Monday, January 28, 2013

The All Things Patent Newsletter - January 2013

January 28, 2013
 

All Things Patent

PCT APPLICATION FILING AND PROSECUTION IN INDIA
India is a member of WTO and a member country in the Paris Convention and a contracting state to the PCT. Any country, union of countries or inter-governmental organizations which are members/ contracting states to the above convention/treaty/agreement are convention countries for the purposes of the Act. The objective of this article is to clarify filing and prosecution procedures before the Indian Patent Office (“IPO”), the current landscape of patent filings in the field of medical devices and a few prosecution instances to show the examiner’s approach and practices followed at the IPO.
The Indian Patents Act defines "convention application" as an application for a patent made by virtue of section 135. Apart from the Act and Rules, the Indian Patent Office has in an announcement dated July 2, 2012 simplified the filing procedures for PCT applications. Under the new procedures, the Form 2 columns pertaining to priority information as well as the complete specification and claims will be directly downloaded by the Indian Patent Office from the International Bureau (“IB”). 
Filing Procedure
A convention application filed in India can either be filed electronically through the new e-filing system, or in hard copy as preferred in a majority of the applications filed with the IPO. The following forms and declarations are required:  
  • Form 1 (names, addresses, contact information, priority numbers, declarations by inventors, assignee, etc.).
  • Form 2 requires only  the title, applicant information and the last page of claims duly signed by the applicants, and if any other part of the specification or claims are filed, the version accessed from the IB shall be considered by the Office.
  • Form 3 declaration as to foreign filings and undertaking to keep the Controller informed on such filings. 
  • Form 5 declaration as to inventorship.
  • Form 26 power of authority appointing an agent in India authorized to practice before the Patent Office.
  • Fee covering the number of pages and number of claims. The basic fee of Rs.4000 (~USD 72) covers applications with 30 pages and up to 10 claims, with additional fee of Rs.400 (~7 USD) per additional page and Rs.800 (~14 USD) per additional claim. 
On any patent application filed in India, the proof of right to apply for a patent under section 7(2) is served by filling in the corresponding declaration in Form 1. If the application is filed by an agent, the power of authority is required to be filed within 6 months of the filing date, if it does not accompany the application. Other cases where proof of right to apply would be required are in cases where the legal representative, assignee or subsidiary of an overseas applicant files an application in India.

Since there are four locations of the Patent Office in India at New Delhi, Kolkata, Mumbai and Chennai, a convention application, if filed on paper is required to be filed at the office of appropriate jurisdiction, which is the Office nearest to the address where the agent/representative’s place of business is located. In case of electronic filing the patent application is deemed to have been filed at the Office of appropriate jurisdiction, with further interactions continuing from that Office.

The total number of patents issued and applications published between January 2005 and the present date in the four IPC (International Patent Classification) classes of A61B (surgical devices and methods), A61F (stents, vascular filters and dressings), A61M (injectors, inhalators and catheters) and A61N (electrotherapy devices - stimulators, etc.)  are shown in Fig. 1. These figures were obtained by querying the Indian Patent database available on the official Website and show the enormous backlog in number of applications waiting to be examined, as already highlighted in our previous newsletter


FIG. 1: Number of granted patents and published applications in India for IPC classes pertaining to medical devices during the
           period January 2005 to December 2012

A breakup of the top assignees within each patent class is shown in Figs. 2(a) to (d), while the technology breakup in each class is shown in Fig. 3(a) to (d). In A61B (Fig. 3(a)), the breakup of technologies shows high numbers for diagnostic devices, surgical instruments/implants and endoscopy/medical imaging. In A61F (Fig. 3(b)), the major filings have been in wound dressings, and other hygiene products, while there are very few filings for vascular implants such as stents or filters, which have traditionally been imported for use in India for several years. In class A61M (Fig. 3(c)), the major filings have been in inhalators, injection devices including insulin pens, and catheters. The field in class A61N (Fig. 3(d)) for electrotherapy devices appears to be much smaller, with filings in the areas of cardiac pacemakers, stimulators and defibrillators, followed by iontophoresis and cosmetic treatment devices.


Fig. 2: Top assignees in granted patents in India for various medical device classifications during the period 2005 January to
          December 2012

Patent Office Practice
The Patent Office practice is codified in the Manual of Patent Office Practice and Procedure. Chapter III of the Manual provides guidance as to procedures within the Patent Office. The recent developments in electronic filing and the rules regarding dispensing with filing of specifications in case of PCT applications should generally make it easier to file a PCT application in India. 

