USTR launched Out of Cycle Review for India

USTR has today launched an Out-of-Cycle Review for India, per this year’s Special 301 Report. USTR is accepting public comments until October 31st. (Interesting to note that it is only a two week window. For the last Review it was 3 weeks for public comments.)

Read the announcement here

In the 2014 Special 301 Report, the Office of the United States Trade Representative (USTR) announced that, in order to assess progress on engagement with the Government of India on intellectual property rights (IPR) issues, an Out-of-Cycle Review (OCR) would be conducted for India. USTR requests written submissions from the public concerning information, views, acts, policies, or practices relevant to evaluating the Government of India’s engagement on IPR issues of concern, in particular those identified in the 2014 Special 301 Report. The 2014 Special 301 Report is available at www.ustr.gov.

Deadlines:

Friday, October 31, 2014—Deadline for the public, except foreign governments, to submit written comments.
Friday, November 7, 2014—Deadline for foreign governments to submit written comments.

Posted in Indian Patent Law, Intellectual Property, Special 301 report | Leave a comment

DIPP defers decision on issuance of compulsory licence for cancer drug Dasatinib

Source: Economic Times

The department of industrial policy and promotion, or DIPP, has delayed a decision on issuing a compulsory licence for cancer drug Dasatinib by seeking fresh clarification from the health ministry early this week.

Through compulsory licensing — provided under the Indian Patent Act — the government can allow someone else to produce Dasatinib without the consent of the patent owner,Bristol-Myers Squibb. If the DIPP had agreed to issue such a license on health ministry’s recommendation, it would have cheered the public health activists, but would have had adverse repercussions on Indo-US relations.

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Posted in access to medicines, Compulsory Licensing, Indian Patent Law, Intellectual Property, Out of Cycle Review (OCR), patent, US pressure on India, USTR 301 report | Tagged , , , | Leave a comment

USTR Begins Special 301 Report Out-of-Cycle Review of India

Source: USTR

Washington, DC – In the 2014 Special 301 Report published in April, USTR called for renewed and intensive engagement on intellectual property (IP) issues with the Government of India, announcing that the United States would “redouble our efforts to seek constructive engagement that will both improve IP protection and enforcement in India and support India’s efforts to achieve a ‘decade of innovation’ and advance its legitimate public policy goals, including access to affordable medicines.”  USTR also announced that we would initiate an Out-of-Cycle Review (OCR) of India in the fall of 2014 to evaluate progress on this engagement. Continue reading

Posted in IPR Enforcement, IPR policy, Out of Cycle Review (OCR), US pressure on India, USTR 301 report | Tagged , | Leave a comment

Is India pulling the leg?

Source: The Asian Age

The Modi government has abandoned the fig leaf of adherence to public health goals… The first salvo was fired by Nirmala Sitharaman, signalling prior to Mr Modi’s visit to the US that India was willing to wash its IP sins

In 2005, during the parliamentary debate on the Patents Amendment Bill, Bharatiya Janata Party leader V.K. Malhotra stated, “The government will be now responsible for the consequences of the bill and the hardships that will heap upon the people”. Senior BJP leaders Murli Manohar Joshi and Yashwant Sinha argued that the new “product patent” regime would deliver a death blow to the Indian generic drug industry and many African nations would be deprived of low cost AIDS drugs. The BJP then was expressing its concerns regarding the switchover to a “product patent” regime mandated by the WTO’s TRIPS Agreement, and its consequences on Indian generic manufacturers and their ability to continue production of low cost versions of new medicines that were patented. But, sitting in the Opposition, their utterances could be seen as a ploy to embarrass the incumbent United Progressive Alliance government. To the latter’s credit, however, the final amendments enacted by the Indian Parliament incorporated many “health safeguards” (higher patentability standards, compulsory licensing, pre and post-grant opposition provisions, etc.) designed to mitigate the impact of TRIPS compliance on patients in India and developing countries. In fact, many commentators have since labeled the Indian Patents Act as a “model law”. Continue reading

Posted in Compulsory Licensing, Generic drug, USTR 301 report, TRIPS, Sec 3 (d), Hepatitis - C, IP Rights, patent, Novartis Case, access to medicines, WTO, Right to Health, Sofosbuvir, US pressure on India, IPR policy, Out of Cycle Review (OCR) | Tagged , , | Leave a comment

Inside Views: USTR’s Investigations On IP Rights Against India: Is There A Tenable Case?

