Monthly Archives: December 2015

Term of Patent in India: What’s with date 20th May 2003?

Section 53 of the Patents Act, 1970 deals with the determination of term of patent in India.  Subsection 1 of section 53 provides that the term of every patent granted, after 20th May 2003, and the term of every patent which is not expired and is not ceased to have effect, on 20th May 2003, under this Act, shall be twenty years from the date of filing of the application for the patent.

Rules applying to the calculation of the term of every patent granted before 20th May 2003 i.e. commencement of the Patents (Amendment) Act, 2002, are based on the field to which the invention relates. Being specific, patent expiration date is fourteen years from the date of the patent (date of filing application), except for the inventions claiming the method or process of manufacture of a substance, where the substance is intended for use, or is capable of being used, as food or as a medicine or drug, for which patent expiration date is the earlier of two dates, first of them being five years from the date of sealing (grant) of the patent and second being seven years from the date of the patent.

For example, a patent was granted on May 20, 2002. In such case, its term is calculated as 20 years from the date of filing of the application (assuming that the patent was maintained till the effective date) for the patent irrespective of the type of invention to which it relates. Emphasis needs to be added to the part of subsection 1 of section 53 which states that “the term of every patent which is not expired and is not ceased to have effect, on 20th May 2003”.

Those patents for which maintenance fees was not paid within the required time limit and could be restored under section 60, on May 20, 2003, were/are also be eligible for the benefit of the extended term of patent i.e. 20 years from the date of filing according to new rules.

However, it explicitly provides that the term of patent in case of National Phase Applications entering India through International applications filed under the Patent Cooperation Treaty, shall be twenty years from the international filing date accorded under the Patent Cooperation Treaty for the purposes of the calculation of the term of the patent according to the subsection 1 of section 53.

Subsection 2 of section 53 provides that a patent shall cease to have effect notwithstanding anything therein or in this Act on the expiration of the period prescribed for the payment of any renewal fee, if that fee is not paid within the prescribed period or within such extended period as may be prescribed (maximum six months).

According to Subsection 4 of section 53, a patent once expired due to non-payment of renewal fee or on expiry of term of patent, can’t protect its subject matter.

Patent expired due to non-payment of renewal fees can be restored under certain provisions of the Patents Act, 1970, the discussion on which needs separate accounting and does not fall within scope of this article.

Happy Reading and Happy Patenting!

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com.

Germany’s Boehringer Repudiated Patent on HIV Drug- Nevirapine

The Indian Patent Office has repudiated Germany’s Boehringer Ingelheim patent on its key HIV drug- Nevirapine, Patent Application Number: 4724/DELNP/2009 entitled “Extended release formulation of Nevirapine”, for a version sold as Viramune XR (extended release), once again forestalling attempts by Big Pharma for “exclusivity” extension on their patented drugs to reportedly block entry of reasonably priced generics.

Boehringer Ingelheim, one of the few family-owned pharma company globally, is working on biosimilars, immuno-oncology and, new treatment options for psychiatric disorders like forms of depression or schizophrenia etc. Globally, it has a strong pipeline in oncology, respiratory, stroke and diabetes prescription medicines – all of which are of importance to the demographics in India, and some of which have already been launched in India. At present, the company has several patented drugs in the domestic market – Xovoltib (afatinib), two biologics Metalyse and Actilyse, Pradaxa anticoagulant, and two diabetes medicines named Trajenta and Trajenta duo.

Some Facts

Boehringer Ingelheim had filed a patent application (application number: 4724/DELNP/2009) in India on extended release of the HIV drug on 20th July 2009, against which, Cipla had filed a pre-grant opposition in 2011, and later on launched its generic version.

Reportedly, the applicant (Boehringer) did not respond to the pre-grant opposition and also did not appear at the hearing fixed for the same on September 15, 2015. N R Meena, deputy controller of Patents & Designs, said in the order, since the applicant did not appear in the hearing fixed under section 25(1) before the controller, and no arguments were offered to rebut the objections raised in the FER (first examination report), and by the opponent, the application for grant of patent is refused.

Objections raised in the First Examination Report (FER)

Some of the below mentioned objections were raised in the first examination report (FER):

  1. Claims1-7, 8-10, 11-14, 15-20 and 21-24 are rejected u/s 3(e) of the Patents (Amended)Act, 2005 as the said claims define a mere admixture resulting only in aggregation of the properties of components thereof.
  2. It is not clear if thecombined agents act together to provide a technical effect that is greater thanjust the sum of the two or more agents alone, or whether the combination is in fact a mere juxtaposition with no interaction of the agents.
  3. Claim 1 and dependent claims thereof do not constitute an invention under section
    2[1(j)] of Patents Act 1970 (as amended in 2005) as the claims lack inventive step in view of following patent documents:
  • US2002/0006439
  • WO00/035419
  • WO2007/047371
  • US2002/0068085

Grounds of Opposition

Some of the grounds of opposition that were raised and relied upon by the opponent in the pre-grant opposition include:

  1. Section 25(1)(e): Obviousness and Lack of Inventive Step

Opponent had presented numerous prior arts to demonstrate obviousness and lack of inventive steps for the claims of the impugned application.

