The Indian Patent Office took heat for its incompetence when Valganciclovir was granted patent in 2007. The matter was remanded back to the Patent Office by the IPAB to reconsider and this time the patent was revoked. This decision comes at the time when India’s National intellectual property policy is in its final stages, awaiting approval by the Cabinet and with mounting International pressure from Pharmaceutical lobbies, rejecting patent of Pharmaceutical giant F.Hoffmann-La Roche AG will have repercussions. But why so much hoopla about Valganciclor?
Valganciclovir or Valcyte manufactured by Roche 1,040 Rupees per tablet, is an anti-retroviral drug which prevents eye blindness due to an infection called Active Cytomegalovirus Retinitis in HIV/AIDS patients, and prevents other infections in persons undergoing post-operative treatment, it’s recommended course is 4 months and it approximately costs 2, 74,560 per patient. This expensive lifesaving critical drug was granted patent without hearing Public Interest Groups.
After the grant, the patient advocates namely Delhi Network of Positive People (DNP+), Indian Network of People living with HIV/AIDS & the Tamil Nadu Networking People with HIV/AIDS came out in aid to challenge the grant of the patent on Valganciclovir.
This issue, for now ended as on 1st July 2015 in the favour of public interest with the IPAB revoking the patent grant. The Court reached this decision after vacillating various issues, the primary one with regards to the patentability of the patent.
The Controller stated that for deciding any patent application or in opposition proceedings, the basic requirements are disclosure, relevant prior ad and judgements available at the time deciding the case. The mandatory requirement for concluding patentability is prior disclosure. The Controller then questioned the credibility of expert evidences which were relied on by the Defendants (Roche), stating that expert opinion were individual opinion on the invention/prior art,not impartial enough to warrant as prior art document in deciding a case, albeit they can be considered for understanding the prior art document.
The Controller then had to decide whether the patent was anticipated by prior art document. The main prior art in question EP’329 and US’924. The Controller stated that EP’329 has a Markush type formula and the disclosure made is such that a person of ordinary skill in the art could arrive at the claimed invention (“The synthetic method for preparing mono valine ester”). The Controller relied on the infamous Section 3(d) of the Patents Act, which denies patentability to a new form of a known substance. Then the Controller focused on the aspect that the patent claims to address which is to provide a prodrug of Ganciclovir with improved oral bioavailability. Ganciclovir is a known substance with poor oral bioavailability, it was converted into a new ester compound with increased bioavailability which shares Ganciclovir’s core structure. But according to the Controller, it is derived from a prior art US’924, and it could be derived similarly by an ordinary person skilled in the art. The Controller reasoned that in the present matter, “the original identity and pharmacological activity of the molecule hardly changes when there is certain chemical change in the molecule. Sometimes such a chemical modification exhibits improvement in the efficacy than the original substance significantly, then it is considered as a new substance.” The Controller contemplated on this interpretation of efficacy, taking the Novartis explanation “the ability to produce a desired or intended result”, the context of Section 3(d) then differs according to the product function, utility or the purpose of the product under consideration. Hence, Ganciclovir’s new form should enhance the molecule so that it would become significantly different with the known substance. In this case however, the new form was considered as the same substance, as improved oral bioavailability cannot be considered as improvement in efficacy, as it cannot be directly equated with significant difference in the efficacy. Hence, the Controller ruled that this was in contravention with Section 3(d).
The final issue was of whether NGOs were persons interested i.e. “a person engaged in, or in promoting, research in the same field as that to which the invention relates” as under section 2(1) (t) for opposing the patent. The Controller conclusively decided that the locus standi in the post-grant opposition is to be viewed in a broader perspective and that the inventor has to pass the test, not only in the Patent Office but also from the public because they are the end users or persons who will be directly and severely affected, if the patent is granted. Thus, the NGOs have locus standí to oppose the present case.
The statistical outcome of this decision may only be known in coming months or years, but one thing is clear, Indian Government has once again ruled in favour of preventing evergreening and facilitating access to medicines, safeguarding public health. The international medical humanitarian organization Médecins Sans Frontières (MSF) had earlier hailed India as an example of how IPR to be followed and this decision has been welcomed by health care advocates. The pharmaceutical companies on the other hand have suffered another blow in their deep pockets and their next move is yet to be seen. This battle as it’s said has just begun.
Authored by Aditi Ameria.