Monthly Archives: March 2014

Clarification on Small Entity Status of Patent Applicants in India

I really wonder if the Indian Patent Act was already less troublesome that we needed a new set of rules, substantially increased fees, and more importantly introduction of the Small Entity Status of Applicants, which creates even more confusion on retrospectively payable fees, implications of change in status during prosecution, timeline for submission of Form 28, qualification for foreign applicants, among many other allied issues, which would now need clarity and potentially cause issues wherein there is deficiency of fees. Really hoping that this does not become a reason for abandonment of the patents applications, especially when even the provision of deposit account (Rule 7(5)), although mentioned in the Patent Act, is still not in practice.

Barely 2-3 days had passed by after our sending an update on the new rules and introduction of small entity status that we started receiving queries from across law firms, corporate houses with clarifications on small entity status for foreign entities. This led to this piece to help clarify certain doubts that have been asked for and we hope there is a FAQ released by the Patent Office soon to clarify and bring on record certain obvious questions arising out this amendment.

To go back one step, as a background, Rule 2(fa) of the Amended rules contains the definition of small entity. An entity will be a small entity if one of the two conditions is met:

(i)   the enterprise is engaged in the manufacture or production of goods, and has investments in plant and machinery that do not exceed ten crore rupees (approx. US$1,611,085),

(ii)  the enterprise is engaged in providing or rendering services, and has investments in equipment that do not exceed five crore rupees (approx. US$807,495)

The above amount limits are based on clause (a) and (b) of sub-section (1) of section 7 of the Micro, Small and Medium Enterprises Development Act, 2006 (27 of 2006), which can be accessed here.

  1. A new Form 28 has been introduced which needs to be filed by a small entity applicant. For Indian entities, Form 28 must be accompanied with the proof of registration under The Micro, Small and Medium Enterprises Development Act, 2006 (27 of 2006), whereas, for Foreign entities, Form 28 must be accompanied by any other document as proof. Such ‘any other document’ can be, for example, executed copy of Balance Sheet/P&L, Declaration by a Govt. Entity of Respective country, among other applicable documents)
  2. In case an application processed by a small entity is fully/partly transferred to a, say a large entity, the difference in the scale of fee(s) between the fee(s) charged from a small entity and the fee(s) chargeable from the large entity in the same matter, would be paid by the new applicant along with the request for transfer. Therefore, in case the Applicant transforms from a small entity to a large entity while filing the request for examination, as it presently appears, the increased fee would need to paid retrospectively, i.e., the difference in fee as would have been taken place at the time of filing of the Application, would also need to be paid.
  3. It would therefore be safer for companies to be aware of their current entity status at all times, as any change in the status, would lead to a change in the applicable fee, and as per the point 4 of the public notice dated 28’th Feb 2014 having Ref. No. CG/F/Public Notice/2014/307, it has been clarified that it shall be the sole responsibility of the Applicant(s) to select the correct category of the Applicant and file all supporting documents in respect thereof while filing an application or other documents, failure of which may attract provisions of section 142(3) of the Indian Patents Act.
  4. In case any Applicant believes that it is a small entity right now, they should, as soon as possible, file the executed Form 28 along with the MSME registration certificate in order to be eligible to pay the small entity fees. Even a provisional MSME registration certificate should ideally serve as an acceptable evidence, but the same may be at the discretion of the Examiner/Controller.
  5. Also, as the present online filing system does allow filing an application as a Small entity with no compulsion on the uploading of the Form 28, any such uploading of an application without an executed Form 28 may attract provisions under Section 142(3) of the Indian Patents Act,which may severely impact the patent rights during national phase filings, and therefore in case Form 28/Evidence thereof is not available, its much safer to file the Application as a normal (that is large) entity and then submit the Form 28 along with the evidence at a later date to gain benefits for subsequent activities.
  6. In case of joint applicants, as is usually the case, the highest fee category of the applicant among the joint applicants will be taken into consideration for the purposes of fee calculation.
  7. Incorrect claiming of Small entity status, or non-declaration of conversion from small-entity to large-entity, may also become a ground of revocation of patent by a third party trying to invalidation the patent in context, and therefore a careful note is to be made and stringent compliance of the amount limits should be done in case small-entity status is being claimed.
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Roche sues Biocon and Mylan over biosimilar version of Herceptin in India

Trastuzumab/Herceptin has been amidst several controversaries off lately and this time it is regarding a biosimilar which has jointly been manufactured by Biocon and Mylan.

Background

Roche’s breast cancer drug Herceptin sold under the brand names HERCEPTIN, HERCLONTM and BICELTIS is a biological drug used primarily for the treatment for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer on a worldwide basis and enjoys a global reputation.

Since its the most prevalent cancer among Indian women,  with approximately 150,000 new patients getting diagnosed every year in India, the originator drug costing around US$3,000–US$4,500 (INR 1.64–2.45 lakh) for a month’s treatment, making it unaffordable to many of Indian citizens leading to lack of affordable treatment options for HER2+ patients which also lead to a campaign in March 2013 to urge the Govt to take appropriate measures to ensure affordability of Herceptin.

