Summary
The Indian Patent Office revoked the Valganciclovir patent held by Roche after a remand from the IPAB, citing failure to meet the requirements under Section 3d of the Patents Act and lack of significant improvement in efficacy over known substances. The decision followed opposition from public interest groups who challenged the validity of the patent and advocated for greater access to this critical antiretroviral drug. The Controller found that the new form of Ganciclovir did not demonstrate a significant difference in efficacy, thus contravening Indian patent law. Importantly, the Controller also broadened the locus standi to include NGOs as interested parties in post-grant opposition. This ruling is a notable step towards preventing evergreening and ensuring affordable access to essential medicines in India.
Background
The Indian Patent Office granted a patent for Valganciclovir in 2007. The Intellectual Property Appellate Board (IPAB) subsequently remanded the matter to the Patent Office for reconsideration, following which the patent was revoked. The decision attracted attention given that India’s National Intellectual Property Policy was at the time in its final stages, awaiting Cabinet approval, and that mounting international pressure from pharmaceutical lobbies was already evident. Valganciclovir, sold under the brand name Valcyte and manufactured by F.Hoffmann-La Roche AG, is priced at 1,040 Rupees per tablet. It is an anti-retroviral drug that prevents blindness caused by Active Cytomegalovirus Retinitis in HIV/AIDS patients and also prevents post-operative infections. The recommended course is four months, at an approximate cost of 2,74,560 per patient. The original patent had been granted without hearing Public Interest Groups.
Opposition Proceedings
Following the patent grant, patient advocates — specifically the Delhi Network of Positive People (DNP+), the Indian Network of People living with HIV/AIDS, and the Tamil Nadu Networking People with HIV/AIDS — filed a challenge to the grant of the patent on Valganciclovir.
IPAB Revocation and Patentability Analysis
The IPAB revoked the patent on 1st July 2015 in favour of the public interest. The revocation turned on the primary issue of patentability.
The Controller stated that for deciding any patent application or opposition proceedings, the basic requirements are disclosure, relevant prior art, and judgements available at the time of deciding the case. The mandatory requirement for concluding patentability is prior disclosure. The Controller also questioned the credibility of expert evidence relied upon by Roche, stating that expert opinions were individual views on the invention and prior art, not sufficiently impartial to constitute prior art documents, though they could be considered for the purpose of understanding prior art.
Prior Art Analysis: EP’329 and US’924
The Controller was required to determine whether the patent was anticipated by prior art. The main prior art documents in question were EP’329 and US’924. The Controller found that EP’329 contains a Markush-type formula and that the disclosure is such that a person of ordinary skill in the art could arrive at the claimed invention, namely the synthetic method for preparing mono valine ester.
Application of Section 3(d)
The Controller relied upon Section 3(d) of the Patents Act, which denies patentability to a new form of a known substance unless it results in enhanced efficacy. The patent in question claimed to provide a prodrug of Ganciclovir with improved oral bioavailability. Ganciclovir is a known substance with poor oral bioavailability; its conversion into a new ester compound with increased bioavailability shares Ganciclovir’s core structure and, on the Controller’s analysis, could be derived from prior art US’924 by an ordinary person skilled in the art.
The Controller reasoned that the original identity and pharmacological activity of the molecule do not change materially on certain chemical modifications. Where such a modification exhibits significant improvement in efficacy, the modified compound may be treated as a new substance; however, in this case, improved oral bioavailability was not equated with a significant difference in efficacy. Taking the interpretation of “efficacy” as “the ability to produce a desired or intended result”, the Controller held that Ganciclovir’s new form had not been shown to enhance the molecule so as to make it significantly different from the known substance. The new form was accordingly treated as the same substance and the patent was found to contravene Section 3(d).
Locus Standi of NGOs under section 2(1)(t)
A further issue was whether the NGO opponents had locus standi as “persons interested” within the meaning of section 2(1)(t) of the Patents Act, which defines a person interested as “a person engaged in, or in promoting, research in the same field as that to which the invention relates”. The Controller held that locus standi in post-grant opposition proceedings is to be viewed broadly: an inventor’s patent must pass scrutiny not only before the Patent Office but also from the standpoint of the public, who are the end users and the persons most directly and severely affected if a patent is granted. The NGOs were accordingly found to have locus standi to oppose the patent.
Significance
The international medical humanitarian organisation Médecins Sans Frontières (MSF) had previously cited India as an example of sound intellectual property practice in relation to access to medicines, and health care advocates welcomed the revocation decision. Pharmaceutical companies, on the other hand, sustained another adverse outcome, and their response to this decision remained to be seen at the time of reporting.
Disclaimer
This article is for general information and does not constitute legal advice. Readers should consult a qualified attorney before acting on any matter discussed here.