US, India Commit to ‘Collaboration’ in Health Sector

Posted 26 January 2015 | By Michael Mezher 

US, India Commit to ‘Collaboration’ in Health Sector

The governments of the US and India released a joint statement affirming the two countries’ commitment to work together in a number of key areas, including intellectual property rights and healthcare-related trade. The statement comes after US President Barack Obama met with Indian Prime Minister Narendra Modi during with India’s his visit coinciding 66th Republic Day celebrations.

The Statement

The 59-paragraph statement, released 25 January 2015, discusses the two countries’ relationships in a number of critical areas ranging from nuclear security to energy policy. Among these topics are several issues critical to the healthcare products industry in both countries.

The leaders of the two countries affirmed their commitment to cooperate on the topic of intellectual property rights (IPR) and to support advances made during the India-US Trade Policy Forum. The two countries’ engagement on IPR will be discussed in 2015 through the newly formed High Level Working Group on Intellectual Property.

The countries also agreed to “strengthen collaboration, dialogue and cooperation between the regulatory authorities of the two countries to ensure safety, efficacy and quality of pharmaceuticals, including generic medicines.” This collaboration will be fostered in part by a Healthcare Dialogue that will cover “affordable healthcare, cost saving mechanisms, distribution barriers, patent quality, health services information technology and complementary and traditional medicine.”

India-US Trade Policy Forum

Momentum has been gathering for intellectual property reform in India. In November 2014, India’s minister of commerce and industry, Nirmala Sitharaman, met with US Trade Representative Ambassador Michael Froman to discuss ways to boost trade and investment between the two countries.

The two representatives agreed to the importance “of ensuring the poorest populations in India and the US have access to quality healthcare [while] identifying ways in which trade and innovation policies can enhance access to quality health and affordable medicines.”

During the meeting, Sitharaman presented a draft policy that would revamp India’s IPR policy and “stimulate innovation.” The Indian government is soliciting comments on the draft policy through 30 January 2015.

Criticism of US Pressure on India

International humanitarian organization Médecins Sans Frontières (MSF) issued a press release in advance of Obama’s visit to India warning that the US pressure on India will have negative impacts on access to affordable drugs for the country.

MSF is highly critical of the US for “pushing” India to adopt IPR laws that are more in line with those in the US and EU. The organization also opposes India’s draft IPR policy, stating that the policy “emphasizes patent monopolies as the key driver of innovation,” which it views as a barrier to access and innovation.

Recent IPR Controversies in India

The topic of intellectual property rights (IPR) in India has been hotly debated in recent years following contested IPR decisions by India’s Patent Office and Supreme Court.

In 2013, Novartis AG lost its appeal to India’s Supreme Court over the denial of a patent for its cancer drug Glivec. In the case, the court ruled that Glivec was too similar to a previously patented compound and thus did not satisfy Section 3(d) of the Patents Act.

For more on India’s patent system see our January 2015 article, “In Major Decision, India Rejects Patent on Gilead’s Hepatitis C Drug Sovaldi.

Western companies have also criticized India for its use of compulsory licenses, which are covered in Section 84 of the Patents Act. In 2012, India issued its first compulsory license to Natco Pharma to produce a generic version of Bayer’s cancer treatment drug Nexavar. After an unsuccessful attempt to license Nexavar from Bayer, Natco filed a petition for a compulsory license to India’s Patent Controller. The Patent Controller found that Natco’s filing met the provisions of Section 84(1), which state:

“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 license on patent on any of the following grounds, namely:

  1. that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
  2. that the patented invention is not available to the public at a reasonably affordable price, or
  3. that the patented invention is not worked in the territory of India.”

In December 2014, Bayer lost its bid to India’s Supreme Court, which upheld a lower court’s ruling in support of the compulsory license.

White House Press Release

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles