Welcome to the April 2021 Issue of legal news in the field of Intellectual Property Rights by Singhania & Partners. This issue summarizes the latest news and provides a quick overview of the judgments and legal developments which took place in the month of April, 2021.
PATENTS
Madras High Court seeks trial in attempt to settle longstanding dispute concerning a patent claiming an invention to augment kidney function1
A patent infringement suit was filed before the High Court of Madras ('Court') by Centaur Pharmaceuticals Pvt. Ltd. and Kibow Biotech Inc. ('Plaintiffs') against La Renon Health Care Pvt. Ltd. and Stanford Laboratories Pvt. Ltd. ('Defendants').
One of the Plaintiffs, Centaur Pharmaceuticals Pvt. was an exclusive licensee of the patented invention that augmented kidney function ('Impugned Patent') which was granted to Kibow Biotech Inc. The Impugned Patent was sold under the brand name 'Renadyil'. The Plaintiffs alleged that the infringing products namely, 'Cudo', 'Cudo Forte', and/or 'Probigress' of the Defendants, used the same strain of probiotic bacterium, i.e. 'Streptococcus thermophilus' which dissolved in the same bowel area as the Impugned Patent having the same purpose.
In response to the allegations, the Defendants argued that their product 'Cudo Forte', not only contained 'Streptococcus thermophiles' but also contained two other bacteria namely, 'Lactobacillus acidophilus' and 'Bifidobacterium longum' whose colony forming units were much higher than that used in the Impugned Patent. The Defendants, while relying on Section 3(c), Section 3(e) and Section 3(j) of the Patents Act, 1970, argued that 'Streptococcus thermophiles' is a commonly available bacteria, therefore, there can be no claim for a patent in the Impugned Patent of the Plaintiffs.
Interestingly, the Defendants, prior to the present suit had filed an application of revocation of the Plaintiffs Impugned Patent before the Intellectual Property Appellate Board ('IPAB') which was subsequently rejected. Also, a writ petition was filed before the Court which too was unsuccessful. Further, a special leave petition was also filed by the Defendants before the Supreme Court wherein the Defendants suffered an order of dismissal.
The Court noted that the task of distinguishing beneficial bacteria (as that of the Plaintiffs) from the non-beneficial bacteria requires research to determine the required colony forming units, and which cannot be discovered overnight. Nevertheless, the Court was of the opinion that a trial was necessary to determine how both parties made their discoveries centering on 'Streptococcus thermophiles' as a probiotic bacterium which can be used for alleviating the pain of persons who suffer from kidney related disease(s). The Court held that since the Plaintiffs claim has been successfully upheld by the IPAB, the Court, and the Supreme Court, the balance of convenience lies in the favor of the Plaintiffs and accordingly the Court ordered an interim injunction restraining the Defendants from manufacturing, selling its products till the conclusion of the trial and the disposal of the suit.
Supreme Court contemplates mandatory licensing of Covid-19 drugs and vaccines2
The Supreme Court ('Court') while taking suo moto cognizance of the distribution of essential supplies and services during the Covid-19 pandemic, enlisted the flexibilities with respect to Compulsory Licensing of patented drugs and vaccines to tackle the vaccine requirements in an equitable and expedient manner.
In line with the international treaties and agreements such as the Trade Related Aspects of Intellectual Property Rights Agreement and the Doha Declaration, the Indian Patent law provides for Compulsory Licensing in circumstances of national emergency and extreme urgency. As a result, the Court urged the Central Government to take action as per the following provisions of the Patents Act, 1970:
- Section 92 of the Patents Act, 1970 envisages the grant of Compulsory License wherein once a national emergency is declared and the relevant patents are notified, any person interested in manufacturing the drug can make an application to the Controller of Patents for the grant of a Compulsory License with respect to the said drug. As a result, the Patent Holder of the Drug or Vaccine would be compensated accordingly.
- Section 100 of the Patents Act, 1970 provides for the Central Government to authorize certain companies to use any patents for the "purpose of the government". This would pave the way for pharmaceutical companies to manufacture the vaccine while the royalty would be negotiated by the Central Government.
- Section 102 of the Patents Act, 1970 provides for the Central Government to acquire the patents from a Patent Holder, whereby the High Court may reasonably fix the royalty that has to be paid to the Patent Holder in the event pricing negotiations fail with the Central Government.
- Notably, the Central Government is also permitted to revoke a patent in public interest under Section 102 of the Patent Act, 1970.
The Court observed that the extent of the application of the abovementioned possibilities is something that the Central Government would have to decide by way of policy decisions.
Footnotes
1. Centaur Pharmaceuticals Pvt. Ltd & Anr v. La Renon Health Care Pvt. Limited & Anr
2. Suo Motu Writ Petition (Civil) No. 3 of 2021
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