Reflections on the Pending Supreme Court Challenge to the Affordable Care Act in California v. Texas: Part One in a Series

VIKRAM DAVID AMAR, EVAN CAMINKER, JASON MAZZONE

In this first of a series of columns on the latest prominent challenge to the Affordable Care Act (ACA), Illinois law dean Vikram David Amar, Michigan Law dean emeritus Evan Caminker, and Illinois law professor Jason Mazzone examine the stare decisis effects of the Supreme Court’s initial blockbuster decision involving the ACA. The authors demonstrate several, perhaps surprising, ways that the earlier decision should shape how the Court views the present challenge.

Read More

Akebia Therapeutics, Inc. v. Azar

Court: US Court of Appeals for the First Circuit

Docket: 20-1161

Opinion Date: September 30, 2020

Judge: Selya

Areas of Law: Drugs & Biotech

The First Circuit affirmed the judgment of the district court denying Akebia Pharmaceuticals, Inc.'s motion for a preliminary injunction, holding that the district court did not err or abuse its discretion in denying a preliminary injunction in this case. Akebia sued the Administrator of the Centers for Medicare & Medicaid Services (CMS), the Secretary of the Department of Health and Human Services, and other related defendants asserting that CMS acted arbitrarily, capriciously, and contrary to law regarding the reimbursement protocol for Auryxia, a drug owned by Akebia, when prescribed for treatment of iron deficiency anemia in patients with chronic kidney disease. Akebia moved for a preliminary injunction seeking to pause the coverage determination until CMS's interpretation could be entirely litigated. The district court denied the motion. The First Circuit affirmed, holding that the district court did not err in holding that Akebia failed to carry its burden of showing that it was likely to succeed on the merits of its claims.

Federal Trade Commission v. AbbVie Inc

Court: US Court of Appeals for the Third Circuit

Docket: 18-2621

Opinion Date: September 30, 2020

Judge: Hardiman

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

AndroGel is a testosterone replacement therapy that generated billions of dollars in sales. The Federal Trade Commission sued under Section 13(b) of the Federal Trade Commission Act, alleging that AndroGel’s patent owners filed sham patent infringement suits against Teva and Perrigo and entered into an anticompetitive reverse-payment agreement with Teva. The FTC accused the patent owners of trying to monopolize and restrain trade over AndroGel. The District Court dismissed the FTC’s claims to the extent they relied on a reverse-payment theory but found the owners liable for monopolization on a sham-litigation theory and ordered disgorgement of $448 million in ill-gotten profits. The court denied the FTC’s request for an injunction. The Third Circuit reversed in part, holding that the district court erred by rejecting the reverse-payment theory and in concluding the owners’ litigation against Teva was a sham. The court erred by ordering disgorgement because that remedy is unavailable under Section 13(b) of the FTC Act. The court affirmed in part. The district court correctly concluded that the Perrigo litigation was a sham and that the owners had monopoly power in the relevant market but did not show the monopolization entitles the FTC to any remedy. The court did not abuse its discretion in denying injunctive relief.

Biogen MA Inc. v. EMD Serono, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1133

Opinion Date: September 28, 2020

Judge: Richard Linn

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

Biogen’s patent is directed to a method of treating a viral condition, a viral disease, cancers, or tumors, by the administration of a pharmaceutically effective amount of a recombinant polypeptide related to human interferon-β (IFN-β). Biogen sued Serono, alleging contributory and induced infringement of the patent by the sale and marketing in the U.S. of Rebif, a recombinant IFN-β product used for the treatment of Multiple Sclerosis. A jury found that the patent claims were anticipated by two references teaching the use of native IFN-β to treat viral diseases; that the asserted claims not invalid for lack of enablement or written description, or for obviousness; that patients and prescribers directly infringed the asserted claims; and that Serono contributorily infringed the claims but did not induce infringement thereof. The district court granted judgment as a matter of law of no anticipation in favor of Biogen and conditionally granted a new trial on anticipation; sustained the jury’s verdict of no invalidity based on written description or enablement; overturned the verdict of no induced infringement; sustained the verdict of contributory infringement; and held that the claims were not patent ineligible. The Federal Circuit reversed with respect to anticipation and the conditional grant of a new trial. A reasonable jury could find the claims of the patent anticipated on the record presented. The court remanded with instructions to reinstate the verdict of anticipation.

Dolt, Thompson, Shepherd & Conway, P.S.C.

Court: Kentucky Supreme Court

Dockets: 2019-SC-0197-DG, 2019-SC-0199-DG

Opinion Date: September 24, 2020

Judge: Wright

Areas of Law: Drugs & Biotech, Government Contracts

In this case related to the disbursement of Purdue Pharma funds, the Supreme Court reversed the court of appeals' grant of summary judgment for the Office of the Attorney General (OAG) and Dolt Thompson declaring that a contract was enforceable and a payment to Dolt, Thompson, Shepherd & Kinney, P.S.C. (Dolt Thompson) was proper, holding that the circuit court did not err. The then-attorney general filed a lawsuit against Purdue Pharma regarding the OxyContin epidemic. The OAG selected Dolt Thompson to assist in the Commonwealth's litigation against Purdue Pharma. After the OAG settled with Purdue Pharma it paid Dolt Thompson in part. The Legislature then passed a 2016 budget bill directing payment of attorney's fees and expenses in the Purdue Pharma case. The OAG filed a complaint seeking a declaration that the payment to Dolt Thompson was proper. The Finance Cabinet filed an action against Dolt Thompson. The circuit court consolidated the cases and entered summary judgment for the OAG and Dolt Thompson. The court of appeals reversed and ordered the circuit court to allow the Cabinet to conduct discovery. The Supreme Court reversed, holding that the Legislature acted within its authority in stating that the attorney's fees should be paid prior to any other disbursement of the Purdue Pharma funds.