Source: Ip-Watch

On 14th October, the US Trade Representative (USTR) began the out-of-cycle review (OCR) of India’s intellectual property (IP) laws, the mandate which it gave itself in the 2014 Special 301 Report. Like several years in the past, the USTR once again included India in the Priority Watch List, but this time, India’s IP laws are being subjected to the additional scrutiny through an OCR. It is to be seen whether the OCR sets the stage for naming India as a Priority Foreign Country (PFC), viewed by the USTR as worst offender of intellectual property rights (IPRs), in the next Special 301 report. Continue reading

Posted in Compulsory Licensing, USTR 301 report, TRIPS, US India BIT, patent, Novartis Case, access to medicines, WTO, Intellectual Property, US pressure on India, Innovation, Out of Cycle Review (OCR) | Tagged , , | Leave a comment

Egypt starts distributing Hepatitis C drug

Ahram Online , Thursday 16 Oct 2014

Egypt has started distributing Sovaldi, a drug for treating Hepatitis C.

Health Minister Adel Adawi announced at a press conference on Thursday that a new national plan was underway for the prevention of viral Hepatitis, which is rampant in Egypt.

The plan involves creating a database of patients in order to offer them future treatment strategies, and employing the latest treatment methods in hospitals.

Adawi had announced earlier that Egypt had received the first batch of Sovaldi – 50,000 doses – and his ministry was taking procedures to examine and distribute it. Media reports say that another 100,000 doses are expected by February.

Gilead Sciences will provide the drug for one percent of its market price, LE2,200 ($300), according to a previous statement by the health ministry.

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Posted in Drug Pricing, Hepatitis - C | Tagged , | Leave a comment

Investment: UN Rapporteur on right to health call for review of investment treaties

Source: TWN

17 Oct 2014

New Delhi, 13 October (K M Gopakumar) – Investment treaties should be reviewed to ensure that States have the right to make changes in their laws and policies to further human rights regardless of the impact of such changes on investors’ rights.

This recommendation came from the Special Rapporteur on Right to Health, Mr. Anand Grover, who just completed his term, in his last report to the UN General Assembly (UNGA). The UNGA is expected to consider this report in the third week of October.

The report notes that nearly 40 countries have already began renegotiation of international investment treaties.

Bilateral investment agreements are under intense scrutiny of various governments and civil society organizations due to the onerous obligations they create on governments, and the upscaling of the rights of TNCs.

[The call for reform of international investment treaties and agreements will also be made this week during the UNCTAD Investment Forum, which is taking place on 13-16 October in Geneva.]

The Grover report also calls for an international treaty to hold transnational corporations (TNCs) accountable for their violations on human rights.

[The Human Rights Council at its 26th session passed a resolution to start a process for an internationally legally binding instrument on TNCs. The resolution is titled “Elaboration of an international legally binding instrument on Transnational Corporations and other Business Enterprises with respect to Human Rights” available on: http://www.twn.my/title2/unsd/2014/unsd140605.htm]

The fifth part of the report deals with the accountability deficit of TNCs on human rights violations including the right to health. This part presents the current state of play with regard to the accountability of TNCs with regard to human rights violations. Two other sub-sections discuss the shortcomings of international investment treaties and the investor -state dispute settlement mechanism.

The report also discusses the justifiability of right to health, progressive realization of the right to health and enforcement of right to health (undocs.org/A/69/150).

TNCs and Human Rights

The report notes that TNCs’ “increasing presence in the world economy has enabled them to influence international and domestic law-making and infringe upon States’ policy space”.

On human rights violation, the report states that TNCs “have also affected the rights of large communities with impunity, causing displacement, contamination of groundwater and loss of livelihood. They have directly perpetrated serious human rights violations, in particular in developing and least developed countries.

They have thus seriously affected the laws, policies and social and economic environments of States and have violated the economic, social and cultural rights of individuals and communities, including the right to health.”

