Gibbons Law Alert Blog

Baxalta Inc. v. Genentech, Inc.: The Federal Circuit Addresses Enablement After Amgen v. Sanofi

Baxalta Inc., v. Genentech, Inc., Appeal No. 2022-1461 (Fed. Cir. Sept. 20, 2023) is another in the line of cases where claims to biological compounds are drafted functionally and raise §112 issues. This decision was an appeal from a grant of summary judgment that held certain claims of Baxalta’s ‘590 patent invalid for lack of enablement. The technology involved antibodies for enhancing the mechanism for blood clotting to treat patients with hemophilia type A. Claim 1 of the patent recited “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.” (Emphasis added). The claim is drafted functionally; it describes what the antibody does, rather than what the antibody actually is, and it encompasses any antibody capable of achieving that function. The specification of the ‘590 patent disclosed only 11 actual antibodies that fell within the claim’s scope, and referred to generally known methods for producing and screening antibodies. Relying on the analysis provided by the Supreme Court’s recent decision, Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), the court found that the ‘590 patent’s specification simply provided a roadmap for one to engage in the same iterative, trial-and-error process that the inventors used to find their 11 antibodies. It did not identify any common...

PTAB Finds Service of Complaint for Infringement Without Exhibits Does Not Trigger 35 U.S.C. § 315(b) Time Bar

In Lightricks Ltd. v. Plotagraph, Inc., the Patent Trial and Appeal Board (PTAB or “Board”) recently clarified the standard for what triggers the 35 U.S.C. § 315(b) time bar for filing a petition for inter partes review. Section 315(b) requires that petitions for inter partes review be filed with the Board within “[one] year after the date on which the petitioner … is served with a complaint alleging infringement of the patent.” 35 U.S.C. § 315(b). In Lightricks v. Plotagraph, the Patent Owner (“PO”) argued that the petition at issue was filed outside of the one-year anniversary of the service of its complaint for infringement in the related federal district court action and was therefore time barred. The PO had attempted to serve its complaint at two of the petitioner’s office locations more than one year before the petition was filed. However, the exhibits to the complaint were not included in either of those two service attempts. The petitioner argued that the date of service for purposes of § 315(b) was the date that it filed a waiver of service with the district court, and that because the waiver of service was filed less than one year before the petition was filed, the petition was not time barred under § 315(b). The Board agreed with...

New Jersey Enacts Anti-SLAPP Legislation

Lawsuits filed to intimidate or punish those who are engaged in constitutionally protected activity by, in effect, suing them into submission or silence through the prospect of expensive and time-consuming litigation are commonly referred to as strategic lawsuits against public participation (SLAPP). On September 7, 2023, Governor Murphy signed New Jersey’s first anti-SLAPP legislation, which is designed to thwart such lawsuits by providing a process for early dismissal of these suits and an award of costs and counsel fees to a prevailing moving party. New Jersey now joins 32 other states that have enacted some form of anti-SLAPP legislation. The legislation applies to a civil cause of action against a person based on the person’s: (1) communications during a legislative, executive, judicial, administrative, or other governmental proceeding; (2) communications on an issue under consideration or review by such a body; or (3) engagement in any other activity that is protected by the First Amendment freedoms guaranteed by the United States Constitution or New Jersey Constitution and that relates to a matter of public concern. Modeled after the Uniform Public Expression Protection Act (UPEPA), the New Jersey legislation: permits a SLAPP defendant to file an early application for an order to show cause to dismiss the cause of action in whole or in part establishes a...

Court Sends a Strong “Signal”: Defendants Sanctioned Over Their Failure to Preserve Ephemeral Communications and Surreptitious Use of Encrypted Email

“The Individual Defendants’ systematic efforts to conceal and destroy evidence are deeply troubling and have cast a pall over this action.” These are some of the harsh words used by the Honorable Dominic W. Lanza, District Judge for the United States District Court for the District of Arizona, in Federal Trade Commission v. Noland, in lambasting the defendants for their deliberate deletion of cellphone messages sent via the Signal app and their suspension/clearing of email messages sent through ProtonMail (an encrypted email platform). One day after individual defendant James Noland became aware that the FTC was investigating him and his business Success by Health (SBH), he required the other individual defendants – who are all part of SBH’s leadership team – to start using a pair of encryption communications platforms: the Signal app for their cellphones and ProtonMail for email messaging relating to SBH’s business. After doing so, the individual defendants stopped using their previous messaging platforms for work-related communications and turned on Signal’s auto-delete function. After the FTC filed the action, it obtained a restraining order appointing a receiver to assume control over SBH and required the individual defendants to produce their electronic communications and turn over the mobile devices used to operate the business. In his deposition, Noland failed to disclose the Signal...

