Baker McKenzie | USA | 3 Aug 2022
"Patent linkage" is generally understood to be the practice of linking the granting of marketing approval or any other regulatory approval for a generic or biosimilar medicinal product to the status of a patent for the originator reference product. The concept of patent linkage is a contentious issue in the healthcare industry as it concerns the involvement of drug authorities with patent......
Dechert LLP | USA | 10 Aug 2021
As we sensed when we last wrote about the Federal Circuit’s handling of the infringement dispute over GlaxoSmithKline’s ("GSK") Coreg® product in…
Knobbe Martens | USA | 5 Nov 2020
Venue in Hatch-Waxman cases is proper only in districts where actions related to the Abbreviated New Drug Application (“ANDA”) submission occur. Mylan…
Manatt Phelps & Phillips LLP | USA | 22 Jun 2020
Drug manufacturers should immediately evaluate whether they have been correctly classifying their products in data submitted to the Medicaid Drug…
Squire Patton Boggs | USA | 4 May 2020
Over the last decade, filings of patent lawsuits in the US rose to unprecedented highs in 2013, and remained high for a while thereafter, but have…
Ropes & Gray LLP | USA | 27 Apr 2020
DRUG PRICES HAVE DOMINATED HEADLINES in recent years, and reducing health care costs for the public has been a talking point for both President Trump…
Hogan Lovells | USA | 6 Apr 2020
OTC drug companies will want to review this OTC monograph reform legislation closely, and begin preparing immediately for the innovation opportunities…
Ropes & Gray LLP | USA | 4 Feb 2020
The ongoing public health crises of opioid addiction and youth vaping1 undoubtedly captured Significant attention and enforcement resources in 2019, a…
Morgan, Lewis & Bockius LLP | USA | 8 Jan 2020
US President Donald Trump signed a pair of appropriations bills into law on December 20, including bipartisan legislation intended to facilitate the…
LexOrbis | India | 2 Dec 2019
Patent linkage may be regarded as a link between the marketing approval of the generic product and the patent status of the originator reference…