[Ip-health] US Congressional Committee considers pressure on India over drug patents

Jamie Love james.love at keionline.org
Mon Mar 25 20:04:58 PDT 2013


US Congressional Committee considers pressure on India over drug patents

25. March 2013

On March 13, 2013, the U.S. House of Representative held a hearing on
U.S.-India Trade Relations. Among the several topics under discussion were
"the issuance of compulsory licenses, patent revocations, and other
policies on pharmaceuticals" in India.

The hearing was held in the Trade Subcommittee of the House Ways and Means
Committee, under the new subcommittee chair, Devin Nunes, a Republican from
the 2nd District in California. The title of the hearing was "U.S.-India
Trade Relations: Opportunities and Challenges," and it featured testimony
by Roy Waldron of Pfizer, and four other witnesses who mostly focused on
other topics. I have provided a youtube.com video [2] of the exchanges that
involved Waldron. The video of the entire hearing is available here [3].

Waldron's written testimony [4] included a variety of complaints about the
India patent law, focusing on the failures to obtain patents for some
products, including those denied under Section 3(d) of the India patent
law, the India system of pre-grant opposition to patents under Section
25(1) of the India patent act, the Nexavar compulsory licensing case under
Section 84 of the India patent act, the requirements for local
manufacturing, and the new proposals to grant compulsory licenses under
Section 92 of the India patent act. Waldron also asserted that India had
not complied with TRIPS requirements for the protection of test data, and
complained that drug regulatory authorities did not block drug approval
where there are assertions of patent protection.

The Committee appeared generally sympathetic to the Pfizer complaints,
despite the fact that Waldron made a number of assertions that were wrong
or dubious, and Pfizer was recommending actions that would raise drug
prices for billions of persons living in developing countries. But there
was no consensus on how best to act, even among the witnesses. Pfizer was
asking that the U.S. government "review  all  available  policy  tools  in
 light  of  India’s deteriorating intellectual property environment,"
including increases on tariffs on goods from India. Other witnesses urged
caution on measures that would be seen as unilateral trade relation, and
recommended that the U.S. engage India in broader trade discussions.

In an exchange worth listening to, Arvind Subramanian from the Peterson
Institute for International Economics noted that India officials did not
agree with the assessment that they were not in compliance with trade
standards. Subramanian also was skeptical that certain unilateral sanctions
would be effective. Subramanian suggested that if India was not in
compliance with WTO TRIPS rules, U.S. trade officials use the dispute
resolution procedures within the WTO. (17:15 to 19:13 in the clip above)

Pfizer referred to the WTO dispute resolution option as a blunt instrument
with unintended consequences (19:50).

KEI has repeatedly asked USTR why it continues to assert that India's laws
on patents or drug registration are not consistent with the WTO's TRIPS
rules, while it declines to bring a dispute before the WTO, and we assume
this is because the U.S. thinks it would lose the case.

The fact that the US never litigates its complaints against India in the
WTO permits it continue to exaggerate or lie about the WTO obligations on
India and other countries, and to seek other more political methods of
achieving its objectives. Some of the witnesses at the hearing seemed
uncomfortable with the idea of the pharmaceutical industry having an
excessive amount of influence on U.S./India trade relations, sensing that
there are limits to U.S. influence, and too much attention for Pfizer's
efforts to keep drug prices high in India would have consequences for other
industries that were trying to expand trade with India.

Congressman Larson quotes Gandhi on behalf of Pfizer

At 14:50 in the video clip, Representative John Larson (Democrat
representing Connecticut's 1st Congressional district) had the surprising
idea to quote Gandhi in connection with Pfizer's recommendation that the
United States government pressure government officials in India to raise
prices of drugs for cancer and other illnesses.

Larson: "I believe it was Gandhi that said I want all the winds of the
world to be able to blow freely through my house, but I will not be blown
over by any. And It seems to me, both Mr. Waldron and Mr. Garfield, that
what you have said, this will enhance their ability to stand with the rest
of the world."

In the context of Mr. Waldron's testimony, this was an appalling choice.

*Witnesses at the March 13, 2013 hearing included:

Dan Twining, a Senior Fellow for Asia, German Marshall Fund of the United

Arvind Subramanian, Senior Fellow, Peterson Institute for International
Economics, and the Center for Global Development

Ambassador Allen F. Johnson, Founder, Allen F. Johnson & Associates, and
Former Chief Agricultural Negotiator, Office of the United States Trade

Dean Garfield, President & CEO, Information Technology Industry Council

Roy Waldron, Senior Vice President and Chief Intellectual Property Counsel,

Additional context

March 22, 2011 The production of generic drugs in India: A new trade
agreement with the EU would hinder access to drugs in developing
countries," BMJ 2011; 342:d1694. http://www.bmj.com/content/342/bmj.d1694[5]

March 12, 2012. KEI Statement on India's granting of compulsory license to
patents on cancer drug sorafenib (NATCO Vs. BAYER)
http://keionline.org/node/1384 [6]

Feb 21, 2013. KEI's February 17, 2013 Statement in Nexavar India compulsory
licensing case http://keionline.org/node/1657 [7]

[2] http://www.youtube.com/embed/M46H6bzTOss
[3] http://waysandmeans.granicus.com/ViewPublisher.php?view_id=2
[4] http://waysandmeans.house.gov/UploadedFiles/Pfizer_testimony31313.pdf
[5] http://www.bmj.com/content/342/bmj.d1694
[6] http://keionline.org/node/1384
[7] http://keionline.org/node/1657

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