The report further says that it is “difficult for States or affected individuals to hold foreign transnational corporations accountable for harmful actions that were orchestrated through their domestic subsidiary”.

According to the report, “The magnitude of violations by transnational corporations and the ease with which they can evade responsibility for such violations call for an international mechanism to hold them liable for human rights abuses”.

The report also points out the shortcomings of a 2011 document prepared by the Special Representative of the UN Secretary-General on human rights and transnational corporations and other business enterprises: “Guiding Principles on Business and Human Rights – Implementing the United Nations ‘Protect, Respect and Remedy’ Framework”.

The first pillar of the Principles requires States to take measures including institution of laws to ensure accountability of TNC for their human rights violations. According to the Grover report “it could be argued, however, that the State obligation to protect, which is already an important obligation of States under international human rights law, has been ineffective against transnational corporations”.

Further, the report also critiques the idea of extending incentives for TNCs to comply with human rights standards and states that providing incentives for compliance makes respect for rights a means to attain an end (the promised incentive), but does not foster respect for rights in and of themselves”.

The report further points out that access to remedy against human rights violations mentioned in the Guiding Principles becomes ineffective due to the inability or unwillingness of States to hold TNCs accountable for their human rights violations.

The report adds that, “The Guiding Principles also fail to take into consideration the existing political context, whereby developing countries may be vulnerable to undue influence from transnational corporations. Business interests may be protected at the cost of the human rights of those affected communities that remain dependent on States to hold corporations accountable for violations. Non-binding responsibilities have therefore not prevented transnational corporations from violating human rights”.

According to the report “there is an urgent need for an international instrument that can address the increasing complexities presented by transnational corporations’ multi-jurisdictional organization and global influence. Moreover, because not all States have a robust regulatory mechanism, owing either to their poor negotiating power or because they are unwilling to hold domestic corporations accountable for harms caused, obligations should also be conferred on domestic corporations”.

Apart from the accountability and monitoring mechanism, the report calls for an effective enforcement mechanism to remedy and discourage violations. Towards this the report proposes an adjudicatory mechanism to examine individual or State complaints against transnational or domestic corporations.

International Investment Agreements

The report states that international investment agreements allow TNCs to reduce States’ policy space and States’ power to introduce health laws in the public interest.

It states that, “Given that the agreements are concluded between States, they do confer no obligations on transnational corporations to respect, protect and fulfil the right to health, allowing corporations to continue profit-making activities even if they are violating individuals’ right to health”.

The report questions the secrecy and lack of consultation at national level while negotiating investment agreements. It points out that “The rights to information and to participate in the decision-making process are essential for the enjoyment of the right to health. Those elements of the right to health framework are undermined when international investment agreements are negotiated and concluded in secrecy”.

According to the report “the practice of withholding information from stakeholders such as civil society groups has been held to be non-discriminatory, even where the same information was provided to corporations with the justification that corporations have expertise in matters relating to free trade agreements. Such inequity in access to information can enable corporations to influence the content of an international investment agreement in their favour”.

The report warns of the threat of investment and trade agreements on the enjoyment of right to health. “Pharmaceutical companies may be able to challenge the patent laws of host States if such laws do not comply with investors’ rights under the free trade agreement, even though such patent laws may be compliant with the Agreement on Trade-Related Aspects of Intellectual Property Rights. States may thus be unable to check the increasing cost of medicines, which undermines their core obligation to ensure access to health facilities, goods and services, including essential medicines, especially for vulnerable groups”.

The report notes that “International investment agreements are treated as a stand-alone legal code and often do not contain references to the right to health. They should, however, be interpreted in a manner that does not conflict with human rights law …”

The report calls on States to review these investment agreements to ensure that States have the right to change laws and policies in furtherance of human rights irrespective of the impact of such changes on the investor’s right.

In the absence of an international legal framework to hold TNCs accountable for their human rights violations, the report calls upon States to incorporate provisions in investment agreements to enable them to hold TNCs liable for human rights violations in both the home country and the host country. Furthermore, the report also urges States “to ensure their ability to implement human rights-friendly laws is not in any way hindered by the (investment) agreement”.

