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MONDAY, NOVEMBER 23, 2009
  • Posted: Fri, Jan 30 2009. 12:20 AM IST

Patents grant for mere change under scanner

Examiners have been asked to state the type of objections raised, the firms’ explanations and reasons for waiving objections

C.H. Unnikrishnan

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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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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.

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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.”

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Patman Said:


The real problem lies with the patent office forcing non-chemistry examiners to examine drug and pharma cases.Citing lack of examiners as reason, such specialised cases are thrust on examiners from different backgrounds. Obviosuly these examiners find it difficult to understand whether such patent applications come under the purview of Section 3 d. Adding to the problem is the recemt mass promotion of numerous examiners as Assistant controllers. This has led to an imbalance of the examiner controller ratios whereby in many offices now there are more controllers than examiners. These new controllers have no work to do as they claim that according to the patent act they cant examine patent applications.The patent office has not initiated any steps to solve this problem by recrutiing new examiners.

Posted On 1/30/2009 10:35:04 AM
Re: Unnikrishnan Said:


Yes, as you rightly pointed out, this is another area of concern in the Indian patent grants. We had earlier reported that the number of grants doesn't actually tally with the existing infrastructure and the number of examiners in particular. But assigning non-sector experts to examine the claims is totally undesirable. The government's promise to create another 400 odd posts (mainly examiners) in the department is welcome. But still no clarity about the time frame.

Posted On 1/30/2009 2:42:24 PM
Supratim Said:


Dear Unni, Thanks for your article 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 carrier in patents, I think this type of articles will help student like us to have a practical view on Indian patent review 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 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 you figures in coming future.

Posted On 2/3/2009 2:23:56 PM
Ajay Said:


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 the 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.

Posted On 2/4/2009 8:35:47 AM
sandhya Said:


It would be more interesting to know about those cases where the patent examiners have overlooked the unique section 3(d) or applicant has/has not provided the data for therapeutic efficacy to qualify under section 3(d). But due to lack of transparency in examination and granting procedure, it is not possible for others to get such information [examiners’ objections and applicants’ response for not applying or justifying section 3(d)]. If the examiners or controllers do not raise objections while granting the patents for mere modifications then it will be easy for any one to get the patent grant in India. As per my understanding a unique section 3(d) of IPA is provided to stop evergreening and not to facilitate it. There may be many inventors who do not file patent application for their inventions since they believe that their inventions are not patentable inventions under section 3(d) until they prove therapeutic efficacy. If there would be transparency in examination procedure it would be helpful for those applicants who wish to file patent application and get the grant as MNCs do.

Posted On 2/5/2009 10:45:14 AM
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