[Ip-health] India rejects Gilead's Hepatitis C drug patent request
nehaa at cis-india.org
Thu Jan 15 21:57:54 PST 2015
Gilead to appeal Sofosbuvir patent rejection
bySwaraj Paul Barooah
<http://spicyip.com/author/swaraj-paul-barooah>January 16, 2015
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on fromour post yesterday
where I’d mentioned there were some potential issues with the patent
office’s rejection of Gilead’s patent application over Hepatitis C drug,
sofosbuvir, it appears Gilead will be appealing the decision due to the
patent office’s handling of section 3(d). Also, its worth noting that
besides Gilead’s patent application for sofosbuvir rejected, 13th
January also saw India become the first Asian country to grant
regulatory approval to sofosbuvir.
Gilead’s response is as below:
“Gregg Alton, executive Vice President, Corporate and Medical Affairs
Gilead Sciences said:
The main patent applications covering sofosbuvir are still pending
before the Indian Patent Office. This rejection relates to the
patent application covering the metabolites of sofosbuvir. We are
pleased that the Patent Office found in favor of the novelty and
inventiveness of our claims, but believe their Section 3(d) decision
to be improper. Gilead strongly defends its intellectual property.
The company will be appealing the decision as well as exploring
additional procedural options.
These proceedings do not impact our commitment to enabling access to
our hepatitis C medicines in India and other developing countries,
and our generic licensing program with our Indian partners continues
as normal. We welcome the news that on the 13^th January 2015 the
authorities in India granted sofosbuvir regulatory approval in an
unprecedented four months – the first country in Asia to approve
sofosbuvir – recognizing the need to bring this innovative new
medicine to patients in India as quickly as possible.”
We’ll try to put forth a more detailed Section 3(d) analysis soon. I had
evidently missed the news that regulatory approval for sofosbuvir had
been granted in such a quick span – this is no doubt good news
regardless of which stakeholder’s perspective you take. Regarding ‘the
main’ patent applications that are still pending before the IPO, I’ve
not yet looked at it myself but we did have ananonymous comment
which seems to refer to it, indicating that Gilead Pharmasset has a weak
case for it. I’m pasting the relevant part below.
The data provided in the table as submitted with the application
only relates to the cytidine analogs, not the uridine analog which
forms the base of sofosbuvir in its prodrug form (subject of the
application 3658/KOLNP/2009). Pharmasset itself has said in earlier
publications that (see Clark 2005) that the uridine base
demonstrated no activity (which could translated to efficacy) or
cytoxicity. This is the case also against the known forms which
Gilead Pharmasset compound and the uridine analog derives from. It’s
for this very reason Gilead Pharmasset cannot show how the uridine
analog is more efficacious than the known forms.
[Full comment availablehere
You can also find I-MAK’s Opposition Documents for the above mentioned
patent applications onthis page <http://www.i-mak.org/sofosbuvir/>].
On 15/01/2015 05:25, Giten Khwairakpam wrote:
> This is such a great news Priti. Well done and congratulations to you and all at IMAK.
> -----Original Message-----
> From: Ip-health [mailto:ip-health-bounces at lists.keionline.org] On Behalf Of Priti Radhakrishnan
> Sent: Thursday, January 15, 2015 12:12 AM
> To: ip-health at lists.keionline.org
> Subject: [Ip-health] India rejects Gilead's Hepatitis C drug patent request
> rejects Gilead's Hepatitis C drug patent request 11:45am EST
> By Sumeet Chatterjee
> MUMBAI, Jan 14 (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.
> 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.
> Market access and patent protection for U.S. drugs are expected to feature when Indian Prime Minister Narendra Modi hosts President Barack Obama later this month for India's annual Republic Day celebrations.
> The patent office's order comes amid a growing clamour by healthcare campaigners and doctors to ensure Sovaldi and other new hepatitis C pills are affordable in developing countries.
> In a bid to make Sovaldi available in 91 developing nations including in India, Gilead licensed the drug, hailed by doctors as a breakthrough in treating the liver-destroying disease, to seven India-based drugmakers in April last year.
> Campaigners, however, were critical of the licensing deals, saying they would not ensure access to several middle-income countries where health authorities would still struggle to provide treatment to patients.
> (Reporting by Sumeet Chatterjee; Editing by David Holmes
> *Priti Radhakrishnan*
> Co-Founder and Director of Treatment Access, I-MAK Echoing Green Fellow | Pop!Tech Fellow | Asia Society Associate Fellow
> *"Where innovation meets access to affordable medicines"*
> *Website: *www.i-mak.org
> *Skype:* pritiwho
> *Mobile:* +1 917 703 2876
> *E-mail:* priti at i-mak.org
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