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  • FCBA Program on Innovation and Incentive Systems

    Federal Circuit Bar Association_2The Federal Circuit Bar Association (FCBA) will be offering a remote program entitled "Innovation and Incentive Systems" on May 26, 2020 from 11:00 am to 12:00 pm (EST).  Laura Masurovsky of Henderson, Farabow, Garrett & Dunner, LLP will moderate a panel consisting of  Eb Bright of the Alliance of U.S. Startups & Inventors for Jobs (USU); Bill Harmon, Director, IP and Trademarks, Uber Technologies, Inc.; Philip Hirschhorn of Panitch Schwarze Belisario & Nadel LLP; and Liane Peterson of Foley & Lardner LLP.  The panel will discuss the types of incentives (and disincentives) that exist in the Global IP community and their impact on innovation.  The panelists will also discuss their viewpoints including:

    • Medtech perspective on innovation and incentives with an overview from startup ecosystems to aggregators to investors, focusing on practical experience and experience with what works and what does not.
    • Recent PTO initiatives related to promoting new COVID-19 treatments on the market more quickly, discussion of the COVID-19 Prioritized Examination Trial Program and the Patents 4 Partnerships IP marketplace platform.
    • Tech perspective and global incentive systems from different vantage points, discussion of compulsory reward system in China and comparison to other systems in terms of impact on innovation.
    • Inventor incentives globally, importance of certainty in marketplace for IP, discussion of laws, e.g., antitrust laws, that incentivize or discourage innovation or add to the uncertainty investors and patentees lace.

    The webinar is complimentary for FCBA members and students, $25 for government and students, or $75 for private practitioners.  Those interested in registering for the program, can do so here.

  • Webinar on Licensing and Collaborations

    IAMLexology Webinars, iam, and Potter Clarkson will be offering a free webinar entitled "Licensing and Collaborations: Common Pitfalls and Best Practice" on May 26, 2020 from 11:00 am to 12:00 pm (EDT).  Intellectual property licensing experts Oliver Laing and Mark Snelgrove will explore deal-making best practice and common pitfalls to avoid, focusing on protecting and maximising the value of your intellectual property.

    Those interested in registering for the webinar, can do so here.

  • Webinar on Modern Patent Research

    DerwentDerwent and IPWatchdog will be offering a webinar entitled "Modern Patent Research: Capitalizing on Information Across Your Organization" on May 26, 2020 at 12:00 pm (EDT).  Gene Quinn of IPWatchdog, Vashe Kanesarajah of Clarivate Analytics, Debra Banville of Dupont, and Benoit Sollie of Cargill will discuss lessons about patent research learned from top-performing companies and what should be considered to adapt and evolve traditional models to current informational best practices.

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • CLE on Trade Secret Litigation

    MyLawCLEThe Federal Bar Association and MyLawCLE will be offering a video CLE webinar entitled "Trade Secret Litigation 101: What All Attorneys Should Know as Employees Work from Home and Jobless Claims Continue to Rise" on May 26, 2020 from 3:00 to 4:00 pm (ET).  Michael T. Renaud and Nicholas W. Armington will provide an overview of trade secret litigation, including the scope of what qualifies as a trade secret under the Defend Trade Secrets Act and state trade secret statutes, what qualifies as reasonable measures to maintain the secrecy of trade secret information, and protections available to trade secret owners through the Defend Trade Secrets Act and state trade secret statutes.  The webinar will also discuss economic and social drivers of a likely increase in trade secret litigation in the coming years resulting from the ubiquitous work-from-home arrangements due to social-distancing requirements in the wake of the COVID-19 pandemic and the present economic downturn, and discuss steps businesses can take to protect their trade secrets, including preventative measures against misappropriation including risk factors to be aware of, and responsive steps for businesses to take where misappropriation has already occurred.

    The registration fee for the webinar is $95.  Those interested in registering for the webinar can do so here.

  • Webinar on IAM Benchmarking Survey 2020

    IAMIPBC Talking Heads and iam will be offering a free webinar entitled "Key findings from the IAM Benchmarking Survey 2020" on May 27, 2020 from 11:00 am to 12:00 pm (EDT).  With an exclusive reveal of the IAM Benchmarking Survey of hundreds of senior corporate and private practice IP decision makers, this webinar will explore how market players view the state of play in deal making and corporate IP strategies, as well as the performance of key patent offices and litigation venues.  The webinar will address the following topics:

    • The state of the current global IP market
    • Threats to IP value creation
    • How the leading patent offices are performing

    Those interested in registering for the webinar, can do so here.

  • Genetic Variant Responsible for Short Stature in Human Population

    By Kevin E. Noonan —

    Gregor Mendel's great good fortune (or extraordinary prescience) was that he chose for the traits he used to illustrate the genetic control of inheritance (despite having no inkling of its mechanism) traits in his pea plants that were controlled by discrete genes (yellow v green, wrinkled v smooth, tall v short).

    Image
    Mendelian inheritance exists in most species (ABO blood type in humans, for example), but many traits are multivariate (i.e., being caused by expression of several genes).  While these include susceptibility to many diseases like cancer, the most common multivariate trait is height, which varies widely in different human ethnic and racial groups.

    Recently an international group of genomics researchers* published a paper in Nature entitled "A positively selected FBN1 missense variant reduces height in Peruvian individuals."  The interest in this Peruvian population is that they are recognized as being among the shortest known existing human group that is otherwise ethnically diverse (165.3 cm or 5'5" for men and 152.9 cm or 5' for women).  The FBN1 gene variant reported by these researchers was found to have a specific aspartic acid residue changed to a glycine residue (E1297G, due to a change from a transition mutation of a T to a C) correlated with an average reduction in height of 2.2 cm in heterozygotes and 4.4 cm in homozygotes (corresponding to 0.87 in and 1.75 in, respectively).  The FBN1 gene encodes extracellular matrix protein fibrillin 1, a major structural component of myofibrils.  Individuals homozygous for the variant have less densely packed fibrillin-1-rich microfibrils with irregular edges in skin tissues.

