Patent

Patent Oppositions in India: The "Efficacy" of Section 3(d)


Last week, CH Unnikrishnan of the Mint reported on a study that I had conducted with my research associate, Souvik Guha. Let me highlight some of the findings of this study prior to moving on to Unni’s report.

After reviewing a slew of information from the Indian patent office website, we found as follows:
i) The total number of pharmaceutical applications filed between 2005 and 2008 were around 9719.

ii) The number of pharmaceutical patents granted during the above time frame was around 2734.

iii) Of the 9719 pharma applications filed, only 34 were challenged—an abysmal .3%!

iv) Out of the 34 challenges, one was a post grant oppn (in favour of Roche covering Pegasus) and the remaining 33 were pre-grant challenges.

v) 25 out of 34 oppositions resulted in rejections i.e. a significantly high ratio of 73.5%! The patent applicant won in only 9 cases (9/34 or 26.5% of the time)

v) 20 out of the 25 rejections above were based on section 3(d). In other words, 80% of the rejections were based on section 3(d), indicating the “efficacy” of this controversial section.

However, barring a Madras High Court decision in the controversial Novartis case which attempted to interpret section 3(d) in the context of a constitutional challenge, there has been no case that interprets the scope and ambit of section 3(d). The Supreme Court of India lost a fabulous opportunity to do so in Roche vs Cipla; and it is now hoped that we’ll have some clear standards emerging from the Supreme Court in the Novartis “Glivec” matter (the Business Standard reports that notices have been issued to the Indian government and other parties in this case).

Analysis:

It is not immediately clear as to what accounts for the rather paltry number of oppositions filed…a mere .3% of the total number of pharma applications were opposed! Particularly since India has a vibrant generic sector and a very active NGO community that opposes frivolous pharma patents.

One explanation, though a highly improbable one is that many of these applications were “strong” and meritorious ones. Another is that the patent office website has not included many of these oppositions. Going by the various errors that we spotted on the Indian patent office, this is more probable. Though we find it unlikely that the numbers omitted by the patent office could be so significant as to increase the opposition numbers substantially.

Lack of Awareness?

Another reason could be that the generic industry and public health groups are still coming to grips with this powerful mechanism and are taking some time to leverage it. Some may also falsely expect the patent office itself to do its job well. They have to understand that patent offices are fallible and make mistakes, even in countries like the US and EU, where the offices are better staffed than India. Therefore, they must come forward and leverage the opposition mechanism to help the Indian patent office make the right decision, granting patents to only meritorious inventions.

Perhaps the government ought to set up a committee to study the opposition mechanism and why its been under-utilised. It ought to undertake more awareness drives around patents and the opposition mechanism, and provide logistical support, where possible, particularly to non profit NGO’s.

Is the Opposition Mechanism Being Gamed?

There are also allegations that the opposition process is being gamed and unduly delayed, with multiple challenges to the same patent application by the same entity, albeit under different names. Paradoxical perhaps that although the total number of applications that are attacked are fairly few, the ones that are attacked involve multiple opponents! The government ought to also investigate this “gaming” allegation in a bid to better the opposition mechanism.

Other Oppositions

This study is still in draft form and we will publish the final version soon. Prior to reproducing Unni’s report below, I want to clarify that the term (“other oppositions”) used by him actually refers to a decision made by the patent office after hearing the patent applicant (under sections 14 and 15). It is therefore not really an “opposition” but a normal prosecution by the patent office, where they opt to hear the party to satisfy themselves on the merits of the patent application.

Here is Unni’s report:

“Three patent provisions that have come under flak from foreign companies and governments for not being compliant with global intellecutual property regimes have actually helped India weed out frivolous patents since 2005, when the country moved to a new patent regime.

This is the finding of a study conducted by the intellectual property rights (IPR) law department of National University of Juridical Sciences (NUJS) at Kolkata.

The study shows that these three provisions were the basis of rejecting seven out of 10 patents rejected in the area of drugs, and 15 out of 20 rejected in other areas.

However, the study also shows that very few patent applications are being challenged at all under these provisions, an indication of the reluctance of Indian companies to take on Big Pharma, which is behind most of the applications.

While a lobby group for domestic drug companies said the findings highlight the large number of frivolous claims being made by Big Pharma, a lobby group for foreign drug firms said the numbers weren’t significant enough to make inferences.