  1. Section 25(1)(f): Not Patentable/ Not an Invention –
  • Claim lack inventive step under Section 2(1)(ja)

The claims of the impugned application falls under section 2(1)(ja) i.e. being devoid of inventive step. The definition of inventive step states that the invention should be a technical advancement over the prior art or it should show economical significance or both and should not be obvious to a person skilled in the art. It was also stated that the alleged invention is neither a technical advancement nor does it give any economic significance.

  • Claims not a invention as per section 2(1)(ta)

The challenged invention falls under Section 2(1)(ta), being devoid of inventive step as according to the definition of ‘pharmaceutical substance’.

  • Claims not patentable as per Section 3(d)

The alleged pharmaceutical product (dosage form) as claimed in the impugned patent application does not provide any additional advantage or therapeutic efficacy over the form(s) known in the prior art i.e. 400 mg immediate release form or 200 mg immediate release form.

  • Claims not patentable as per Section 3(e)

The claimed invention i.e. claims 1 and 2, falls under the Section 3 (e) which clearly states that a substance obtained by a mere admixture results only in a aggregation of properties of components thereof is not patentable. The alleged invention in the impugned patent application is a mere admixture of nevirapine and conventional excipients for extended release for once-daily administration without any demonstration of improvement over the prior art.

Previously, an objection under section 3(e) to the dosage form (pharmaceutical product) in claims 15 and 21 of the original claims was also raised in the First Examination Report.

  1. Section 25(1)(g): the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed

Conclusion

After hearing all the parties and considering all facts, the Controller denied patent on HIV drug under Section 3(d) of Indian Patent act.

Please refer to the link (http://goo.gl/uw21Kh) for further information.

About the Author: Sugandhika Mehta, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:sugandhika@khuranaandkhurana.com.

Extension of Time to submit the objections or suggestions to the Proposed Draft of Amendment of Trade Marks Rules, 2002

This post comes as an update to the previous one in context of the Proposed Draft Trade Mark Rules by the Central Government, which has been dealt few days back. The proposed draft rules were published on 17th November 2015 for information of all persons likely to be affected, inviting objections or suggestions, if any, with an indication that the said draft rules shall be taken into consideration after the expiry of a period of thirty days from the date of publication.

It has been notified that the last date for consideration of objections or suggestions on the draft Rules stands extended for a further period of Fifteen days from 17th December, 2015 and any Objections or suggestion may be addressed to the Secretary to the Government of India, Ministry of Commerce and Industry (Department of Industrial Policy and Promotion), Government of India, Udyog Bhawan, New Delhi or by e-mail at Sahni.palka@nic.in. by 01.01.2016. Official Press Release can be accessed here.

About the Author: Mr. Abhijeet Deshmukh, Trade Mark Attorney, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Abhijeet@khuranaandkhurana.com.

Proposed Trademark Amendment Rules 2015

Recently, Ministry of Commerce and Industry (Department of Industrial Policy and Promotion (DIPP)) issued out Draft of proposed Rules for Trade Marks. The proposed draft rules are open as of now to receive objections and comments from the concerned person, which shall be taken into Consideration by the Central Government. The draft rules proposed significant changes in the Government Filing fees and the Format of Forms for Trade Mark Prosecution.

The Draft Rules proposes to increase the fees through Schedule 1, to mention a few, Trademark filing fees for each class is proposed be Rs. 8000/-, renewal charges to be Rs. 10,000/- each and request to make entry of the mark as well known mark proposed to be Rs. 100000/-. Schedule 1 of the proposed rules clearly mandates the preference to online filing instead of physical submission wherein the physical filing of forms would cost more to the applicants as compared to the online filing which indeed give rise to the online filing of the applications. Further the draft rules proposes significant change in the format and numbering of the Forms wherein the Form would be identified on alphabetical manner such as Form A, Form B instead of the present numerical as Form TM 1 and so on. The Format seems to be more systematic and seems to be a good move.

The draft rules also proposes the provision for Sound marks under Rule27 (5) which provides that the Sound marks are to be submitted in MP3 format along with the graphical notation of the same.

The draft rules also propose to provide discretionary powers to the Registrar under Rule 127 to determine a mark as Well Known mark upon application filed requesting for such determination. However it would be interesting to note that what will be the criteria to determine the trademark is well known, in the absence of any stipulations by the proposed rules and possibly it shall be governed by the precedents in that regard. Proposed draft rules may be accessed here.

Thus it can be concluded that the main highlight of the proposed draft rules mainly is the increase in fees and format of Forms to be filed. However it would be interesting to note the effect of such increase in fees upon the timeline of the prosecution and efficiency in quick disposal of the pending applications.

About the Author: Mr. Abhijeet Deshmukh, Trade Mark Attorney, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Abhijeet@khuranaandkhurana.com.