LAW4031: Patenting Life Forms

These flashcards cover the vocabulary, legal cases, and scientific concepts from the lecture series on 'Patenting Life Forms,' focusing on international treaties, significant court rulings in the US and India, and the evolution of genetic engineering patents.

Double Helix

The physical shape of a DNA molecule, consisting of two strands that twist around each other to form a helix, similar to a twisted ladder.

Recombinant DNA Technology

A technique involving either the combining of DNA from different genomes or the insertion of foreign DNA into a genome to produce genetically modified organisms.

Genotype

The complete set of DNA, or genetic material, in an organism containing all the information needed to develop and function.

Genentech Inc

The first known biotechnology company, established in 1976 in Berkeley, California, by Boyer and Swanson.

Somatostatin

The first human protein manufactured in a bacterium (1977), acting as a hormone that inhibits the secretion of human growth hormone.

Sanger Methodology

A laboratory method identified in 1977 used to determine the entire genetic makeup of a specific organism or cell type by reading DNA sequences.

Polymerase Chain Reaction (PCR)

A method developed by Mullis in the 1980s for the selective amplification of DNA fragments, significantly reducing the time required for cloning.

Diamond v. Chakrabarty (1980)

A landmark United States Supreme Court case determining that a living, human-made microorganism is patentable subject matter as a 'manufacture' or 'composition of matter'.

Bayh-Dole Act

A 1980 U.S. law providing that intellectual property rights arising from publicly funded research vest in the organizations carrying out the research.

Humulin

The first drug produced using recombinant DNA technology, approved by the FDA in 1982 to provide human-identical insulin for diabetics.

Protropin

A recombinant human growth hormone approved in 1985, becoming the first genetically engineered drug both manufactured and marketed by a biotech company.

GloFish

A type of transgenic zebrafish modified with a green fluorescent protein (gfp) gene, marketed as the first genetically engineered pets in 2003.

Expressed Sequence Tags (ESTs)

Short DNA fragments used to identify gene transcripts and analyze gene expression, which became a subject of patent controversy in the 1990s.

TRIPS Article 27

International agreement provision stating that patents shall be available for any inventions (products or processes) in all fields of technology if they are new, involve an inventive step, and are capable of industrial application.

Directive 98/44/EC

The European Union Biotechnology Directive establishing legal protection for biotechnological inventions while ensuring ethical rules are respected.

Biological Material

Defined in Art. 2 (1) (a) as any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

Essentially Biological Process

A process for the production of plants or animals that consists entirely of natural phenomena such as crossing or selection.

Summa divisio

Latin for 'highest division,' referring to the fundamental legal classification such as the distinction between discovery and invention in patent law.

Gene Splice Germ Line

Specifically excluded from patentability under the European Directive, this involves making edits to DNA in egg, sperm, or embryo cells.

Human Genome Project (HGP)

An international 13-year collaboration (1990-2003) that determined, mapped, and stored the sequences of almost all genetic content in the human genome.

Moore v. Regents of the University of California

A 1990 ruling that individuals do not have property rights to share in profits earned from research performed on their bodily materials.

Informed Consent

The process by which healthcare professionals ensure a patient understands the purpose, benefits, and risks of a test or treatment, including any alternatives.

Cell line

A group of cells that multiply on their own outside of an organism, typically in a research laboratory, used to study disease mechanisms.

Hairy-cell leukemia

A rare type of cancer occurring when the body overproduces defective lymphocytes that exhibit a 'hairy' appearance under a microscope.

Article 21 (Constitution of India)

Guarantees the fundamental right to privacy, which Indian courts suggest is violated if cell lines are taken without informed consent.

Section 3(j) (Indian Patents Act, 1970)

A provision excluding plants and animals from patentability but allowing the patentability of microorganisms.

Restriction Enzymes

Discovered in 1968, these enzymes are essential to genetic engineering for their ability to cleave DNA at specific sites.

Plasmids

Small rings of DNA in bacteria, independent of the chromosome, capable of directing protein synthesis and reproducing.

CRISPR-Cas9

A 21st-century gene-editing technology that allows researchers to customize genetic sequences by making specific changes to DNA.

Gene Therapy

The introduction of a normal gene into an individual’s genome to repair a mutation that causes a genetic disease.

Sumant v. State

Invention criteria which must be new, involve an inventive step, and be capable of industrial application.

TSM Test

The 'Teaching, Suggestion, and Motivation' test used in U.S. patent law to identify if prior art suggests a combination of elements to achieve an invention.

Problem-Solution Approach

A three-stage assessment used by the EPO to determine inventive step by identifying the closest prior art and establishing the objective technical problem.

Industrial Application

The patentability requirement that an invention must be capable of being made or used in some form of industry, including agriculture.

Bio-piracy

The use of biological material and associated traditional knowledge without consent or compensation, often for commercial gain by corporations.

TKDL (Traditional Knowledge Digital Library)

An Indian initiative converting ancient texts on Ayurveda, Siddha, Unani, and Yoga into a digital database to prevent misappropriation in international patent offices.

Claim Construction

The process of defining the terms used in patent claims to resolve and interpret the scope of an invention during legal proceedings.

Purposive Construction

A principle of claim interpretation focused on how a person with practical knowledge in the field would understand the claim's requirements.

Biosimilars

Therapeutic drugs highly similar but not structurally identical to a brand-name biologic (reference product), requiring specialized regulatory pathways.

CDSCO (Central Drugs Standard Control Organization)

The primary regulatory body in India that ensures the safety, efficacy, and quality of biologic drugs and clinical trials.