In a recent decision dated 26th June, 2018, the Assistant Controller of Patents and Designs exercised his power under Section 15 of the Patents Act, 1970 (“the Act”) and rejected the bid for a patent application. Below, I give a brief description of the patent application and the reasons which led the Controller to come to such a decision, before analyzing the final order.
About the Patent Application
The applicant, Bayer Intellectual Property Gmbh (Initially, Bayer Animal Health Gmbh was the applicant and they later assigned their patent rights to the present applicant), had applied for patent application number 9382/DELNP/2010 for a pharmaceutical invention entitled “Use of nifurtimox for treating giardiasis” on 31st December, 2010. A perusal of the abstract, claims and full description reveals that the said application proposed several compositions containing nifurtimox and an anthelmintic (anti-parasitic drug) for treatment of giardiasis (a particularly nasty intestinal infection caused by parasites belonging to the genus Giardia) in dogs and cats. The disease can spread to humans, by cysts of cats and dogs, circulated via infected water or feces. The description stated that, prior to this, nifurtimox was only known for its efficacy against protozoans of the genus Trypanosoma, which cause African and American trypanosomiasis, or sleeping sickness. However, the applicant’s invention proposed that nifurtimox was effective against the Giardia species too and it could target the gut-pathogenic stage and prevent cyst formation, thereby reducing spread of the infection.
Consequent Events
Stating that the mere “use” of nifurtimox does not amount to an invention under Section 2 (1) (j) of the Act, the First Examination Report (FER), dated 17th March, 2017, proceeded to object to the patent application on mainly three grounds, listed below:
Lack of Inventive Step: The Report stated that the requirement of inventive step under Section 2(1) (ja) was not met since the combination of nifurtimox with an anthelmintic (both previously known substances, as per the applicant’s disclosure) would be within the technical knowledge of a person skilled in the art. Further, the combination did not yield any “unexpected/surprising and/or enhances or synergistic technical effect”.
Non-Patentable Subject Matter: The Report stated that the invention merely amounted to a new use of a known substance since the prior art revealed that nifurtimox was already used against organisms of the genus Trpanosoma and hence it fell within the ambit of Section 3(d) of the Act. It further stated that Section 3(e) of the act would apply since the composition merely amounted to an admixture of nifurtimox and an anthelmintic, without any synergistic effect.
Insufficiency of Disclosure: The Report stated that the requirements of full disclosure under Section 10(4) (a) and (b) and 10(5) were not met since no working examples had been given for the claimed compositions of the components and hence, there was no disclosure of the best method of performing the invention.
The Reply to the FER, dated 17th September, 2017, does not reveal much since the Applicant merely deleted a few claims from its Application and requested the Controller to accordingly waive off the afore-mentioned objections. The Applicant was consequently offered a hearing on 19th March, 2018 and 23rd April, 2018 for clearing the outstanding objections the application related to non-patentability and insufficiency of disclosure.
Reflections on the Final Order
And here comes the twist! Instead of filing further submissions and dragging the application procedure, the applicant’s agent informed the Controller via telephonic conversation that they wished to withdraw their application, resulting in the consequent rejection of the patent application by the Controller. Hence, we see, that in accepting the inevitable outcome at an early stage of the procedure, the applicant’s step effected speedy disposal of the matter.
Which brings us to the issue of pendency in the Indian Patent Office: This issue is currently being effectively tackled by the Government and measures such as computerization of work-flow, automation, electronic transfer of applications between branches etc. have indeed led to a decline in the number of pending matters. Self-initiated steps taken by future patent applicants, such as the one taken in the present decision, will also go a long way in tackling the issue head-on.
H/T: On behalf of the SpicyIP team, I would like to thank Mr. Sandeep Rathod for alerting us about this interesting development!
Image from here.
Hi Prarthana!
I read your post and also reviewed file wrapper for patent application 9382/DELNP/2010 as available on Indian Patent Office website. I am sorry that I could not agree with your analysis of Controller’s final order.
The applicants did not officially withdraw their application. Instead, they merely conveyed to the Controller of their decision of not pursuing their application further. Most patent applicants resort to such a recourse whenever they believe that outstanding objections on their application can not be addressed and hence, investing more in terms of time and resources (including monetary) they prefer abandoning the case. In such instances the Controller issues order under Section 15 of the Patents Act.
There are numerous instances where such recourse is taken by patent applicants. A few cases which I handled earlier and readily recall while I was associated with previous organizations are listed below –
2504/DELNP/2008
932/DELNP/2010
2019/DEL/2004
7157/DELNP/2010
6613/DELNP/2008
6037/DELNP/2008
In all these cases, applicants decided not to pursue their case post an official hearing was appointed under Section 14 of the Act. Accordingly, their decision was informed both verbally and in writing to the respective Controller. All these cases were then refused under Section 15 of the Act.
I will be pleased to learn more from you in case I missed on reaching to the main crux of your article.