    Population genetic studies revealed that non-African populations showed the variant to be under positive selection (i.e., the variant conferred a selective advantage) in the Peruvian population studied, preferentially associated with coastal rather than mountain environments.  The cohort in this study comprised 3,134 subjects / 1,947 households, that found negative statistical correlation between height and Native American ancestry.

    Genome-wide association studies were performed, and five highly linked single-nucleotide polymorphisms (SNP) were found that overlapped at the chromosomal location of FBN1 (15q21.1).  One of these produces the missense variant (E1297G) in the coding sequence of the FBN1 protein (fibrillin); the other SNPs are located in introns.  The variant in the coding sequence was localized to the neonatal region of the protein, specifically the calcium-binding epidermal growth factor (cbEGF) domain (which have been associated with Marfan syndrome and the like, which paradoxically are characterized by greater than normal height).  This is in contrast to all other height-related FBN1 mutants, which localized to the TGFβ-binding domains.  Molecular analysis showed that this variant was adjacent to residues known to be involved in calcium binding.  The authors conceded that "[u]nderstanding the cellular mechanisms that connect FBN1(E1297G) to microfibril structures and height requires further functional studies."

    These results were also obtained when genotypes from 598 individual Peruvians were obtained.  Similar results were also obtained when height information from databases (Genetic Investigation of Anthropometric Traits, GIANT) and Population Architecture using Genomics and Epidemiology, PAGE).

    For comparison, previous studies on predominantly European populations (n~700,000 individuals) "have identified 3,290 independent common height-associated variants."  These height-associated variants explained only about 25% (6.1%) of height variants found in European populations (24.6%).  There was some evidence that these predictive differences were related to population structure and the relatively lower proportion of European ancestors in the Peruvian population.

    Another difference between these European genome-identified height variants is that these show on average of difference on 0.5 cm per variant allele, while the FBN1 variants identified in the Peruvian population had on average a 2.2 cm difference in height of individual bearing these genetic variants.  Statistical analyses indicated that this variant had been the subject of positive selection.  Alternative explanations were not persuasive; for example, the FBN1 locus is located only 266 kilobases (kb) away from SLC24A5 gene, known to be under positive selection because of its involvement in skin pigmentation; but there was no linkage found between variants in FBN1 and SCL24A5.

    FBN1 variants and their patterns of inheritance were also examined from three geographically separated Peruvian populations:  coastal, Andes, and Amazon.  These analyses showed that the frequencies of the variant allele in these populations was  9.7%, 1.7%, and 0%, respectively.  The authors state that these differences were extreme, appearing in only 0.7% of all variants (where n = 9,381,550).  Looking more closely at subpopulations, the frequency of the variant FBN1 allele is higher in the coastal Moches population, who are "far below" average height for Peruvian ("158 cm and 147 cm for Moches men and women versus 164 cm and 152 cm for Peruvian men and women measured in the same year").

    The paper also addresses the molecular biology of the genetic change, noting that the changes genetic sequence (T -> C) resulted in substitution of "a large, negatively charged glutamic acid for a glycine, the smallest amino acid" in the encoded protein.  This protein is "an extracellular matrix glycoprotein that serves as the structural backbone of force-bearing microfibrils in elastic and non-elastic tissues and is also involved in tissue development, homeostasis and repair by interacting with transforming growth factor (TGFβ) and other growth factors."  Besides its effect on height there is no known association of this variant with any human disease.  This is in contrast with other mutations in the gene, which are associated with nine "dominantly inherited Mendelian diseases" that include "skeletal anomalies and changes in skin elasticity."  A physiological analysis of 11 individuals in the studied cohort ("2 homozygous (C/C) individuals, 2 heterozygous (C/T) individuals and 7 matched controls with the reference (T/T) genotype") showed no frank skeletomuscular abnormalities, while one individual (having the  C/C genotype) "had a notably thicker skin as assessed in a total body skin examination and appeared older than the stated age," where another individual with this genotype did not.  The authors also reported that "[s]kin biopsies, on the other hand, showed shorter microfibrillar projections from the dermal–epidermal junction into the superficial (papillary) dermis as well as less fibrillin 1 deposition in the deeper dermis."  And electron microscopic analysis showed "individuals with the C/C genotype have less densely packed microfibrils with irregular edges and with microfibrils embedded in less dense collagen bundles, confirming the abnormal appearance of fibrillin 1 observed in immunohistochemical analysis of the skin biopsies."

    The paper closes with an acknowledgement that understanding selection of this genetic variant in this population "is a challenging task and requires further investigation" and:

    In addition to its implications in medical and population genetics, this study highlights the importance of large-scale genetic studies in underrepresented and founder populations.  Our findings show that genetic studies in different populations can uncover previously undescribed trait-associated variants with large effects in functionally relevant genes.  Similar studies in diverse populations are required to capture the extent of human genetic diversity and to expand the benefits of genetic research to all human populations.

    * Samira Asgari, Yang Luo, Ali Akbari, Gillian M. Belbin7, Xinyi Li, Daniel N. Harris, Martin Selig, Eric Bartell, Roger Calderon, Kamil Slowikowski Carmen Contreras, Rosa Yataco, Jerome T. Galea, Judith Jimenez, Julia M. Coit, Chandel Farroñay, Rosalynn M. Nazarian12, Timothy D. O'Connor, Harry C. Dietz, Joel N. Hirschhorn, Heinner Guio, Leonid Lecca, Eimear E. Kenny, Esther E. Freeman, Megan B. Murray & Soumya Raychaudhuri from Harvard Medical School, the Broad Institute/MIT, Mt Sinai School of Medicine, University of Maryland Medical School, University of Pennsylvania, Boston Children's Hospital, Socios en Salud, Lima, Peru, University of South Florida, Johns Hopkins University School of Medicine,  University of Manchester, UK, and Instituto Nacional de Salud, Lima, Peru.

  • PTAB Hears Oral Argument on Motions in Interference No. 106,115

    By Kevin E. Noonan —

    USPTO SealOn Monday, the Patent Trial and Appeal Board (PTAB) heard oral argument (remotely) from Senior Party the Broad Institute (and its partners as Senior Party, Harvard University and MIT) and Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") on the substantive motions filed in the Motions Phase of Interference No. 106,115.

