The growing pandemic has toppled the entire world and shows no signs of stopping its rampage anytime soon. As the countries pace in anxiety and anticipation for an increase in the death toll, the R&D of the entire world has come together to provide a means to stop or at least combat COVID-19. As with every innovation and invention, there emerges the need to protect it and to safeguard the rights of the innovator. The patent registrations and hearings have been delayed all across the world, opening up a window for a plethora of patent infringements. The situation also burns down to the point where the government must strive to protect the humanitarian aspect over the commercial intent of the existing medical patents holders while drawing the ire of the big pharma houses. This article tries to delve into the needs of both the spectra and provide a middle ground for the same.
The COVID-19 outbreak which originally happened in Wuhan has now claimed the lives of millions and is undoubtedly the biggest threat in a century. It has brought the economies of the nations on its knees and is likely to cause more damage as Serum Institute of India and ICMR rush to counter the devastation. The Indian GDP has contracted by 23.9% and experts are of the opinion that it may take two or three years at the minimum to undo the damage that has been done.
The Indian judiciary also came to a standstill as nationwide lockdowns were issued and then continued for months. It can be certainly said that the judicial landscape of India has undergone a significant change, both in terms of the advent of video conferencing to carry on court proceedings, and the humongous amount of pending cases that will flock the courtrooms once physical hearings resume. As the country goes through ‘Unlock 4.0’, the judiciary continues to implement a host of actions to counter the increasing burden of pending cases.
Period of limitation
On 23rd March, 2020, the Supreme Court took suo moto cognizance of the difficulties faced by the legal practitioners and the litigants. In order to tackle such difficulties in accordance with the government mandates of social distancing, the apex court invoked its plenary powers provided under Article 142 of the Constitution of India to extend the period of limitation in all proceedings along with suspending all physical court proceedings.
Situation of IP in pandemic
On 26th August, 2020, in accordance with the TM Rules, 2017, the Government of India released a circular which stated that the Show-Cause hearings would be conducted henceforth through video conferencing. However, the circular also states that this remedy shall only be available to those who can submit their consent within 25th September, 2020. Further proceedings can only be done after physical hearings resume.
Patenting in the times of Corona
The most important factor in the patent registration process is identifying what can actually be patented. The primary criteria that needs to be fulfilled for a person to get a patent is stipulated under the Indian Patents Act, 1970. The necessary conditions are that the product or the service must not be obvious, must satisfy novelty and must be of utility.
The patent laws in India also prevents any process of treatment from being patented. This means that a process for diagnosis cannot be patented. Only the instrument used for the diagnosis can be patented.
However, e-filing options are open even during the lockdown imposed. One must remember that a patent is mostly a territorial right and thus can be filed through their Patent Cooperation Treaty or in their respective jurisdictions according to the priority date.
Powers of the Government during public health emergencies
IP has taken one of the hardest hits as the pandemic continues to topple the world. A lot of pharmaceutical companies are aggressively working to develop medicines to counter the effects of this outbreak. This means that there will be a surge in new patent filings as well as licensing existing ones. A prime example of this can be the PPEs.
The PPE saga
The PPE is a covering that allows the medical professionals to approach patients who have contracted COVID-19 without risking themselves to the contagion. It is thus needless to say that PPE is the need of the hour throughout the world and needs to be manufactured in large quantities. Recently India has started floating tenders for the supply of the same but given the acute crisis all over the world, little to no help shall have to be expected.
This means that the country will have to look forward to native manufacturers for the same. The bulk manufacturing of PPEs will certainly entail patent infringements as obtaining of licenses by local distributors is nigh impossible. Given the crisis situation, the Indian Government is granting Compulsory Licensing of Patents.
The compulsory licenses, according to the provisions stated in Section 92 of the Indian Patent Act, 1970, are issued by a sovereign authority to a third party so that they can manufacture, use and sell a product without obtaining prior permission from the owner of the patent. The provisions of Section 100 and 102 of the Patents Act provides that a government is capable of taking suo moto control of granting licenses for public use and benefit.
The Indian Patents Act, 1970 under the provisions stated in Section 107A allows the usage, production and sale of patented medicines and drugs for research purposes in times of public healthcare crisis. This means that all medicine companies are open to test patented medicines for the cure of COVID-19.
One of the most important questions that has surfaced is if the innovators can be sufficiently rewarded for their contributions. A patent grant takes several years in most jurisdictions. Added to this, the innovators may not be willing to file for patents before commercializing their inventions.
However, this should not hinder proper acknowledgement of such innovators. Innovators can still be credited with joint ventures, acquisition deals and royalty deals.
Patent Infringements and Commercial Intent
Activities like Bolar exemptions and Compulsory Licensing has created a wave of dissent worldwide. Even in the Indian perspective, reference can be drawn to the landmark feud between the government and Bayer over the compulsory licensing of Nexavar. Nexavar is one of the most sought after drugs for the treatment of liver and kidney cancer. Bayer Pharmaceuticals being the patentee charged a sum of INR 2,80,428/- for one month’s dose.
When approached to the government with the matter, the government issued a Compulsory Licensing to Natco Pharma (who brought down the price to INR 8,800/- for the same dosage) on grounds that the reasonable demands of the public were not met due to the exorbitant charging of a life-saving drug and that the invention was non-working in the territory of India. Bayer Pharmaceuticals challenged the grant and fought its way through to the apex court where they eventually lost. However, repeated instances will not bode well with the big pharma houses.
There is also the risk of a mountain of patent infringement cases once the courts reopen. As stated earlier, the local vendors will infringe tons of patents in a desperate bid to grab profits in a time when all regulatory protocols are shut down. The only way out will be for the patentee companies or individuals to move the court with the plea of granting a permanent injunction on the malpractice and to ascertain the damages caused due to the same. This provides for a massive dilemma in the mind of the patentee.
If during the proceedings it is found that the respective material is of importance in light of a public healthcare disaster, the Central Government might opt for a grant of Compulsory Licensing, cause a company to grant non-exclusive licenses to eliminate the possibility of a Compulsory Licensing (Gilead Life Sciences on Remdesivir) or may move to acquire the patent on grounds of public welfare.
Patenting makes for an important right and the extraordinary times have brought into sharp contrast the difference between commercial intent and the duty towards the community. The question that is of staggering importance is if the innovators are willing to let go of large boosts in the turnover of their companies out of compassion and humanity. Patent holders will find this opportunity to be an excellent chance to exploit their medical patents and generate tremendous revenues. On the other hand, it is also the moral obligation of the community to appraise and give due credit to an invention, or research.
Another facet of the problem is that a significant dearth of the cases will also feature medical patents infringements that were caused due to the inability of getting hearings at proper times. The damages caused to the patent owner may even be unrecoverable. In most circumstances, the damages will be unquantifiable or ridiculously high.
The entire world is fighting the pandemic. Under these circumstances, it is only reasonable to expect that compulsory licensing, joint ventures and royalty-based deals shall be more lenient rather than enforcing strict patent rights.