Brazil: An Update of the Most Relevant Events for Pharmaceutical Companies in 2014: Part 1 of a 5-Part Series

The second half of 2014 has proven to be very busy for companies having business and other interests in Brazil that rely on intellectual property (IP) protection. This is part 1 of a 5-part series  providing updates on: 1) mailbox patent litigation; 2) the constitutional challenge filed by ABIFINA against the 10-year patent term guarantee; 3) prior approval challenges and ANVISA; 4) a new Productive Development Partnership (PDP) rulemaking draft proposal; and 5) an opinion issued by the Brazilian Antitrust authority (CADE) regarding sham litigation.

Mailbox Patent Litigation

On September 2013, the Brazilian Patent and Trademark Office (INPI) filed more than 35 lawsuits seeking a declaration of invalidity of 222 mailbox patents (namely, patent applications filed between January 1, 1995 and May 14, 1997, under the terms of Article 70.8 of the TRIPS Agreement). According to INPI, these patents should have received a term of 20 years from their filing date. However, these patents mistakenly received a term of 10 years from the date of grant.

Since June 2014, three mailbox cases have been decided by the Federal Judges (Judges) in Brazil. Two Judges ruled in favor of the patent holders and one against. Not surprisingly, the Judges each conveyed different points of view regarding the inefficiency of the INPI to examine patent applications in a reasonable time and to deal with its current backlog.

The Judges ruling in favor of the patent holders stated INPI violated the IP Statute when it failed to comply with the rule requiring examination of mailbox applications before 2004 (as required by the IP Statute). The Judges also stated that the lawsuits filed by INPI to invalidate these patents are a violation of the constitutional principle of “legitimate expectation,” which requires a certain amount of predictability and trust in the acts of the Public Administration.

However, right after the first favorable decisions were issued, Judge Maria Nunes rendered a decision against certain patent holders and granted an injunction to change the term of the patents at issue to 20 years from filing. Interestingly, Judge Nunes is handling a majority of the pending mailbox cases (she has 17 in total).

According to Judge Nunes, the interpretation of the law defended by the mailbox patent holders would be significantly more prejudicial to society as a whole and, as a result, society would have to accept the burden of an amplified patent term and would have to pay more for the drugs covered by such patents. Additionally, Judge Nunes also stated that constitutional principles that defend the social (and public) interest would have clear precedence over principles that protect private interests, such as legitimate expectation. Therefore, in Judge Nunes’ view, the rejection of the INPI’s claim would prioritize the interests of large companies and would unduly harm free competition, national development and the access to health.

The appeals filed by the INPI and by the patent holders will be heard by the Federal Court of Appeals in 2015. In the meantime, it will be interesting to see how Judge Nunes will rule regarding the counterclaims filed by some patent holders seeking damages from the INPI, since she has already ruled that patent holders who can prove that they were damaged as a result of INPI’s conduct would be entitled to compensation.

A pictorial summary of the mailbox patents challenged by INPI as prepared by the Licks Attorneys can be viewed by clicking here:  MAILBOX.

Please continue to watch the BRIC Wall Blog for further updates on the mailbox patent litigation in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys.

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

This is Part 10 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. To view Part 5 (The Thorny Problem of Patent Eligible Subject Matter: Brazil), click here. To view Part 6 (The Thorny Problem of Patent Eligible Subject Matter: Europe), click here. To view Part 7 (The Thorny Problem of Patent Eligible Subject Matter: China), click here. To view Part 8 (The Thorny Problem of Patent Eligible Subject Matter: Australia), click here. To view Part 9 (The Thorny Problem of Patent Eligible Subject Matter: South Africa), click here.

Patentable Subject Matter in Japan 

The Japanese Patent Act (Act) contains two provisions regarding patent eligible subject matter. The first provision is found in Article 2(1) of the Act which states that an “invention” must be a “highly advanced creation of technical ideas utilizing the laws of nature.” Specifically, an invention must be a “statutory” invention to be patentable. A list of “non-statutory” inventions is provided in section 1.1 of the Examination Guidelines of the Japanese Patent Office (Guidelines). Section 1.1 of the Guidelines states:

Since it is not a ‘creation of a technical idea utilizing a law of nature,’ any one of the following is not considered to be a statutory invention.

1.  A law of nature as such.

Since statutory inventions shall utilize a law of nature, a law of nature as such, like a law of preservation of energy or a law of universal gravitation, is not considered as a statutory invention.

2.  Mere discoveries and not creations.

One of the requirements for a statutory invention is to be a ‘creation,’ and thus, mere discoveries, such as discoveries of natural things like an ore or natural phenomena, for which an inventor does not consciously create any technical idea, are not considered to be a statutory invention.

However, if things in nature such as chemical substances or microorganisms have been isolated artificially from their surroundings, then those are creations and considered to be a statutory invention.

3.  Those contrary to a law of nature.

If a matter necessary to define an invention involves any means contrary to a law of nature, the claimed invention is not considered to be a statutory invention (See: Example 1). The so-called perpetual motion is an example contrary to the second law of thermodynamics.

4.  Those in which a law of nature is not utilized.

If claimed inventions are any laws as such other than a law of nature (e.g. economic laws), arbitrary arrangements (e.g. a rule for playing a game as such), mathematical methods or mental activities, or utilize only these laws (e.g. methods for doing business as such), these inventions are not considered to be statutory because they do not utilize a law of nature (see Examples 2-4).

Example 1: Computer programming languages

Example 2: A method of collecting money for an electricity bill or a gas bill etc., by rounding off the total amount to be collected to the nearest 10 yen unit.

