Indian Pharmaceutical Alliance (IPA) withdrew its opposition to the patent application for Gilead Pharmasset’s Hepatitis C drug sofosbuvir, marketed as Sovaldi, after the latter entered into a voluntary licensing agreement with 11 companies to sell the generic version at a lower price.
Hyderabad-based Natco Pharma, which had filed a pre-grant opposition with the Indian Patent Office, also pulled out from the litigation after entering into a licensing agreement with Gilead.
IPA’s position is that it would oppose patents that block access to medicine. In this case, the company offered an unconditional voluntary licence to 11 companies, which means the patent would not block access to medicine.
“We wanted to give a message to the world that here is a model, where IP (intellectual property) and access co-exist. We also wanted to tell big pharma that IPA is not unreasonable and we aren’t blindly following an idea that we must oppose patent application. If you provide access, we have no issue,” said D G Shah, secretary-general, IPA.
Shah added that despite the withdrawal of IPA’s opposition, the patent office would judge whether the Gilead’s application qualifies for a patent or not. If it qualifies, the voluntary licences would still be valid.
IPA had filed its opposition on January 6, 2014, and gave a letter on February 9, 2015, to withdraw its pre-grant opposition representation “due to some operational reason”, according to the Indian Patent Office. The Patent Office disposed of the pre-grant oppositions of both IPA and Natco last week. Gilead officials were not available for comments.
The patent application filed on October 20, 2009, is for Nucleoside Phosphoramidate Prodrugs, an invention claim to provide novel chemical compounds that can treat Hepatitis C.
According to market sources, at least nine players including Cipla and Ranbaxy are already selling the drug through a licensing agreement with Gilead. More companies are in the process of signing licensing agreement with the company for the generic product, they added. Gilead sells the drug at $1,000 per pill in the US.
According to the agreement with Natco, Gilead will get royalties in exchange for the rights for Sovaldi. The firms that have agreements with Gilead are currently selling the product at an MRP Rs 19,900 for a bottle of 28 pills. However, the actual selling price is around Rs 10,000, as the drug is sold at a huge discount, said an official with one of the companies.
A latest news report says that nine companies including Zydus, Cipla, Natco, Mylan, Abbot India, Dr Reddy's Laboratories, Hetero Healthcare, Ranbaxy and Biocon has together sold around Rs 28 crore worth of sofosbuvir in the market in five months.
The withdrawal of pre grant opposition by IPA and Natco would not have an impact on its opposition or legal proceedings related to the prodrug patent application, since five other oppositions including Initiative For Medicines, Access & Knowledge (I-MAK), a legal advocacy group, and Delhi Network of Positive People (DNP+) still raise challenge against it, said Tahir Amin, I-MAK's Co-Founder and Director of Intellectual Property.
"The only impact is that because Natco and Zydus (which is a member of the IPA) took a license from Gilead, the withdrawal of their oppositions is akin to a settlement agreement. The other impact is there will be two less generic companies that can now supply non-licensed territories because of the restrictive nature of the licenses. So by taking the licenses it reduces the competition in the non-licensed territories which is Gilead's intention," he said.
It may be noted that the Patent Office has rejected an application (no. 6087/DELNP/2005) related to the same drug, which was on the base compound or metabolite that is inactive in itself and is only activated in the prodrug form, earlier this year. This decision was reversed by the High Court after Gilead petitioned for a re-examination of the matter, and the application for the base compound, thus, is still under examination. The application for the prodrug is different from the base compound/metabolite, though it is as important as the 6087 application because the prodrug covers sofosbuvir in its marketed form and what makes the base compound active in the body, he said.
The license agreements do not help to reduce the prices of the drug for two reasons, he said, since the licenses restrict where licensed Indian companies can buy their raw material from, to make the drug and this causes the prices of the final product to be higher than need be. For example if licensed Indian companies could buy the raw material from China (which the agreements do not allow because Gilead want to control and keep the price of raw material high), the prices would come down even further and the licenses restrict which countries the licensed Indian companies can sell to.
He added that approximately 12-18 million people in India are infected with HIV. "We understand the generic versions of sofosbuvir are in the region of $900-$1000 currently for a full 3 month treatment, but may be slightly less for community procurements in the northeast region of India. It is believed that with the right economies of scale the drug can be produced and sold for around $200-$300. We believe this price needs to be attained to really make it accessible and affordable for all."
According to a list of prices compiled by a website managed by Asia Pacific Network of People Living with HIV (APN+), market price for a bottle of 28 sofosbuvir pills in India ranges from $161 by Emcure Pharmaceuticals Ltd to $258 by Natco and Zydus Heptiza, as on September 10, 2015.
The massive licensing agreements between Gilead and the Indian generic players have its significance in the field of patent litigations in India, said a patent expert.
"The move shows that the ultimate interest of the patient groups and the generic firms, though they have overlapped till now in fighting for the goal of affordable availability of medicines, are different. This also shows that the larger generic players are expanding their focus to a larger geographic area. One hopes that now the smaller companies take on the onus of challenging patents and going for making drugs more affordable," said Swaraj Paul Barooah, editor-in-chief of intellectual property blog SpicyIP and visiting faculty at Nalsar University of Law, Hyderabad.
He added that one of the conditions in these originator-generic pharma agreements is that the generic manufacturer has to adhere to anti diversion measures, where it has to provide the patient information to the originator. One should look at how this would impact on the right of the patient for privacy, especially in disease like Hepatitis C and HIV, he said.