Mumbai: The Mumbai patent office has initiated an inquiry into alleged violations in granting patents for modified forms of existing drugs, even as newly available documents related to these present evidence of negligence.
The office has asked patent examiners, assistant controllers and other officials to state—their reasons for not raising objections while granting certain patents. The inquiry was triggered by a Mint story on 10 December, “India granting drug patents for mere modifications”.
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Companies that have allegedly benefited from such patent grants include the world’s largest drug maker Pfizer Inc., GlaxoSmithKline Plc., Wyeth Pharmaceuticals Inc., Teva Pharmaceuticals Industries Ltd and AstraZeneca AB, as well as Mumbai-based Cipla Ltd and Sun Pharmaceutical Industries Ltd.
W.M. Dhumane, joint controller and head of the Mumbai patent office, in an official memo issued in late December quoted the Mint report and asked three assistant controllers and two patent examiners whether the granted patents are valid under section 3(d) of the Patent Act.
Dhumane also asked them to state the type of objections raised in the examination report, the company’s explanations and the reasons for waiving those objections.
Documents obtained from the Mumbai patent office after the inquiry was launched show that the applications for at least three patent grants had no mention of improved therapeutic efficacy.
The examiners or controllers had not raised objections related to this while granting the patents.
In October, Mint had reported the findings of a month-long investigation, which showed that some patents were awarded because of an alleged nexus between so-called patent agents, or lawyers employed by drug firms to manage their patent application process, and patent officials.
Patent law experts and scientists in India say that so-called evergreening of patents, or extending the patent life of known drugs by big drug makers, has been a major problem all over the world.
K.G. Rajendran, a pharmaceutical scientist and patent expert based in Mumbai, said: “The Indian Patents Act, which was drafted keeping such genuine concerns in mind, has been grossly overlooked by the authorities.”
The documents obtained from the Mumbai patent office relate to two patents granted to Pfizer and AstraZeneca and show that neither the examiner nor the granting authority raised any questions regarding improved therapeutic efficacy as required by law.
Pfizer was granted a patent for a new variant of its best-selling anti-migraine drug sold under the brand name Relpax, while Swedish drug maker AstraZeneca received a patent for a crystalline form of its cardiac drug Exanta. AstraZeneca had to withdraw this drug globally in 2006 after reports of liver damage.
The documents also show that Teva was granted a patent for a hydrate form of muscle pain drug, alendronate sodium, even after the examiner raised an objection. Alendronate sodium is sold by Merck and Co.under the brand name Fosamax. It went off-patent in 2008 and Teva sells the generic version globally.
In all these cases, the companies have claimed that the new forms are different in pharmaceutical structure and stability, according to the records at the patent office. None have said their drugs show improved therapeutic efficacy over the existing products.
Gurgaon-based patent law firm Remfry and Sagar had filed these patents for Pfizer, AstraZeneca and Teva in India. Remfry and Sagar is one of the top three patent law firms that handle at least 90% of all patent applications filed by foreign drug companies in the country. The other two are De Penning and De Penning and Lall Lahiri and Salhotra.
“The applications were prosecuted in compliance with the Patents Act. No opposition whether pre-grant or post-grant was filed in any of the cases. Apparently, everybody was convinced that the grants were unassailable,” said a spokesman for Remfry and Sagar in an email reply to Mint on 22 January. The spokesperson also claimed these patents had lapsed as the companies were not interested in renewing them.
“The mere fact that the patentee let them lapse does not in any way exonerate the controller who overlooked section 3(d) while granting the patents,” said Shamnad Basheer, a professor in intellectual property law at the National University of Juridical Sciences, Kolkata, who was appointed by the ministry of human resource development. “If true, this lack of application of mind casts serious doubt on the level of scrutiny in examination and the situation needs to be remedied.”
“On the whole, such incidents demonstrate the importance of transparency and of having a full-fledged patent database that would enable stakeholders and members of the public to monitor patent grants and ensure that such 20-year monopolies are doled out to truly meritorious inventions,” Basheer added.
“Teva has faith in the Indian Patent Office, which is certainly well acquainted with the Indian Patent law,” Teva spokesman Shir Altay wrote in an email reply on 21 January.
AstraZeneca’s global media relations executive Zhou Yi said: “All of AstraZeneca’s Indian patents are subject to examination by the Indian Patent Office to ensure that they meet the requirements of Indian Patent Act. We strongly believe that patent No. 203050 (its new form of the Exanta drug) was validly granted, and complied with patent requirements in India.”
Pfizer did not respond to Mint’s queries. In a response to an email query for an earlier story, the company had said it “believes its patents, duly issued by the Indian Patent Office after full examination on the merits, are valid and enforceable”.