    The Broad had four substantive motions to be decided by the Board:  Broad's Substantive Motion No. 1, requesting the Board to find (as it had in the earlier, 105,048 interference between these parties) that there was no interference-in-fact; Substantive Motion No. 2 to Substitute the Count; Broad's Substantive Motion No. 3 to de-designate claims as not corresponding to Count 1; and Broad's Substantive Motion No. 4 for priority to U.S. Provisional Application No. 61/736,527.

    CVC for its part filed only two motions to be decided by the Board:  CVC's Motion No. 1 was to be accorded the benefit of priority to three earlier-filed provisional applications for Count 1 of the Interference as declared; and CVC's Responsive Contingent Motion No. 2 was to be accorded the benefit of priority to three earlier-filed provisional applications contingent on the PTAB granting the Broad's Motion No. 2 to Substitute the Count of the interference.

    The hearing began at 10:30 am Monday morning with Raymond Nimrod from Quinn Emanuel arguing for Senior Party the Broad et al. and Eldora Ellison from Sterne Kessler arguing for CVC.  Administrative Patent Judge Katz presided, joined by Judges Lane and Moore.  Despite the number of motions before the Board, the panel imposed the conventional time limits on the parties of 20 minutes for argument.  Senior Party reserved 3 minutes for rebuttal while Junior Party split its time evenly, to be able to provide its arguments for benefit of priority and then to rebut Broad's arguments in opposition.

    The Broad went first, summarily mentioning its Substantive Motion No. 1 (with regard to slides 38-44 of its demonstrative exhibits) that the Board should reach the same conclusion here that it had in the '048 interference, that there is no interference-in-fact based on the same analysis and decision reached by the Board and affirmed by the Federal Circuit.

    Turning to CVC's motions for priority benefit, Mr. Nimrod argued that the Board's earlier fact-finding in the '048 interference was not only relevant and dispositive but bound the Board to reach the same conclusion. That conclusion was that CVC's specification was not enabling for the practice of CRISPR in eukaryotic cells and the prior art did not provide routine methods that would have permitted the skilled worker to practice CRISPR in eukaryotic cells.  Mr. Nimrod maintained that CVC's arguments in its motions contradicted those earlier Board findings and that specifically CVC's expert, Dr. Peterson (who did not testify in the '048 interference) advanced arguments opposite to the Board's earlier findings of fact and provided no additional information or data that rebutted those earlier Board findings.

    Mr. Nimrod attempted to address what he termed CVC's five arguments (and succeeded in addressing the first four of them):

    1.  That the Board's earlier fact finding was not applicable because reduction to practice was not determined in the '048 interference.  Senior Party argued that the Supreme Court in B&B Hardware Inc. v. Hargis Industries, Inc. held that issue preclusion precludes this argument ("we cannot relitigate this issue" and "CVC is simply wrong about that").  Mr. Nimrod also argued that CVC's argument was a repudiation of the PTAB's fact-finding in the '048 interference.

    2.  That CVC's second argument (which he termed their "second excuse"), that neither priority document (termed P1 and P2 in the interference, corresponding to USSN 61/652,086, filed May 25, 2012, and USSN 61/716,256, filed October 19, 2012, respectively) was considered in the '048 interference, was unavailing because there was nothing disclosed in these applications that had not been disclosed in CVC's Jinek 2012 reference and thus the factual bases for the Board's earlier decision remained sound and applied in this interference.  Mr. Nimrod asserted that CVC's expert admitted to this.  Mr. Nimrod took this occasion to tell the Board that the mere assemblage of broad categories of prior art methods did not change the state of the prior art and "compelled" the Board to deny CVC's motions for priority benefit.

    3.  That CVC's third argument ("excuse"), that the facts and bases for determining non-obviousness in the '048 interference were not relevant to the issue before the Board here, satisfaction of the written description requirement under Section 112(a), was contrary to the Federal Circuit's decision in Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., which Mr. Nimrod quoted as saying that "a description that does not render a claimed invention obvious is not sufficiently described that invention for purposes of Section 112, paragraph 1."

    4.  CVC's fourth "excuse" is a purported bright line rule that experimental evidence is not required to show adequate written description, which Mr. Nimrod asserted is a fact-specific inquiry.  Satisfaction of the requirement is dependent on many factors, the most [important] of which is unpredictability.  (In the heat of argument it appears Mr. Nimrod was discussing enablement here.)  He cited Novozymes A/S v. DuPont Nutrition Biosciences APS, which Mr. Nimrod argued stands for the proposition that to show possession the patentee needs to actually make embodiments of the claimed invention.  He attempted to rebut CVC's assertion of Alcon Research Ltd. v. Barr Laboratories Inc. in favor of its position by citing Nuvopharm v. Dr. Reddy's Labs (a case nicely relevant to the tension that can exist, and here Senior Party argues does exist in CVC's arguments, between the lack of reasonable expectation of success in asserting non-obviousness versus the ability of the skilled worker to rely on what is known in the art to supplement what is expressly disclosed in a specification).

    Having permitted counsel to argue for the full amount of Senior Party's time, Judge Katz asked the first question, which was where in Broad's motions was it shown which claims encompass "dual molecule" CRISPR embodiments and which are limited to single-molecule embodiments (Mr. Nimrod ultimately referenced the panel to its Substantive Motion No. 2 at page 28).  This colloquy ended Senior Party's argument.

    Counsel Ellison argued for CVC, and she addressed the benefit motions just argued by Broad's counsel.  Her argument was simple:  the disclosure of the P1 application satisfies the requirement for constructive reduction to practice and thus for priority benefit.  CVC's strongest argument is that several groups used the same methods and techniques disclosed in P1 (which, as admitted by Broad in its argument, were the same as those disclosed in the Jinek 2012 scientific journal reference) to practice CRISPR in eukaryotic cells (although counsel missed the opportunity to press home CVC's best equitable argument, that Broad merely copied CVC's invention in eukaryotic cells and thus should not be entitled to priority in the interference).  CVC counsel argued that Broad is wrong about priority depending on the existence of a working example and deftly distinguishes the differences in case law between what is required to satisfy Sections 103 and 112(a).  Specifically, Counsel Ellison argued that what was required was not a simple reasonable expectation of success, but rather the factors as set forth in In re Wands.  And she was careful to link these arguments with the availability of post-filing date evidence to show enablement.

