A couple of weeks back, he reported on the fact that a number of pharma patents were granted, where it appeared that the patent office did not check for compliance with section 3(d). Pursuant to his report, the patent office ordered an investigation. Not only does Unni need to be lauded for his fine work on this front, the patent office needs to be congratulated as well for ordering a prompt investiation into this affair. Such swift action on their part demonstrates a commitment to set things right and to better existing standards of governance, accountability and transparency.
CH Unni now reports as follows:
Patents grant for mere change under scanner
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”.
Indian law, specifically section 3(d) of the Patent Act, states that patents cannot be granted for modified forms of existing drugs if they do not improve therapeutic efficacy. Mint had reported that in the past year, India had granted at least 10 patents to foreign and local drug makers for what were mere modifications, or new forms of known drugs.
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”.
Undoubtedly, the issue of transparency calls for a viable system to be in place. Moreover, such issues can not be resolved until availability of the whole set of documentation covering each and every stage of the patent proceedings with respect to every matter being entertained or attended at the Indian Patent Office be made public in the form of interactive electronic data. The term transparency must not, therefore, be limited within the premises of Indian Patent Office but it should be made available to the public as “The Patent Application Information Retrieval System (PAIR)” – the electronic databse of United States Patent and Trademark Office (USPTO).
We do not think that there should be any problem in sharing the official documentation on dedicated server. As we know, USPTO and EPO are doing these things since so many decades and have successfully implemented the complete transparency over the internet across the globe. Following the same path by implementing the real transparency we would also be able to keep track on the alleged nexus between patent agents or lawyers or law firms or big companies and patent officials in a transparent manner. In addition, that will also allow our intellect brains or any person interested or concerned people to keep track of these attempts of evergreening concepts at the very early stage before any such thing get monopolized.
To draw conclusion out of this, we would like to give stress on the point that Indian Patent Office is definitely lagging behind and we need to act, that too very fast. As a welcome thing, the official sources from the Indian Patent Office have already indicated that the digitization of each and every document relating to every patent application is in progress. Therefore, the need of the hour demands urgency which must be injected in the project of the digitization of patent database for Indian Patent System and fructify in an interactive user friendly data retrieval system.
Once again Mr. Unnikrishnan of Mint has done an excellent piece of investigative journalism. It is very surprising to know that Multinational Pharmaceutical companies are getting patents for new form of known substance without showing the enhancement of known efficacy of that substance . The purpose of putting Section 3(d) in the Patents Act was to have a check on evergreening of patents for mere modification. But still the companies are getting benefited from Patent Offices’oversight of Section 3(d) of Indian Patents Act . It is alarming situation that the Examiners are not raising the objection under section 3(d) when they issue FER (First Examination Report) to the applicants. It is expected from the Examiner that he should be well aware of the Patents Act before examining a patent application. The Section 3 (d) is an unique provision in Indian Patents Act and it is expected from each Examiner that they should be aware of this particular section of the Indian Patents Act. Moreover the term enhancement of known efficacy has a huge relevance in the statute of section 3(d). In the case Novartis AG vs Union of India, the Madras High Court held that enhancement efficacy as the enhancement of therapeutic efficacy. So it is expected from the Examiners that they should keep in mind this interpretation of enhancement of efficacy before issuing FER for such applications. Not raising the objection of Section 3(d) in the FER has left some questions unanswered:
Whether the Examiners deliberately avoided Section 3(d) in their FER?
Whether the Examiners are not aware of the relevance of Section 3(d) of Indian Patents Act?
If either of these is the case, then the Section 3(d) of Indian Patents Act will become redundant and the purpose of putting this Section in the Indian Patents Act will be defeated. Slowly and surely our Generic Pharmaceutical Industry in which we are called as proficient will succumb.
If a Biotechnology examiner is examining Pharma/Drug cases how will he/she know whether to raise 3(d) or not? There is an urgent requirement for Pharma experts as examiners. but the patent office has not even a single M.Pharm examiner and no indication about plans to recruit such people. Also allotment of applications to examiners by Controllers should be subject-based, free and fair.
Ya you are right that for sometimes Mr.CH Unni of the Mint has been striving towards enhancing transparency norms at the patent office. I thanks specially Unni and Spicy IP for publishing articles which citing the lack of potential of Indian examiners and how much bias they can be. As I am a student and planning of pursuing my career in IPR, I think this type of articles will help student like us to have a practical view on Indian patent prosecution system. I don’t think they even know what exactly is section 3d and for which claims a patent get a status of section 3d. After reading your and Unni’s article, what I feel is that our examiners don’t have enough eligibility to in scientific background to deal with patents application of pharmaceutical industry. Another interesting fact which I came across while going through your article is that of private law firms, what I feel is that these law firms have some tie up with the examiners or patent offices, as we all know how many application they file and what is the success ratio of these firms in getting grants. Sir, I am very thrilled and happy after reading your article and I wish you will carry on the job and hope you will bring more facts with your figures in coming future. And even I will try to put some light on the matter of transparency norms of patent office and patent prosecution system through my blogs in http://www.patentvortex.blogspot.com putting a step forward towards enhancing transparency.
Dear Anonymous,
I want to ask a simple question from you , if an Examiner is from Biotechnological background, does this mean he/she is not aware of this section 3(d) of Indian Patents Act? In the Statute of Section 3(d) it is clearly mentioned “For the purpose of this clause , salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.” It is expected from the person who is having a science background to be aware of Polymorphs and other terms mentioned in the explanation of section 3(d), so what I feel is if the Examiner is not raising the objection under Section 3(d) in the FER because he/she is having a biotechnological background that means they are not aware of these terms which are meant to be studied in 12th class at school level. It is surely a matter of concern that Examiners are examining the Patent applications which are not related to their field of background. You are right that there is an urgent need for M.Pharm Examiners who can better understand Pharma/Drugs cases . But it is also expected from the Examiner to be well aware of Patents Act before examining a patent application.