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Supreme Court Finds CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Hospitals was Not Authorized by Statute

FDA Law Blog

Circuit, but today, the Supreme Court reversed again and upheld the District Court’s opinion in American Hospital Assn v. Writing for a unanimous court, Justice Kavanaugh explained that the Medicare statute provides CMS a choice between two options on how to set reimbursement rates for drugs provided in the hospital outpatient setting.

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Patent Law at the Supreme Court February 2022

Patently O

Eligibility under Section 101 : American Axle & Manufacturing, Inc. 20-1394 (CVSG requested October 4, 2021); Undermining Jury Decisions : Olaf Sööt Design, LLC v. Qualcomm , a case focusing on appellate standing following an IPR final written decision favoring the patentee. Neapco Holdings LLC, et al. , Patreon, Inc.,

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Reviewing the Patent Eligibility Restoration Act of 2022

Patently O

The short provision has remained essentially unchanged since it was originally handwritten in the 1700s and signed into law by President George Washington. ” Unfortunately, due to a series of Supreme Court decisions, patent eligibility law in the United States has become confused, constricted, and unclear in recent years.

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Second Circuit Decision A Reminder that Alleged FDCA violations don’t always equal FCA violations

FDA Law Blog

Brevig, Senior Regulatory Device and Biologics Expert — Earlier this year, we posted on the still unsettled state of the law regarding whether “FDCA violations may, in certain circumstances, be material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.” By JP Ellison & Holly N.

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Prefiling Offer by Business Partner Dooms Patent

Patently O

The collaborative idea was that Eddings would manufacture the sheaths because Junker did not have that capability. The Federal Circuit relies upon traditional contract law principles to determine whether a particular communication constitutes such an offer. Thus, the court has held that an offer-to-manufacture doesn’t count.

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Animal rights and the First Amendment, due process and a confession of error

SCOTUSBlog

Two pending petitions raise the question of the constitutionality of state statutes providing that corporations are deemed to have consented to “general” personal jurisdiction by virtue of having registered to do business in a state. Some older Supreme Court decisions support that theory of consent. Next up is Kelly v.

Statute 105
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Eligibility and the U.S. Solicitor General: Patenting the Scientific, Technological, and Industrial Arts

Patently O

These cases broadened scope of the “abstract idea” and “law of nature” exclusions in ways that largely overlap with other patent law doctrines, such as obviousness, indefiniteness, and even enablement. One difficulty with the law here is that it is entirely judge made. Prometheus Labs., 208 (2014).