Pharmaceutical patent

2013 SCMR 922 SUPREME-COURT-INDIA Judicial Precedent

Pharmaceutical patentEver greening of pharmaceutical patentPharmaceutical drug derived from a patented chemical compound/ substanceGrant of patent for such a drugScopeLegal requirement that patent for such a drug could only be granted if it qualified as an "invention"

Multi-national pharmaceutical company ("company") had a patent for a chemical compound with which it manufactured a cancer treatment drug ("drug")

Subsequently company made some alterations to the chemical compound and launched an updated version of the drug, which the company claimed was a new "invention"

Company was refused patent for updated version of the drug on the basis that it was not a new drug but an amended version of its earlier product; that invention claimed by the company was anticipated by its previous patent of the chemical compound; that the invention claimed was obvious to a person skilled in the art in view of the disclosure provided in previous patent specifications; that if company was granted patent for updated version of its drug, it would adversely affect lives of poor cancer patients and their families due to the high price of the drug

Validity

Updated version of the drug emerged from the chemical compound for which the company already had a patent

Company had obtained approval for updated version of the drug (in a foreign country) on the basis that it was part of the patented chemical compound

Company had also used the chemical compound patent (in a foreign country) to stop another pharmaceutical company from selling its cancer drug, which contained the same active pharmaceutical ingredient as present in the updated version of the drug

Pharmacological properties of the updated version of the drug were also known in the patented chemical compound

Updated version of the drug did not qualify the tests of "invention" and patentability, in circumstances

Appeal filed by company was dismissed accordingly with cost.

2013 SCMR 922 SUPREME-COURT-INDIA Judicial Precedent

Pharmaceutical patentEver greening of pharmaceutical patentPharmaceutical drug derived from a patented chemical compound/substanceGrant of patent for such a drugScope

Legal requirement that patent for such a drug could only be granted if it was shown that it had enhanced "efficacy" compared to the chemical compound/substance it was derived from

Enhanced "therapeutic efficacy" of a pharmaceutical drug

Scope

Multi-national pharmaceutical company ("company") had a patent for a chemical compound with which it manufactured a cancer treatment drug ("drug")

Subsequently company made some alterations to the chemical compound and launched an updated version of the drug, which the company claimed was a new "invention"

Company was refused patent for the updated version of the drug

Plea of pharmaceutical company that patented chemical compound from which the updated version of the drug was derived did not have any known efficacy, therefore, there was no question of showing that the updated version had any enhanced efficacy, and that even otherwise the updated version of the drug had a 30% increased bioavailability and was more easily absorbed as compared to the patented chemical compound

Validity

Updated version of the drug was a new form of a known substance, i.e. patented chemical compound, efficacy of which was well known

Company was obliged to show the enhanced efficacy of the updated version of the drug over the patented chemical compound, however, there was no material (on record) to make any such comparison of efficacy

Test of efficacy depended upon the function, utility or the purpose of the product, therefore, in the case of a medicine that claimed to cure a disease, the test of efficacy could only be "therapeutic efficacy"

"Therapeutic efficacy" of a medicine had to be judged strictly and narrowly, thus, not all advantageous or beneficial properties (of an updated version of a drug) were relevant, but only such properties that directly related to its therapeutic efficacy

Additional properties that could be attributed to the updated version of the drug were limited to its improved process ability and better and longer storability but, on the basis of such properties alone, the updated version of the drug could not be said to possess "enhanced therapeutic efficacy" over the patented chemical compound

Increased bioavailability (of an updated version of a drug) alone might not necessarily lead to an enhancement of therapeutic efficacy

Increase in bioavailability leading to an enhancement of therapeutic efficacy had to be specifically claimed and established by research data, which was lacking in the present case

Appeal filed by company was dismissed accordingly with cost.

2013 SCMR 922 SUPREME-COURT-INDIA Judicial Precedent

Pharmaceutical patentPharmaceutical drug derived from a known chemical compound/substance with known efficacyGrant of patent for such a drugConditions

Where the (pharmaceutical) product for which patent protection was claimed was a new form of a known substance with known efficacy, then the product must pass the test of "invention", "inventive steps" and the test of enhanced (therapeutic) efficacy.