Drug Regulation Patent

IPO Grants Patent to Brodalumab


Last week, our IPO granted a patent to Amgen covering the drug Broadlumab.  Brodalumab is a human monoclonal antibody designed for the treatment of inflammatory diseases including psoriasis  In the United States, Broadlumab is known as Siliq and in Europe it is Kyntheum.

The application for Broadalumab was filed as a PCT application – PCT/US2007/021174 (click here to see the page on WIPO – Patentscope) and was accorded application number: 2350/CHENP/2007. One can see the entire file on this link – https://www.quickcompany.in/patents/il-17-receiptor-a-antigen-binding-proteins

Sandeep Rathod – sent a link (http://ipindiaservices.gov.in/decision/2350-CHENP-2009-63576/2350chenp2009.pdf ) indicating that the patent had been granted: This was the controller’s decision in granting the patent.  It is a concise half page document as can be seen in the snapshot below:

 

 

Once I saw the decision, I was curious to the the submission made on 04/04/2018 – It is a whopping 60 page document! It includes responses made to the office action issued – granted EP patent claims, studies done by Amgen and submitted to the US FDA.

It is my belief that the decision granting a patent should include basic reasoning that why it is being granted.  This would be helpful to the patentee – the absence of reasoning for grant is indicative of the (less) amount spent in analysing the response.  Typos aside (the hearing and notice dates are reversed) this half page order basically agrees with the detailed submissions made.

Reasoning is helpful.  For example, the recent post where patent was denied to Standard Innovation Corp for a sexual stimulation device (See complete application and file wrapper here: https://www.quickcompany.in/patents/electro-mechanical-sexual-stimulation-device

This application had a reasoned order where the objections were not removed. These included objections on the ground of novelty / obviousness. As far as morality is concerned, even though I do not agree with the Controller decision, the reasoning is there.

 

 

 

 

 

Rajiv Kr. Choudhry

Rajiv Kr. Choudhry

Rajiv did his engineering from Nagpur University in 2000 in electronics design technology. He has completed his LL.B. from Delhi University, Law Center II in 2006, while working as an engineer at ST Microelectronics in NOIDA. After his LL.B., he went on to The George Washington Univeristy, Washington DC to do his LL.M. in 2007. After his LL.M., he has worked in the US at a prestigious IP law firm based out of Philadelphia. Till 2014, he was Of-Counsel to a Noida based IP law firm where he specialized in advising clients on wireless, telecommunication, and high technology. Rajiv is a co-founder of RHA Legal, a New Delhi based law firm specializing in IP law, with a focus on high - technology, and patent law. His core IP interest areas are the intersection of technology and IP, Indian IP policy, innovation, and telecommunications patents. He is also an inventor with pending applications in machine-to-machine communications domain (WO2015029061).

13 comments.

  1. Sathya

    I am surprised you noticed the fact that Controllers aren’t writing speaking or reasoned orders just today which has been the practice since quite a while. 80% of the grants are without speaking orders and some controllers don’t even write those one liners but merely grant patents.

    If you are really curious, Please take a look at this http://ipindiaservices.gov.in/disposal1/
    which dynamically shows the number of cases disposed (granted or refused) by every patent office, month wise and discipline wise. Take a look the applications disposed by clicking the number. Check for controllers’ decision pertinent to the application number from here http://ipindiaservices.gov.in/patentdecisionsearch/patentsearch.aspx

    You will either find no decision for an application or only a one liner – saying objections are met and patent is granted.

    As Prof.(Dr.) Basheer points out in comments on this post, https://spicyip.com/2018/08/sexual-pleasure-is-immoral-so-says-the-indian-patent-office.html
    Controllers are supposed to write speaking orders in clear, lucid language so the applicant, public and other stake holders can know how and why a particular case is granted, and it is minimum expected of a quasi-judicial authority vested with power to give away 20 year monopilies for which they are paid from tax payers’ money. But It is something controllers aren’t doing since a long time.

    Not just grants, even orders pertinent to refusals are just one liners, and merely reproduce the content of hearing notice (which is prepared by examiner by the way, and not controller) following one line that says that the application is refused u/s 15 of the Act since applicant didn’t attend the hearing.

    Reply
  2. Alok kumar

     As written by sathya “http://ipindiaservices.gov.in/disposal1/
    which dynamically shows the number of cases disposed (granted or refused) by every patent office, month wise and discipline wise ”
    Do you think the number of file being disposed by the patent office on monthly or annual basis, is according to any global standard w.r.t. to manpower in the Patent Office. I am surprised to see that.

    According to an RTI Reply, Order no 56 of 2016 says The target of Controller to issue 45 FER, and 30 Disposal per month and for examiner is 30 per month. This target as set by office, on personal basis I personally feel the target is like mount everest, and the carrer prospect in Patent Office is known to everyone. Based on the time available per file, it’s a decent decision. If anyone from us would have been on the other side of table, I am daam sure the report will be limited to one paragraph only.