    APJ Katz then asked about the significance of using fish cells as showing use of CRISPR in eukaryotic cells, which might have provided an opportunity to state that these cells are relatively easy to use and provide clear evidence of successful genetic manipulation.  Although counsel mentioned microinjection as one feature, her argument was grounded more on how using these cells were well known.  Counsel then yielded to Broad counsel's rebuttal before continuing her argument regarding Broad's motions.

    In his rebuttal. Mr. Nimrod disputed CVC's characterization of the Novozymes case again, and termed post-2012 work by others to be "hindsight" that is irrelevant to the skilled worker's expectations in 2012.  He reiterated his arguments regarding the primacy of the expectation of success prong, and stated that CVC is limited by its earlier arguments in the '048 interference.  Finally, and for the first time (and perhaps as a way to anticipate similar arguments from CVC), Mr. Nimrod implied that it was only after discussing eukaryotic CRISPR with Broad scientists that CVC's scientists understood how to adapt CRISPR to the eukaryotic environment.

    In her rebuttal, Counsel Ellison addressed the (ir)relevance of the Board's earlier '048 interference decision to the questions before the Board in this interference.  She addressed and attempted to rebut Broad's estoppel arguments and distinguish the Supreme Court's B&B Hardware decision relying on the differences in facts relevant to the issues here versus the issues in the earlier interference.  She stated that there is no authority that would permit the Board to avoid the priority issues in this interference, and reminded the Board of the history of serial interferences (i.e., that having decided one interference between parties having multiple patents and applications does not prelude the Board from decided additional interferences).  Counsel referenced CVC's arguments regarding Rule 127 to rebut Broad's "failure to move" argument with regard to the earlier interference, reminding the Board that this principle applies only to losing parties and, insofar as the earlier interference was resolved on the grounds of there being no interference-in-fact, CVC was not a loser in that interference.  CVC's counsel then argued that the Broad had established no basis for changing the Count in its Substantive Motion No. 2 and the Board should not make "changes for changes' sake."

    Judge Katz then asked about the significance, as a claim interpretation question, of the Broad's claim 1 in its patent in interference seeming to encompass both dual and single molecule embodiments, based on express recitation of single molecule embodiments in a dependent claim.  Counsel Ellison argued in response that claim differentiation is not a rule, and that fused RNAs were but one way of making single molecule RNAs according to intrinsic evidence.  This response initially led to a difficult question from Judge Katz (asking how else such a molecule could be made), but Counsel recovered in arguing that it was for Broad to explain this point, referencing Broad's express definition in their specification.  She reminded the Board that all Broad's claims were directed to single-molecule embodiments, and that the existence of a dependent claim that does not further limit the scope of the independent claim interpreted in light of the Broad's specification is merely invalid under Section 112(d).

    Counsel Ellison's final argument related to Broad's Substantive Motion No. 4, and the issue that this application disclosed RNA comprising both uracil and thymidine residues, and thus did not enable what was claimed.  Judge Katz did ask about CVCs expert's "admission" that he did not read this (initially) to be inoperative, but Counsel countered by mentioning Broad's reliance in this regard to "Molecular Biology for Dummies."

    The only remarkable aspect of this argument is that Judge Katz was the only active questioner; it is foolhardy to attempt to read the judicial tea leaves based on the "limited" questions from the panel.  A decision should be issued in the next several months.

  • USPTO Announces COVID-19 Prioritized Examination Pilot Program

    By Donald Zuhn —

    USPTO SealEarlier this month, the U.S. Patent and Trademark Office announced that it would be implementing a COVID-19 Prioritized Examination Pilot Program, in which applicants that qualify for small or micro entity status will be allowed to request prioritized examination without paying the fees typically associated with such prioritized examination.  Under the new pilot program, the Office will try to reach final disposition of applications within six months, provided that applicants respond promptly to Office communications.  USPTO Director Andrei Iancu noted that the new pilot program was intended to help independent inventors and small businesses, adding that "[a]ccelerating examination of COVID-19-related patent applications, without additional fees, will permit such innovators to bring important and possibly life-saving treatments to market more quickly."

    Last week, the Office published a notice in the Federal Register (85 Fed. Reg. 28932), which provides additional details regarding the new pilot program.  In the notice, the Office indicates that the goal of the new pilot program is to provide final disposition within 12 months from the date an application has been granted prioritized status.  However, the Office believes that it can achieve final disposition in six months if applicants provide more timely responses to notices and actions from the Office.  Nevertheless, the notice points out that "[a]ny failure to meet the 12-month goal, or other issues related to this goal that arise, are neither petitionable nor appealable matters."  In addition to expedited examination, the new pilot program will also eliminate the requirement to pay the prioritized examination fee set forth in 37 C.F.R. § 1.17(c) ($1,000 for micro entities and $2,000 for small entities) or the processing fee set forth in 37 C.F.R. § 1.17(i)(1) ($35 for micro entities and $70 for small entities).

    As discussed in the notice, the basis for the new pilot program is 37 C.F.R. § 1.183, which permits the Office, in an extraordinary situation, to suspend or waive sua sponte any requirement of its regulations that is not a requirement of the patent statutes.  And as the Office explains in the notice, it "considers the effects of the COVID–19 outbreak that began in approximately January 2020 to be an 'extraordinary situation' within the meaning of 37 CFR 1.183 for affected patent applicants and innovators."

    While the new pilot program will be limited to small and micro entities in order "[t]o focus the USPTO's resources on those applicants that may be more resource constrained," the Office notes that it will periodically evaluate the new pilot program to determine whether its coverage should be expanded or narrowed.  In addition, to qualify for the new pilot program, the claims of an application must cover a product or process related to COVID–19, and such product or process must be subject to an applicable FDA approval for COVID–19 use.  The notice notes that such approvals may include, for example, an Investigational New Drug (IND) application, an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologics License Application (BLA), a Premarket Approval (PMA), or an Emergency Use Authorization (EUA).

