Breaking News: Roche Loses Valcyte Case

Specifically, Roche’s patent which covered the “L-Valinate Ester of Gancyclovir” and all acceptable salts, was opposed under section 25 (2) by the following parties:

i) Cipla (represented by Majumdar and Company and Ramesh Kumar of RK Legal)
ii) Bakul Pharma (represented by Majumdar and Company)
iii) Matrix Labs (represented by Feroz Ali)
iv) Indian Network for People Living with HIV/AIDS (INP+ (represented by Anand Grover)
v) Tamilnadu Networking People with HIV/AIDS (TNNP+ (represented by Anand Grover)
vi) Ranbaxy (represented by Lakshmikumaran of Lakshmikumaran and Sridharan)

Compared to the IPAB’s “Gleevec” decision which meandered into flights of fancy, this decision appears more grounded and logically coherent (well, at least relatively).

Inventive Step:

The Controller, SP Subramaniyan, appears to have struck down the patent mainly on grounds of lack of inventive step. The reasoning ran thus:

i) Roche’s patent claimed the L Valinate ester of “Gancyclvoir”.

ii) Gancyclovir was already present in the market and was being administered intravenously for anti viral purposes (mainly HIV infections). Owing to problems with intravenous administration, a person skilled in the art would have been motivated to look out for an oral dosage form with increased bio-availability.

iii) Acyclovir, a molecule similar in structure and function (anti viral properties) to Gancyclovir was already in the market. In order to make Acyclovir more bio-available, it had been “esterized” and converted to a pro-drug. Specifically, certain select amino acids were used to result in the L-valinate ester of Acyclovir called Valacyclovir. Valacyclovir was then combined with hydrochloric acid to result in Valacyclvoir Hydrochloride (sold as Valtrex, an anti Herpes drug by GSK).

iv) Based on the above, the person skilled in the art would have been motivated to follow a similar route with Gancyclvoir–and this would have resulted in the L-valinate ester of Gancyclovir (namely Valgancyclovir) and later, a combination with hydrochloric acid to result in Valgancyclovir Hydrochloride (sold as Valcyte by Roche).

To this extent, the Indian patent office appears to have endorsed an “obvious to try” test. Compared to the IPAB’s shaky ruling on inventive step in the Novartis “Gleevec” case, this ruling by the IPO appears sound, succinct and logically coherent.

Section 3(d):

Unfortunately, the ruling on section 3.d is not as clear as the one on inventive step. The Controller appears to suggest that an increase in bio-availability does not necessarily lead to more efficacy (defined as per the Madras High Court decision as “therapeutic efficacy”). And that Roche’s claim of an increase in bio-availability does not necessarily equate to an increase in “efficacy”. The Controller does not however indicate as to what quantum of increased bio-availability would suffice to constitute an increase in “efficacy” as well.

Locus Standi and “Person Interested”

What I liked most about the decision is the fact that the IPO has finally opened up the meaning of “person interested” in section 25 (2). It placed emphasis on the term “includes” in the definition of “person interested” and held that a person interested could include a patient group that was interested in opposing bad patents that resulted in increased drug prices.

This will certainly engender more oppositions from civil society and patient groups and is a welcome development. As a previous post noted, the number of patent oppositions are very small. It will also help the case of the Rajashtan Drug Control official that I alluded to in the earlier post.

Conclusion:

The IPO’s decision in the Valcyte case deals yet another blow to MNC pharma patents in India. Barring Pegasus, most other pharma patent decisions appear to be going against MNC’s.

The first high profile MNC case was Novartis’ Gleevec, where the patent was refused by the IPO and the IPAB (an appeal is now pending before the Supreme Court). The second was Roches’ Tarceva (Erlotinib), where the court refused to restrain Cipla from selling a generic version (the trial is still on and it remains to be seen whether this patent will also end up being invalidated). And the third case is that of Roche’s Valcyte where the IPO has now struck down the patent. This means that Cipla can safely sell its Valcept version, unless the IPO’s ruling is reversed by the IPAB or the courts.

With all these decisions, India appears to be sending out a strong signal that it will not tolerate frivolous pharmaceutical patents. Rather, only the most meritorious pharmaceutical inventions will make it past the patentability filter.