The Thorny Problem of Patentable Eligible Subject Matter: Part 5 of a 10-Part Series: Brazil

This is Part 5 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 Patent Eligible Subject Matter: U.S.), click here. To view Part 2 (The Thorny Problem of Patent Eligible Subject Matter: Canada), click here. To view Part 3 (The Thorny Problem of Patent Eligible Subject Matter: India), click here. To view Part 4 (The Thorny Problem of Patent Eligible Subject Matter: Russia), click here.

Patentable Subject Matter in Brazil

Article 10 of Brazilian patent law defines what is not considered to be an invention or a utility model and thus, not patent eligible subject matter. Article 10 may be considered the counterpart of 35 U.S.C. § 101 in the U.S. According to Article 10, the following are considered to not be patent eligible subject matter:

1. Discoveries, scientific theories, and mathematical methods;

2. Purely abstract concepts;

3. Schemes, plans, principles or methods of a commercial, accounting, financial, educational, publishing, lottery or fiscal nature;

4. Literary, architectural, artistic, and scientific works or any aesthetic creation;

5. Computer programs per se;

6. Presentation of information;

7. Rules of games;

8. Operating or surgical techniques and therapeutic or diagnostic methods for use on the human or animal body; and

9. Natural living beings, in whole or in part, and biological material, including the genome or germplasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes.

Additionally, Article 18 of Brazilian patent law further limits what may be patentable and indicates that the following are not patentable:

1. Anything that is contrary to morals, good customs, and public security, order, and health;

2. Substances, matter, mixtures, elements or products of any kind, as well as the modification of their physical-chemical properties and the respective processes of obtaining or modifying them, when they result from the transformation of the atomic nucleus; and

3. Living beings, in whole or in part, except transgenic micro-organisms* meeting the three patentability requirements provided for in Article 8 (i.e., novelty, inventive activity, and industrial application) and which are not mere discoveries.

*For the purposes of this law, transgenic micro-organisms are organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that cannot normally be attained by the species under natural conditions.

Accordingly, even if a patent application is directed to patent eligible subject matter under Article 10, as described above, and meets the requirements for novelty and inventive step, it may still be rejected under Article 18 for being directed to non-patentable subject matter, if the foregoing requirements are not satisfied by the patent application.

Additionally, arguments under Article 18 may be used to limit prior approval by the National Agency of Sanitary Surveillance (ANVISA). Prior posts relating to ANVISA can be found in the links below:
Prioritization of Examination of Patent Applications for Pharmaceutical Products and Processes, and Devices and Equipment Related to Public Health
Understanding Biologics and Biosimilars in Brazil
Is the Patent Term “Guarantee” in Brazil Unconstitutional?
Brazil’s Ministry of Health Issues New List of “Strategic” Drugs
Recent Brazilian Jurisprudence Concerning the Scope of ANVISA’s Prior Consent
Request for Public Comments by ANVISA on the Interchangeability of Branded Generic Drugs with Reference Drugs in Brazil
Examination of Pharmaceutical Patent Applications by ANVISA in Brazil
Cloning: It’s not what you think – Changes to ANVISA’s “clone” procedure

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 Brazilian 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 is directed to patent ineligible subject matter under Article 10, section 9, because it encompasses a biological material found in nature or isolated therefrom. If, however, the plasmid was a synthetic plasmid, then the claim would be directed to patent eligible subject matter.

Analysis of Claim 2: This claim may or may not be directed to patent eligible subject matter. If the bacterium is found in nature, then this claim would be rejected under Article 10, section 9, for encompassing a natural living being. If, however, the bacterium has been genetically modified due to direct human intervention, then this claim would be directed to patent eligible subject matter.

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 is directed to patent ineligible subject matter under Article 10, section 9, because it encompasses a biological material found in nature or isolated therefrom. This claim may also be rejected under Article 10, section 1, for encompassing a discovery. To protect amazonic acid under Brazilian patent law, the claim should be rewritten as a pharmaceutical composition claim comprising amazonic acid and one or more excipients. With regards to excipients, mere dilution with an inert carrier is not allowed.

