Pharma patents - the other side of the story

By: Karimullah Adeni

How important is a court order in an IP rights' case? Can it be a life-saver? And for whom? In cases of patents, especially those related to pharmaceutical industry, a lot of life-saving drugs might become cheaper and more accessible for the poor only if we could have specialized judiciary to deal with IP cases.

For example, recently, a judge stopped a local pharmaceutical company from manufacturing a cheaper version of a drug because a multinational produced a certificate issued by the copyright office stating that the lab test documents for that drug were copyright.

Now, if that copyright is accepted, it cannot stop anybody from making that drug because it would be covered in the fair use clause of the Copyright Act. In any case, exclusivity of manufacturing a drug is protected, among other things, under the Patents Act, and the Copyright Act has got nothing to do with this situation. In this case, there was no legal way with the multinational to prevent the cheaper version of the drug from being manufactured by the local industry using the patent law.

The law is clear in this regard. The patent cannot be claimed as a matter of right. The mere fact that a patent has been applied does not mean that patent is automatically granted. The government has the sovereign authority to grant a patent if it is convinced that the claim is genuine and that the process/invention/innovation claimed has some utility for the mankind.

This authority does not come alone. The responsibility to ascertain these two facts is quite enormous. The government's patent office needs to conduct two kinds of examinations. The first one is called, formal Examination', and is carried out to ascertain the completeness of the application and the registration requirements. This ensures, besides many other technicalities, that there are no challengers to the claim.

For this purpose, all the claims are notified in an official gazette issued by the industries ministry. But how many people actually read the gazette notifications. The document is not a widely circulated one, and of course, never a popular reading. Even in the scientific community, not many people have access to this important publication. Thus a lot of people would not know if a false claim is made. The government itself has no means to know the truth. Of course, we all know how high the government rates the importance of seeking truth.

The government is also supposed to conduct substantial examination. It shows whether the product or the process under consideration has any utility. In case of our own Patent Office, the formal examination takes a little longer than it should take but no substantial examination is conducted. The result is that the Pakistan Patent Office takes the smallest number of days to issue a patent, as compared to any other country's patent office.

This is not something to be proud of. It does not show any efficiency, it shows our irresponsible behaviour. It demonstrate the flaw in the patent regime. The inept nature of the patent office's conduct shows what priority the government has assigned to the issue of the intellectual property rights, lip service notwithstanding.

The role of various multinationals is also quite disturbing. Instead of following the law, they take advantage of this loophole. Every now and then, some foreign-based pharmaceutical company approaches the judiciary claiming that certain drug is their patent, and with the monopolistic right patent law gives them, they stop the local drug manufacturer from producing the cheaper version of that medicine.

In many such cases, the patent shown is not a legitimate one. This is done either by simply showing the receipt of the patent application (which by no means is an evidence of the patent, since, unlike copyright or a trademark, cannot be claimed as a matter of right) or using the original patent license even when it has expired. A lot of times, the judges unsuspectingly accept the stance.

The judges cannot be blamed for this mistake because they are not specialized IP judges, and also because they are overburdened. In any case, they don't know that there is no such thing as an "evergreen patent". All patents pass on to the public domain after a stipulated time period.

Any fresh application will have to show some new innovation and even then the patent thus granted can only cover that new innovation. The original process or invention (drugs in case of pharmaceutical industry) now come into public domain, meaning that now any other pharmaceutical company can manufacture it without needing a license from the patent owner or the patent office. Of course, there are other regulations for drug manufacturing, but the point is that the patent law cannot be used to take away the public's right of getting cheaper medicines.

Today, we need specialized judiciary for IP cases. IP does include trademarks, copyrights, and patents along with industrial designs, service marks, and a host of other related fields. But no two IP laws are similar. The patent laws do not govern copyright issues, and the copyright act does not come into play in the matters of trademarks. It is like cricket and hockey.

They are both sports but their rules are entirely different. One cannot club all IP issues together into one law. An IP judge would know the difference and would have time to focus on the relevant issue. This is what we need today. Only they can create a new IP order. Otherwise, the disorder would continue.