Licensing and working patents in India: an update

As the globe continues to shrink, this Kat wonders at the growing amount of fascinating and indeed commercially important information that speeds his way from readers around the world.  Even with a team of internationally-minded Kats, it's quite impossible to cover everything ourselves, so we are occasionally sometimes often generally always grateful when our friends near and wide come to our assistance.

India is a case in point.  The massive subcontinent, which is literally seething with IP activity of all kinds, is so well covered by our blogging cousins at Spicy IP that we rarely cover any Indian material ourselves. No disrespect is meant on our part, but we do feel the odd pang of guilt at focusing so infrequently on such a major player in IP today.  That's why this Kat is particularly pleased to have received two items from katfriend Michael Lin, from Marks & Clerk's Hong Kong office.  And here they are:

Compulsory licence update 

As many are aware, in 2012 India issued her first compulsory licence (CL) to Natco for Bayer’s anti-cancer drug Nexavar, and this CL was upheld by the Intellectual Property Appellate Board in Spring 2013 (see, for example, hereand here).  Also in Spring 2013, BDR Pharmaceuticals, Ltd applied for a CL for Bristol Meyers Squibb’s anti-cancer drug Dasatinib.  This request is still pending.  This may mark the beginning of a trend for Indian companies to start requesting CLs.

The Indian Ministry of Health has also stepped into the fray, recommending in March 2013 that the Indian Department of Industrial Policy and Promotion (DIPP) also grant a compulsory licence for local companies to manufacture Trastuzumab (a.k.a. Herclon by Roche, and Herceptin by Genentech) for the treatment of certain breast cancers.  A major argument for the granting of this CL is the fact that the price of Trastuzumab appears to range from £16,500-27,500 per patient in India. Regardless of which end of the range you believe, this cost is far beyond the level at which either the typical Indian individual or insurance policy will be able to pay.
However, the DIPP has decided not to issue a CL for Trastuzumab, as reported by the Times of India on July 23.  Observers feel that the DIPP was likely feeling the heat from the international community and patent holders after granting the CL to Nexavar, on which basis it refused to grant the CL. This resulted in the Indian Ministry of Health then recommending that the Indian Government “break” the patent for Trastuzumab.  

The DIPP also suggested that this is not needed as the relevant patent, presumably IN 205534, is already undergoing post-grant opposition proceedings.  However, as anyone used to practising in India well-knows, opposition proceedings are excruciatingly slow in India; in some cases, the patent may even expire before the opposition proceedings are completed …

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 Statements of Working 

Another Indian practice tidbit is that Indiahas had in its law for a long time the ability under Section 146 of the Patents Act 1970 for the  Controller to require patentees/licensees to submit annual “Statements of Working” (a.k.a., Form 27) which are intended to detail if/how a patent is being used/commercialized in India.  While it is theoretically possible to fine a patentee who has not filed a Form 27, the requirement to file a Statement of Working was routinely ignored by most foreign and domestic companies for many years as few, if any, requests were actually sent out.  About five years ago, the Indian Patent Office (IPO) actually started to request that patentees file updated Form 27s.  Thus the IPO indicated that they were starting to take such forms seriously, and they have reiterated this position every one-to-one-and-a-half years or so.  Even so, I am not aware of any companies actually being fined for failing to submit an appropriate Form 27. 

It was always assumed that these forms would be kept confidential but recently, and for the first time, the IPO has published the Form 27s submitted by patentees for 2012.  Such information is now searchable and available online, here.  Thus for Indian patent holders there is a significant amount of competitive information which can be gained from viewing the working statements of your competitors, licensees, licensors, etc. – -and which your competitors may glean from your statements. 

 As a further point to watch out for, it is my understanding that the information in such working statements will likely have an impact when a company petitions the DIPP for a CL.  It is possible that the lack of a recently-filed Form 27 and/or an indication in a Form 27 that the patented technology is not being worked in India may be viewed by the DIPP as weighing in favour of granting a CL.  Accordingly, companies with patents in India will need to look seriously at these Form 27s and strategically decide what information will be provided, and to what level of detail. 

Working statements here, here and here
Non-working statements here and here
Working Cats here and here