IP Law 360

APRIL 22, 2024

Supreme Court on Monday rejected Vanda Pharmaceuticals Inc.'s s request for review of how the Federal Circuit is deciding whether patents are invalid as obvious, ending the company's attempt to revive patents covering its sleep disorder drug Hetlioz.

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IP Patent 52

Patently-O

APRIL 16, 2024

Pharmaceutical innovators are voicing concern that these disclosures are increasingly being used as prior art to invalidate patents arising out of, or otherwise relating to, these trials, in a manner that threatens to disincentivize investment in pharmaceutical innovation. By Chris Holman Salix Pharms., Norwich Pharms. Norwich Pharms.

Art 75

Art Patent Journalism Publishing 75

LexBlog IP

FEBRUARY 6, 2024

The legal battle between VANDA Pharmaceuticals, Inc. and the United States government provides guidance on the minimum requirements that the government must meet to protect trade secrets provided during the regulatory approval process for pharmaceuticals. ” 18 USC § 1905. ” 18 USC § 1905. ​

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Government Confidentiality Contracts Branding 52

IP Law 360

SEPTEMBER 26, 2023

Vanda Pharmaceuticals Inc. has hit federal drug regulators with a lawsuit claiming they wrongly gave the green light to an application on a generic version of the company's brand-name sleep drug Hetlioz, saying the government "turned a blind eye to" problems in the generic drug's studies.

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Branding Brands Branding Government 40

Patently-O

DECEMBER 11, 2023

Gateway, Inc., Assume also that the company selling the software doesn’t provide specific instructions on how to use the five features, thus taking potential liability outside the realm of § 271(b). 2019)(“In a pharmaceutical case, the noninfringing use must be in accordance with the use for which the product is indicated.”

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Patent Technology Litigation Reporting 44