After reflecting upon the events of the past twelve months, Patent Docs presents its 13th annual list of top patent stories. For 2019, we identified fifteen 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 #15 to #11, and in the coming week, we will work our way towards the top stories of 2019. As with our other lists (2018, 2017, 2016, 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 2019" on January 22, 2020 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.
15. USPTO Declares Interference Between Broad Institute and UC Berkeley over CRISPR Technology
In December 2015, the journal Science picked the CRISPR (clustered regularly interspaced short palindromic repeats) technology as its "Breakthrough of the Year," declaring that the technology had "matured into a molecular marvel." Not surprisingly, CRISPR's status as breakthrough molecular marvel has resulted in a battle over who has the best patent position with respect to this technology. In June, the U.S. Patent and Trademark Office declared an interference between patents (and an application) assigned to the Broad Institute, Inc., the Massachusetts Institute of Technology, and the President and Fellows of Harvard College and applications assigned to the Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier. If the new interference sounds to Patent Docs readers like deja vu all over again, it is and it isn't –– the strategy employed by UC Berkeley has induced the Office to address the issues of priority raised in the earlier interference between the parties. The parties have filed a number of motions and responses to those motions, as evidenced by the links below, and Patent Docs will continue to cover the latest battle over the rights to this revolutionary genome engineering technology.
For information regarding this and other related topics, please see:
• "CRISPR Interference Update," December 26, 2019
• "Broad Files Reply Brief to Berkeley's Opposition to Substantive Motion No. 1," December 17, 2019
• "Berkeley Files Responsive Motion to Broad's Substantive Motion No. 2 in Interference," December 12, 2019
• "Berkeley Files Substantive Motion No. 2 to be Accorded Benefit to Earlier Priority Application in Interference," December 10, 2019
• "CRISPR Housekeeping," November 25, 2019
• "CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 4," November 24, 2019
• "CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 3," November 20, 2019
• "CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 2," November 18, 2019
• "Berkeley Files Opposition to Broad's Substantive Motion No. 1 in Interference," November 10, 2019
• "Board Denies CVC Motion to Seal Priority Statement," November 4, 2019
• "Sigma-Aldrich Tries Again," October 27, 2019
• "University of California/Berkeley et al. Authorized to File Motion Opposed to Broad Substantive Motion No. 1," September 30, 2019
• "Broad Institute Takes Its Turn in Interference Motion Practice," September 24, 2019
• "CRISPR Interference: Motion Practice," September 11, 2019
• "PTAB Redeclares CRISPR Interference and Grants Leave for Some (But Not All) of Parties' Proposed Motions," August 29, 2019
• "University of California/Berkeley Granted Yet Another CRISPR Patent," August 25, 2019
• "CRISPR Interference Parties Propose Motions," August 1, 2019
• "Sigma-Aldrich Wants Its Piece of CRISPR Pie," July 21, 2019
• "New CRISPR Interference: The Details," July 8, 2019
• "CRISPR Battle Joined Again," July 1, 2019
• "Another U.S. Patent Issued for CRISPR," April 28, 2019
• "CRISPR Patent Watch," March 12, 2019
14. Solicitor General: Berkheimer Not Appropriate Vehicle for Addressing Uncertainty Concerning § 101 Standards
Berkheimer v. HP Inc. was decided by the Federal Circuit in February 2018 and stands for -- in the words of Judge Moore -- "the unremarkable proposition that whether a claim element or combination of elements would have been well-understood, routine, and conventional to a skilled artisan in the relevant field at a particular point in time is a question of fact." In September 2018, HP petitioned the Supreme Court for certiorari, and earlier this year, the Court requested that the Solicitor General file a brief expressing the views of the United States in this matter. That brief arrived in December, and the Solicitor General expressed the opinion that the overall lack of clarity regarding the fundamental issues surrounding patent eligibility under 35 U.S.C. § 101 makes addressing the points of Berkheimer premature. The Solicitor General began the brief by declaring that "this Court's recent decisions have fostered uncertainty concerning those substantive Section 101 standards," noting that the uncertainty lies mainly in the "the scope of the exceptions and the proper methodology for determining whether a particular patent implicates them." Berkheimer being largely a procedural case, the Solicitor General suggests that it would not be the appropriate vehicle for addressing the more fundamental substantive questions, opining that HP's question "would be difficult to answer in any cogent manner while uncertainty about the substance of the Section 101 inquiry persists." The Supreme Court is scheduled to discuss HP's petition at Conference on January 10, 2020.
