Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 06 July 2015 | By Michael Mezher
An Indian manufacturer has filed the third-ever compulsory license application in India for AstraZeneca's type II diabetes drug saxagliptin, SpicyIP reports.
Compulsory licensing is a legal provision that allows for the licensing of intellectual property rights without the rights holder's consent.
The power to grant these licenses is seen by some countries, especially low- and middle-income ones, as a powerful tool to ensure important drugs are available and accessible to their citizens. On the other hand, the innovative pharmaceutical industry sees compulsory licensing as a threat to intellectual property rights, and has campaigned to limit their use.
Despite complaints from industry, compulsory licenses are relatively rare. One study found only 24 instances of compulsory licenses being issued for 40 specific pharmaceutical patents between 1995 and 2011. In its history, India has issued only one compulsory license for a drug, Bayer's cancer drug Nexavar in 2012.
On an international level, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes standards for issuing compulsory licenses for World Trade Organization (WTO) members. Outside of TRIPS, individual countries' national law must dictate the specific terms and requirements for compulsory licensing.
In India, compulsory licenses are covered in Chapter XVI of The Patents Act, which establishes the criteria for obtaining a compulsory license as well as the terms of such licenses and the powers of the government related to them.
On 25 June 2015, Lee Pharma filed an application to obtain a compulsory license for Patent No. IN 206543 covering saxagliptin. The patent in question was originally granted to Bristol-Myers Squibb (BMS) in 2007 before being transferred to AstraZeneca.
To obtain a compulsory license in India, a company must satisfy at least one of the grounds established in Section 84 of The Patents Act:
"84. Compulsory licences.—(1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely:—
that the reasonable requirements of the public with respect to the patented invention have not been satisfied, orthat the patented invention is not available to the public at a reasonably affordable price, orthat the patented invention is not worked in the territory of India."
Additionally, the company must prove they have made reasonable efforts to voluntarily license the patent before a compulsory license can be issued.
According to SpicyIP, it is likely Lee Pharma's efforts to voluntarily license saxagliptin will be enough to satisfy the requirement for reasonable effort in Section 84. The company claims it initiated voluntary licensing efforts with BMS in May 2014, but after several exchanges with BMS and its lawyers, Lee Pharma said it stopped receiving responses.
In its application, Lee Pharma makes the case that it should be granted a compulsory license to manufacture saxagliptin under all three grounds laid out in Section 84 of The Patents Act.
Lee Pharma alleges BMS and AstraZeneca do not import enough of the drug to meet demand in India, where they estimate some 60 million people have type II diabetes. The company also claims the drug is too expensive, costing around 45 rupees per pill, versus the 30 rupees per pill Lee Pharma would charge.
However, there are several possible points of contention to Lee Pharma's claims. First, saxagliptin is one of several dipeptidyl peptidase-4 inhibitors used to treat type II diabetes which are also available in India. Lee Pharma's cost and availability claims are obscured given that patients can already obtain an Indian-manufactured generic version of a similar drug, sitagliptin for slightly less than what Lee Pharma says it would sell saxagliptin for.
Because of the availability of other drugs for type II diabetes, and the relatively small difference in price being offered by Lee Pharma, it is likely the case for a compulsory license will hinge on availability or the specific need for saxagliptin versus alternative treatments.
SpicyIP, IP India (Select PDF dated 29-6-2015)
Tags: Compulsory license, saxagliptin, Lee Pharma, AstraZeneca
Regulatory Focus newsletters
All the biggest regulatory news and happenings.