Gilead To Appeal India Patent Rejection, Hails Regulatory Approval

Pharmaceutical manufacturer Gilead has given its side to this week’s story of the rejection of its patent on a hepatitis C treatment in India, and it insists it will prevail in making its medicines available in India on its terms.

In a high-profile decision this week, India’s Patent Controller rejected a key Gilead patent application for sofosbuvir, a hepatitis C (HCV) drug that has been reportedly priced at as much as $1000 per pill in some countries. The rejection was hailed by public health advocates as opening the door to cheaper generic versions of the drug (IPW, Public Health, 14 January 2015).

But in a response to the decision, Gilead offers a different interpretation.

Gregg Alton, executive vice president, Corporate and Medical Affairs at Gilead Science, said in a statement sent to Intellectual Property Watch:

“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.”

Section 3(d) of the India Patent Law states:

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

Alton went on to say:

“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 13th 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.”

Gilead had filed its regulatory dossier four months earlier, according to a company spokesperson.

The passage in the Patent Controller’s decision [pdf] that Gilead cites to supports its regulatory approval is found on page 28, and states in part:

OBSERVATION:- In respect of novelty & Inventive Step of the present claims 1 to 10 the arguments of the Ld Attorney is agreeable. It has been noticed that learned examiner has raised citation from D1 to D9 in the hearing letter wherein D1, D2 and D5 were similar to the citation raised in the FER for examination of Novelty and inventive step. Therefore only Matching citations of hearing letter and FER are being considered for finalization of this application w.r.t. novelty and inventive step of the invention. The D1 is the closest prior art to this claimed invention. On comparing the finally revised claims from 1 to 10 with citation given in the FER and hearing letter primafacie does not appear to affect the novelty and inventive step of the present set of the claims. This has further been confirmed by grant of patent with similar set of claims in various jurisdictions namely JPO (Patent No. 4958158 and 5266357), US (Patent No 7429572 and 8415322). Therefore I have no hesitation to acknowledge Novelty and Inventive step of the present set of claims.

MSF Warning

Médecins Sans Frontières (MSF, Doctors without Borders) yesterday released a warning that:

“In the course of discussions with Gilead to purchase the drug, MSF has learned that the company will institute an ‘anti-diversion’ programme in developing countries through its distributors and licensees (generics companies that have signed a voluntary license with Gilead) to prevent what they characterize as the possible ‘bulk diversion’ or re-sale of such medicines from low- or middle-income countries to high-income countries.

With this programme, Gilead is demanding that patients and treatment providers in developing countries comply with a web of onerous and potentially harmful procedures that aim to preserve Gilead’s ability to charge exorbitant prices in developed countries (up to US$1,000 per pill, or $84,000 per treatment course).”

MSF also had noted that the rejection of the patent in India would not change the fact that many leading generics producers in India (known as the leading generics producing nation in the world) had already signed licence agreements with Gilead and so may be unaffected by the patent rejection.