    Reply
  3. RajivRajiv

    Sathya & Alok – you both make interesting points. They are a bit related.
    We have in the past lamented about this very issue on this blog. For example, see https://spicyip.com/2016/11/analysis-of-controllers-decisions-april-2016.html and https://spicyip.com/2012/06/may-2012-controllers-decision-at-patent.html

    As regards grant numbers and comparison with global trends, I feel that it is in line with global trends. A separate post would be coming in to analyse these.

    I would also hasten to add that we should not look at merely grant numbers but the quality as well – Examiners and Controllers have all incentive to grant – and the structure is built accordingly as pointed by Alok. We should be careful to note that having a focus on grants reduces the grant quality. This issue was captured in the 2016 GAO report for the US patent office. It claimed average cost to the system for an invalid patent was more than $5 Million.

    I understand that there are time constraints – and it is true on both sides. That said having reasons for grant spelled out clearly would help the patentee. Eg. US has a requirement to have reasons for allowance – and they are supposed to record the reason for grant – Eg. Applicant showed no reason why references A and B should be combined to reach the claimed invention. Also showed that the references actually teach away, etc…
    As I was discussing with a few colleagues, a decision having no reasoning is worse than a decision having bad reasoning!

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  4. Patman

    The Patentee would not have any complaints as long as the patent is granted. It is very clear that the patent was granted after following due procedure. A reasoned order is essential if it is adverse to the Applicants’s interest. In this case, the applicant would be happy that his submissions have been considered and accepted by the Controller thereby resulting in a grant of patent. There is no room for complaint from the Patentee. If any other interested person feels that this patent should not have been granted, they should file a post grant opposition. Frankly, I cant find the raison-d’etre for this post.

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    1. Anonymous

      Patman: The availability of a mechanism to file a post grant opposition cannot be a justification for a non-reasoned order. A reasoned order is essential whether it is adverse or favourable to applicant’s interest. It is not sufficient to just state that applicant arguments are persuasive and therefore patent is being granted. Controller need to apply his/her mind and state why the arguments of applicant supporting patentability are persuasive vis-à-vis the objections raised. What stops Controller from stating that for x, y, z reasons the invention is found novel and non-obvious and therefore it is being granted rather than taking the refuge under the vague words “written submissions have been carefully considered and found persuasive”. Are the Controllers afraid…………………of what……..?????

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      1. Anonymous

        If the submission is considered means, the whole 60 pages of the submisson is accepted. As it is already available to the public, moreover controller also satisfies, then what is the question of reasoned statement. Only on refusal order we can expect this justification. If applicant is not interested/attended the hearing, then also no point in expecting reasoned statement. Controllers are working in right way only. This type of blogs unnecessarily projecting the patent office in a wong way. How do we know that the report is prepared by the examiner only. This type of vague statements are wrong. I feel that this decision is good.

        Reply
        1. Sathya

          Its not the job of the public to peruse the 60 page response filed by applicant, read it vis-a-vis objections communicated in First Examination Report and/or Hearing Notice to see how and to what extent the objections are met. Its the job of a person upon who an authority to grant 20 year monopolies was conferred, to state out why such a monopoly is granted and a reasoned order is minimum expected of such an authority holding a quasi-judicial position and is paid from tax payers’ money. A judge in the court will not convict or acquit someone because he ‘personally’ feels to do so or because his instincts dictate him to do so. when you are not working according to personal whims and fancies but under the statutory provisions laid down as ‘Act’, every action taken and the authority exercised under the Act, must be justified with ‘reasons’ which if is not done so, will be against the provisions of said Act and Natural Justice. When general public are not supposed to know the ‘reasons’ why an application is granted a patent or refused for a patent, why even make such documents as Examination Report, response, hearing notice Public when you can just say ‘an application was filed, objections were communicated, applicant filed a response, I am satisfied/not satisfied with response and hence, a patent is granted/refused’?

          Reply
          1. Anon

            The real problem lies with the Patent Office sending regular memos to officers to increase output. Anyone not meeting targets is issued warning letters. Because of this it is easier to grant patents with a single page order rather than refuse a patent with a detailed decision. Officers need to save their jobs rather than bother about some article appearing in a blog. Just check engineering and chemistry patents to know the ratio between granted and refused patents and reasoned orders for granted patents. The public is least bothered about all these

  5. Sathya

    Compromising Values to save the job, and Granting a Patent without applying mind thereby putting public interest at stake just because a memo or warning will be received otherwise, sound so reasonable. A public servant is supposed to discharge duties at the behest of general public paying taxes for his salary and the country, and not by trading off quality and essential job duty with time. The first page of Circular 4 of 2011 issued by the then Controller General on Examination of Patent Applications says “Being an important and distinct statutory authority under the Patents Act, 1970, an Examiner is required to discharge his statutory duties with due diligence, keeping in mind that a wrongly granted patent can be detrimental to the public, in general, and the industry, in particular.” On Page-2 It says “The controller is expected to apply his mind judiciously….”. So, what exactly is applied in writing one-liners?

