Disclaimer

This website http://www.maxipconsult.com (hereinafter referred to as the "website") is a public resource website and provides general information about the location of the firm MAXIPCONSULT LLC. Current Rules of the Bar Council of India do not permit lawyers to solicit work or advertise their services. The website is a resource website for non-commercial, general informational and educational purposes only and there has been no advertisement, personal communication, solicitation, invitation or inducement of any kind whatsoever from MAXIPCONSULT LLC, or any of its members, to solicit any work or create an Attorney-Client relationship through this website.

Although every effort is made to update this website and provide its visitors /users with accurate, updated and latest information, MAXIPCONSULT LLC does not guarantee or undertakes any warranties concerning the accuracy or completeness of the information provided on the website. Nothing on this website should be interpreted to constitute any legal advice. MAXIPCONSULT LLC is not liable for any consequences arising out of any action taken by the visitor / user relying on material/information provided on this website, and the visitor / user should seek the advice of competent counsel licensed to practice in the relevant country/state for any legal issue.

By proceeding further and clicking on the "I Agree" button herein below, the visitor /user acknowledges that he/she on his own accord wishes to know more about MAXIPCONSULT LLC and the website for his/her own information and use.

MaxiConsult LLC
img1
Trademark

Patent

Design Patent

Copyright

Domain Names

Custom Laws

    PATENT CASE LAWS IN INDIA

    Patent Case Laws:

    1) When a patent is said to be granted under the Act:

    The case of Dr Snehlata C. Gupte v. Union of India & Ors (W.P. (C) No 3516 and 3517 of 2007) Delhi High Court) was significant in determining when a patent can said to be granted under the Patent Act. The Court, while holding that the date of grant of a patent is the date on which the Controller passes an order to that effect on the file, noted that the language, “a patent shall be granted as expeditiously as possible” (u/s 43) does point out that a patent has to be granted once it is found that either the application is not refused in a pre-grant opposition or otherwise is not found in contravention of any provision of the Act.

    Therefore, the decision taken by the Controller on the file is the determining event for ascertaining the date of grant of patent and the acts of sealing of the patent and entering the same in the Register are ministerial acts evidencing the grant of patent. The case highlights that Intention to Grant by the Controller on file is the date of grant.

    The Chemtura Corporation vs Union Of India (CS(OS) No. 930 of 2009 highlights the fact the administrative requirement of the Act must be strictly met and the facts must not be suppressed from the Patent Office. It was held that the plaintiff had suppressed information regarding prosecution of the patent applications at the USPTO and the EPO. The plaintiff argued that the patent was granted in India after due examination by the IPO and should be valid. The defendants argued that due to non-sub-mission of facts of the claims being narrowed down in the USPTO and EPO, the IPO could not look into the matter and granted the patent with the broadest claims. The High Court held that the status of prosecution of a patent application in jurisdictions abroad must be provided in detail, including information regarding searches conducted and objections raised. The case underlined the fact that Section 8, though held to be a procedural formality, could solely be a ground for revocation under Section 64 of the IPA. It points out that requirement of S. 8 are a continuous obligation and should be done on a periodic basis.

    The most common section used for invalidating a pharmaceutical related patent in pre-grant; post grant or counter claim for infringement is the invalidation u/s 3 (d). The section provides that salts, esters, ethers etc, are considered to be the same substance and hence are non patentable unless they differ significantly in properties with regard to efficacy. However the term efficacy has not been defined in the Act and its interpretation depends on the discretion of the Controller.

    In Tata Chemicals Limited vs Hindustan Unilever Limited (ORDER No.166 of 2012) IPAB noted that “once the Controller had called upon the applicant to furnish foreign particulars under Section 8 (2), it becomes the duty of the applicant to furnish those details that are required under Section 8(2)”

    The Supreme Court’s decision in case of Novartis AG Vs Union of India would be touted as the landmark judgment in all the years to come for the Pharma Industry as well as the Indian Patenting System. The Supreme Court of India rejected Novartis’s plea on its blood cancer drug Glivec and denied patent to it.