    Other requirements for participating in the new pilot program include making the request at the time of filing of a non-continuing original utility or plant nonprovisional application; at the time of filing of an original utility or plant nonprovisional application claiming the benefit of an earlier filing date under 35 U.S.C. §§ 120, 121, or 365(c) of one prior nonprovisional application or one prior international application designating the United States; or at the time of filing or after the filing of a Request for Continued Examination of a plant or utility application or a national stage of an international application.  The notice points out that any application that claims the benefit of the filing date of two or more prior filed nonprovisional U.S. applications or international applications designating the United States under 35 U.S.C. §§ 120, 121, or 365(c) will not be eligible for participation in the new pilot program.

    Moreover, applicants seeking to participate in the new pilot program will be required to certify that at least one of the pending claims covers a product or process related to COVID–19 and that such product or process is subject to an applicable FDA approval for COVID–19 use, and to certify that the applicant qualifies for either small or micro entity status when the request is made.  The Office encourages applicants seeking to participate in the new pilot program to use Form PTO/SB/450, which includes the required certifications.  Requests to participate in the new pilot program must also include an Application Data Sheet.  As with other prioritized examination requests, under the new pilot program the application and request must be made via the Office's patent electronic filing systems (EFS-Web or Patent Center) if the application is a utility application, and qualifying applications cannot present more than four independent claims, more than 30 total claims, or any multiple dependent claims.

    While the notice indicates that the Office will begin accepting requests under the new pilot program beginning on July 13, 2020, and will accept requests until the Office has accepted 500 requests, the Office issued a correction in a Patent Alert e-mail today that the Office actually started accepting requests under the new pilot program on May 14, 2020.  As with other USPTO pilot programs, the Office may extend the new pilot program (with or without modifications) or terminate it depending on the workload and resources needed to administer the program, feedback from the public, and the effectiveness of the program.  The notice also indicates that applications accepted into the First Action Interview (FAI) Pilot Program will not be eligible for the COVID-19 Prioritized Examination Pilot Program, and that applications accepted into the COVID-19 Prioritized Examination Pilot Program will not be eligible to participate in the FAI Pilot Program.

    The Office will be accepting comments regarding the new pilot program, which can be sent by e-mail to Covid19PrioritizedExamPilot@uspto.gov.  Such comments must be received by July 13, 2020 to be considered.

    Additional information regarding the new pilot program can be found at the Office's website.

  • Life Sciences Court Report & COVID-19 Impact on District Court Filings

    By Bryan Helwig —

    The COVID-19 pandemic has brought the world economy to a standstill and the U.S. legal industry has not been immune.  Firms continue to implement cost-saving measures by reducing salaries, implementing furloughs, and in dire situations, reducing staff and attorney numbers.  The legal industry is now clearly a COVID-19 work-from-home profession.  District courts, in an effort to adapt to the changing landscape while maintaining a sense of normalcy, have been forced to shift dockets, institute remote hearings, and postpone cases.

    A review of patent-related district court filings over the past eight weeks reveals that, starting in late March, the number of new district court cases in the pharmaceutical industry began to show a COVID-19-related slowing of new filings.  As shown in the graph below, while total new district court filings remained steady, and have even trended upwards in the last two weeks, pharmaceutical-related filings, including ANDA filings, have seen a significant decline.  The drop is accompanied by an increase in statewide stay-at-home orders, many of which are being partially lifted in the month of May, reflecting an industry-wide conservative litigation approach in the pharmaceutical industry during the ongoing COVID-19 crisis.

    Chart
    The eight-week review of new district court patent litigation filings spans from March 9 to May 1.  Week 1, beginning March 9, 2020, saw 62 new patent-related district court filings.  Twenty of those filings, or 32%, were in the pharmaceutical field.  However, the pharmaceutical filings trended above average for the week as on March 11 Celgene filed seven ANDA-related infringement complaints related to POMALYST®, used for the treatment of multiple myeloma.  Similarly, on Friday, March 13, Bausch Health (f/k/a Valent Pharmaceuticals) filed nine ANDA litigations related to its efinaconazole topical solution to treat nail fungus.  March 13 is further characterized by the National Emergency declared by President Trump under the National Emergencies Act.[1]

    Despite the National Emergency, district court filings remained steady during the week of March 16, with 9 of the 71 (15%) district court filings related to infringement of pharmaceutical patents.  The normalized trend continued into the week of March 23, where 13 of the 68 district court filings were pharmaceutical-related.  The consistent trend occurred at a time when only 9 states (i.e., CA, IL, LA, MA, NJ, NY, OH, OR, and WA) enacted statewide orders to stay-at-home or shelter-in-place.

    Highlighting the urgency of containment efforts, three days later on March 26, statewide stay-at-home orders were enacted in 26 states.  Included in the stay at-home-orders were New Jersey, on March 21 and Delaware on March 24, two states that represent a significant number of pharma-related district court filings.

    The CARES ACT, announced Friday, March 27, marked a second major event in the COVID-19 timeline.  As previously summarized, the CARES ACT mainly impacts patent prosecution and prosecution-related deadlines.  The CARES ACT was accompanied, by numbers reported on March 30, of statewide stay-at-home orders issued in 30 states.  Although a decline in district court filings may have been expected as the spread of COVID-19 strengthened its grip on a dormant U.S. economy, March 30 saw 85 new district court filings.  However, the upward trend in total filings included only three new pharmaceutical-related district court filings (i.e., 3.5% of all new filings) for the week.  This trend continued into the first week of April where only 3 of the 72 district court patent-related filings (i.e., 4%) were from the pharmaceutical industry.  As of April 7, all but eight states had enacted stay-at-home-orders.

