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GSK drops claims on two ARTs Abacavir/Trizivir
  7 Dec, 2007, 0111 hrs IST,Khomba Singh, TNN
NEW DELHI: In a relief to around 2.5 million HIV patients and generic firms like Cipla and Ranbaxy, GlaxosmithKline (GSK) has pulled out the patent applications of two anti-AIDS medicines in India.
While GSK has formally withdrawn the application of Abacavir, it is learnt that the UK giant's other drug, Trizivir, is deemed withdrawn after it made a request to the patent office not to examine its case.
Abacavir is a second-line anti-retroviral (ARV) drug used to treat patients who have developed resistance to first-line medications. Trizivir is a combine of three ARV drugs used for first and second-line treatments. Both are on the list of drugs the Centre and WHO recommend for HIV treatment.
Indian firms like Cipla, Ranbaxyand Hetero, among others, already market one or both these drugs in India. If GSK had secured the patent, they would have had to pay a royalty to the company. This would up HIV treatment costs.
"The applicant (GSK) of this instant application has withdrawn the application under reference (Abacavir). Accordingly, there will be no more further proceedings towards the representation," the examiner of the Patent and Design office in Kolkata said in a order, a copy of which is with ET.
GSK had filed the patent application in the Kolkata patent office last year. NGO sources said the office has also considered the application of Trizivir 'withdrawn' after GSK officials made a 'no request for examination' application. When contacted, GSK declined to comment on the status of application of the two drugs.
A GSK spokesperson said, "We do not comment on specific patent applications. However, as part of our policy, routine reviews of our patent applications are undertaken on a regular basis."
A source said GSK's move is the result of Swiss drug giant Novartis' failed attempt to invalidate section 3(d) of the Patent Act, which says patents based on incremental innovations can be granted only if new drugs provide major therapeutic advantages than known ones.
GSK drugs were salt forms of existing drugs. The company deemed it prudent to withdraw the application rather than being rejected as such a verdict would weaken its chances of securing a patent in other developing countries. Another source said many similar patent applications based on the same grounds may also be either withdrawn or abandoned.
Civil societies group I-MAK and MSF (Medecins Sans Frontieres) had challenged the patent application on behalf of Indian Network of Positive People (INP+). "The government should not wait for opposition but strictly implement the 3(d) provision before granting any patents," said MSF project manager India Leena Menghaney.
Incidentally, Novartis (maybe they mean BMS) abandoned the patent application of its ARV drug Atazanavir in India earlier this year. However, a company spokesperson said, "Novartis has not given up its rights in India to patent Atazanavir. Indian patent application 805/MAS/9 has lapsed; however, the patent rights to Atazanavir are being pursued by Novartis under a continuing patent application known as a divisional patent application."
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