Gibbons Law Alert

Gibbons Law Alert Blog

Surveying the CRISPR-Cas9 Patent Landscape in the United States

On August 20, 2018

This post will discuss the patent landscape of the groundbreaking CRISPR-Cas9 systems in the United States, including pending legal disputes. A CRISPR-Cas9 system is a combination of protein and ribonucleic acid (“RNA”) that can alter the genetic sequence of an organism. CRISPR-Cas systems occur naturally in bacteria and help the bacteria target and cut identified virus deoxyribonucleic acid (“DNA”). The CRISPR-Cas9 system is being developed as a powerful tool to modify specific DNA in the genomes of more complicated organisms, including plant and animal cells. For the purpose of this overview, the mechanism of CRISPR-Cas9 is explained in the Patent Trial and Appeal Board (PTAB)’s Broad Institute v. The Regents of the University of California interference decision. As the decision explains, the CRISPR-Cas9 system comprises three effective parts: a guide-RNA sequence, an activator-RNA sequence, and a protein called Cas9. CRISPR-Cas9 alters a target DNA molecule by first binding the guide-RNA sequence to a specific sequence in the DNA of interest. The activator-RNA sequence then interacts with the Cas9 protein, and the Cas9 protein cuts the target DNA at a specific site. By linking a DNA-cutting protein (Cas9) to a specific site on the target DNA, the CRISPR-Cas9 system achieves specific targeted manipulation of DNA. The U.S. Patent and Trademark Office (USPTO) has granted patents to variations...

New Jersey Appellate Division Affirms Dismissal of Four Putative Class Actions Claiming Violations of Section 16 of the TCCWNA

by Michael R. McDonald and Caroline E. Oks

Posted in Class Action Defense

On August 9, 2018

In Duke v. All American Ford, the New Jersey Appellate Division affirmed dismissal of four putative class actions (consolidated for appeal) alleging that agreements to purchase, lease, or rent motor vehicles violated the Truth in Consumer Contracts, Warranty, and Notice Act’s (TCCWNA) Section 16. The trial courts had dismissed all such claims for failure to plead a violation of Section 16. While the appeals in these matters were pending, the Supreme Court issued its decision in Spade v. Select Comfort, holding that “an adverse consequence is a necessary element of the TCCWNA cause of action.” As a result of the Supreme Court’s decision in Spade, the Appellate Division in Duke rejected the appeals and affirmed the orders of dismissal without even considering the various substantive Section 16 arguments. Each of the putative class action complaints alleged that certain clauses in purchase, lease, or rental documents violated Section 16 of the TCCWNA, which, among other things, prohibits language in a written contract “that any of its provisions is or may be void, unenforceable, or inapplicable in some jurisdictions without specifying which provisions are or are not void, unenforceable or inapplicable within the State of New Jersey.” Three of the cases (Duke, Barbarino, and Greenberg), involved contracts for the lease or purchase of vehicles, which contained a...

Applications Now Open for Six Additional Alternative Treatment Centers

by Michael D. DeLoreto

Posted in Regulatory Counseling and Departmental Action

On August 6, 2018

New Jersey’s Department of Health is seeking applications for six new medical marijuana dispensaries, known as Alternative Treatment Centers (ATCs), to be located in the Northern, Central, and Southern regions of the State. Below is some critical information on the application process which closes on August 31, 2018. Why the Department Needs Additional ATCs The six current licensed ATCs are reaching their limit in terms of the number of patients they can treat. In March 2018, Governor Murphy and the Department added five additional medical conditions to the list of qualifying diagnoses eligible for treatment with medicinal marijuana. Among the conditions were two new types of chronic pain, as well as anxiety, migraines, and Tourette’s Syndrome. Since the addition of these conditions, the program has grown by over 7,000 patients and the total number is in excess of 25,000 people. What the New ATCs Can Do The six ATCs to be licensed will be vertically integrated and allow for the cultivation, manufacturing, and dispensing of marijuana. The Department’s objective is to have two licensees located in the Northern region (Bergen, Essex, Hudson, Morris, Passaic, Sussex, and Warren), two in the Central region (Hunterdon, Middlesex, Mercer, Monmouth, Ocean, Somerset, and Union), and two in the Southern (Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, and Salem). Key Dates...

