Office announced that it was in the process of designing new patent quality metrics for use in FY2017 and requested comments from stakeholders regarding the new metrics. The Office also held a Patent Quality Community Symposium at its headquarters in Alexandria, VA in April, and offered several webinars in its patent quality chat webinar series. In November, the Office issued a request for public feedback regarding its reevaluation of examination time goals, and announced that it would be holding five roundtables on examination time goals (the last of which will be held on January 11 in San Jose, CA).
For information regarding this and other related topics, please see:
• "USPTO Seeks Comments and Will Hold Roundtables on Examination Time," November 3, 2016
• "USPTO Selects Topics for Quality Case Study Pilot Program," May 31, 2016
• "USPTO Holds Patent Quality Symposium," May 4, 2016
• "USPTO Seeks Comments on New Patent Quality Metrics," May 1, 2016
• "IPO Responds to USPTO Call for Case Study Topics," March 15, 2016
18. CRISPR Patent Battle Begins
CRISPR (an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats), which is part of a system for altering chromosomal sequences in situ in a cell in combination with a bacterially derived protein called Cas9, was hailed as a "Breakthrough of the Year" for 2015. CRISPR provides a mechanism for inserting or deleting specific DNA sequences using CRISPR-associate targeting RNAs and the Cas9 RNA-guided DNA endonuclease enzyme. Given the commercial potential of this method, patenting is an obvious concern and, as it turned out, more than one group of inventors has filed patent applications on the reagents, methods, and cells produced or used to produce CRISPR modifications. Because these applications were filed prior to March 16, 2013, the dispute regarding who was the first to invent will be resolved in an interference. On January 11, 2016, the USPTO declared Interference No. 106,048, naming Feng Zhang and his colleagues, the named inventor of the Broad Institute/MIT's patents, as the Junior Party, and Jennifer Doudna and her colleagues at UC/Berkeley as Senior Party. Oral argument in the interference was held last month, so the dispute could reach a resolution in 2017 and make a return trip to our list of top stories next year.
For information regarding this and other related topics, please see:
• "The Patient Side of the CRISPR Patent Battle," December 19, 2016
• "CRISPR Interference Motions Set," March 23, 2016
• "CRISPR Interference Declared," January 28, 2016
17. AbbVie Engages Amgen in BPCIA Dispute over HUMIRA®
Earlier this year, we noted that Amgen has been the reference product sponsor for many biosimilar applications, and as a result has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price Competition and Innovation Act ("BPCIA"). It was therefore noteworthy that Amgen once again became involved in a BPCIA litigation -- but this time as the aBLA filer. In August, AbbVie sued Amgen pursuant to the BPCIA and 35 U.S.C. § 271(e)(2)(C) because Amgen submitted an application to the FDA to market a biosimilar version of adalimumab, AbbVie's anti-TNFα therapeutic antibody, HUMIRA®. Prior to the filing of AbbVie's complaint, it was not known whether the parties had been engaging in the BPCIA's "patent dance," because the process consists of various disclosures and exchanges, none of which are meant to be publicly available. In September, the FDA approved Amgen's application to market Amjevita (adalimumab-atto) -- which marked the fourth biosimilar approved by the FDA pursuant to the BPCIA. Notwithstanding the approval, Amgen indicated in its counterclaims and answer to AbbVie's complaint that it would not begin commercial marketing of its biosimilar before at least one of the patents identified by AbbVie had expired on December 31, 2016.
For information regarding this and other related topics, please see:
• "FDA Approves Amjevita -- Amgen's HUMIRA® Biosimilar," September 25, 2016
• "AbbVie v. Amgen: The Litigation Phase for a HUMIRA® Biosimilar Begins," August 9, 2016
16. Defend Trade Secrets Act Signed into Law
In May, President Obama signed the Defend Trade Secrets Act of 2016 ("DTSA") into law, creating a new Federal cause of action for misappropriation of trade secrets. The new law is a significant expansion of Federal intellectual property law, and brings with it significant benefits -- but also new responsibilities -- for intellectual property owners and employers. And in this era of narrowed subject matter eligibility for patenting, the DTSA may provide enough of an incentive for intellectual property owners to keep more information as trade secrets. Prior to the enactment of the DTSA, trade secret owners could protect their rights under state law or a patchwork of Federal laws that provided criminal and civil sanctions for interstate trade secret misappropriation or misuse of computerized data, such as the Economic Espionage Act ("EEA") and the Computer Fraud and Abuse Act ("CFAA"). The DTSA includes three key provisions that intellectual property owners should know about: (1) the Federal civil cause of action for misappropriation of trade secrets; (2) an ex parte seizure provision that can be invoked in extraordinary circumstances; and (3) whistleblower protections that preempt criminal and civil liability under either Federal or state law, and place certain new obligations upon employers.
For information regarding this and other related topics, please see:
• "President Obama Signs Defend Trade Secrets Act," May 11, 2016
• "Defend Trade Secrets Act Passes House, Moves to President for Signature," April 27, 2016
• "House Judiciary Committee Unanimously Reports Defend Trade Secrets Act of 2016," April 20, 2016
