Posts by: Michael Bech Sommer | (3) posts

The Indian Jungle – an IP perspective, part 2

To foreign applicants filing a patent application in India takes place “at the IPO”, but in reality there is a choice of venue which is not trivial. The Indian patent office (IPO) is headquartered at Kolkata (formerly known as Calcutta) with branches in Chennai (formerly Madras), New Delhi and Mumbai (formerly Bombay). The office of the Controller General for Patents and Trademarks is located in Mumbai, a city regarded as the commercial capital of India (Delhi being the actual capital). The four branch offices are fully functional, so once an application is filed with a particular office it normally stays there throughout the life of the application. Foreign applicants can choose where to file, no matter which Indian associate they work with, but as most Indian patent agents are located in the Delhi area, most foreign applications are by default filed with the Delhi patent office, as this is most convenient for the patent agent.

There is presently a huge backlog of unexamined patent applications at the IPO which means that it takes ~4 years before an applicant receives the first examination report. Due to differences in staffing and workload the Mumbai office is however almost 2 years ahead of the Delhi office and 1 year ahead of the other two offices. Secondly, there is a difference in the way the Indian Patent Act and case law is followed at the four offices. Thus the Delhi and Chennai patent offices are unkindly referred to as “pharma application graveyards”. The Kolkatta office is regarded as the best place to file mechanical and automotive applications, whilst the Mumbai office is best equipped to handle pharma, biotech and computer science applications. Applicants who need a speedy prosecution should thus consider filing in Mumbai, especially if their application falls under the pharma, biotech and computer science areas.

Disclosure formalities

The IPO imposes very extensive disclosure (IDS) requirements. The IPO thus requires that information regarding any related foreign applications to be filed periodically with the IPO. The time period within which the applicant is required to notify the IPO regarding any related foreign application is currently six months. In addition the applicant is required, within six months of receipt of communication to that effect from the Controller, to furnish information relating to objections or rejections in respect of novelty and patentability during prosecution of corresponding applications elsewhere. Not furnishing this information is one of the grounds of invalidation of a patent. The disclosure requirements can be complied with by scheduling six-monthly filings in Form 3 with details of prosecution progress of related applications elsewhere.

Compulsory licensing

The compulsory licensing provisions according to Indian law are contingent on a determination: (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in the territory of India. In 2012 India granted its first compulsory license ever to the Indian pharmaceutical company NATCO against Bayer Corporation. Natco cited the high cost of treatment using the drug Nexavar (sorafenib tosylate) in their application. The above example is thus far the only compulsory license being granted.

Summary

India’s IP laws can be seen as a balancing act between on one hand a desire to fully comply with WTO/TRIPS requirements and on the other providing affordable medicines to its vast numbers of poor people. India however also offers exciting opportunities in the electronics, automotive and computer science areas where the quickly growing Indian middle class wants access to new, imported products which should be protected by patents, designs or trademarks. Please contact Awapatent if you need strategic advice on how to protect your IP rights in India!

Michael Bech Sommer, European Patent Attorney

The Indian Jungle – an IP perspective, part 1

Now these are the laws of the jungle, and many and mighty are they…” – Rudyard Kipling wrote these lines over 100 years ago in his “Law for the Wolves” from the famous Jungle Book. As IP practitioners we are constantly reminded of the complex nature of today’s Indian IP jungle and the many and mighty laws therein. This article will discuss some of the peculiarities of the Indian patent laws with the 1st part focusing mostly on differences in patenting practice between Europe and India. The differences in practice between the four Indian patent offices will be discussed in the 2nd part of the article, incl how clients should use this strategically.

India is a WTO member and has signed the TRIPS Agreement which provides patent protection for a period of 20 years from the filing date of the application. In addition to the typical requirements for novelty, inventive step and industrial application the subject matter of the invention must moreover not fall under one of the (many!) excluded classes from patentability, the best known being the Section 3(d) exception relevant to many pharmaceutically active compounds, which holds i.a. that a new form of a known substance is not an invention unless it shows “enhanced efficacy”.

Indian case law (Glivec case: Novartis vs. Union of India) has established that by “efficacy” is meant therapeutic efficacy which means that arguments for inventive step accepted under EP law like eg. higher stability of new crystalline compounds or salts will not be accepted as “enhanced efficacy” under Indian law. Improved bioavailability is on the other hand specifically mentioned in Glivec as not ruled out as an example of “enhanced efficacy”. Thus some hope still exists!

