Innovations are important for the growth of an economy of any country. However, guarding these innovations through patent, is also equally important. That the pharma industry has taken the path of innovation more than any other industry has already been proved. For instance, as per [email protected], while a mere 94 patents were granted to food products, a whopping 1810 patents were granted for medicines/pharma inventions in a three year period from 2009 to 2011. Granting a patent is a complex legal process, requiring a lot of documentations, filing requests for examinations etc. However, for a long time, the Indian patent office has been at the receiving end for not being able to appoint enough resources to speed up the patent granting process.
Inevitable innovations
Innovation is a good thing that is happening to the Indian pharma industry. However, looking at the quantity of the patent applications and patents that have been granted, one wonders how many patents are really genuine and truly justify the word ‘innovation’.
Milind Sathe, Deputy General Manager, Projects, Unichem Laboratories, says, “There is nothing like genuine. All granted patents are valid till they are revocated. Granted patent means it conforms to objective criteria specified by the Act and therefore the grant. If we correlate the word ‘genuine’ to working of the patents, then unless the data is provided as to how many of these granted patents are worked in this land, an opinion cannot be expressed. There is no firm relationship between quality and quantity unless the attributes of quality are specified.”
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| Milind Sathe |
While speaking about the procedure of patent processing, Sathe informs, “There is no separate procedure for prosecuting pharma patents. The manner of processing patents in general is specified in manual and in the Act and Rules. The eligibility criteria for examiner as is displayed on IP office website.”
Though the number of patent applications is increasing, India’s share among patents granted is still not considerable. Out of 185 product patents granted by Indian patent office in 2010, about 38 per cent of product patents were granted to the US. India’s contribution is about 10 per cent. As already said, from 2009 to 2011, 1810 patents were granted for pharma innovations. A look at the list of patents granted and those pending clearly reveals a skew towards overseas applications.
There are some contradicting view as well. According to Suhas Tuljapurkar, Managing Partner, Legasis Partners & Director, Legasis Services, though the figure of 1810 pharma patents granted by Indian patent office from 2009-11 appears to be a big number, it is indeed not the case that the patent office is granting patents generously to either domestic or overseas pharma companies. Indeed the number of pharma patent granted in India is on a decline year-on-year.
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| Suhas Tuljapurkar |
Tuljapurkar informs, “The reason why a handful of examiners and controllers (less than 50 in all four branches of Indian Patent office) from the life sciences division could grant so many patents in so less time was, majority of these patent applications were filed during the black box period (1995-2005) and were already granted in major patent granting authorities. The patent examiners would very often take into cognizance the fact that the patent is granted in key jurisdictions to arrive at a decision for grant.”
He adds, “However the tripping point that led to the decline in numbers was the decision of Intellectual Property Appellate Board (IPAB) in the famous Novartis-Gleevec case (in July 2009) that incorporated additional requirements of ‘therapeutic efficacy’ in a pharma product patents. With regard to ‘quality’ of these patents, the mere grant of patent does not ensure its validity and many such patents have been revoked during the IPAB trials or found invalid in the hands of the judiciary. The most recent victim is patent for Sutent, an anticancer drug licensed by Sugen to Pfizer.”
Amit Hariani, Partner and Solicitor, Hariani and Company, feels that when a patent is granted, the test of novelty and utility is required to be considered before any patent is granted to an invention. Therefore the number of patents granted will not affect the quality of the patents
Scouting for experts
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| Amit Hariani |
In the last ten years there is a rise of 250 per cent in patent applications. Does the Government of India have enough experts to examine patent applications? If not, is the Government putting innovators and innovations at risk in India with such an approach? According to experts such a situation prevails not just in India, but in many other countries as well.
“It is not only India that is witnessing the rise in applications. All developing and least developed countries, more specifically, emerging economies are experiencing this rise,” opines Sathe. As the phenomenon is new, it is natural that there will be some mismatch. According to Sathe, such mismatch is observed in the US and in the developed world as well. This is a global phenomenon. The Government is not putting innovators and innovations at risk in India with such approach. Patents are effective from the date of application. “If any country is propagating this view, it is out of hatred and selfish interest of some interested parties that are conspiring against India,” asserts Sathe.
