When Children Stay Home—A COVID-19 Consequence

KATHRYN ROBB

Kathryn Robb, executive director of CHILD USAdvocacy, describes how the COVID-19 pandemic uniquely endangers children who are being sexually abused by people close to them. Robb describes ways in which teachers, coaches, and other adult figures in children’s lives must do to ensure the safety of children in this time when schools and other safe spaces are shut down.

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Valeant Pharmaceuticals International, Inc. v. Mylan Pharmaceuticals Inc.

Docket: 18-2097

Opinion Date: April 8, 2020

Judge: Alan David Lourie

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

Valeant’s patent claims stable methylnaltrexone pharmaceutical preparations; methylnaltrexone, a quaternary amine opioid antagonist derivative, can be useful for reducing the side effects of opioids but is unstable in aqueous solution. The inventors discovered that when the pH of a methylnaltrexone solution is adjusted, the percentage of total degradants drops significantly. The patent is listed in the Orange Book for Relistor®, an injectable drug used to treat constipation as a side effect of taking opioid medication. Mylan filed an Abbreviated New Drug Application seeking FDA approval to market a generic version of Relistor®. Mylan conceded that its ANDA product would infringe claim 8 of the patent. The district court entered the parties’ stipulation to the construction of claim 8’s stability limitation: the phrase “the preparation is stable to storage for 24 months at about room temperature” means “the methylnaltrexone degradation products in the preparation do not exceed 2.0% of the total methylnaltrexone present in the preparation and the preparation is suitable for pharmaceutical use when stored for 24 months at room temperature” and granted summary judgment that claim 8 would not have been obvious. The court rejected Mylan’s expert testimony and cited references and Mylan’s theory that the claimed pH range would have been obvious to try. The Federal Circuit reversed. Mylar raised at least a prima facie case of obviousness. The district court’s obvious-to-try analysis is inconsistent with precedent.

Sistek v. Department of Veterans Affairs

Docket: 19-1168

Opinion Date: April 8, 2020

Judge: Stoll

Areas of Law: Government & Administrative Law, Labor & Employment Law

In 2011, Sistek was appointed as a director at the VA’s Chief Business Office Purchased Care. Sistek subsequently made several protected disclosures to the VA’s Office of the Inspector General (OIG) questioning various financial practices and perceived contractual anomalies. Sistek’s supervisor became aware of Sistek’s concerns. Sistek was subsequently subjected to an investigation. Sistek filed a complaint with the Office of Special Counsel (OSC) alleging whistleblower reprisal based on several personnel actions, including the letter of reprimand. Sistek later filed an individual right of action appeal with the Merit Systems Protection Board, alleging retaliation under the Whistleblower Protection Act. The Administrative Judge declined to order any corrective action, finding that a retaliatory investigation, in itself, does not qualify as a personnel action eligible for corrective action under the Act. The OIG subsequently confirmed that the concerns raised by Sistek were justified. Sistek retired from the VA in 2018. The Federal Circuit affirmed. The Act defines qualifying personnel actions at 5 U.S.C. 2302(a)(2)(A); retaliatory investigations, in and of themselves, do not qualify. The Act provides that a retaliatory investigation may provide a basis for additional corrective action if raised in conjunction with one or more of the qualifying personnel actions.

BASF Corp. v. SNF Holding Co.

Docket: 19-1243

Opinion Date: April 8, 2020

Judge: Alan David Lourie

Areas of Law: Intellectual Property, Patents

SF’s 329 patent is directed to an improved process for preparing high-molecular-weight polymers for use as super-absorbers in fields such as waste treatment and paper manufacturing. The district court entered summary judgment that certain claims were invalid as anticipated and that another was invalid as obvious. The court concluded that a process performed by a third party, Celanese’s “Sanwet® Process,” evidenced prior art knowledge and use of the patented invention under 35 U.S.C. 102(a), and constituted both a public-use bar and an on-sale bar to the patented invention under 35 U.S.C. 102(b). The Federal Circuit reversed. The district court misinterpreted section 102(a) and the public-use bar of section 102(b); under the proper legal standard, genuine issues of material fact precluded summary judgment. The “known or used” prong of 102(a) means “knowledge or use which is accessible to the public.” Members of the public had access to the plant, where they could view the shape of the conical taper; no evidence suggests that any of these guests was a skilled artisan. The parties dispute whether the remaining elements of the Sanwet® Process were known, and to the extent they were not, whether they were concealed from the public on these tours, in newspaper articles, and in the commemoration video.

Technical Consumer Products, Inc. v. Lighting Science Group Corp.

Docket: 19-1361

Opinion Date: April 8, 2020

Judge: Stoll

Areas of Law: Intellectual Property, Patents

The 968 patent is directed to replacement light-emitting diode (LED) light fixtures and seeks to minimize the need for customization by creating “low profile downlighting for retrofit applications” that accommodates various housing shapes and sizes. TCP petitioned for inter partes review of several claims. The Patent Trial and Appeal Board determined that TCP did not demonstrate by a preponderance of the evidence that claims 1–4, 6, 14, and 15 were anticipated by the “Chou” patent or that claims 3, 4, 7, 8, 11, 12, 16, 17, and 19–23 would have been obvious over Chou alone or in view of other prior art. The Board based its determinations exclusively on its finding that Chou does not disclose a single limitation (H/D limitation) in claims 1 and 20 of the 968 patent, the only independent claims at issue. The Federal Circuit vacated as to claims 2– 4, 6–8, 12, and 16. The Board’s determination that Chou does not disclose the H/D limitation in claim 1 of the 968 patent is not supported by substantial evidence. The Board’s conclusions regarding the H/D limitation resulted from an erroneous interpretation of the claim language and a misunderstanding of case law. The Board did not address any other arguments regarding the other limitations of claim 1 or of the rest of the challenged claims.

In Re: Forney Industries, Inc.

Docket: 19-1073

Opinion Date: April 8, 2020

Judge: O'Malley

Areas of Law: Intellectual Property, Trademark

Forney sells welding and machining products in packaging that displays its proposed mark. Forney applied for a trademark based on use in commerce under the Lanham Act, 15 U.S.C. 1051(a). Forney sought to register the mark without showing acquired distinctiveness, identifying its mark as a “color mark.” Forney stated: “[t]he mark consists of a solid black stripe at the top. Below the solid black stripe is the color yellow which fades into the color red. These colors are located on the packaging and or labels.” The examining attorney refused registration, finding the mark “not inherently distinctive” and stating that “[s]uch marks are registrable only ... with sufficient proof of acquired distinctiveness.” Forney revised the description: “The mark consists of the colors red into yellow with a black banner located near the top as applied to packaging for the goods. The dotted lines merely depict placement of the mark on the packing backer card.” The examining attorney again refused registration. The Trademark Trial and Appeal Board affirmed, treating the proposed mark as a color mark consisting of multiple colors applied to product packaging. The Federal Circuit vacated. The Board erred in finding that a color mark can never be inherently distinctive in the trade dress context and that, even if a color mark could be inherently distinctive, it cannot be absent a well-defined peripheral shape or border.