The pharmaceutical industry is stepping up the rhetoric against the Indian government and its various moves to provide wider access to certain medicines. The trade groups for both drugmakers and biotechs have joined a new coalition that maintains India is engaging in unfair trade practices and failing to respect patent rights on numerous products, but particularly medicines.
And on the same day that the Alliance For Fair Trade With India was announced with backing from PhRMA and BIO, 170 members of Congress wrote a letter to President Barack Obama and urged him to send a “strong signal” to the Indian government in the upcoming US-India Strategic Dialogue and other talks about a “growing trade imbalance” and the “bad precedent” its actions are setting (here is their letter).
In its own inaugural announcement, the coalition – which is co-chaired by the National Association of Manufacturers and the US Chamber of Commerce’s Global Intellectual Property Center – accused India of “systematically” discriminating against a “wide range of innovative products and exports in order to benefit” its own businesses at the expense of American jobs.
The moves come after a series of contentious developments in India. Two months ago, the Indian Supreme Court rejected a patent sought by Novartis for its Gleevec cancer medication after deciding the drugmaker sought to win additional intellectual property protection, but did not meet the standard for enhanced efficacy. Critics accused Novartis (NVS) of making minor changes to win added patent life, a practice called evergreening (back story).
That followed a decision by India's Intellectual Property Appellate board to reject an appeal from Bayer, which was fighting a compulsory license that permitted the sale of a generic version of its Nexavar cancer drug. The license was issued last year after Indian authorities determined that Nexavar pricing was deemed too expensive for most people in India (more here).
More recently, Indian authorities indicated still more compulsory licenses would likely be issued, but also began considering a proposal to eliminate licenses that would be granted based on the price of a brand-name medicine (read here). Meanwhile, though, the US Trade Rep recently kept India on its Priority Watch list of countries that have raised concerns about intellectual property rights, citing the two decisions (see this).
Drugmakers and biotechs argue that such compulsory licensing by the Indian government not only tramples their patent rights, but also dissuades them from making further investment in the country. Patient advocates counter that compulsory licenses are a needed tool to ensure that the poorest patients can afford needed medicines.
For years, in fact, advocacy groups have worked with the Indian generic drug industry to make it possible to provide lower-cost versions of brand-name medicines. And they note the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, offers compulsory licensing as an option to countries to make patented drugs more affordable for citizens.
“As a result of the Bayer license, the cost of the cancer medicine has now fallen more than 97 percent, showing the excess mark-up that Bayer imposes on patients. Rather than acting arbitrarily, the legal system in India allows a court review of the compulsory license decision, which Bayer is now pursuing,” writes Brook Baker, a professor at Northeastern University School of Law and an affiliate with the Program on Human Rights and the Global Economy. “Moreover, instead of acting protectionist in a trade sense, India is protecting public health, public resources and common sense in the face of monopoly pricing.”
In their letter to Obama, however, the lawmakers cited the Novartis and Bayer rulings to argue that “the intellectual property climate has become increasingly challenging in India. US companies have suffered from a whole host of IP issues” and that decisions related to compulsory licensing “are being improperly driven by an interest in growing the pharmaceutical market in India.”
Meanwhile, the new AFTI coalition vows to “ work with the Administration and members of Congress to pursue public policy options that help create a level playing field for US exporters operating in India” and “outline the consequences of inaction, specifically as they relate to job creation, economic growth and continued innovation.”
STORY ENDS HERE