The Economic Times reports on a post grant opposition filed by Dr Reddy’s against Chantix, a hugely profitable anti smoking drug patented by Pfizer in India and many other countries in the world.
The Economic Times Reports:
The company stated the patent should be rejected on the ground that the alleged invention relating to varenicline has already been claimed in a prior Indian patent application and that it falls squarely within the ambit of Section 3(d), which says that the said invention is merely a new form of a known substance. Varenicline is a partial against of one of the nicotinic acetylcholine receptors in the brain and nervous system and is currently the only marketed and approved drug with this mechanism of action.”
This news item appears to have been picked up from Varun Chhonkar’s excellent post at Patent Circle. He raises an issue that is often forgotten in the pharma patent debate: whither drug safety issues? He notes:
“In November 2007, the United States FDA issued a safety alert, reporting cases of suicidal thoughts and aggressive and erratic behavior in patients taking Chantix. Report also described Chantix affecting patients’ ability to drive or operate machinery. Later in May 2008, the United States FDA issued another alert highlighting important revisions made to the prescribing information for Chantix. Earlier this year in February, CBC News reported that Health Canada received 818 complaints for Canadian patients, many of them reporting mood swings, depression or suicidal thoughts.
We really wonder whether the Indian Drug Regulatory had taken the Varenicline adverse reports seriously enough and into consideration before giving marketing approval in India. Particularly considering that in India, it is not unusual to buy prescription drugs without doctor’s prescription – Varenicline may seriously pose high risk to Indian patients. And what if Varenicline generic versions also steps in?”
Varun refers to a Mint article by Bhuma Srivastava who notes in relation to Chantix (sold as Champix in India):
“Doctors and experts have expressed concern over an anti-smoking drug, manufactured and marketed by the world’s largest drug maker Pfizer Inc., being launched in India barely a month after the US health regulator issued safety warnings and said it was continuing investigation whether the drug triggers mood changes and, in some instances, suicides.
….Indian rules are fuzzy on actions based on such information. The government official responsible for regulating drugs sold in the country, Surinder Singh, the drug controller general of India, or DCGI, could not be reached for comment. Local rules do not mandate patient trials of a drug here if sufficient safety and efficacy data from international studies are produced. The Indian drug regulator gives approval to new drugs if they have been approved by regulators of the US and Europe. No clinical trials were carried out in India in the case of Champix.
Only in specific cases when the safety or efficacy data does not satisfy DCGI are clinical trials asked for but this is always “on a case-to-case basis”, explained a senior official in the DCGI’s office who did not wish to be identified. There is what is called “a pharmacovigilance department to take note of any ADRs (adverse drug reports)” but it is very new and would take time to be fully functional, this official added. Former DCGI M. Venkateswarlu added that there “is always a risk-benefit ratio to a drug. One cannot just keep out a drug especially when it addresses an issue of major public health concern.”
Although one can understand the logic of a risk-benefit ratio above, one wonders as to whether the DCGI did undertake such a computation and whether doctors and even members of the public can be privy to his reasoning on this count.
Just as we have been pointing out the need for more transparency in the grant of patents and the need to make more patent information public, there is a greater need to open up the drug regulatory process as well and wherever possible authorities ought to give their reasons for the grant or rejection of drug marketing approvals.
ps: Interestingly, Pfizer is considering funding a clinical trial to test whether this drug can be useful in preventing heart attacks in smokers. Some rubbish this claim, stating that since this is an anti smoking drug and a smoker will either give up or smoke less after taking this drug, they will naturally have a lower susceptibility to an attack. Anyway, let’s wait and watch to see if Pfizer manages to get lucky with establishing such second medical use, ala Viagra.
Given India’s bar on second medical use patents under section 3(d), it is clear that even if Pfizer establishes this “new medical use” in India, it will not procure a patent.
why does one find an increasing lewdness in the kind of pictures or legends put up with posts? As a regular and conscientious reader of SpicyIP, i must say that i find them distasteful..
Anon., did you miss the joke entirely? The pun is on the word “butt” as in the end of a cigarette
The last line..”it will not procure a patent” is totally misleading and wrong as a patent has already been granted.
In the interest of all readers, it may be noted that a post grant opposition can be filed anytime after the grant but before the expiry of one year from the date of publication of the grant.(which people in practice know happens much after date of the grant). So in effect, the opposition period is not a year as most people generally understand it to be. For example, the date of grant of the patent in the post is December 2006 and the opposition was filed in 2008!
(This is another anonymous reader)…i agree with the previous anonymous reader on the kind of pictures put up with posts…for instance, there was one post with a hot pic of mallika sherawat…Considering that this is a serious blog dedicated to ip issues which have serious repurcussions on the public, such pics should be done away with….it takes away the seriousness of the posts….Pls take this as a comment of an ardent fan of spicy ip
We are born in a smoke free world and it is just right that we strive to offer our children the same kind of environment. Be involved and help empower everyone by taking part in the yearly WORLD NO TOBACCO DAY which will be on May 31st!
Pfizer is involved in a post-grant opposition proceeding for its patent covering hugely popular antismoking drug Chantix.
Anon@2
There is nothing misleading in Shamnad’s argument that “it will not procure a patent.” If I am correct, Shamnad is not referring in context of present invention (that is Varenicline Tartrate) rather he is referring about the possible case of second medical use of Varenicline. He is quite correct that even if Pfizer establishes second medical use of Varenicline, it will not procure a patent claim for second medical use.
Anon@3
Post-grant opposition is strictly need to be made within one year from the date of publication of grant of a patent. Please note, one year deadline is not calculated from date of grant of patent but from the date of publication of grant of a patent. There are many patents which are granted by the Indian Patent Office but got published after quite a delay, sometimes even after 6-10 months from the date of issuance. Varenicline Tartrate is one of such delayed publication case.
The patent has not been granted in December 2006. It has been granted on 25th May 2007 and accordingly DRL has filed the opposition within a year, i.e. on 24th May 2008. Since we are the people in practice, we know that the post-grant oppositions have to be filed within the prescribed time of 1 year and not any time after the grant of patent. And most importantly, no patentee would allow any such opposition filed after the prescribed time when our Patent Act has strictly put time lines for the same.
Thanks for all your comments,
Re: lewdness, I didn’t particularly think so. But I appreciate your views and have nonetheless removed the graphic from this post, since it didn’t have much of a connection with the thesis of the post.
Thanks VC,
you’re right. My comment was in relation to an attempt to obtain a prospective patent on a new use of chantix.