New Jersey Supreme Court Approves Special Rules for Matters in the Complex Business Litigation Program

by Christopher Walsh

Posted in General Litigation

On August 2, 2018

On January 1, 2015, the New Jersey Superior Court implemented statewide the Complex Business Litigation Program (“CBLP”) for complex commercial and construction cases with amounts in controversy exceeding $200,000. Each case in the CBLP is managed by a single judge assigned in each county to handle cases in the program, thus providing each case with individualized case management and a jurist experienced in managing and resolving similar matters. On July 27, 2018, the New Jersey Supreme Court adopted special rules for cases in the CBLP to take effect on September 1, 2018. The current rules in Parts I and IV will continue to apply to CBLP cases, unless contradicted by a new rule. The new rules, largely adapted from rules in the federal courts and other business courts, mainly modify certain aspects of case management, discovery, and motion practice. The more substantial practice changes prompted by the new rules are: Initial Disclosures: Following the federal courts’ innovation of requiring mandatory disclosures, litigants in the CBLP will be required to disclose early in the case: 1) all individuals with knowledge of information that the disclosing party may use to support its claims or defenses, 2) copies or a description of (including the location of) all documents, electronic data, or tangible things that the party may use...

NYSDEC Adopts Update to SEQR Regulations

by Howard D. Geneslaw

Posted in Development/Redevelopment / Environmental and Green Issues

On August 2, 2018

The New York State Department of Environmental Conservation (“DEC”) announced on June 28, 2018 that it had adopted a rulemaking package directed at updating its regulations relating to the State Environmental Quality Review (“SEQR”). The updates – DEC’s first to its SEQR regulations in more than two decades – are the product of an effort that began in February 2017 with the DEC’s filing of an initial notice and, following a series of public comment periods and subsequent revisions, culminated with its publication of the Final Generic Environmental Impact Statement (“FGEIS”) and revised text of the regulations. As revised, the regulations become effective on January 1, 2019 and apply to all actions for which a determination of significance has not been made by January 1, 2019. For projects that receive a determination of significance made prior to January 1, 2019, the existing SEQR regulations (which originally took effect in 1996) will continue to apply. Once effective, the revised regulations could have a significant impact on SEQR’s applicability to future development projects. The new regulations contemplate a number of mechanical changes to the environmental review process itself, including mandatory scoping of environmental impact statements, changes to the required content of environmental impact statements (“EIS”), as well as new requirements relating to the preparation and filing environmental impact...

NY Commercial Division Promotes Technology Assisted Review

by Gibbons P.C.

Posted in E-Discovery: Legal Decisions and Court Rules / Litigation Preparedness and Strategies

On August 1, 2018

On July 19, 2018, the Chief Administrative Judge of the Courts issued an administrative order adopting a new rule for the New York Commercial Division supporting the use of technology-assisted document review. Based on a recommendation and proposal by the Subcommittee on Procedural Rules to Promote Efficient Case Resolution, Commercial Division Rule 11-e has been amended to state: The parties are encouraged to use the most efficient means to review documents, including electronically stored information (“ESI”), that is consistent with the parties’ disclosure obligations under Article 31 of the CPLR and proportional to the needs of the case. Such means may include technology-assisted review, including predictive coding, in appropriate cases. The parties are encouraged to confer, at the outset of discovery and as needed throughout the discovery period, about technology-assisted review mechanisms they intend to use in document review and production. The Subcommittee noted that document review “consumes an average of 73% of the total cost of document production in cases involving electronic discovery.” With that in mind, the Court adopted a rule meant to streamline and make electronic discovery more efficient in large, complex and e-discovery-intensive cases. The use of technology-assisted review is still optional. It should be considered on a case-by-case basis and the parties are encouraged to confer about its potential use....

Third Circuit Overturns Summary Judgment Based on the Faragher-Ellerth Defense

by Richard S. Zackin

Posted in Discrimination

On August 1, 2018

Employers who are sued for sexual harassment committed by a supervisor may be able to avoid liability, even if harassment had, in fact, occurred, by asserting the so-called Faragher-Ellerth affirmative defense, named after the two United States Supreme Court cases that first recognized the defense. An employer may assert the Faragher-Ellerth defense to supervisor harassment when no tangible employment action has been taken against the harassed employee and the employer is able to demonstrate (a) it exercised reasonable care to prevent and correct promptly any sexually harassing behavior and (b) the employee unreasonably failed to take advantage of any preventive or corrective opportunities provided by the employer. Recently, the United States Court of Appeals for the Third Circuit, in Minarsky v. Susquehanna County, addressed the requirements of the Faragher-Ellerth defense in the context of the assertion of a female employee that she acted reasonably in not taking advantage of the procedures made available by her employer to prevent or correct the harassment against her by her supervisor. In so doing, the Third Circuit reversed the district court’s grant of summary judgment to the employer based on the Faragher-Ellerth defense and held on the facts of the case a jury should decide the whether the defense applied. Background Sherri Minarsky worked as a part-time secretary at...

Third Circuit Affirms Remand of Class Action to State Court Under “Local Controversy” Exception

by Gibbons P.C.

Posted in Class Action Defense

On July 25, 2018

In a decision that may broaden application of the “local controversy” exception to removal under the Class Action Fairness Act (“CAFA”), 28 U.S.C. § 1332(d)(4), the Third Circuit recently affirmed the remand of a putative class action to New Jersey state court holding a corporate defendant with New Jersey citizenship could be considered a “local defendant” because it did not fully divest itself of liability after previously transferring its potential liabilities to a Delaware entity and, thus, remained a real party in interest. In Walsh v. Defenders, Inc., putative class members filed their complaint in New Jersey Superior Court alleging that the contracts they entered into with Defendants related to the class members’ purchase of home security equipment and monitoring services violated New Jersey’s Truth-in-Consumer Contract, Warranty, and Notice Act (“TCCWNA”) and the New Jersey Consumer Fraud Act (“NJCFA”). Defendants removed the matter to federal court asserting CAFA jurisdiction, and Plaintiff moved to remand under CAFA’s local controversy exception. After initially denying Plaintiff’s motion to remand, the District Court granted Plaintiff’s motion for reconsideration when additional discovery showed that the only defendant with New Jersey citizenship, ADT SSI-Tyco, had contracted with 35.3% of the putative class members. Defendants appealed and argued that ADT SSI-Tyco should have been ignored in the District Court’s diversity of citizenship...

Superfund Task Force Listening Session on Recommendation 16-2, Part 2: Improving Implementation of Cleanup Agreements for Response Actions by PRPs

by Paul M. Hauge

Posted in Environmental and Green Issues

On July 20, 2018

On June 18, 2018, the United States Environmental Protection Agency’s (“EPA”) held the last of eight listening sessions on the recommendations of its Superfund Task Force. This last listening session concerned Part 2 of Recommendation 16-2018, which calls for improvement in the process of implementing cleanup agreements under which potentially responsible parties (PRPs) commit to carry out site cleanups under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). EPA speakers included Ellen Stern (Office of Regional Counsel, Region 10), Ken Patterson (Office of Site Remediation Enforcement (OSRE), Douglas Dixon (OSRE), and Charles Howland (Office of Regional Counsel, Region 3). They noted a number of reasons for delays in the completion of cleanups under such agreements, ranging from the submission of multiple versions of the same deliverable and time-consuming dispute resolution procedures to lax (or, conversely, excessively stringent) enforcement of deadlines and imposition of stipulated penalties. They also acknowledged EPA’s reluctance to exercise its most extreme enforcement tool – taking over the work and using financial assurance established by the PRPs. Outside participants called on EPA to expand the number of PRPs that are called upon to perform cleanups (including municipalities) to reduce the financial burden on any one PRP. The Superfund Task Force was created in May 2017 to propose recommendations for streamlining and strengthening the...

Supreme Court To Review Whether Non-Public Sales Are Invalidating Under Post-AIA Section 102

by Gibbons P.C.

Posted in Biotech / Patent / USPTO

On July 18, 2018

The Supreme Court recently agreed to review Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., a case with broad implications for the pharmaceutical industry. In the opinion below, the Federal Circuit held that after the America Invents Act (“AIA”), “if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale” for the sale to be invalidating under Section 102. The Court granted Helsinn’s petition for certiorari to answer “[w]hether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.” Before the AIA, § 102(b) barred the patentability of an invention that was “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent.” By enacting the AIA, Congress amended § 102 to bar the patentability of an “invention [that] was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” In its petition for certiorari, Helsinn argued...