Pay Equity Compliance Front and Center in New Jersey Department of Labor’s Proposed Regulations for the Temporary Workers Bill of Rights

The New Jersey Department of Labor recently issued proposed regulations for the Temporary Workers Bill of Rights (TWBR). The proposed regulations include new definitions and further guidance for employers to comply with TWBR’s pay equity requirements. The proposed regulations are open for public comment until October 20, 2023. By way of background, the TWBR, which became fully effective on August 5, 2023, seeks to protect more than 127,000 temporary workers working in the state and employed through a temporary help service firm in designated occupations, including protective services; food preparation and serving; building and grounds cleaning and maintenance; personal service and care; construction labor, helpers, and trades; installation, maintenance, and repair; production; and transportation and material moving. The TWBR, among other things, implements detailed wage notice requirements to be provided to temporary workers in both English and the temporary worker’s primary language, recordkeeping requirements, advanced notice for changes to temporary worker schedules, pay equity, and anti-retaliation rights with a rebuttable presumption for any disciplinary action taken within 90 days of a temporary worker’s exercise of those rights. The goal of the TWBR is to strengthen employment protections for temporary workers in these designated occupations, and employers need to be mindful of the TWBR’s requirements for compliance purposes. The TWBR’s pay equity component requires temporary workers...

The District of Delaware Adopts the Federal Circuit’s Factors in Rejecting Regulatory Bar in a Protective Order

In Amicus Therapeutics US, LLC v. Teva Pharmaceuticals USA, Inc., United States Magistrate Judge Christopher J. Burke rejected the defendants-generic drug manufacturers’ demand that a so-called regulatory bar be included in the parties’ proposed protective order. In denying the request, Judge Burke adopted the Federal Circuit’s approach as set forth in cases like In re Deutsche Bank Trust Co. Ams., 605 F.3d 1373 (Fed. Cir. 2010). Despite denying the defendants’ request, and while noting the rarity of courts ordering the inclusion of similar provisions in protective orders, Judge Burke explicitly left the door open to the possibility, emphasizing the highly fact-sensitive nature of these disputes. The defendants sought the inclusion of a regulatory bar that would preclude anyone who was granted access to information marked “Confidential” or “Highly Confidential” under the proposed protective order from participating in any FDA proceedings concerning migalastat (the drug at issue in the case), including by filing a citizen petition. In deciding under what factors to analyze this discovery dispute, Judge Burke identified two possibilities: (a) the Third Circuit’s Pansy factors, or (b) the Federal Circuit’s Deutsche Bank factors. The court and the parties agreed the latter should be applied because the Third Circuit’s Pansy factors generally concern whether information should be protected from intentional disclosure from the public, whereas...

What Employers Should Know About the EEOC Proposed Rulemaking on the Pregnant Workers Fairness Act

The Pregnant Workers Fairness Act (PWFA) went into effect on June 27, 2023. The PWFA protects pregnant employees and job applicants by filling the gaps in protections for pregnant workers under existing federal laws (Title VII, Americans with Disabilities Act (ADA), Family Medical Leave Act). Specifically, the PWFA imposes broader and more widely available reasonable accommodation responsibilities for employers with 15 or more employees. On August 7, 2023, the Equal Employment Opportunity Commission (EEOC) posted its Notice of Proposed Rulemaking (NPRM), to implement the PWFA. On August 11, 2023, the EEOC published the NPRM for public comment in the Federal Register. The purpose of this alert is to present a high-level overview of particularly relevant considerations within the proposed regulations and highlight some potential pitfalls and protections under the PWFA of which employers should be aware. As noted above, the intention of the PWFA is to fill in gaps existing within federal legislation, while at the same time streamlining the accommodation process and making it less burdensome for workers affected by pregnancy, childbirth, or related medical conditions. In essence, the PWFA aims to make pregnancy accommodations more accessible, while still preserving the spirit of the interactive accommodation process. Indeed, there are many similarities in the PWFA and the ADA interactive process. In addition, the PWFA...

