The Thorny Problem of Patentable Eligible Subject Matter: Part 3 of a 10-Part Series: India

This is Part 3 of a 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries. To view Part 1 (The Thorny Problem of Patentable Eligible Subject Matter: U.S.), click here. To view Part 2 (The Thorny Problem of Patentable Eligible Subject Matter: Canada), click here.

Patentable Subject Matter in India

In India, Chapter II of The Patents Act, 1970, which was amended in 2002 and 2005, defines what are not inventions under Indian patent law. Specifically, sections 3 and 4 of Chapter II indicate that the following are not inventions:

1. An invention which is frivolous or which claims anything obviously contrary to well established natural laws {section 3(a)};

2. An invention which is the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudices to human, animal or plant life or health or to the environment {section 3(b)};

3. The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature {section 3(c)};

4. The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant {section 3(d)};

5. A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance {section 3(e)};

6. The mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way {section 3(f)};

7. A method of agriculture or horticulture {section 3(h)};

8. Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products {section 3(i)};

9. Plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals {section 3(j)};

10. A mathematical or business method or a computer program per se or algorithms {section 3(k)};

11. A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions {section 3(l)};

12. A mere scheme or rule or method of performing a mental act or method of playing a game {section 3(m)};

13. A presentation of information {section 3(n)};

14. Topography of integrated circuits {section 3(o)};

15. An invention, which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of a traditionally known component or components {section 3(p)}; and

16. An invention relating to atomic energy, if the invention falls within subsection (1) of section 20 of the Atomic Energy Act, 1962 (33 of 1962) (section 4).

*Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of a known substance are considered to be the same substance under Indian patent law, unless they differ significantly in properties with regard to efficacy.

Prior BRIC Wall blog posts directed to decisions involving section 3(d) can be found here and here.

Analysis of Examples under the U.S. PTO Guidance

In view of recent U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo), the U.S. Patent and Trademark Office (U.S. PTO) on March 4, 2014 issued guidance for evaluating subject matter eligibility under Section 101 (Guidance). The Guidance superseded the June 13, 2013 memorandum issued on the day of the Myriad decision. While the Guidance was issued without public notice or opportunity for the public to comment, the U.S. PTO held a forum on May 9, 2014 to receive feedback from organizations and individuals regarding the Guidance.

The Guidance is divided into four sections. Part I discusses the 3-part test for determining subject matter eligibility. Part II explains how to determine whether a claim (as a whole) is “significantly different.” This portion of the Guidance provides a list of 12 factors – six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference). Part III provides seven examples explaining the application of the factors. Part IV provides a new form paragraph for Examiners to use when rejecting claims in accordance with the Guidance.

In addition to the Guidance, the U.S. PTO prepared detailed training materials (containing 93 PowerPoint slides) for Examiners. The detailed training materials contain numerous examples not provided for in the Guidance.

We at the BRIC Wall thought it would be insightful to examine the analysis of subject matter eligibility under Indian patent law for several of the examples contained in the Guidance and training materials.

Composition/Manufacture Claim Reciting a Natural Product – Example A – U.S. PTO Guidelines

Claim 1: A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.

Claim 2: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

Background: Stable energy-generating plasmids exist within certain bacteria in nature. Pseudomonas bacteria are naturally occurring bacteria. Naturally occurring Pseudomonas bacteria containing a stable energy-generating plasmid and capable of degrading a single type of hydrocarbon are known.

Analysis of Claim 1: This claim would be rejected for being directed to non-patentable subject matter under section 3(c) of Chapter II of the Indian Patents Act, 1970, discovery of any living substance(s) occurring in nature is non-patentable subject matter (see item (3) above).

Analysis of Claim 2: This claim may qualify as patentable subject matter provided that is directed to a non-naturally occurring microorganism.

Composition vs. Method Claims, Each Reciting a Natural Product – Example B – U.S. PTO Guidelines

Claim 1: Purified amazonic acid.

Claim 2: Purified 5-methyl amazonic acid.

Claim 3: A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

Background: The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon basin region in Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in treating breast cancer, however, to be effective, a patient must eat 30 pounds of the leaves per day for at least four weeks. Many have tried and failed to isolate the cancer-fighting chemical from the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has named it amazonic acid. The purified amazonic acid is structurally identical to the amazonic acid in the leaves, but a patient only needs to eat one teaspoon of the purified acid to get the same effects as 30 pounds of the leaves. Applicant has discovered that amazonic acid is useful to treat colon cancer as well as breast cancer, and applicant has also created a derivative of amazonic acid in the laboratory (called 5-methyl amazonic acid), which is structurally different from amazonic acid and is functionally different because it stimulates the growth of hair in addition to treating cancer.