For information regarding this and other related topics, please see:
• "Solicitor General Files Brief in Berkheimer v. HP," December 9, 2019
13. Federal Circuit Revisits Safe Harbor Provisions of 35 U.S.C. § 271(e)(1)
The Federal Circuit has grappled with, divisively in some instances, the extent to which the safe harbor provisions of 35 U.S.C. § 271(e)(1) extend to activities that are not strictly for obtaining regulatory approval, such as post-approval quality testing and "stockpiling" product used for commercial purposes. For example, in 2011, in Classen Immunotherapies, Inc. v. Biogen IDEC, then-Chief Judge Rader joined by Judge Newman held that "routine" post-approval submissions are outside the safe harbor (over a vigorous dissent by Judge Moore), whereas in 2012, in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the roles were reversed, with Judge Moore finding herself in the majority (with Judge Dyk), and then-Chief Judge Rader filing a dissent. In December, the Federal Circuit revisited these issues in Amgen Inc. v. Hospira, Inc., in a decision authored by Judge Moore and joined by Judges Bryson and Chen. The Federal Circuit affirmed the jury's decision that fourteen batches of Hospira's erythropoietin (EPO) were not protected under the § 271(e)(1) safe harbor, and that seven other batches were clearly made for purposes related to obtaining FDA approval and therefore were protected under the safe harbor.
For information regarding this and other related topics, please see:
• "Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2019)," December 18, 2019
12. Supreme Court on Preemption of State Tort Liability by Compliance with Federal Law and Regulations
In May, in Merck Sharp & Dohme Corp. v. Albrecht, the Supreme Court continued its explication of the balance between state law tort liability that can be imposed on drug makers and the extent to which this liability can be pre-empted by the drug maker's compliance with Federal laws and regulations, particularly those related to FDA approval. In an opinion authored by Justice Breyer, the Court held that the pre-emption question is for a judge to decide, and not a jury. The Court also found that pre-emption is limited to those circumstances where "it is 'impossible for a private party to comply with both state and federal requirements.'" The Court also explained that the meaning of "clear evidence" (in the context of the evidence that the FDA would not have approved a manufacturer requested change to the label) to be "evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug's label to include that warning."
For information regarding this and other related topics, please see:
• "Merck Sharp & Dohme Corp. v. Albrecht (2019)," May 27, 2019
11. Federal Circuit: When "No Identifiable Efforts" Could Have Been Undertaken, Applicant Has Not Failed to Engage in Reasonable Efforts to Conclude Prosecution
In January, the Federal Circuit determined in Supernus Pharmaceuticals, Inc. v. Iancu that the U.S. Patent and Trademark Office had erred in calculating the Patent Term Adjustment (PTA) for Supernus' U.S. Patent No. 8,747,897. In particular, the Court found that because there were "no identifiable efforts" that Supernus could have undertaken in the time period between the filing of an RCE during prosecution of the application that issued as the '897 patent and the mailing of an EPO notification of opposition for a European counterpart patent (which resulted in Supernus filing a supplemental Information Disclosure Statement), Supernus had not failed to engage in reasonable efforts to conclude prosecution (pursuant to 35 U.S.C. § 154(b)(2)(C)(i)) during that time period. In October, the USPTO published a notice of proposed rulemaking in which the Office proposed certain revisions to the rules of practice concerning PTA in view of the Federal Circuit's Supernus decision. In particular, the Office proposed revising the period of reduction of PTA for several provisions of 37 C.F.R. § 1.704, in which the period of reduction will correspond to "the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution" as opposed to the consequences to the Office of applicant's failure to engage in reasonable efforts to conclude prosecution.
For information regarding this and other related topics, please see:
• "USPTO Proposes Revisions to PTA Rules in View of Supernus v. Iancu," October 6, 2019
• "Intra-Cellular Therapies, Inc. v. Iancu (Fed. Cir. 2019)," September 26, 2019
• "Mayo Foundation for Medical Education and Research v. Iancu (Fed. Cir. 2019)," September 17, 2019
• "USPTO Issues Notice on Impact of Federal Circuit's Supernus Decision on PTA Procedures," May 29, 2019
• "Supernus Pharmaceuticals, Inc. v. Iancu (Fed. Cir. 2019)," January 27, 2019