The three provisions relate to pre-grant opposition, post- grant opposition, and section 3(d) that prevents the issue of a patent for any known substance or concept unless the basis of the new patent claim makes the product’s efficacy substantially higher.

All three have been criticized by foreign companies and governments since 2005 for allegedly being non-compliant with the Trade Related Intellectual Property Rights dispensation of the World Trade Organization.

The study, however, shows that the three have been critical in filtering out frivolous patent claims.

In all, 58 patent applications were opposed between 2005 and 2008: 34 under the pre- and post-grant opposition provisions; and 24 under other options.

Of these, 41 were rejected: 27 under section 3(d).

However, these numbers pale in comparison with the total number of pharmaceutical applications filed. According to the study, 9,719 pharmaceutical applications were filed between 2005 and 2008; of these 2,734 patents, or less than one in three, were granted. The rest are being processed.

Interestingly, most of the 25 patent applications rejected under the pre- and post-grant opposition category were made by foreign drug makers, including Novartis AG, Pfizer Inc., Gilead Sciences Inc. and AstraZeneca SA, according to Mint’s own analysis of the rejections.

The analysis also showed that most of the oppositions were filed by Indian drug makers such as Cipla Ltd, Ranbaxy Laboratories Ltd, Sun Pharmaceutical Industries Ltd and Torrent Pharma Ltd.

Other challenges came from non-profit patient groups such as Mumbai-based Cancer Patients’ Aid Association, Sankalp and Positive People Living with HIV/AIDS.

Shamnad Basheer, who led the study, along with Shouvik Guha, a research associate at NUJS finds the statistics on patent opposition inadequate. “It is pitiable that despite such a large number of pharmaceutical applications filed, only around 34 were challenged, an abysmal 0.3%,” he said.

A representative of a lobby group for local firms said the numbers highlighted both the need for increased awareness among local companies and activist groups, as well the large number of possibly frivolous patents that were being filed.

“One can see only a few Indian companies coming forward to oppose such frivolous patents. The local industry and the NGOs (non-governmental organizations) should be made more aware of these provisions to use these tools very effectively,” said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance.

“At the same time, it is very important to look at the rate of rejections, which is very high corresponding to the number of oppositions, and it shows there are alarming number of frivolous patents being claimed in the country,” he added.

Shah’s opposite number had a diametrically opposite point of view.

“It is too early to draw statistical trends from an implementation of a law where all the participants are on a steep learning curve,” RanjitShahani, president of Organisation of Pharmaceutical Producers of India, an industry association that represents foreign drug makers in the domestic market, wrote in an email.

Mint couldn’t immediately ascertain why few patent claims are opposed. Shah said it could be because of poor understanding of these provisions by local companies and patient groups.

P.H. Kurian, India’s controller general of patents designs and trademarks, agrees.

“There is a need for increased awareness on these provisions, which are strong tools to block frivolous patents, though the small number of opposition cases also indicate that the department’s high level of scrutiny on frivolous claims lead to rejection of many such applications at the examination stage itself, even without a formal opposition,” he said.

Basheer, however, has a few other possible explanations. One, which he admits may be improbable, is that many of the patent claims are “strong”.

Another is that the patent office’s website, the source of data for the study, may not have uploaded data on other patents that were opposed.

“Going by the various errors that we spotted on the Indian patent office, this is more probable, though we find it unlikely that the numbers omitted by the patent office could be so significant as to increase the numbers substantially,” Basheer said.

Some of the patent claims that fell to pre-grant oppositions.

Gilead Sciences Inc.: HIV drug Tenofovir, Sep 2009

Novartis AG: Combination of valsartan and amilodipine, Mar 2009

Novartis AG: Alfa crystal form of its blood cancer drug imatinib mesylate, Mar 2009

Greaves Cotton Ltd: Improved diesel oil engine, Mar 2009

Pfizer Inc.: Cardiac drug atorvastatin and amilodipine combination, Feb 2009

AstraZeneca SA: Patent application for lung cancer drug Iressa, Nov 2007

Eli Lilly: Application for osteoporosis drug Forteo, Sep 2007

Novartis AG: Lung cancer drug Glivec, Jan 2006

ps: image from here.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

8 comments.