Since January 2012, the Controller has issued approximately over 90 letters of appointments to patent examiners. Innovations are important for the growth of any country however, bringing those innovations into practical use is even more crucial. This is possible only if the patent granting process picks up pace and the applicant is free to use his innovation for the public.
“In this highly competitive world that we live in, innovation is the key and it is constantly evolving. The Government cannot afford to delay the patent grant process and needs to clear the backlog. The patent office is, nonetheless, is doing its best to deal with the rising number of patent applications. Undoubtedly, the number of experts/ examiners needs to be increased substantially, but by following due process,” says Hariani.
“The pharma patents in the Indian patent offices are processed by patent examiners that have at least a masters degree in life sciences domain. These examiners are selected through a recruitment drive mandated by Department of Industrial Policy and Promotion (DIPP) and executed by Council of Scientific and Industrial Research (CSIR),” informs Tuljapurkar. On the other hand, Tuljapurkar also highlights some flaws in the system. He indicates that for a long time Indian patent office couldn’t recruit patent examiners in sufficient quantities that might have subsequently led to delays in patent application processing.
Tuljapurkar explains, “In last attempt Indian patent office could hire only 135 of 257 mandated examiner posts. Thus there has always been acute shortage of experts that can handle the pending cases in the Indian Patent offices.” He adds, “Though DIPP is taking steps to modernise the patent offices, equip them with up to date electronic databases and making the patent process more transparent and user friendly, the efforts are slower as compared to other countries like China or South Korea. Majority of patent applications filed in India (up to 80 per cent) are filed by non-Indian applicants.”
Vivek Mittal, Legal Counsel, Lupin, gives the pharma perspective. He says, “The Government stands challenged to keep up with not only the pace of growth of the Indian pharma industry but also the growth of the Indian pharma market. Having said that, in my view the pace is not that bad either; however, there is large scope for improvement that could fuel further growth.” He wants the Government to keep pace with changes in the industry, with research and changes in laws and legalities globally as also make sure that the patents offices are staffed with the right scientific minds who would ensure swift processing and filings of patents.
Streamlining the process
The quantity of patent applications is a pointer towards the fact that there is no dearth of talent and innovation-oriented minds in the country; however, the credibility of the respective discovery can always be challenged. On the other hand, delay in patent application processing is an injustice for those who have toiled hard to innovate something extraordinary and which also holds national importance. India has already managed to shed its image of a backward country in the field of innovation. Not just pharma, but many other industries have been adding to the list of patent applications that are piling up in the Indian patent office. However, there is a common consensus among different industries that the Government needs to employ some crucial operational changes in the patent office.
Tuljapurkar says, “With the decision on the constitutionality of section 3(d) still pending with Supreme Court the existing requirements stipulated under section 3(d) shall continue to apply. So much has been said and written about section 3(d) that the industry expects the office to release interim guidelines on what is patentable under section 3(d) and by drawing various scenarios with examples that will enable an applicant to prepare a 3(d) compliant specification and also avoid heterogeneity in the judgment of patentability under section 3(d) amongst various controllers in different branches of the same office.”
According to Sathe, the Intellectual property Office, Ministry of Industry and Commerce, Ministry of Finance should publish the data collected under FORM 27, action taken against patentees providing submissions and depositions which are found to be different from facts, install effective mechanism to recover the dues, install a mechanism where by non-worked patents are declared by Government as open for Compulsory Licensing. This will save critical time and ensure public interest, fulfilment of sovereign duties and social welfare.
Sathe insists, “The Government should declare that a patentee which contradicts the law of the land may be declared as enemy and thereby may be prevented from commissioning, continuing any litigation in any of the Indian courts. All tangible and intangible property of enemy shall be confiscated.”
The greener side
There are visible drawbacks in the patent application processing system, however, Indian patent office has also taken steps to become operationally more efficient. Even the pharma industry’s general perception is that there is an improvement in patent processing over previous methods. “Online database is made available for searches, which was not available earlier,” informs Hariani. However he highlights that delay in clearing backlogs of applications remains the cause of concern.
Introducing an electronic module would help in imparting accuracy, efficiency and transparency to patent examination system. While such initiatives would avoid delays to some extent, it will be interesting to observe what further steps the Indian patent office will take to make the patent processing system closer to global standards. How industry responds to them will also determine the success of these moves.
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