ARTHROGEN V. PATENT CONTROLLER, INDIA

BACKGROUND

Arthrogen filed for a patent on a process for manufacturing protein-enriched blood serum using gold particles. The Controller of Patents raised objections under Sections 3(c) (mere discovery of a scientific principle), 3(d) (mere discovery of a new form of a known substance), 3(e) (substance obtained by a mere admixture), 3(f) (mere arrangement/re-arrangement/duplication of known devices), and 3(j) (discovery of plants and animals), Indian Patent Act 1970.

During the subsequent hearing, the Controller of Patents came up with new objections under other sections of Indian Patent Act 1970 like Sections 3(b) (innovations posing threats to public order, morality, or the well-being of humans, animals, plants, or the environment) and 3(i) (processes relevant to medical treatment for humans or animals, including diagnosis, therapy, or disease prevention), not being included in the original examination report. As a result, the Controller of Patents rejected the patent application, by raising an objection from the examination report under Section 3(j) and a new objection from the hearing notice under Section 3(i). Aggreived by the same, the applicant appealed to the Delhi High Court, arguing that the refusal order violated principles of natural justice under Section 3(j) and contended that Section 3(i) was not applicable to the invention.

ISSUES

1. Did the Controller General violate the right to fair treatment of Arthrogen by raising new objections without a prior notice?
2. Did the patent exclusion for “methods of treatment” apply to Arthrogen’s method, which only produced a substance?

ARGUMENTS BY BOTH THE PARTIES

Arthrogen (Plaintiff):

• Patentability of the technique: Arthrogen claimed that their technique for manufacturing protein-enriched blood serum using gold particles is unique and innovative, meeting the conditions for patent protection under Indian law. They most likely addressed the Controller’s office’s original reservations to show that the procedure was compliant.

• Focus on Substance Production, Not Treatment: In response to the Controller’s new objection defining the technique as a treatment under Section 3(i), Arthrogen is expected to claim that their innovation is only focused on manufacturing a novel substance (protein-enriched serum) and does not directly entail giving therapy to a patient.

Controller General of Patents (Defendant):

• Initial Objections: The Controller may have expressed concerns about innovation, non-obviousness, or other patentability standards under the Patents Act (details not included in the sources). Arthrogen most likely addressed these issues with revisions.
• Method of Treatment Classification (Section 3(i)): The Controller’s main argument appears to be that the method’s possible application in treatment disqualifies it from patent protection under Section 3(i) of the Act, which prohibits methods of treatment for humans or animals.

JUDGEMENT

The Delhi High Court ruled in favour of Arthrogen, and overruled Controller’s decision on two grounds:

• Violation of natural justice:The Controller introduced fresh objections at the hearing that were not mentioned earlier, depriving Arthrogen a sufficient response.
• Misinterpretation of the law:The court rejected the Controller’s classification of the technique as a “method of treatment” under Section 3(i) of the Patents Act. The court noted that the procedure was only concerned with generating a drug and did not directly entail therapy.

The court overturned the refusal order and referred the case back to the Patent Office for further review based on the clarified legal understanding. This case emphasizes the necessity of following established procedures in patent applications to ensure transparency and fairness for applicants. It also emphasizes the difference between patentable innovations and methods of treatment under the Indian patent law.