India IPR Policy Update: Final Draft Circulated

The final draft of India’s national intellectual property policy has been circulated for inter-ministerial consultation and will be sent to the Cabinet for approval after receiving comments, the Ministry of Commerce and Industry said this week. Meanwhile, today public health groups in India announced that revocation of a Roche pharmaceutical patent has been upheld under Indian law. 

Commerce & Industry Minister Nirmala Sitharaman gave the update at the opening of a seminar on brand protection organised by FICCI along with the World Intellectual Property Organization and the India IP office (Department of Industrial Policy and Promotion).

Sitharaman gave few details of the draft policy, which is not yet publicly available, but said it “focusses on stronger enforcement of IPR by increasing the manpower strength in IP offices and reducing the pendency of IPR filings,” according to an official press release.

The minister showed awareness of recent pressure from abroad that India has been under regarding IP rights.

“She sought to allay apprehensions in the minds of foreign investors about the strength of the Indian IPR regime, stating that the final draft of the National IPR Policy has been arrived at through a transparent process with inputs from all stakeholders,” the release said.

The update comes as news emerged from nongovernmental organisations that the revocation of a pharmaceutical patent on a drug used for blindness held by Roche has been upheld. The full press release from the Lawyers Collective is below:

Press Release: Patient groups strike yet again: Patent on Valganciclovir stands revoked

22nd July, 2015: In what comes a huge victory to patient groups around the world, the Indian Patent office in Chennai, revoked the grant of a patent on Roche’s Valganciclovir.

Valganciclovir is an important drug for the treatment of active cytomegalovirus retinitis (CMV) infection which, if left untreated, can lead to blindness in persons living with HIV. It is also an important drug for post operative treatment for patients who have received an organ transplant. CMV can be effectively treated with oral doses of valganciclovir consisting usually of 264 tablets given over four months.

Valganciclovir was granted a patent in 2007 which prevented the marketing of low-cost generic versions of the medicine. Priced at Rs. 1,040 per tablet, the entire treatment would cost approximately Rs. 2,74,560 per patient. But with this victory, low-cost generic versions can now be marketed and made accessible to patients across the world at affordable rates.

Patents allow drug manufacturers to charge exorbitant prices and this, coupled with the medicine merely being a new form of a known substance, led Delhi Network of Positive People (DNP+), Indian Network of People living with HIV/AIDS & The Tamil Nadu Networking People with HIV/AIDS to challenge the grant of the patent on Valganciclovir.

The patent was primarily revoked on the grounds that it was obvious i.e. it did not involve an inventive step and was a known substance under section 3(d) of the Indian Patents Act, 1970. When Roche alleged that the patient groups were not ‘persons interested’ and are therefore not eligible to file a post-grant opposition, the Patent Office acknowledged that patient groups are the end users and are severely affected and ergo, had every right to challenge the grant of a patent.

Mr. Anand Grover, Director of Lawyers Collective and the representative of the patient groups in this case, welcomed the decision of the Patent Office as a “highly significant victory” for the patient groups in India and across the world.

Mr. Vikas Ahuja, the President of DNP+ said, “Drug manufacturers these days end up filing patents on older medicines which makes the medicines unaffordable. We are delighted with this decision and we hope that the Patent Office continues to scrutinize patent applications strictly to ensure access to affordable medicines.”

Mr. K.K. Abraham, General Secretary, INP+ said, “We are happy with the Patent office’s decision and we hope that the implications of this decision will benefit millions across the globe.”