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Jun 13, 2024 | 
mondaq.com | Chad Landmon |Ross Blau
Over the past year, FTC has placed two sets of Orange Book listings in its
crosshairs, but, to date, FTC has not actually begun any litigation
on its own.
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May 7, 2024 | 
mondaq.com | Chad Landmon |Matthew Murphy |Ross Blau
As discussed in November and December, the FTC has placed improper Orange
Book patent listings squarely in its crosshairs.
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Feb 15, 2024 | 
mondaq.com | Rebecca Clegg |Ross Blau
Tomorrow, the Federal Circuit will hear oral argument in
Contour IP Holding LLC v. GoPro, Inc., Case Nos. 2022-1654, -1691, once again stepping into complex questions of
patentable subject matter pursuant to 35 U.S.C. § 101 under
Alice. This case underscores the difficulty that courts
face in applying the judicially created exceptions to §
101's patent eligibility criteria.
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Feb 7, 2024 | 
jdsupra.com | Ross Blau |Rebecca Clegg
Today, the Federal Circuit will hear oral argument in Contour IP Holding LLC v. GoPro, Inc., Case Nos. 2022-1654, -1691, once again stepping into complex questions of patentable subject matter pursuant to 35 U.S.C. § 101 under Alice. This case underscores the difficulty that courts face in applying the judicially created exceptions to § 101’s patent eligibility criteria.
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Dec 22, 2023 | 
mondaq.com | Ted Mathias |Ross Blau |Chantelle Ankerman
On October 31, 2023, FDA approved Amgen's Wezlana
(ustekinumab-auub) as a biosimilar to and interchangeable with
Janssen's Stelara (ustekinumab). Stelara has been selected by
the Center for Medicare & Medicaid Services ("CMS")
as one of the first 10 drugs subject to the Inflation Reduction
Act's ("IRA's") price negotiations. Because of
price caps that the IRA will impose on Stelara, Wezlana will face a
different competitive landscape than the 6 interchangeables for
other drugs approved to date.
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Dec 21, 2023 | 
mondaq.com | Chad Landmon |Ross Blau
As discussed last month, the FTC sent letters to 10
pharmaceutical companies, asserting that their listing of over 100
patents in FDA's Orange Book for a variety of products was
improper. Shortly thereafter, the FTC began using the
administrative process with FDA to challenge these patent listings,
and all of the companies had until December 16, 2023 to respond.
It appears that prior to this deadline at least two companies
– Impax Labs and Kaleo, Inc.
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Dec 15, 2023 | 
jdsupra.com | Chantelle Ankerman |Ross Blau |Ted Mathias
On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services (“CMS”) as one of the first 10 drugs subject to the Inflation Reduction Act’s (“IRA’s”) price negotiations. Because of price caps that the IRA will impose on Stelara, Wezlana will face a different competitive landscape than the six interchangeables for other drugs approved to date.
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Dec 15, 2023 | 
jdsupra.com | Ross Blau |Chad Landmon
As discussed last month, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in FDA’s Orange Book for a variety of products was improper. Shortly thereafter, the FTC began using the administrative process with FDA to challenge these patent listings, and all of the companies had until December 16, 2023 to respond. It appears that prior to this deadline at least two companies – Impax Labs and Kaleo, Inc.
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Nov 13, 2023 | 
jdsupra.com | Ross Blau |Chad Landmon |Matthew Murphy
FTC recently placed improper Orange Book patent listings squarely in its crosshairs.
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Sep 11, 2023 | 
mondaq.com | Chad Landmon |Matthew Murphy |Ross Blau |Gulrukh Haroon
Today, the Supreme Court denied certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, locking in the
Federal Circuit's second panel decision (hereafter
"GSK v. Teva"), which held that Teva's
attempted section viii carveout of an indication covered by a
patented method of use was not "skinny" enough to avoid
being liable for infringement.