COSTS

Even if the applicant submits an amendment with a reduced set of claims, the application fee is payable on all the claims in the original application, irrespective of whether some of the claims cover matter not claimable as per the Indian statute such as method of treatment of humans or animals (section 3(i)). If there are multiple priority applications preceding the PCT application, one basic filing fee of Rs. 4000 is charged for each priority application irrespective of whether the application qualifies as one invention in terms of unity or not. This is presumably done in order to charge the same fee for an overseas applicant as a domestic applicant would have been charged for filing the provisional applications.



Fig. 3: Technology breakup of filings in various medical device classifications during the period 2005 January to December 2012

PROSECUTION TIMELINE
Prosecution typically takes between 4-6 years, with the current backlog in examination making for a current waiting period closer to 6 years. Prosecution involves one, or sometimes two rounds of office actions, with the decision most often finalized at a hearing (interview, usually personal) with the applicants. The applicant is given twelve months from the date of first office action to respond to the objections (rejections) in the office action according to section 21 and rule 24(4). Many examiners ask for reference numbering to be included in the claim elements, although a 1979 Supreme Court ruling is cited against this practice: 
"Before looking at a claim the description of the invention should be first read in order to prepare the mind to understand what it is that the inventor has claimed." [(1979) 2 see 511 at 525]
The first office action may constitute a request under section 8(2) to comply with providing search reports/allowed claims of applications for “the same or substantially the same invention” filed in other jurisdictions. This condition is to be complied with within 6 months of such request. With increasing electronic availability of information and with the section 8(1) requirement of notifying the office of any change in status within six months of the event, such requests may be rendered unnecessary in the future.
Interesting Decisions
Patent application 1683/DELNP/2005 entitled Medication Delivery Pen and assigned to Becton Dickinson & Co. was granted on March 4, 2011 as IN246377. The first examination report of this application constituted objections on grounds of lack of unity of invention according to section 16. These were addressed in the applicant’s response, which was accepted and the claims were granted as filed. The corresponding PCT application is WO2004030730 and the corresponding US application was granted in 2007 as 7169132 with substantially the same claims as the Indian patent.
IN254651 entitled An Integrated Diagnostic Instrument for Analyzing a Fluid Sample with corresponding PCT publication WO2007021979 was issued to Bayer Healthcare LLC on December 7, 2012. The claims are directed to an integrated diagnostic instrument for analyzing a fluid sample with multiple sensors and a lancing mechanism. The first examination report (FER) cited references and objected to claims 1-9 for lack of inventive step over a combination of cited references. Amended claims were submitted in response to the FER and a second set of objections were addressed after a hearing in October 2012. 

An interesting case of an application that was refused is 1526/MUMNP/2006 filed on 13/12/2006 by Polymedix, Inc., entitled Polycationic Compounds and Uses Thereof.The application filed with priority number PCT/US2005/021323 dated 15/06/2005 was directed at anti-angiogenesis agents that suppress tumor growth, with original claims 1-15 directed to “A compound for inhibiting angiogenesis comprising a therapeutically effective amount of a polycationic compound,” while claims 16-24 were directed to a method of inhibiting angiogenesis in an animal. In each case, the dependent claims recited chemical compounds. However, the amended claims of the corresponding Indian application were objected to on the grounds of section 3(d) pertaining to the polymorphic form of a known substance and under section 59 relating to lack of support in the original specification. In a hearing and order dated October 5, 2012 the amended claims were refused on the grounds that the claims “were not claimed in the original application” under section 59 as well as not claimable under section 3(d). The examiner in this instance is therefore seen as taking a rather narrow view of support to claimable matter with reference to the PCT application as filed. Section 3(d) defines that a polymorphic form of a compound “which does not result in the enhancement of the known efficacy of that substance” is not an invention - is subject to debate, since there is no standard definition of “enhancement of the known efficacy”. The corresponding US patent issued as US7745662 with 9 claims including claim 1 reciting a chemical compound and formulations thereof in the dependent claims.
Indian patent 253682 entitled Cooling Topical Patch Preparation to Teikoku Pharma USA issued on August 13, 2012, also published as WO2006073767. The examiner initially objected on grounds of lack of novelty to the original version of claims directed at a patch device with certain characteristics. Applicants subsequently amended the claims to a patch device incorporating a specific chemical compound. The corresponding US application issued in January 2012 as US8105624 with additional claim matter pertaining to pain treatment.

Summary

This article discussed the laws and rules and procedures for filing PCT national phase applications in India, and discussed in general the practices followed by the Patent Office in relation to these applications, including recent procedural changes. The number of filings in the past 7 years in various IPC classes pertaining to medical devices was analyzed to derive information as to the kind of devices and market being targeted by the applicants. In the last part of the article, a few prosecution instances of granted patents and abandoned applications were examined to show the approach and procedures followed. 

References
The Patents Act 1970 [As amended by Patents (Amdt.) Act, 2005 (15 of 2005), dt. 4-4-2005]

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