On July 25, 2016, the China Food and Drug Administration ("CFDA") published the Administrative Provisions for Drug Registration (Revision) (the
The so-called Bolar exemption, which allows third parties to test patented drugs and agricultural products, has long produced uncertainty in the life sciences sector, owing to the disparate understanding of EU member states of its scope and a lack of clarity over which acts are exempt from infringement
Early last month we blogged about the case Moore v. Mylan, Inc., 2012 U.S. Dist. LEXIS 6897 (N.D. Ga. Jan. 5, 2012) another post-Mensing generic preemption case.
Prior to the enactment in 2006 of the amendments to section C.08.004.1 of the Food and Drugs Regulations (Data Protection Regulations), Canada did not have an effective regime of data protection exclusivity.
A recent Federal Court decision highlighted the differences in prohibition proceedings under the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations) and impeachment actions under the Patent Act.
The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics).
In October, FDA issued a draft guidance entitled "Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can be Conducted Without an IND."
Marketing authorisation holders of generic medicinal products sometimes remove information from the summary of product characteristics (SmPC) and the patient information leaflet to prevent the potential infringement of a use patent.
In a decision of 30 June 2010, the Spanish Supreme Court ruled that the Bolar provision implemented in Spain in July 2006 did not have a retroactive effect.
Does the inventor or "innovator" of a brand-name drug have a duty of care to the consumers of that drug's generic equivalent manufactured by a competitor?