India does not permit claims to a method of medical treatment, nor claims presented in 1st or 2nd medical-use format. Claims to a pharmaceutical composition containing two or more active components may be permitted, provided 1) all the active components and their concentrations are specified in the claim and 2) support for an unexpected synergistic effect are provided in evidence of an enhanced efficacy of the claimed composition in comparison to known compositions. Such comparative data (ie not stand-alone) must be present in the application at filing in India.

India does not allow for utility model protection, but does allow for “Patents of Addition” which relate to improvements or developments of the invention to which the patent application or granted patent relates; the subject matter does not have to involve an inventive step over the parent patent or application, but must share the same inventive concept and have absolute novelty. The term of a Patent of Addition is the unexpired term of the main patent. No annuity is payable. Patents of addition should be considered as an interesting option for European clients.

Publication of the unexamined Indian application occurs at 18 months after filing; an examination for novelty etc. is subsequently conducted before a decision is made whether to grant the application. Typically this process takes 5-8 years. In contrast to European practice, pre-grant opposition may be filed at the IPO by any party, and without payment of fee. Post-grant opposition may be filed within 12 months of grant at the Indian courts but only by an “interested party”, and can be a very longwinded affair. The grounds for both pre- and post-grant opposition include i.a. the right to the invention.

Once granted, India has a working requirement: Every patentee and licensee has to furnish annual statements regarding the working of the patented invention on commercial scale in India. Importation does not count towards the working of the invention. Compulsory licensing may be granted to local Indian companies in case working requirements are not met.

In the second part of the article we will discuss some further peculiarities of the Indian patent system incl. options for patent office “forum shopping”, the extensive disclosure formalities and compulsory licensing issues.

Michael Bech Sommer, European Patent Attorney

The UPCA Opt-in/Pin-out scenario

The Unified Patent court agreement (UPCA) has been ratified in 2014 by both Denmark and Sweden, so even if the actual advent of the unitary patent and UPC is still some way off, potential patent rights holders in the two countries should already now prepare for the new regime.

The coming into force of the UPCA – presumably in early 2016 – will bring about many changes to the patent system in Europe. Most importantly, the unitary patent will provide enforceable protection of IP rights in all the participating EU member states based on a single EP application without the costly and cumbersome validation and translation requirements associated with the present, nationally enforced “bundle patents”.

Enforcement of patent rights based on the unitary patent will take place via the UPC, which will have exclusive, centralized jurisdiction not only over unitary patents, but also over “regular” European patents (EPs) and supplementary protection certificates (SPCs) in those EU countries which have ratified the UPCA (Art. 3 UPCA).

The UPCA allows for a transitional period of at least seven years (Art. 83 UPCA). During this time, rights holders can choose to “opt out” of the exclusive competence of the UPC and stay with the “bundle patents” solution, provided that no action has already been brought before the UPC. This potential problem can even be prevented by opting out of the still pending EP application, so that the ensuing patent is automatically “opted out” from the unitary system at grant.

The opt-out will remain in effect until the patent expires unless the rights holder decides to “opt back in” again, i.e. to withdraw his “opt-out” application and accept the unitary patent solution. This choice should be made carefully, however, as there is no possibility of opting out of a Unitary Patent and reverting to the “bundle patent” situation (Rule 5.11 of the Rules of Procedure of the UPC (RoP), currently available in draft number 16).

It is foreseen that many cautious rights holders will choose to opt out since it can be seen as a “free ride” (apart from a fee), since Art. 83(4) UPCA allows European patentees, applicants or holders of SPCs who make use of the opt-out to change their minds under certain circumstances. They are thus “entitled to withdraw their opt-out at any moment”, but only if no action has already been brought before a national court.

The rights holder’s strategic decision to opt back in again once a central attack on a presumed infringer is desired can thus be blocked if just one of the bundle patents resulting from the opt-out has been “pinned out” by an action brought before a national court. At the present time the legal provisions for the UPCA transition period are far from clarified, and thus how much or how little will constitute “an action” is not certain. It is also not known what the effect will be if said action is completely overcome by the rights holder – will he/she then be allowed to opt back in?

In conclusion, present and future rights holders in Europe should be very careful when choosing to strategically opt out of the UPCA, as they can be outsmarted and prevented from opting back in again by a just as strategic pin-out by a competitor.

Michael Bech Sommer, European Patent Attorney