Regards,
Noopur
Referring to this as “withdrawing” the application is misleading, given that term’s specific meaning in india. Also, As the previous commentator suggests, what is described here is common, applicants notify the IPO that they won’t attend the hearing and the application is refused. We discuss this in a recent article:
“Indian pharmaceutical patent prosecution: The changing role of Section 3(d),” PLoS ONE 13(4): e0194714. — https://doi.org/10.1371/journal.pone.0194714
Referring to this as “withdrawing” the application is misleading, given that term’s specific meaning in india. Also, As the previous commentator suggests, what is described here is common, applicants notify the IPO that they won’t attend the hearing and the application is refused. We discuss this in a recent article:
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0194714
To me, The withdrawal or abandonment was not the unique aspect at all. Rather for me, the decision was interesting in the way that the Controller stood his stand on 3(d) and 3(e). Far too often, I see 3(e) objections being withdrawn without proper data or traverse.
Hi Sandeep — Nice to exchange thoughts with you (we’ve not met in person but have discussed things over email as I’ve asked you the occasional question).
I agree with you: the interesting thing here is not what the applicant did, as we all seem to acknowledge that applicants giving up is not such a rare event, but rather the interesting thing is what the IPO did, in sticking to his ground.
In the article I referred to above we examined a sample of pharmaceutical patent applications filed in India from 2000-2010. For each application we recorded the grounds of the objections raised by examiners in the FERs. We focused on 3(d), and also novelty and inventive step; we did not record anything about 3(e). We did this overall and overall and specifically for claim 1, and then we looked at final outcomes. Although we did not look at 3(e), so our findings cannot speak to the observation you make here, we think the findings may be interesting to you nonetheless.
Of the 22 applications in our dataset that had a 3(d) objection on claim 1 and which were ultimately refused, we reviewed the full prosecution history of 20 (for the other two the materials beyond FERs were not available), comparing . Here I quote from the paper: “In six of these the post-FER prosecution process appeared to feature rigorous application of standard patentability criteria: in three instances examiners’ 3(d) objections were successfully overcome, but the application was still rejected on grounds of lacking novelty or inventive step, and in another three instances novelty and inventive step objections were not raised in the FERs but were cited as grounds for final refusal (in one case solely, without 3(d)). By contrast, in three other instances the FERs cited novelty or inventive step but these were no longer mentioned as grounds for refusal in the final patent office decisions. In the remaining 11 applications, both 3(d) and standard patentability criteria were used the same ways in FERs and final decisions.”
While the data do not allow us to reach firm conclusions, we think it’s reasonable to interpret these findings as suggesting that early use of 3(d), e.g. in FERs, creates opportunities for the patent office to probe deeper about whether applications meet even standard patentability grounds. Or, to put it differently, examiners early use of 3(d) may create opportunities, later in the prosecution process, for the patent office to discover or consider in depth other problems with the application that were not fully appreciated in the initial examination.
Hi Sandeep — Nice to exchange thoughts with you (we’ve not met in person but have discussed things over email as I’ve asked you the occassional question). I agree: the interesting thing here is not what the applicant did, as we all seem to agree that giving up is not such a rare event, but rather the interesting thing is what the IPO did, in sticking to his ground.
In the article I referred to above we examined a sample of pharmaceutical patent applications filed in India from 2000-2010. For each application we recorded the grounds of the objections raised by examiners in the FERs. We focused on 3(d), and also novelty and inventive step; we did not record anything about 3(e). We did this overall and overall and specifically for claim 1, and then we looked at final outcomes. Although we did not look at 3(e), so our findings cannot speak to the observation you make here, we think the findings may be interesting to you nonetheless.
Of the 22 applications in our dataset that had a 3(d) objection on claim 1 and which were ultimately refused, we reviewed the full prosecution history of 20 (for the other two the materials beyond FERs were not available), comparing . Here I quote from the paper:
“In six of these the post-FER prosecution process appeared to feature rigorous application of standard patentability criteria: in three instances examiners’ 3(d) objections were successfully overcome, but the application was still rejected on grounds of lacking novelty or inventive step, and in another three instances novelty and inventive step objections were not raised in the FERs but were cited as grounds for final refusal (in one case solely, without 3(d)). By contrast, in three other instances the FERs cited novelty or inventive step but these were no longer mentioned as grounds for refusal in the final patent office decisions. In the remaining 11 applications, both 3(d) and standard patentability criteria were used the same ways in FERs and final decisions.”
While the data do not allow us to reach firm conclusions, we think it’s reasonable to interpret these findings as suggesting that early use of 3(d), e.g. in FERs, creates opportunities for the patent office to probe deeper about whether applications meet even standard patentability grounds. Or, to put it differently, examiners early use of 3(d) may create opportunities, later in the prosecution process, for the patent office to discover or consider in depth other problems with the application that were not fully appreciated in the initial examination.
(Apologies if this posted twice, i’m having trouble with the website.)
I have also let go of few applications by informing the Controller that we would not like to pursue the case further and would not be attending the hearing. This does not mean that the objections were meritorious and could not be overcome. In most of the cases that I have not pursued, it was more to do with business decisions than anything to do with the objections.
In patent office, Grant rate is more than 95 %….only those case are rejected or refused in which applicant is not interested…..otherwise all other cases are granted ( 95%) to complete the controllers target…….
In next some months , this grant rate will be 99% as CG office has to show only numbers to ministry …if u filed any invetion…u will get patent sure as nobody in office have to time to understand invention and refuse the same….so best way …grant every invention…..