    This trend continued into the week of April 13 when 67 total district court cases were filed, but included only two pharmaceutical-related district court cases (2% of all new filings).  The week of April 20 was characterized by an almost 30% increase in district court filings, but no pharma-related district court filings.  This trend continued into the week of April 27, where total district court filings increased by almost 40% compared to the week of April 20, but only included 4 pharma related filing.  Overall, there were 382 district court filings in the month of April, but only 12 of these filings, as summarized below, were in the pharma space (~3%).  When compared to pre-COVID filings, the total number of pharma-related district court filings for the month of April was approximately the same as the weekly pharma-related district court filings prior to the COVID-19 pandemic.

    Meanwhile, the trend of pharmaceutical cases accounting for less than five percent of all district court filings is likely to continue.  Consistent with this, pharma-related district court filings for the week of May 4 revealed two pharma-related cases out of the first 22 district court filings for the week.

    The end of April brought discussions of states instituting partial reopenings as shown on the graph by a drop in the total number of states instituting strict stay at home orders.  The re-openings, while ill-advised by health experts, are unique to each state, with health experts raising valid concerns of a second COVID-19 outbreak.  Until the pharma industry is successful in producing a vaccine or antibody test, it is possible that district court pharmaceutical-related filings will not return to pre-COVID-19 levels in the near future.

    [1] https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/

    District Court Cases — April 2020

    GavelTherapeuticsMD, Inc. v. Teva Pharmaceuticals USA, Inc.
    2-20-cv-03485; filed April 1, 2020 in the District Court of New Jersey

    • Plaintiff:  TherapeuticsMD, Inc.
    • Defendants:  Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.

    Claim:  Infringement of U.S. Patent Nos.:

    • 10,258,630: "Vaginal inserted estradiol pharmaceutical compositions and methods"
    • 10,398,708: "Vaginal inserted estradiol pharmaceutical compositions and methods"
    • 10,471,072: "Vaginal inserted estradiol pharmaceutical compositions and methods"
    • 9,180,091: "Soluble estradiol capsule for vaginal insertion"
    • 9,289,382: "Vaginal inserted estradiol pharmaceutical compositions and methods"

    Synoposis:  TherapeuticsMD asserts infringement of the '630, '708, '072, '091, and '382 patents.  TherapeuticsMD is the holder of approved NDA No. 208564 for the manufacture and sale of Imvexxy® (estradiol vaginal inserts) for the treatment of moderate to severe dyspareunia.  Teva has submitted ANDA No. 214137, seeking approval to engage in the commercial manufacture, use, and/or sale of generic estradiol vaginal Inserts.  TherapeuticsMD asserts that the method of manufacture and/or the sale of of generic Imvexxy® are covered by one or more claims of the patents-in-suit.

    View the complaint here.


    Merck Sharp & Dohme B.V. v. Mylan Pharmaceuticals Inc.
    1-20-cv-61; filed April 2, 2020 in the District Court of West Virginia

    • Plaintiffs:  Merck Sharp & Dohme B.V. and Organon USA Inc.
    • Defendants:  Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan API US LLC

    Claim:  Infringement of U.S. Patent No.:

    • RE44733: "6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block"

    Synoposis:  Merck asserts infringement of the '733 patent.  The '733 patent is a reissue of U.S. Patent No. 6,670,340.  Organon is the holder of approved NDA No. 022225 for the manufacture and sale of Bridion® (sugammadex) Injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.  Mylan has submitted ANDA No. 213915, seeking to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of generic sugammadex.  Merck asserts that the method of manufacture and/or the sale of generic Bridion® are covered by one or more claims of the '733 patent.

    View the complaint here.


    Chiesi USA, Inc. v. Hikma Pharmaceuticals USA Inc.
    1-20-cv-00484; filed April 8, 2020 in the District Court of Delaware

    • Plaintiffs:  Chiesi USA, Inc. and Chiesi Farmaceuti S.P.A.
    • Defendants:  Hikam Pharmaceuticals USA Inc., Europhealth (U.S.A.) Inc., and Hikmma Pharmaceuticals PLC

    Claim:  Infringement of U.S. Patent No.:

    • 7,049,328: "Use for deferipron"

    Synoposis:  Chiesi asserts infringement of the '328 patent.  Chiesi is the holder of approved NDA No. 021825 for the manufacture and sale of the Ferriprox® (deferiprone) for iron chelation in patients with transfusional iron overload due to thalassemia syndromes.  Hikma has submitted ANDA No. 213239, seeking approval to engage in the commercial manufacture, use, and/or sale of generic deferiprone.  Chiesi asserts that the method of manufacture and/or the sale of generic Ferriprox® are covered by one or more claims of the '328 patent.

    View the complaint here.


    Actelion Pharmaceuticals Ltd. v. MSN Pharmaceuticals Inc.
    2-20-cv-03859; filed April 9, 2020 in the District Court of New Jersey

    • Plaintiffs:  Actelion Pharmaceuticals Ltd. and Nippon Shinyaku Co., Ltd.
    • Defendants:  MSN Pharmaceuticals Inc., MSN Laboratories Private Ltd., Alembic Pharmaceuticals Ltd., Vgyaan Pharmaceuticals LLC, Aizant Drug Research Solutions Private Ltd., Zydus Worldwide DMCC, and Zydus Pharmaceuticals (USA) Inc.

    Claim:  Infringement of U.S. Patent Nos.:

    • 7,205,302: "Heterocyclic compound derivatives and medicines"
    • 8,791,122: "Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same"
    • 9,284,280: "Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide"

    Synoposis:  Actelion asserts infringement of the '302, '122, and '280 patents.  Actelion is the holder of approved NDA No. 207947, for the manufacture and sale of UPTRAVI® (selexipag) for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for pulmonary arterial hypertension.  Defendants have submitted ADNA No. 214414 (Alembic), ANDA No. 214367 (MSN), ANDA No. 214055 (Aizant), and ANDA No. 214302 (Zydous), seeking approval to manufacture, use, market, or sell generic selexipag tablets.  Actelion asserts that the method of manufacture, use, market, and sale of generic UPTRAVI® are covered by one or more claims of the patents-in-suit.

    View the complaint here.