However after several months of deliberation and debates, the Department of Industrial Policy and Promotion (DIPP) refused a plea for compulsory licensing for Trastuzumab.

Also, last year in a very surprising development Roche decided not to pursue Herceptin patents in India.

Keeping in mind all these factors, the approval by the Drugs Controller General of India (DCGI)  and launch of Biocon’s CANMAb December last year the world’s first biosimiliar versions of Roche’s blockbuster cancer drug ‘Herceptin’ , is highly likely to be an alternative affordable option, being marketed at about 25% discount to the current list price of the reference product in India.

But inspite of all the pricing advantage, ex parte proceedings by Roche at the Delhi High Court last week has led to an injunction stopping two pharmaceutical companies i.e.; Biocon’s Canmab and its partner Mylan’s Hertraz from being launching, introducing, selling, marketing and/or distributing  its branded drug Herceptin on the grounds of not being able to satisfy the requirements for a biosimilar drug in accordance with the guidelines. Also, the other issue raised was that of passing off; where Roche contended that the defendants were seeking to pass off their products as being equivalent in quality and class to Herceptin by referring to their products as “biosimilar version of Trastuzumab/Herceptin.

Requirements for Biosimilars in accordance with guidelines

“Biosimilars” are biological products that are similar to the innovator biopharmaceutical product.

In view of the structural and manufacturing complexities involved in the production of the biopharmaceuticals, a biosimilar product can only be similar to the innovator biopharmaceutical product; it cannot be a generic equivalent of the innovator biopharmaceutical product.

Also, with the development and growth of the market for biosimilars in India and the international standards for approval of such products, the Guidelines on Similar Biologics were issued in 2012 which lay down specific standard for development and evaluation of similar biosimilar biologics.

After the issuance of the Guidelines on Similar Biologics, all the applications for manufacturing and marketing authorization of similar biologics in India are required to be evaluated on the basis of the standards set forth on it ie;

the demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a reference biologic.

However, Roche claims that DCGI has approved Biocon’s “protocol and design study for testing” related to the proposed drug even before its own regulatory guidelines were firmed up and there is no public record available, in the clinical trial registry India (CTRI) or elsewhere to show that these firms actually conducted phase-I or phase-II clinical trials for the drug.

Also, Roche has casted doubts in its submission saying the Indian drug regulator’s approval for biosimilars couldn’t have come about in ‘such a short period’ when its ‘prescribed procedure’ in the guideline is so long.

The Swiss company argues that there is no public record available, in the clinical trial registry India (CTRI) or elsewhere to show that these firms actually conducted phase-I or phase-II clinical trials for the drug.

In my opinion no matter whether it’s a biosimiliar of Herceptin or not, clinical trials should be rigorously practised according to the new guidelines issued by the Indian Govt.

With respect to the human safety, there is a very big question which highlights the negligence of the drug controller who gave an approval to Biocon and its partner Mylan without the necessary clinical trials being conducted.

About the Author: Sugandhika Mehta, Patent Intern at Khurana and Khurana and can be reached at: sugandhika@khuranaandkhurana.com

 

Patent (Amendment) Rules, 2014

The Patent (Amendment) Rules, 2014 has come in force with effective from 28th February 2014. The major changes are the hike in official fee and an introduction of a “small entity” to which a separate (reduced) fee shall be applicable. Further, in order to promote online filing of patents, different schedule of charges is proposed for the online and offline filing whereas high official fee is proposed for offline filing as compared to the online filing. Form 28 and Form 7A are the new forms introduced in the rules. The Controller’s public notice on the same is available here.

Some of the Salient features of the amended rules:

1. A revised fee structure has been provided for filing of patent application as well as other proceedings before the Patent Office in the First as well as Fourth Schedule of the amended rules. You can have a complete look at the fee structure here

2. A third category of applicant for patent has been introduced in the form of “small entity”. The fees charged to them have been fixed and are in between the fees for natural person and legal entity. Small entity is defined as an enterprise engaged in the manufacture or production of goods, an enterprise where the investment in plant and machinery does not exceed the limit specified for a medium enterprise under Micro, Small and Medium Enterprise Development Act, 2006.

3. A new Form 28 has been introduced. Form 28 has to accompany every new application. For subsequent documents for which a fee has been specified and for which the fee applicable for a small entity is claimed, it must be ensured that a Form-28 must be filed at least once.                                                                 In case of change in status of applicant (for example when an applicant no longer remains a “small entity”), it is a duty of the applicant to inform the Patent office about such change.

4. A new Form 7A has been provided for filing “Representation Opposing Grant of Patent” (Pre-grant opposition). Earlier there was no form for filing pre-grant opposition. However, like before, no fees shall be payable for the same.

5. The amended rules provide for 10% additional fee when the applications for patent and other documents are filed through the physical mode, i.e., in hard copy format as opposed to the online mode.

6. In case an application processed by a small entity is fully or partly transferred to a person other than a natural person (except a small entity), the difference, if any, in the scale of fee(s) between the fee(s) charged from a small entity and the fee(s) chargeable from the person other than a natural person (except a small entity) in the same matter, shall be paid by the new applicant with the request for transfer.