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Baker McKenzie | USA | 3 Aug 2022
Patent linkage in the United States: key considerations for drug manufacturers
"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
Federal Circuit Tailors its Decision on Skinny Labels
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 tied to acts of ANDA submission
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 Asked to Correct Medicaid Drug Data
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
Patent Litigation Filings on the Increase with the COVID-19 Pandemic
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
Can They Really Do That? The Specter of Government-Authorized Infringement of Pharmaceutical Patents
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
At long last, landmark OTC Drug reform legislation is enacted
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
2019 FDA Enforcement Review: Drugs, Biologics, Devices, and Dietary Supplements
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
Congress to Pharma: Hand Over Those Samples
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 and Indian Laws
Patent linkage may be regarded as a link between the marketing approval of the generic product and the patent status of the originator reference…