Analysis of Claim 1: This claim would be rejected for being directed to non-patentable subject matter under section 3(c) of Chapter II of the Indian Patents Act, 1970, discovery of any living substance(s) occurring in nature is non-patentable subject matter (see item (3) above). Additionally, this claim would further be rejected because the product itself is not novel under Indian patent law and thus, would be considered non-patentable subject matter.

Analysis of Claim 2: This claim would be rejected for being directed to non-patentable subject matter under section 3(d) of Chapter II of the Indian Patents Act, 1970 (i.e., see item (4) above), because purified 5-methyl amazonic acid would be considered a new form of a known compound, i.e., a derivative of amazonic acid. If, however, it could be shown that purified 5-methyl amazonic acid provided an enhanced therapeutic efficacy relative to amazonic acid, then purified 5-methyl amazonic acid may be patentable subject matter in India.

Analysis of Claim 3: Method of treatment claims constitute patent ineligible subject matter in India, specifically, under section 3(i) of Chapter II of the Indian Patents Act, 1970, i.e., see item (8) above. However, an Applicant may pursue product, composition/combination, kit, dosage or apparatus claims. Also, a patent maybe obtained for a surgical, therapeutic or diagnostic instrument or apparatus. Thereupon, depending on the subject matter of the patent, the most suitable kind of claims could be drafted to suit Indian practice.

Composition vs. Method Claims, Each Reciting Two Natural Products – Example E – U.S. PTO Guidelines

Claim 1: A pair of primers, the first primer having the sequence of SEQ ID NO:1 and the second primer having the sequence of SEQ ID NO:2.

Claim 2: A method of amplifying a target DNA sequence comprising:

(a) providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine;

(b) heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other;

(c) cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers;

and repeating steps (b) and (c) at least 20 times.

Analysis of claim 1: The subject matter of claim 1 is not patentable subject matter under section 3(c) of Chapter II of the Indian Patents Act, 1970, i.e., see item (3) above.

Analysis of claim 2: The claimed method may qualify as patentable subject matter under the Indian Patents Act, 1970.

Process Claims Involving A Natural Principle – Example G – U.S. PTO Guidelines

Claim 1: A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to sunlight, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Claim 2: A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to a synthetic source of white light, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Claim 3: A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: providing a light source that emits white light; filtering the ultra-violet (UV) rays from the white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a predetermined period ranging from 30-60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Background: It is a well-documented natural principle that white light affects a person’s mood. Exposure to white light changes neuronal activity in the brain, which changes a person’s mood. Sunlight is a natural source of white light. It is well-understood, purely conventional and routine in the art of treating mood disorders to expose a person to white light in order to alter their neuronal activity and mitigate mood disorders.

Analysis of claims 1, 2, and 3: Each of these claims is directed to non-patentable subject matter under section 3(i) of Chapter II of the Indian Patents Act, 1970, i.e., see item (8) above.

Diagnostic claim from Mayo Collaborative Services v. Prometheus Laboratories, Inc. – Examiner Training Materials

Claim 1: A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject, and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Analysis of claim 1: This claim is directed to non-patentable subject matter under section 3(i) of Chapter II of the Indian Patents Act, 1970, i.e., see item (8) above.

Claim from U.S. Patent No. 6,573,103 – Examiner Training Materials

Claim 1: A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome, the method comprising the steps of:

measuring the level of at least one screening marker from a first trimester of pregnancy by:

(i)         assaying a sample obtained from the pregnant woman at said first trimester of pregnancy for at least one first biochemical screening marker; and/or

(ii)        measuring at least one first ultrasound screening marker from an ultrasound scan taken at said first trimester of pregnancy;

measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:

(i)         assaying a sample obtained from the pregnant woman at said second trimester of pregnancy for at least one second biochemical screening marker; and/or

(ii)        measuring at least one second ultrasound screening marker from an ultrasound scan taken at said second trimester of pregnancy; and

determining the risk of Down’s syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies.

Analysis of claim 1: This claim is directed a method of diagnosis which constitutes patent ineligible subject matter under section 3(i) of Chapter II of the Indian Patents Act, 1970, i.e., see item (8) above.

This post was written by Lisa Mueller and Laura Opperman of Michael Best & Friedrich and Nidhi Anand of Chadha & Chadha.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s