Monday, February 09, 2009

Valganciclovir PreGrant Opposition: A Case of Frivolous Objection I

It seems to be that the Chennai Patent Office was quite correct in its approach not to consider giving opportunity of hearing for Valganciclovir pre-grant opposition filed by the Tamil Nadu Networking People with HIV/AIDS and the Indian Network for People living with HIV/AIDS (collectively hereinafter referred as ‘the NGOs’) which not only lacked substance to challenge the issuance of patent but also irrationally burdening the Indian Patent Office with legally absurd and unsupported objections. No doubt it takes no special efforts to make public statement quoting Valganciclovir a pre-1995 molecule not qualifying for patent protection but when it comes to patent law one do require pre-dated publications to corroborate the statement. This is what Valganciclovir pre-grant opposition seems to reflect that the NGOs just went on stating pre-1995 objection without any proper understanding and records to prove it. In their application for pre-grant opposition, the NGOs made objections on the following grounds namely:

(1) That the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act under section 25(1)(f); and

(2) That the applicant has failed to disclose to the Controller of Patents the information required by section 8 or has furnished the information which in any material was false to his knowledge under section 25(1)(h).

The objections was raised relying on four supporting evidences submitted by the NGOs which include a copy of press release from Hoffman-La-Roche dated 2nd April 2001, a copy of European Patent No. EP 0694547A2, a copy of online European Patent Register, and a copy of US Patent No. 6083953. What is notably important to note that none of the supporting evidences was published before the priority date (and even the filing date) of Valganciclovir Application 959/MAS/1995 which is sufficiently enough for someone of Assistant Controller rank in the Indian Patent Office to acknowledge the fact that none of the evidences even adequate to uphold the pre-1995 objection. Now before going further into objections raised by the NGOs let us discuss what exactly pre-1995 argument mean? After India amended its patent law to allow patent applications for drug compounds under mail-box provision, it was well considered that drug compounds known prior to 1995 are not eligible for patent protection. In other words, it is consider that any drug compound known or published prior to 1995 (in short pre-1995 public disclosure) is not to be granted patent in India (the argument reasonably acceptable in patent law that any invention publicly known or published in literature cannot be patented). Based on such theory, the NGOs objected Valganciclovir patent application, however, while submitting the pre-grant opposition the NGOs went a step ahead on pre-1995 argument to conclude that any compound even though not published or reported prior to 1995 but was invented before 1995 is a pre-1995 public disclosure and not eligible for patent protection in India. Quoting section 25(1)(f), the NGOs argued that the Valganciclovir patent application ought to be rejected as it claims priority from a pre-1995 convention country application (precisely referring to Valganciclovir priority document i.e. US Serial No. 08/281,893 dated July 28, 1994). Again it is a well-known fact that a patent application is not considered to be in public domain till it is published which is usually made on completion of 18 months from the date of filing of application. Now considering that Valganciclovir priority document was filed on July 28, 1994 then the possible earliest date for its publication would have been January 27, 1996 (reasonably beyond 1995). Further to prove their pre-1995 argument, the NGOs submitted documents which are published on much later date of filing of Valganciclovir Indian Application. Obviously after reviewing the NGOs pre-1995 argument (i.e. an invention not published but invented before 1995 is a pre-1995 public disclosure) and inappropriate documents submitted to corroborate the objection, the Assistant Controller would have been in no better position to dismiss the pre-grant opposition. But what is even more interesting that the NGOs were so damn confident about their arguments that they in fact approached the Chennai High Court to order the Chennai Patent Office to consider their frivolous objections.

7 comments:

  1. VC,

    Almost worked 6 years in pharma companies, done diploma course in patents from Nalsar and attended various seminars/speakers but still one question comes to mind. I regular reader of patent circle and often surprise the way you cover and write your posts – mostly different the way other says. But why others do not think or speak like you? Who is more expert in patent law? If do not mind can I know your educational and professional background. Thanks

    Valganciclvir post is good and informative.

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  2. Anonymous7:26 PM

    Great post Varun! You have continued keeping your good work.

    Anonymous@Mumbai

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  3. Anonymous8:37 PM

    Atul,

    The world is very big....Open your eyes and your illusion will be gone. With due credit to VC, there are others also [which I would not like disclose here] are equally/or even more competent in interpreting such cases in India.

    Hope u understand.....[if your are not a die-hard fan of VC]....

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  4. Varun Chhonkar11:29 PM

    Hi Atul,

    I have no idea what to reply but obviously can’t say anything about others. There are indeed some professionals who are well-knowledgeable and respected in the field of patents but most of them often avoid making any public statement. Yes there are some others also whose faces you can keep seeing in seminars or as visiting faculties. It is all up to you to judge them.

    I do not write what I hear from others, I rather analyze and write based on my knowledge and reasoning which I acquired working in pharmaceutical companies and law firms and from my formal education in Intellectual Property Laws from National Law University Jodhpur.

    Being formally trained in patent laws and worked practically in field, I cannot make any irrational reasoning. Though some people do not agree with my writings but I never argued that I am correct. It is only my reasoning which sometimes makes my posts look like conclusive.

    Kind Regards,
    ---
    VC | Patent Circle

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  5. Varun Chhonkar11:31 PM

    Thanks Anonymous@Mumbai!

    VC | Patent Circle

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  6. Ashwini8:03 PM

    Anonymous,

    No doubt there are competent patent professionals in india but there is no doubt also that patent circle has been exceptional source of patent learning in india. Knowing Varun almost more than three years, I can say he is (if not best) then obviously among the finest young patent professional in india and more than that he is a rare professional who like sharing his knowledge with others.

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  7. Anonymous2:11 PM

    NOW that the Supreme Court too has found prima facie substance in the argument laid by the NGOs, and allowed them to file an affidavit at the Chennai Patent Office, which is going to decide on at least 3 post grant oppositions, do you mind changing the terminology 'damn confident'?

    I guess the Supreme Court has seen and heard more of this case and it never used the words [above] while still giving them a shot to file the affidavit.

    Regards,
    Frequently Anon.

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