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King & Wood Mallesons | China | 1 Aug 2016

Highlights on the draft rules of drug registration

On July 25, 2016, the China Food and Drug Administration ("CFDA") published the Administrative Provisions for Drug Registration (Revision) (the


Marks & Clerk | United Kingdom, European Union | 6 Mar 2014

CJEU referral on Bolar exemption

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


Dechert LLP | USA | 3 Feb 2012

What is an RLD and why does it matter?

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.


Gowling WLG | Canada | 28 Jun 2011

Data protection in Canada: too much? Too little?

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.


Stikeman Elliott LLP | Canada | 1 Dec 2010

Apotex succeeds in getting a NOC despite itself

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.


Shook Hardy & Bacon LLP | USA | 18 Nov 2010

Stakeholders provide input on FDA review standards for biosimilars

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).


Alston & Bird LLP | USA | 28 Oct 2010

FDA issues new guidance on research not requiring an IND

In October, FDA issued a draft guidance entitled "Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can be Conducted Without an IND."


Bird & Bird LLP | European Union | 21 Oct 2010

Policy on use patents for the registration of generic medicinal products

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.


Hogan Lovells | Spain | 14 Oct 2010

Spanish Supreme Court rules on Bolar and experimental research exemption

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.


McMillan LLP | Canada | 7 Oct 2010

Innovator duty of care in the pharmaceutical industry

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?

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