    The court evaluated the patentability of the beta-crystalline form of “imatinib mesylate” as per the requirements of Section 3(d). The Court dismissed Novartis’s arguments that Section 3(d) does not apply in the instant case. The Court noted that the Zimmerman patent of 1993, had identified the tumour treating potential of the imatinib free base and its derivatives, such as imatinib mesylate and that the prior art documents including the article published in Cancer Research clearly identified the in-vivo experiments carried out with imatinib mesylate.
    The Supreme Court did not specifically clarified “enhanced efficacy” and restricted the criteria of “efficacy” to “therapeutic efficacy” with respect to pharmaceutical drugs. The Court had further ruled that an increase in bioavailability can qualify for protection under 3(d), if evidence is provided to establish that such an increase leads to greater therapeutic efficacy.

    The Supreme Court rejected the claims of Swiss pharma giant stating that the drug had failed to qualify for a patent according to Indian law. The Court also held that patents could be granted only in the case of genuine inventions.

    Novartis had been fighting since 2006 to get the patent for Glivec, which as claimed by oncologists is major advance in treating chronic myeloid leukaemia. It had been continuously pushing for the patent arguing that if the rights of investors are not upheld then it will hit research and development of new drugs.

    Compulsory License in India:

    India’s First Compulsory License On March 9, 2012, the Indian Patent Office granted its first Compulsory License to Natco Pharma Ltd. for producing generic version of Bayer Corporations's patented medicine Nexavar (Sorafenib Tosylate), which is used in the treatment of Liver and Kidney cancer. While the multinational giant was selling the drug at INR 2.80 lakh for a month's course, Natco promised to make available the same at a price of about 3 % (INR 8800) of what was charged by Bayer. Natco was directed to pay 6 percent of the net sales of the drug as royalty to Bayer. Among other important terms and condition of the non assignable, non exclusive license were directions to Natco to manufacture the patented drug only at their own manufacturing facility, selling the drug only within the Indian Territory and supplying the patented drug to at least 600 needy and deserving patients per year free of cost.

    Aggrieved by the Controller’s decision, Bayer immediately moved to the Intellectual Property Appellate Board (IPAB) for stay on the order alleging that the grant of compulsory license was illegal and unsustainable. The Board rejected Bayer’s appeal holding that if stay was granted, it would definitely jeopardize the interest of the public who need the drug at the later stage of the disease. It further held that the right of access to affordable medicine was as much a matter of right to dignity of the patients and to grant stay at this juncture would really affect them.

    Bayer then filed an appeal challenging the compulsory licence granted to Natco by the Controller-General. The Board stated that the invention must be available to the public at a reasonably affordable price and if not, compulsory licence can be issued and observed that the Sub-sections (a),(b) and (c) of S.84(1) are separated by the disjunctive ‘or’ and therefore, even if one condition is satisfied, the Controller will be well within his rights to order compulsory licence.
    The Board further noted that The R&D costs and the prices of other drugs do not assist in deciding what the public can afford reasonably. It stated that the reasonably affordable price necessarily has to be fixed from the view point of the public and the word ‘afford’ itself indicates whether the public can afford to buy the drug.

    It also stated that even if it takes the appellant’s own number (i.e. the number of affected patients) it finds that the supply made by it cannot be said to be adequate and the price definitely is the factor that will determine whether the public will reach out for a particular invention. The Board held that the Controller was right in holding that the sales of the drug by the appellant at the price of about 280,000/- was alone relevant for the determination of public requirement and he was also right in considering the purchasing capacity of the public and the evidence available to conclude that the invention was not reasonably affordable to the public.

    On the percentage of royalty that was to be paid by the Respondent to the Appellant (6% that was fixed by the Controller), IPAB increased it by 1 percent but did not change any other terms and conditions of the licence.
    The IPAB dismissed the appeal and confirmed the grant of Compulsory license stating that it has dealt with each of the issue in detail in view of the significance of the order of compulsory licence made in India for the first time.

    To know more about this case please read here: Patent Office grants its first Compulsory License

    For more information on Patent Case Laws in India please write to us at: admin@maxipconsult.com.
Trademark
Enforcement & Remedies
Passing Off
How to register
What not to register
What to consider
Patent
Enforcement & Remedies
Ancilliary Work
Compulsory Licenses
How to register
What not to register
What to consider
Design Patent
Enforcement & Remedies
How to register
What to register
Copyright
Enforcement & Remedies
How to register
What to register
Domain Names
Enforcement & Remedies
How to register
What to consider
Custom Laws
Site designed and developed by DecizonSoft Infotech Pvt. Ltd.