[Ip-health] Fwd: Indian Patent Office Grants Patent On Sofosbuvir Base Compound

Tahir Amin tahir at i-mak.org
Tue May 10 10:07:05 PDT 2016

Gilead gets a big win as India upholds a Sovaldi patent, after all

*By* ED SILVERMAN <https://www.statnews.com/staff/ed-silverman/>
*@Pharmalot* <https://twitter.com/Pharmalot>

MAY 10, 2016

*I*n a move fraught with political tension, Indian officials reversed
course and granted a patent to Gilead Sciences for its Sovaldi hepatitis C
treatment, handing the drug maker an unexpected victory while angering many
patient groups.

Early last year, the Indian Patent Office rejected
 the company’s patent application on the grounds that it was not a
significant improvement compared with an earlier compound developed by
another company. The decision came in response to a challenge to the Gilead
patent that was filed by several patient advocacy groups and companies that
make pharmaceutical ingredients.

Sovaldi, which became available more than two years ago, has been a
flashpoint in the debate about drug pricing. The original list price for
the medicine was $84,000 in the United States, before rebates to payers.
Gilead has struck various deals to make its drug available at lower prices
in other countries, but patient groups claim the only way to break the
cycle of high pricing is to challenge the patents.

In a 58-page ruling <http://freepdfhosting.com/a03fe3f626.pdf> issued
yesterday, however, Dr. Rajesh Dixit, Deputy Controller of Patents &
Designs, wrote that the Gilead compound was “novel and inventive.” In doing
so, he largely dismissed many of the same arguments that the advocacy
groups successfully used last year to convince patent officials to reject
the Gilead application.

His decision comes amid mounting pressure on the Indian government to
bolster protection of intellectual property. The global pharmaceutical
industry has long argued that the government has been lax about enforcing
patent rights in order to favor its own domestic drug makers, many of which
sell generics in many countries.

Brand-name drug makers are upset, in particular, at Indian laws and court
rulings that, in some cases, have made it easier for their generic rivals
to sell lower-cost, copycat versions of their medicines. Shortly after
taking office in 2014, Indian Prime Minister Narendra Modi responded by
agreeing to form aworking group
 on intellectual property with the Obama administration.

Meanwhile, the US Trade Representative last month again placed India
<https://www.statnews.com/pharmalot/2016/04/28/india-patents-drug-prices/> on
what is known as the annual priority watch list of countries, which are
singled out for enforcement practices that are both favorable and
unfavorable to American companies. As many patient groups see it, these
efforts by the Obama administration are tools for pressuring India to
change its approach to patent law.

For this reason, the reversal by Indian officials was skewered by patient

“This was due to political pressure,” said Tahir Amin, director of
intellectual property at IMAK, one of the advocacy groups, which plans to
file an appeal.

The decision is “flawed, ignores the scientific facts, and fails to uphold
the standards of Indian patent law to ensure only new inventions are
patented.” Sovaldi does not deserve a patent, because “it was developed
using previously published techniques that have been used repeatedly in
other antiviral drugs.” Amin noted that Gilead’s Sovaldi patents have been
rejected by China
Ukraine and Egypt.

Not surprisingly, Gilead praised the decision.

“The recognition of intellectual property is central to investment in
pharmaceutical research and development, and this decision underlines the
scientific innovation involved in the development of this breakthrough
treatment for chronic hepatitis C,” a Gilead spokesman wrote us. “It is the
company’s goal to enable access to these medicines for as many people as
possible, as quickly as possible.”

Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+44 771 853 9472

Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+44 771 853 9472

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