Investor-State Dispute Settlement

Grover’s report stress various shortcoming of the investor-state arbitration process provided in investment agreements.

According to the report, “the high cost of arbitration and the threat of an adverse judgment can create a chilling effect on States, dissuading them from fulfilling their right to health obligations.”  In addition, “These disputes may also deplete States’ resources, which can affect their ability to progressively realize the resource-dependent aspects of the right to health”.

It notes that out of 568 known investor-State arbitrations most of them were brought against developing countries and nearly 85% of the cases were brought by investors from developed countries.

The report states that, “the current system of investor-State dispute settlement also suffers from bias and conflicts of interest. The dispute settlement is controlled by a small clique of arbitrators and lawyers, and the same person may be counsel, arbitrator and adviser to an investor or State at different times”.

According to the report the “ the enormous size of such awards can have a negative effect on the State’s ability to implement health policies. For example, in CME v. Czech Republic, the compensation awarded to the investor was equal to the entire health budget of the States.

The key recommendations of the report are as follows:

- States review, renegotiate or enter into international investment agreements in an open and transparent manner, with the participation of affected communities and other stakeholders;

- International investment agreements should include provisions that:
(a) Confer human rights obligations on host and home States and investors;
(b) Allow host States to modify existing laws, or adopt new laws, to comply with their obligations under the right to health or in times of crisis affecting the entire State;
(c) Enable States to initiate disputes when investors do not comply with or violate the right to health.

- Investor-State dispute settlement systems should be made transparent and be modified to:
(a) Ensure that arbitrators are unbiased;
(b) Establish a regionally representative, permanent panel of arbitrators;
(c) Require the details of a dispute to be published and continuously updated as soon as an investor issues the notice of intent;
(d) Ensure that non-parties to disputes have the right to attend arbitration proceedings;
(e) Ensure that those who are not party to the dispute, especially affected communities, have a right to make written and oral submissions;
(f) Allow arbitration to be conducted in host States to facilitate access to the arbitration by interested parties;
(g) Institute a system of review of arbitration awards to reduce arbitrariness.

- The adoption of an international treaty that will:
(a) Confer specific, binding human rights obligations, including the right to health, on transnational corporations;
(b) Prevent investors from encroaching on States’ policymaking space;
(c) Provide for an accessible and effective adjudicatory forum where States and individuals can hold transnational corporations accountable for violations of the right to health.

- Until an international treaty is formulated, States adopt a declaration on human rights obligations of transnational corporations.+ 

Posted in FTAs, Investment treaties, investor state dispute | Leave a comment

FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions

Source:

Posted 13 October 2014 By Alexander Gaffney, RAC

Source: The Regulatory Affairs Professionals Society (RAPS)

On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value.

Background

In the US, pharmaceutical manufacturers who obtain approval to market a “new” drug from FDA are eligible for varying degrees of market- (rather than patent-) based exclusivity.

For New Chemical Entities (NCEs), that means five years of protection during which time FDA will not approve any generic equivalents. For “new” drugs that represent a new use for an old drug, or a new dose of an old drug, FDA is able to grant just three years of patent protection.

Historically, that meant that a fixed-dose combination (FDC) product consisting of at least one already-approved entity was ineligible for five years of exclusivity—just three.

New Guidance

But on the morning of 10 October 2014, FDA released a new, final policy which markedly changed its interpretation of the drug marketing exclusivity provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act) in response to multiple petitions from the pharmaceutical industry.

“Accordingly, a 5-year NCE exclusivity determination will be made for each drug substance in a drug product, not for the drug product as a whole,” FDA wrote in the guidance, New Chemical Entity Exclusivity Determinations for Certain Fixed-Dose Combination Drug Products.

“As a result, an application for a fixed-combination submitted under section 505(b) of the FD&C Act will be eligible for 5-year NCE exclusivity if it contains a drug substance, no active moiety of which has been approved in any other application under section 505(b).30,” FDA explained. “For example, a fixed-combination drug product that contains a drug substance with a single, new active moiety would be eligible for 5-year NCE exclusivity, even if the fixed-combination also contains a drug substance with a previously approved active moiety.”

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Posted in data exclusivity, Hepatitis - C | Leave a comment