The NLRB’s Ongoing Shift Toward Employee-Friendly Standards

The labor law landscape is constantly in flux as changes in presidential administrations continue to play a significant role in the development of rulemaking and decisional law at the National Labor Relations Board (NLRB or the “Board”). Over the past several months, various NLRB decisions and guidance memorandums have tipped the scales further in the employee’s favor, requiring employers to re-think their current policies and agreements to avoid the pitfalls created by these recent decisions. Employee Handbook Policies The NLRB’s August 2nd opinion in Stericycle, Inc., 372 NLRB No. 113 (2023), found an employee policy unlawful because, from the employee’s perspective, it had a “reasonable tendency” to discourage employees from exercising their rights under the National Labor Relations Act (NLRA). This decision is a departure from the previous standard where the Board examined, “the nature and extent of the potential impact on NLRA rights, and [] legitimate justifications associated with the rule.” Now a policy is unenforceable if an employee could reasonably interpret it to restrict conduct protected under the NLRA, i.e., if the policy was enacted in response to such protected conduct, or if the policy, in practice, limits rights under the NLRA. In other words, the Board’s primary concern is whether an employee believes they cannot avail themselves of the concerted activities protected...

“Say Cheese!” CVS Passport Photo Practices Subject to BIPA Suit

In May 2022, a group of plaintiffs brought a putative class action against CVS Pharmacy, Inc. (CVS) alleging the company violated several provisions of the Illinois Biometric Information Privacy Act (BIPA) through its practices for taking passport photos. On May 4, 2023, in Daichendt and Odell v. CVS Pharmacy, Inc., the United States District Court for the Northern District of Illinois denied CVS’s motion to dismiss, holding the plaintiffs sufficiently stated a claim under Section 15(b) of BIPA. Section 15(b) of BIPA prohibits private entities from collecting “or otherwise obtain[ing] a person’s or a customer’s biometric identifier or biometric information, unless it first”: (1) provides notice of collection; (2) provides notice of the specific purpose of collection; and (3) obtains affirmative written consent. Here, the plaintiffs alleged that CVS required them to “enter[] their names, email addresses, and phone numbers into a computer terminal inside defendant’s stores prior to scanning their biometric identifiers.” Thereafter, CVS’s system would “check” and “verify” an individual’s facial features (i.e., whether the individual is smiling) to comply with government requirements. Against this backdrop, the plaintiffs argued this system violated Section 15(b) because it “collected and stored their personal contact data (‘real-world identifying information’), such as their names and email addresses,” thus allowing CVS the ability to identify the plaintiffs “when...

Landmark Flood Disclosure Bill Now Law in New Jersey, Applies to Both Commercial and Residential Property

On June 30, 2023, the New Jersey General Assembly unanimously passed Bill S3110/A4783, which will require sellers of real property and landlords to make specific disclosures regarding a commercial or residential property’s flood risk. The bill was amended to concur with the recommendations of Governor Murphy’s May 8, 2023, Conditional Veto Statement and was enacted into law upon passage. New Jersey was previously one of less than half of the states in the country that did not require any flood disclosures for real estate transactions. Landlord & Seller Flood Disclosure Requirements Specifically, Senate Bill No. 3110 requires landlords and sellers of commercial or residential real property to disclose to prospective tenants and buyers if a property is located in an area designated by the Federal Emergency Management Agency (FEMA) as a Special Flood Hazard Area (known as the 100-year flood plain) or Moderate Risk Flood Hazard Area (known as the 500-year flood plain), and if the property has suffered flood damage in the past to the owner’s knowledge. Sellers are also required to disclose additional facts related to the property’s flood insurance and flood damage history. Additionally, landlords are required to notify tenants of the possible availability of flood insurance via the National Flood Insurance Program. The New Jersey Department of Community Affairs (NJDCA) is...