India rejects Gilead's Hepatitis C drug patent request

[inanna]

Source: Reuters

(Reuters) - India's patent office has rejected an application from U.S.-based Gilead Sciences Inc for its hepatitis C drug Sovaldi, paving the way for local drugmakers to launch cheaper generic versions of the $1,000-a-pill medicine.

<snip>

The rejection will allow the Indian generic companies to make and sell versions of the drug in country where a majority of people live on less than $2 a day and health insurance is scarce.

Gilead could not immediately be reached for comment. Natco Chief Executive Rajeev Nannapaneni was not available outside regular Indian business hours.

Foreign drugmakers in India, a global hub for making generic drugs, have been frustrated by a series of decisions on patents and pricing, with the government looking to improve healthcare access.



Read more: http://in.reuters.com/article/2015/01/14/gilead-india-patent-idINKBN0KN20V20150114

[djean111]

1. I believe this is one of the reasons the US wants/wanted India to join the TPP -

I don't think they would be able to just say NO.

http://in.reuters.com/article/2015/01/14/gilead-india-patent-idINKBN0KN20V20150114

(Reuters) - India's patent office has rejected an application from U.S.-based Gilead Sciences Inc for its hepatitis C drug Sovaldi, paving the way for local drugmakers to launch cheaper generic versions of the $1,000-a-pill medicine.

The application had been opposed by Indian generic drugmaker Natco Pharma Ltd and New York-based Initiative for Medicines, Access & Knowledge (I-MAK) on the grounds that the drug, chemically called sofosbuvir, is not inventive enough compared with a previous formulation, according to patent office order documents seen by Reuters on Wednesday.

India's patent laws allow a third party to dispute the validity of a pending patent application.

The patent office's order said Gilead's request for Sovaldi, which is normally given for either three or six months and costs $84,000 for a 12-week course in the United States, was rejected on the basis that "minor changes in the molecule" did not improve efficacy of the drug.

This (below) is from 2013 - now, joining the TPP would effectively stop India from producing low cost generics.

http://jonathanturley.org/2013/09/26/obama-to-india-block-production-of-low-cost-generic-drugs-or-else/

Obama will meet with Indian prime minister Manmohan Singh this week at the White House to demand a change to its intellectual property laws. In addition to a long record of yielding to the demands of the pharmaceutical industry, Obama has also yielded to copyright and trademark hawks who has secured ever increasing criminal and civil penalties in the field. Here, the industry wants to cut off the supply of affordable medicine coming out of India due to its large generic drug industry. The industry is alarmed by the fact that India’s market is forcing the cost of drugs down for HIV, TB, and cancer by more than 90 percent.

Critics charge that Obama is basically reading from a script written by Pfizer and the industry in threatening retaliation if India does not change its intellectual property laws to limit the availability of generic drugs. There is no question that India’s legal system needs reform and intellectual property rules could be tightened. However, Doctors Without Borders insists that this is a raw effort to shutdown a country offering millions of people affordable medicine. If successful, the impact on the sick could be breathtaking if not life taking. Most AIDS drugs are generic and India supplies a huge amount of the HIV medicines.

The problem is that Indian courts have already supported the claims of Indian companies to produce such generics. For example, Novartis tried for seven years to block a low-cost generic salt form of the cancer drug imatinib, marketed as Gleevec. The Indian Supreme Court ruled that the company had every right to produce the drug and that the company, and by extension the U.S., was trying to impose effective monopoly pricing on consumers.

http://www.exposethetpp.org/TPPImpacts_Public-Health.html

The TPP would provide large pharmaceutical firms with new rights and powers to increase medicine prices and limit consumers' access to cheaper generic drugs. This would include extensions of monopoly drug patents that would allow drug companies to raise prices for more medicines and even allow monopoly rights over surgical procedures. For people in the developing countries involved in TPP, these rules could be deadly - denying consumers access to HIV-AIDS, tuberculosis and cancer drugs.

The TPP would establish new rules that could undermine government programs in developed countries. The TPP would control the cost of medicines by employing drug formularies. These are lists of proven medicines that the government selects for use by government health care systems. Lower prices are negotiated for bulk purchase of such drugs and new medicines that are under monopoly patents are not approved if less expensive generic drugs are equally effective. Drug firms would be empowered to challenge these decisions and pricing standards. In the United States, these rules threaten provisions included in Medicare, Medicaid and veterans' health programs to make medicines more affordable for seniors, military families and the poor.

[inanna]

2. Thanks for additional info djean111 n/t

[Trillo]

5. "$84,000 for a 12-week course in the United States"

Oh My god. $84,000 for 12-weeks of medicine?

No wonder human euthanasia is not legal.

[McCamy Taylor]

3. Here it comes. Hepatitis C treatment tourism. You can stay at home for $1000 a day

or take a trip to another country and get treated at the same time for less.

[KeepItReal]

4. "We developed it for western patients who can afford it."

Bayer Chief Executive Officer Marijn Dekkers called the compulsory license "essentially theft."

"We did not develop this medicine for Indians," Dekkers said Dec. 3. "We developed it for western patients who can afford it."

https://www.techdirt.com/articles/20140124/09481025978/big-pharma-ceo-we-develop-drugs-rich-westerners-not-poor.shtml

Contrast that with George Merck:

We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

http://todayinsci.com/M/Merck_George/MerckGeorge-Quotations.htm