Analysis of Claim 2: This claim is directed to patent eligible subject matter, assuming 5-methyl amazonic acid is not found in nature and the methylation is due to human intervention.

Analysis of Claim 3: This claim would likely be rejected under Article 10, section 8, for encompassing a therapeutic method for use on the human or animal body.

The claim may be rewritten as a Swiss-type claim, for example, as follows: “Use of amazonic acid, characterized in that it is for the preparation of a pharmaceutical composition to treat colon cancer.” This rewritten claim may be directed to patent eligible subject matter because it indicates a pharmaceutical composition rather than amazonic acid itself as discussed above with regards to claim 1.

However, if this Swiss-type claim also recited the dosage regimen, then the claim may be rejected for encompassing patent ineligible subject matter because Brazilian patent examiners may consider the dosage regimen to reflect a therapeutic method step.

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: This claim may be rejected under Article 10, section 9, for encompassing a biological material found in nature or isolated thereform. This claim may also be rejected under Article 10, section 1, for encompassing a discovery.

However, if the patent application provided support that the primers were synthetic, then the claim may be accepted. In this instance, the claim may be amended to have the following preamble: “A synthetic pair of primers …”

Analysis of Claim 2: This claim is directed to patent eligible subject matter.

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 claim 1: This claim may be rejected under Article 10, section 8, for being directed to a therapeutic method for use on the human or animal body. It may also be rejected for lacking novelty and/or being obvious in view of the background provided above. Further, the claim may be considered to encompass a natural biological process and thus, may be rejected under Article 10, section 9.

Analysis of claim 2: This claim may be rejected under Article 10, section 8, for being directed to a therapeutic method for use on the human or animal body. It may also be rejected for lacking novelty and/or being obvious in view of the background provided above.

Analysis of claim 3: This claim may be rejected under Article 10, section 8, for being directed to a therapeutic method for use on the human or animal body. It is unlikely this claim could be drafted into an acceptable Swiss-type format.

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 may or may not be directed to patent eligible subject matter in view of Article 10, section 8, which indicates that therapeutic methods, for use on the human or animal body, are not an invention or utility model.

In one possible interpretation, it may be considered that only those methods including steps that lead to a cure or an attempt to cure are therapeutic methods under Article 10, section 8. In this interpretation, the Brazilian Patent Office may consider the recited steps of this claim to be ancillary to a therapeutic method, and thus, the claim to be directed to patent eligible subject matter.

In another possible interpretation, this claim would be rejected as being directed to patent ineligible subject matter under Article 10, section 8, because the “administering step” directly provides the drug to the subject and thus, regardless of the remaining steps, brings the claim under Article 10, section 8.

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 may or may not be directed to patent eligible subject matter in view of Article 10, section 8, which indicates that diagnostic methods, for use on the human or animal body, are not an invention or utility model.

The examination guidelines for patent applications in the areas of biotechnology and pharmaceuticals indicate that a diagnostic method has three steps:

(1) examining the patient;

(2) submitting the patient to various clinical tests; and

(3) determining the pathological status of the patient by comparing the data from the various clinical tests to normal values, noting significant deviations (i.e., this is a medical deductive step).

In one possible interpretation, a diagnostic method may be those methods including steps that lead directly to a decision on adequate treatment. Given this interpretation and that the claim indicates determining “a risk,” rather than a treatment decision, the Brazilian patent examiner may consider this claim to be directed to patent eligible subject matter.

In another possible interpretation, the claim provides a method to achieve a conclusion about whether a fetus has an increased risk of Down’s Syndrome. The Brazilian patent examiner may consider achieving this conclusion to be a diagnostic method, and thus, may reject the claim under Article 10, section 8. In this interpretation, removing the “conclusion” from the claim may or may not overcome the rejection because it would be dependent upon the examiner’s understanding of the claim and Article 10, section 8.

This post was written by Lisa Mueller and Laura Opperman of Michael Best & Friedrich, Gustavo de Freitas Morais of Dannemann Siemsen, and Roberto Rodrigues and Breno Souza of Licks Attorneys.

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