These are based on a talk given by Hari Subramaniam on 15 November 2013 at the CIPA Life Sciences Conference.
1. It must be remembered that Indian patent law had always placed considerable importance on the public interest. It still has its uncertainties and difficulties, and is continuing to evolve. One example is the case of injunctions which are normally difficult to get, but important given that it can take up to 6 to 8 years for a patent trial to conclude.
2. There are several ways a third party can attack a patent. Both pre- and post grant opposition are available. Until recently it was possible for an opponent to keep filing pre-grant oppositions in a serial manner. However now only a single pre-grant opposition can be filed by an opponent. In addition previous practice meant appeal was not possible from pre-grant opposition. However the Courts have now decided that appeal is possible for the applicant, but not for the opponent. The opponent can appeal in post-grant opposition though.
3. Section 3(d) is very potent weapon for an opponent. This section requires inventions that relate to new forms of known substances to have increased efficacy. Several cases have been lost on section 3(d) alone. In order to avoid problems under this section the application should have good enabling disclosure, good examples of efficacy and comparisons with the parent compound or the closest prior art. On the whole Indian patent attorneys tend to be fairly optimistic about overcoming objections under this section.
4. File wrappers from other jurisdictions can be important in pre-grant oppositions and post grant proceedings against the patent. Therefore care must be taken as to what is disclosed in other jurisdictions during prosecution of equivalent cases.
5. India has ‘working’ requirements for its patents. Within 3 years of grant every patent has to be commercially worked. In theory the Indian patent office can impose a fine of around $22,000 for failure to meet this, but in practice it finds it difficult to do so as there is no easy means for it to obtain the money. One of the problems for companies is that as part of the requirement they need to submit commercially sensitive information such as the levels of revenue being generated. Instead of working a patent one can give a reason as to why it is not being worked, such as the lack of a viable business opportunity or a regulatory hurdle. Working is defined in terms of reasonably meeting a public demand at a reasonable cost. An interested third party can apply for a compulsory licence for an invention which is not being worked properly. It has to make out its case for being able to supply the invention at a reasonable cost.
6. In India there is an ongoing duty of disclosure that requires the applicant to file information about the status of corresponding applications. Search and examination reports also need to be filed if requested by the patent office. Failure to comply has serious consequences in that a patent can be refused or invalidated. Usually this can be rectified in pre-grant opposition by filing all the necessary information. However in post grant opposition it could be too late. A couple of patents have been revoked on this ground. However the Courts might be persuaded to take a more lenient view if they had the opportunity to decide on the matter.
7. In the famous Novartis Glivec case the patent application was rejected under section 3(d). The appellate board said that though the new form had better properties a patent could not be granted unless those properties led to increased clinical efficacy. However Novartis did not prosecute their case well and failed to file appropriate evidence which would have been accepted by the board. In general the patent office and appellate board are open to post-filing evidence of clinical efficacy.
8. In BMS v BDR Pharma a compulsory licence was not granted. In the Natco v Bayer case a compulsory licence was granted, but Bayer made little effort to show why the cost of their drug was so high and fought the case badly.
9. It was assumed that second medical use claims are not patentable in India. However the Patent Office has now allowed such a case (IN7503/DELNP/2007) and therefore there does seem to be hope for such inventions.
10. At the moment judicial intervention should always be seen as a possibility for sorting out problems. Courts can make the Indian Patent Office change its practice. However Applicants do need to be proactive and be prepared to fight.
You may also wish to see related articles Top 10 Uncertainties in Patents and Top 10 Things That Go Wrong with Patents and Patent Applications.