    Out of curiosity, I just checked some more patents granted recently and some controllers aren’t even writing one-liners but are just granting patents without a decision at all.

    Pendency in Patent office is not the fault of the tax paying public, but is the fault of office itself that didn’t employ sufficient manpower as and when needed, for timely disposal of cases in accordance with deadlines prescribed under the Patent Act. The nature and magnitude of target and time required for its completion is an internal matter and is not a valid excuse to compromise on the prescribed duties or for putting public interest at stake. Somebody pointed out that Examiners are required to examine a certain number of cases every month. How can such a target be fixed when the time taken for examination depends on the application, its subject matter, number of claims etc and several such factors for which even fees is charged by patent office accordingly? Isn’t the logic to charge more fees for more claims is the time taken for examination, in which case, how can a target based on number be etched in stone as if the work is of clerical nature and is not exactly techno-legal as stated in Circular 4 of 2011? Is a judge in court regarded as best judge or best performing judge based on number of cases he disposes every month? Targets, Pendency, Memos and Warnings are internal matters that have to be dealt with people internally but are not valid excuses to compromise with what a public servant is supposed to do by applying his mind as a part of his job.

    Reply
    1. IPR

      BP Singh issues hundreds of FER every month. How many patents he has granted over the last one year. Because of point system, many controller like BP Shingh simply issue FER and do not grant even a single case. When compared to these useless Controllers, those who grant patents either with reasoned decision or not are far better. Controllers like BP Singh are wasting tax payers money. Why can’t IPO publish number of FER issued and patent granted by every controller every month.

      Reply
    2. responsible contributor

      To address a complex problem/s all the issues need to be given consideration which seems to be not happening in the above comment rather than exercising FOE coupled with few factually inaccurate assumptions (could be inadvertent though).

      It is possible that the facts being stated herein may not be even considered to be valid,nonetheless they need to be stated.

      1.Decision/financial power to recruit manpower does not rest with the Office in question.

      2.Metrics cannot be called internal matter, especially when one wants to sincerely comment on the outcomes.

      3.Recruitment is not based on attitude ,which is being questioned here, rightly.

      4. Attitude/s can be corrected in a professional manner with the judicious use of multiple resources.

      thanks for reading.

      Reply
    3. responsible contributor

      To address a complex problem/s all the issues need to be given consideration which seems to be not happening in the above comment rather than exercising FOE coupled with few factually inaccurate assumptions (could be inadvertent though).

      It is possible that the facts being stated herein may not be even considered to be valid,nonetheless they need to be stated.

      1.Decision/financial power to recruit manpower does not rest with the Office.

      2.Metrics cannot be called internal matter, especially when one wants to sincerely comment on the outcomes.

      3.Recruitment is not based on attitude as of now ,which is being questioned here, rightly.

      4. Attitude/s can be corrected in a professional manner with the judicious use of multiple resources.

      thanks for reading.

      Reply
  6. Sathya

    Recruitment of manpower and Metrics are indeed office/internal matters especially when people use them as excuses for inordinate delay in prosecution or standards of quality or for not writing reasoned orders .

    As to the recruitment, office is supposed to communicate the need to Ministry, and following approvals by said ministry and department of expenditure, the vacancies are notified. This is indeed a matter in the control of Office and is an intra-governmental affair where public and other stake holders have no part to play. Neither the pendency is the fault of tax-paying public, nor is it an excuse to compromise on quality and standards in a hurry to get rid of pendency.

    As to the metrics, the target fixed for examiners and controllers is an internal matter for quick disposal of cases. Earlier the target was 12 New and 12 Amended cases for an examiner. Later point system was brought into place for examiners and controllers through Order: 56 of 2016 dated 11 August 2016, giving points for every task undertaken by examiner and controller and by mandating accumulation of 100 points by the end of every month. This point system was later dispensed and through an Order dated 2 Jan 2017 and a target based on number is fixed for officials. How is it not an internal matter when public and other stake holders have no role to play in it?

    No recruitment is based on attitude but is based on a fair and open selection through an examination. The actual question thus must be how responsibly an official appointed through such an examination is discharging the duties at the behest of general public and the country, and especially when the said official is functioning as an independent authority under the Patents Act, factors in office that affect such functioning are indeed Internal issues.

    Reply

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