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559 results found

Article

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…
Article

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…
Article

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…
Article

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…
Article

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…
Article

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…
Article

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…
Article

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…
Article

Banner Witcoff | USA | 7 Nov 2019

Federal Circuit to Decide if Patentee is Bound by Earlier Statement to PTAB

Should a patentee be held to all statements it makes about its claims? Does prosecution history estoppel flow from a patentee’s arguments no matter…
Article

LexOrbis | India, USA | 29 Jul 2019

Competitive generic therapy: Manna for generic companies

The US Food and Drug Administration (FDA) has over the years come up with initiatives to protect the interests of both the Patented and generic drug…
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