    Eisai R&D Management Co. v. Sandoz Inc.
    3-20-cv-03895, filed April 9, 2020 in the District Court of New Jersey

    • Plaintiffs:  Eisai R&D Management Co., Eisai Co., and Eisai Inc.
    • Defendants:  Sandoz Inc. and Sandoz International GmbH

    Claim:  Infringement of U.S. Patent No.:

    • RE46965: "Austad  Intermediates for the preparation of analogs of Halichondrin B"

    Synoposis:  Eisai asserts infringement of the '965 patent.  Eisai is the holder of approved NDA No. 201532 for Halaven® (eribulin mesylate) to treat patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens.  Halaven® has also been approved by the FDA to treat patients with unresectable or metastatic liposarcoma.  Sandoz Inc. submitted ANDA No. 214310, seeking approval to engage in the commercial manufacture, use, offer for sale, or sale generic eribulin mesylate.  Eisai asserts that the commercial manufacture, use, offer for sale, or sale of generic eribulin mesylate are covered by one or more claims of the '965 patent.

    View the complaint here.


    Huvepharma EOOD v. BASF Corp.
    Huvepharma EOOD v. Koninklijke DSM N.V.
    1-20-cv-00513 and 1-20-cv-00514; filed April 15, 2020 in the District Court of Delaware

    • Plaintiffs:  Huvepharm EOOD (f/k/a Huvepharma AD) and Huvepharma, Inc.
    • Defendants:  BASF Corp. and BASF SE (1-20-cv-00513) and Koninklijke DSM N.V.; DSM Nutritional Products, LLC; and DSM Nutritional Products Ltd. (1-20-cv-00514)

    Claim:  Infringement of U.S. Patent No.:

    • 8,993,300: "Overexpression of phytase genese in yeast systems"

    Synopsis:  Huvepharma EOOD asserts infringement of the '300 patent.  Huvepharma sells OptiPhos®, a feed additive for animals.  This includes an E. coli derived 6-phytase, which is recombinantly produced in a heterologous yeast host in a submerged fermentation process.  Huvepharma exclusively licenses OptiPhos® from Cornell University.  Huvepharma asserts that the Defendants, during prosecution of their patent application, cited the child application of the '300 patent.  Despite the application being rejected, Defendants allegedly continued to sell the accused product after the '300 patent issued.  As such, Huvepharma alleges Defendants knowingly infringed the '300 patent.

    View the complaint here (1-20-cv-00513) and here (1-20-cv-00514).


    Purdue Pharma L.P. v. Intellipharmaceutics International Inc.
    1:20-cv-00515; filed April 15, 2020 in the District Court of Delaware

    • Plaintiffs:  Purdue Pharma L.P., Purdue Pharmaceuticals L.P., P.F. Laboratories, Inc., Rhodes Technologies, and Grüenthal GmbH
    • Defendants:  Intellipharmaceutics International Inc., Intellipharmaceutics Corp., and Intellipharmaceutics Ltd.

    Claim:  Infringement of U.S. Patent Nos.:

    • 10,369,109: "Abuse-proofed dosage form"
    • 10,407,434: "Process for preparing oxycodone compositions"

    Synopsis:  Purdue asserts infringement of the '109 and '434 patents.  Purdue is the holder of approved NDA No. 022272 for OxyContin® (oxycodone hydrochloride), an extended-release pain medication.  Intellipharmaceutics submitted NDA No. 209653, seeking approval to engage in the commercial manufacture, use, or sale of a generic extended-release oxycodone product.  Purdue asserts that the method of manufacture and/or the use of generic OxyContin® are covered by one or more claims of the patents-in-suit.

    View the complaint here.


    Astellas US LLC v. Glenmark Pharmaceuticals Ltd.
    1-20-cv-00516; filed April 15, 2020 in the District Court of Delaware

    • Plaintiffs:  Astellas US LLC, Astellas Pharma Inc., and Gilead Sciences Inc.
    • Defendant:  Glenmark Pharmaceuticals Ltd.

    Claim:  Infringement of U.S. Patent Nos.:

    • 8,106,183: "Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs"
    • 8,524,883: "Monohydrate of (1-{9-[4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopu- rin-2-yl}pyrazol-4-yl)-N-methylcarboxamide"
    • RE47301: "Process for preparing an A2A-adenosine receptor agonist and its polymorphs"

    Synopsis:  Astellas asserts infringement of the '183, '883, and '301 patents.  Astellas is the holder of approved NDA No. 022161 for the marketing and sale of Lexiscan® (regadenoson) for use in cardiac nuclear stress tests.  Glenmark submitted ANDA No. 214440, seeking approval to commercially market a generic version of Lexiscan®.  Asrtellas asserts that the method of manufacture and/or the use of generic Lexiscan® are covered by one or more claims of the patents-in-suit.

    View the complaint here.


    Pharmacyclics LLC v. Zydus Worldwide DMCC
    1-20-cv-00560; filed April 16, 2020 in the District Court of Delaware

    • Plaintiffs:  Pharmacyclics LLC and Janssen Biotech, Inc.
    • Defendants:  Zydus Biotech, Inc. and Cadila Healthcare Ltd.

    Claim:  Infringement of U.S. Patent Nos.:

    • 10,010,507: "Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor"
    • 10,106,548: "Crystalline forms of a Bruton's tyrosine kinase inhibitor"
    • 10,125,140: "Crystalline forms of a bruton's tyrosine kinase inhibitor"
    • 10,213,386: "Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor"
    • 10,478,439: "Use of inhibitors of bruton's tyrosine kinase (Btk)"
    • 7,514,444: "Inhibitors of bruton's tyrosine kinase"
    • 8,008,309: "Inhibitors of bruton's tyrosine kinase"
    • 8,476,284: "Inhibitors of Bruton's tyrosine kinase"
    • 8,497,277: "Inhibitors of Bruton's tyrosine kinase"
    • 8,697,711: "Inhibitors of bruton'S tyrosine kinase"
    • 8,735,403: "Inhibitors of Bruton's tyrosine kinase"
    • 8,754,090: "Use of inhibitors of bruton's tyrosine kinase (Btk)"
    • 8,754,091: "Inhibitors of bruton's tyrosine kinase"
    • 8,952,015: "Inhibitors of Bruton's tyrosine kinase"
    • 8,957,079: "Inhibitors of Bruton's tyrosine kinase"
    • 9,181,257: "Inhibitors of Bruton's tyrosine kinase"
    • 9,296,753: "Crystalline forms of a Bruton's tyrosine kinase inhibitor"
    • 9,725,455: "Crystalline forms of a bruton's tyrosine kinase inhibitor"

