SECTION 101-US PATENTS ACT
Section 101 of the US PATENTS ACT plays a crucial role in determining the eligibility and patentability of an invention. It serves as a key criterion for evaluating new inventions. The provision ensures that patents foster technological advancements rather than protecting fundamental principles or abstract concepts.
Section 101 of the US Patents Act states that:
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
The section establishes the novelty of any invention, method, process, composition or discovery. However, Section 101 it also sets clear boundaries, excluding abstract ideas, laws of nature, and natural phenomena from being patentable.
ELIGIBILITY FOR PATENT PROTECTION
According to Manual of Patent Examining Procedure (MPEP), Section 101 of the U.S. Patent Act imposes four key requirements for patent eligibility: s
Utility: The invention must serve a specific, substantial, and credible utility.
Novelty: As per Section 102 of the Act, the invention must be entirely new and not previously disclosed or publicly known.
Non-Obviousness: As per Section 103 of the US Patents Act, the invention must not be an obvious modification of existing technology to a person skilled in the field.
Statutory Subject Matter: The invention must fall under one of the four statutory categories—process, machine, manufacture, or composition of matter. This excludes abstract ideas, natural phenomena, and laws of nature.
BIOTECH INVENTIONS UNDER SECTION 101
The biotechnology sector has been rapidly growing and evolving, encompassing genetic engineering, plant varieties, human cloning, and personalized medicine. Like other technological field, biotech inventions must satisfy the eligibility requirements under Section 101. While natural biological materials and processes are not patentable, genetic modifications, synthetic composition, and engineered biological processes may qualify if they demonstrate significant innovation.
LANDMARK CASE: Mayo v. Prometheus (2012)
The US Supreme Court’s ruling in the present case profoundly shaped the patent scenario for biotech inventions.
Background of the case:
Section 101 establishes fundamental patent eligibility requirements, stating that patent may be granted for "any new and useful process, machine, manufacture, or composition of matter." However, laws of nature, natural phenomena, and abstract ideas are categorically excluded from patent protection. This exclusion presents challenges for biotech patents, particularly for medical and diagnostic innovations based on biological correlations. .
Arguments Presented by Prometheus Laboratories:
Prometheus Laboratories argued that their patented method, which determined the optimal drug dosage based on metabolite levels and therapeutics, was patentable because it applied a natural law in a clinical setting. They emphasized that their method required human intervention and novel steps beyond a mere observation of nature.
Judgment:
The U.S. Supreme Court rejected Prometheus' claims, ruling that the patent merely applied a natural law without adding a significant inventive step. The court reinforced that natural laws cannot be patented unless they are transformed through substantial innovations.
Impact of the decision on Biotech Patents:
The Mayo decision reshaped the patentability of medical and biotech innovations, particularly those based on natural correlations. By restricting patent eligibility for diagnostic methods and personalized medicine, the ruling raised the bar for what constitutes a patentable biotech invention. The decision continues to influence global patent practices, particularly in Europe, China, and India, where biotech patents are subject to similar legal scrutiny.
Insights :
The Mayo v. Prometheus decision reinforced the principle that patents cannot cover laws of nature, abstract ideas, or fundamental principles. It set an important precedent in the life sciences and biotechnology sectors, particularly in cases where the an invention merely observes or utilizes natural laws without demonstrating a sufficiently novel application. This ruling has significantly influenced how patents are evaluated in fields such as diagnostics, personalized medicine, and other biotech inventions, leading to more stringent standards regarding for patenteigibility in these areas.
Article By: Team Aumirahinsight