E-DRUG: Times of India: HC revokes Roche's patent
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http://timesofindia.indiatimes.com/HC_revokes_Roches_patent/rssarticleshow/3798630.cms [repair link]
NEW DELHI: In a first-ever instance of a patent being revoked after being
granted, the Madras High Court has set aside pharma major Roche's patent on
key drug, valganciclovir on procedural grounds. A patent on valganciclovir
was granted to the company in June 2007.
Valganciclovir is a treatment for cytomegalovirus (CMV), a virus that often
attacks the retina of people with lower immune systems, such as AIDS
patients. In addition, it is crucial for prevention of CMV infection in
patients who have received organ transplant.
The court has cited the failure of the Indian patent office to comply with
the patent law and remanded the matter back to the Patent Controller. The
judgment was delivered on a petition filed by civil society groups Indian
Network for People Living with HIV/AIDS (INP+) and Tamil Nadu Networking
People with HIV/AIDS (TNNP+), who had challenged the Indian Patent Offices
decision to grant a patent without hearing the pre-grant opposition filed
by them.
In July 2006, INP+ and TNNP+ had filed a pre-grant opposition before the
Chennai Patent Office objecting to the grant of patent to Roche and
requested for a hearing. Under the Indian law, if an opponent requests a
hearing, the patent office is required to provide the opponent an
opportunity to be heard. However, this was not done.
At Roche's maximum retail price of over Rs 1000 per tablet, a patient who
has to take a treatment course of approximately four months for CMV
retinitis in India would have to pay over Rs 2.5 lakh. This puts the
treatment unafforable for those who need them.
The grant of patent to Roche allowed it to continue charging exorbitant
prices and also prevented the entry of generic versions of valganciclovir.
Hwoever, in May this year, Cipla launched the generic valganciclovir in the
domestic market at a price of Rs 245 for a tablet. Under law, a generic
producer can challenge the patent by taking the risk of launching a generic
version after obtaining marketing approval.
In response, Roche filed an infringement suit against Cipla in the Bombay
High Court in September seeking an injunction, which is till pending. The
dispute between the companies hinges on "patentability'' of the drug. The
validity of the patent is in question under the country's patent laws that
do not allow patents on new forms of old drugs, also known as Section 3(d).
Experts pointed out that valganciclovir is a hydrochloride salt of an old
drug `ganciclovir' and hence not patentable.
The generic producers of the drug, Matrix, Ranbaxy and Cipla have also
filed post grant oppositions.
While the opportunity to oppose the application is only granted to the
patient groups, it is likely that Roche's injunction proceedings against
Cipla for launching the generic version will no longer have a legal basis
as the patent is now revoked. Whether the Mumbai court will keep the
infringement proceedings pending remains to be seen, legal experts say.