    Synopsis:  Pharmacyclics asserts infringement of the '507, '548, '140, '386, '439, '444, '309, '284, '277, '711, '403, '090, '091, '015, '079, '257, 753, and '455 patents.  Pharmacyclics is the holder of NDA No. 210563 for IMBRUVICA® (ibrutinib) to treat mantle cell lymphoma, Waldenström's macroglobulinemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, and chronic graft-versus-host-disease.  Zydus submitted ANDA No. 214296, seeking approval to market generic versions of IMBRUVICA®.  Pharmacyclics asserts that the method of manufacture and/or the use of generic IMBRUVICA® are covered by one or more claims of the patents-in-suit.

    View the complaint here.


    Amgen Inc. v. Hospira, Inc.
    1-20-cv-00561; filed April 26, 2020 in the District Court of Delaware

    • Plaintiffs:  Amgen Inc. and Amgen Manufacturing Ltd.
    • Defendants:  Hospria Inc. and Pfizer Inc.

    Claim:  Infringement of U.S. Patent No.:

    • 10,577,392: "Capture processes for proteins expressed in a non-mammalian system"

    Synopsis:  Amgen asserts infringement of the '392 patent.  Amgen manufactures and sells NEUPOGEN® (filgrastim) for the treatment of neutropenia.  Amgen is a Reference Product Sponsor and Hospira a biosimilar applicant for a biosimilar version of NEUPOGEN®.  Hospira used the subsection (k) pathway and submitted abbreviated Biologic License Application (aBLA) No. 761080.  In July 2018, Hospira received FDA approval for NIVESTYM® (filgrastim), a biosimilar to Neupogen® (filgrastim), for all eligible indications of the reference.  Amgen alleges that Hospira submitted the aBLA before expiration of the '392 patent, thereby infringing the '392 patent.

    View the complaint here.


    Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc.
    1-20-cv-05212; filed April 28, 2020 in the District Court of New Jersey

    • Plaintiff:  Tris Pharma, Inc.
    • Defendant:  Teva Pharmaceuticals USA, Inc.

    Claim:  Infringement of U.S. Patent Nos.:

    • 9,545,399: "Methylphenidate extended release chewable tablet"
    • 9,844,544: "Methylphenidate extended release chewable tablet"
    • 9,844,545: "Methylphenidate extended release chewable tablet"

    Synoposis:  Tris asserts infringement of the '399, '544, and '545 patents.  The patents are directed at QuilliChew ER® (methylphenidate), a long-lasting chewable for the treatment of ADHD in children.  Teva submitted ANDA NO. 214202, seeking approval to manufacture and commercially market a generic version of QuilliChew ER®.  Tris asserts that the method of manufacture and/or the use of generic QuilliChew ER® are covered by one or more claims of the patents-in-suit.

    View the complaint here.


    TherapeuticsMD, Inc. v. Amneal Pharmaceuticals, Inc.
    3-20-cv-05256; filed April 29, 2020 in the District Court of New Jersey

    • Plaintiff:  TherapeuticsMD, Inc.
    • Defendants:  Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, and Amneal Pharmaceuticals of New York LLC

    Claim:  Infringement of U.S. Patent Nos.:

    • 10,052,386: "Progesterone formulations"
    • 10,206,932: "Natural combination hormone replacement formulations and therapies"
    • 8,633,178: "Natural combination hormone replacement formulations and therapies"
    • 8,846,648: "Natural combination hormone replacement formulations and therapies"
    • 8,846,649: "Natural combination hormone replacement formulations and therapies"
    • 8,987,237: "Natural combination hormone replacement formulations and therapies"
    • 8,993,548: "Natural combination hormone replacement formulations and therapies"
    • 8,993,549: "Natural combination hormone replacement formulations and therapies"
    • 9,006,222: "Natural combination hormone replacement formulations and therapies"
    • 9,114,145: "Natural combination hormone replacement formulations and therapies"
    • 9,114,146: "Natural combination hormone replacement formulations and therapies"
    • 9,301,920: "Natural combination hormone replacement formulations and therapies"

    Synopsis:  TherapeuticsMD asserts infringement of the '386, '932, '178, '648, '649, '237, '548, '549, '222, '145, '146, and '920 patents.  TherapeuticsMD holds approved NDA No. 210132 for the BIJUVA® (estradiol and progesterone capsule) for the treatment of moderate to severe vasomotor symptoms due to menopause.  Amneal submitted ANDA No. 214293, seeking approval to commercially manufacture, import, market, offer for sale, and/or sell generic BIJUVA®.  TherapeuticsMD asserts that the method of manufacture and/or the use of BUJUVA® are covered by one or more claims of the patents-in-suit.

    View the complaint here.

  • Conference & CLE Calendar

    CalendarMay 19, 2020 – "Four Key Points for Evaluating and Protecting Your Canna-IP: What Should You Be Doing, Now" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    May 19, 2020 – "Putting the Genie Back in the Bottle: Protecting Trade Secrets During and in the Aftermath of COVID-19" (American Bar Association Section of Intellectual Property Law)

    May 19, 2020 – "Critical Developments in the West" (Federal Circuit Bar Association) – 11:00 am to 12:00 pm (EST)

    May 20, 2020 – "Identifying the new normal: what past downturns tell us about how the IP future will evolve" (IPBC Talking Heads and iam) – 11:00 am to 12:00 pm (EDT)

    May 21, 2020 – "In Denial: The PTAB's 314(a) Discretion, General Plastics, and NHK Spring" (Unified Patents and IPWatchdog) – 12:00 pm (EDT)

    May 21, 2020 – "Alice and Mayo at Trial: Section 101 Litigation After Berkheimer" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (EDT)

    May 21, 2020 – "Sufficiency at the EPO" (J A Kemp) – 16:30 to 17:30 pm (GMT)