  1. Avatarmnbvcxzaq1

    dear shamnad,
    just two comments (1 imporatant n 1 trivial) from me:
    1)”Is the Opposition Mechanism Being Gamed?
    There are also allegations that…..”. in response to this observation of yours, i, for one, can ditto this allegation. in fact, from my personal experience in the valcyte case on behalf of roche (clarification: i am no more associated with it presently), i can say that its not mere ‘allegation’, but probably a ‘reality’. often, these ‘fronts’ r used in order to overcome some legal hurdle. however, there r some other obvious reasons, too. i just wish everybody were playing ‘fair’! but the stark reality is that, no one plays fair in this game; no one is above board.
    2)on the lighter side, i once again disagree with your view that sc lost a ‘fabulous’ (earlier u labelled it ‘brilliant’) opportunity to iron out the creases (am deliberatly using your metaphor) in section 3(d). the reason (preferring the route thru db of delhi hc, despite it being functus officio, n consequently filing the slp very late) is the same as had been mentioned in that comment of mine. this ‘late’ conduct killed its chances of getting heard on merits.

    Reply
  2. Avatarwackes seppi

    Two comments:

    1. Language matters! I do not think that one can use “frivolous” so to speak generically for applications that will not pass muster under Indian law. And one would assume that frivolous applications will be rejected by the Office without there being a need for an opposition.

    2. There are liars, damn liars, and statistics. Taking the preliminary data at hand, there are various ways to interpret them, and caution is thus required for the final analysis. Also, one must be wary of small samples, and 58 patent oppositions is one.

    Reply
  3. AvatarAnonymous

    Dear Shamnad,

    How do you get the number of applications opposed?
    Please revert while keeping the following in mind:

    a) The Patent office gazette does publish post grant oppositions filed, but this is inconsistent;
    b) The Gazette does not have any information on pre-grant oppositions filed;
    c) The decision section on the Patent Office site shows more than 100 decisions in various industrial segments.
    d) At times, 2-3 pharma companies oppose on1 patent application.

    Regards,
    Frequently Anon.

    Reply
  4. AvatarShamnad Basheer

    Dear Wackes Seppi,

    Thanks for your comments. Yes, “frivolous” was used in specific connection with indian patent law and standards.

    Secondly, although this is a but a small dataset–it is the only dataset we have publicly available. I think that qualification was pretty evident from the post itself. But at the very least, some numbers help us to place the debates on slightly firmer footing than plain rhetoric and surmises.

    Reply
  5. AvatarShamnad Basheer

    Dear mnbv,

    Thanks for comments on this. They did file within the time period normally available for an SLP right? And besides, their challenge really ought to have been on the standards governing interim injunctions in India–which was likely to impact future cases. And not really only wtih respect to the speed/expediency which was likely to affect the equities etc in the present case.

    Reply
  6. AvatarShamnad Basheer

    Dear FA,

    our dataset comprises only of decisions that are publicly available on the patent office website. there are a number of decisions that are not available on the IPA website–and i think i make this clear in my interview to the Mint.

    The 100 or so number you have comprises not just of oppns but also of 14/15 decisions (after hearing. of course, all of them were clubbed together on the website–which made our task all the more difficult!

    Reply
  7. Avatarmnbvcxzaq1

    dear shamnad, i was away n hence am responding a lil late.
    well, in the peculiar circumstances (especially, the ‘imperfect understanding’ of the underlying principles/concepts/technical terms by the judiciary) of the case, the speed factor was not directly important by itself; instead, the lack of speed factor was, which in turn made the speed factor obliquely important. moreover, the route (i.e. appealing before a functus officio bench) taken by roche did gain them nothing more than a mere few days’ extension for depositing the ‘cost’. n depositing the ‘cost’ sans appeal, tended to render roche’s claim for urgency appear rather incredulous. lastly, by filing at the fag end of the prescribed time, roche cud not convincingly argue on the urgency for relief. thus, the very basis (though i agree that there r many other determinants of prelim. inj. relief) of prelim. inj. was undermined substantially.
    and i totally agree with u wen u say “their challenge really ought to have been on the standards governing interim injunctions in India–which was likely to impact future cases.” but u know wat shamnad, there is no ‘standard’ (strictly in terms of ‘consistency’) regarding the application of relevant ipr n prelim. inj. principles by the judiciary itself. i always have rued over it, u know it well by now.
    -aditya kant

    ps: (fyi) today i saw that my paper in jipr has been finally published. AT LAST. lol

    Reply

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