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Pfizer/Sugen was granted a patent on anti-cancer drug Sunitib (Patent number: 209251) on Oct 5, 2007.Nearly 5 years later in a post grant opposition initiated by Cipla, this patent was revoked by the patent office on the grounds of obviousness. An excellent analysis of this decision is covered here.
As reported by Prashant, in a rather surprising turn of events, patentees (Pfizer/Sugen) filed a writ petition before Delhi High court requesting that the revocation decision be set aside. The patentees filed the writ petition on the grounds that the recommendations of the opposition board were not supplied to the patentee. A comprehensive and exhaustive analysis of this is covered here and here.
The Delhi High court then granted an order restraining Cipla from marketing a generic version of Sunitinib. Cipla then filed an appeal in the Supreme Court against the High court decision.
In a key judgment, the Supreme Court reinstated the revoked patent and directed the Controller to dispose of the opposition afresh after giving both parties an opportunity to raise arguments for and against the Joint recommendations of the opposition board .The Supreme Court did repeal the injunction much to Cipla’s relief.
On 11th February 2013, the Patent office affirmed its original decision and revoked Pfizer’s patent under Section 25(2), rule 62 of Indian patent act, much to the delight of patient groups.
The prior arts which were considered in the previous post grant opposition were re-evaluated in light of the recommendations of the opposition board. The patentee argued that the opposition board had adopted a hindsight analysis in arriving at the claimed compounds. The patentee also argued that there was no motivation in the prior art that would lead a person of ordinary skill in the art to modify the prior art compounds and arrive at the claimed compound.
After taking into consideration the relevant prior arts, the Controller stated that a person skilled in the art could have arrived at the compound claimed in the instant patent, by simple modification in process of manufacturing without any undue experimentation.
The Controller opined that “I observe that when as the instant claims are clearly obvious to a skilled artisan, so, the commercial success of the instant product (Sunitinib) as submitted by the patentee cannot be considered as an evidence of a patentable invention.” The decision of the controller can be accessed here .
Sunitinib, 50 mg tablet strength is marketed by Pfizer at an exorbitant price of Rs. 61,000 for a strip of seven tablets. As reported by livemint, it is expected that domestic drug maker BDR international will be launching much cheaper generic version soon.
The decision is no surprise given that the Controller would have had to be really out of her mind to have reversed her order given the profile of the matter.
What remains to be seen is whether the decision was judicious in light of the technical analysis of the prior art compounds vis-a-vis the claimed compounds.
Also, the patient groups may not be as delighted as the generics since they can now merrily go ahead and launch copies. Would love to see them slash prices drastically so that the patients indeed benefit. Pricing anyways is a relative thing and even if they slash prices to 1/10th of the current price, it would still remain expensive for others!
While I can understand the joy of patients, increasingly, it appears that cost is being highlighted as the major or rather the only issue with the innovator drugs. So, does it imply that if the innovators slash their prices considerably, the anti-patent camp (read generics) would be satisfied. If not, then does it not mean that the anti-patent camp is not only worried about the patients but in fact about their own position as they would then be infringing and get entangled in litigation minus their patient trump card!
Any answers here?
Anon1
Price , public interest, access to drug etc are the various “MASKS” that generics wear on different stage to suit their convenience. Of course to hike their profit.
Hi Anon1,
Generics,obviously have their own interests in mind and while catering to their own interests they also cater to public interests
Innovators also need to be considerate and adopt differential pricing.Imagine being in intense pain and not being able to afford a drug that would alleviate your suffering..
and regarding the decision of revocation, it is a question of perception and our threshold for inventive step has always been high.