Even if a part of matters defining an invention stated in a claim utilizes a law of nature, when it is judged that the claimed invention considered as a whole does not utilize a law of nature, the claimed invention is deemed as not utilizing a law of nature.

Example 3: A method of plying a container vessel to transport a large amount of fresh water from a region where crude oil is expensive and fresh water is inexpensive to another region where crude oil is inexpensive and fresh water is expensive, and after unloading the fresh water, transporting a large amount of crude oil instead of the water to the homeward voyage.

Example 4: A method of billboard advertising using utility poles, characterized by forming in advance groups A, B, C, D, … with a prescribed number of poles in each group, placing a holding frame to post thereon a billboard for each pole, and posting the billboards in each group on holding frames placed to poles in each group in circulation in a certain time interval. (See: Tokyo High Court Judgment Sho 31.12.25 (Syowa 31 (Gyo Na) 12))

On the contrary, even if a part of matters defining an invention stated in a claim does not utilize a law of nature, when it is judged that the claimed invention as a whole utilizes a law of nature, the claimed invention is deemed as utilizing a law of nature.

As stated above, the characteristic of the technology is to be taken into account in judging whether a claimed invention as a whole utilizes a law of nature.

Notes:

For inventions relating to a method for doing business or playing a game, since there are cases in which the claimed invention a part of which utilizes an article, apparatus, device, system, etc., is judged as not utilizing a law of nature when considered as a whole, careful examination shall be required. (See: Examples 5-7)

There is possibility for an invention to be qualified as statutory where the invention is made not from a viewpoint of a method of doing.

5.  Those not regarded as technical ideas.

a.  Personal skill (which is acquired through personal experience and cannot be shared with others as knowledge due to lack of objectivity).

Example: A method of throwing a split-fingered fast ball characterized in the way of holding the ball in fingers and throwing the same.

b.  Mere presentation of information (where the feature resides solely in the content of the information, and the main object is to present information).

[Examples]

Written manual for instructing an operation of a machine or directing a use of a chemical substance, audio compact disc (where the feature resides solely in music recorded thereon), image data taken with a digital camera, program of an athletic meeting made by a word processor, or computer program listings (mere representation of program codes by means of printing them on paper, displaying them on a screen, etc.).

However, if technical features reside in presentation of information (presentation per se, a means for presentation, a method for presentation, etc.), claimed inventions are not considered as mere presentation of information.

Example 1: A test pattern for use in checking the performance of a television set (where a technical feature resides in the pattern per se).

Example 2: A plastic card on which information is recorded with characters, letters and figures embossed on it (enabling one to copy the information by affixing the card on a paper, in this sense the technical feature residing in the means for presentation).

c.  Aesthetic creations

Example: paintings, carvings, etc.

6.  Those for which it is clearly impossible to solve the problem to be solved by any means presented in a claim.

Example: A method for preventing explosion in a volcano by forming balls of neutron-absorbing material (e.g., boron) covered with substance having high melting temperature (e.g., tungsten) and throwing them into the volcanic vent (This invention allegedly works on the assumption that volcanic explosion is caused by nuclear fission of substances like uranium at the bottom of the volcanic vent).

The second provision is found in Article 29(1) of the Act which states that “[A]ny person who has made an invention which is industrially applicable may obtain a patent therefor …” Thus, this provision requires an invention be “industrially applicable.” According to the Guidelines, the term “industry” is to be interpreted broadly and includes inventions resulting from mining, agriculture, fishery, transportation, telecommunications, etc., as well as manufacturing. In fact, section 2.1 of the Guidelines provides a list of industrially inapplicable inventions and in principle, any invention which does not correspond to one of the following is considered as industrial applicable. Industrially inapplicable inventions include:

1.  Methods of surgery, therapy or diagnosis of humans.

2.  Commercially inapplicable inventions. Such inventions include inventions applied only for:

a.  Personal use (such as a method of smoking); and

b.  Academic or experimental purposes.

However, the Guidelines state:

It should be noted that such an invention as a ‘method of waving hair,’ which is used in the beautician field while being personally applied, is not considered as an ‘invention applied only for personal use.’ Likewise, a ‘kit for scientific experiments,’ which is used in experiments at school, is not considered as an ‘invention applicable only for academic or experimental purposes’ as it is marketable and tradable.

3. Practically inapplicable inventions. Such inventions include inventions which cannot be practically implemented. The example given in the Guidelines is a method for preventing an increase in ultraviolet rays associated with the destruction of the ozone layer by covering the whole earth’s surface with an ultraviolet ray-absorbing plastic film.

Therefore, in order for an invention to constitute patent eligible subject matter, it must be “statutory” and “industrially applicable.” Pursuant to the Guidelines, the burden of proof is on the Applicant to establish that an invention is industrially applicable. However, if an Examiner is of the opinion that an invention does not comply with the requirements of industrial applicability, he or she is required to provide specific reasons for his or her refusal.

In principle, under the Guidelines, natural products (namely, genes, microorganisms and chemical substances isolated from nature) constitute patent eligible subject matter. However, claims to a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein or a monoclonal antibody the utility for which is not described in or cannot be inferred from the specification will likely be found not to be industrially applicable thus not constitute patent eligible subject matter.

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 Japanese 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: The subject matter of this claim constitutes patent eligible subject matter. According to the Guidelines, natural products that have been isolated artificially from their surroundings are patent eligible. Additionally, because the plasmid appears to be useful for degradation of hydrocarbon, this claim appears to be industrially applicable.

Analysis of claim 2: In light of the above background information, the claimed bacterium appears to be artificially prepared and industrially applicable. Therefore, this claim constitutes 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 of 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: The subject matter of this claim constitutes patent eligible subject matter because the purified amazonic acid has been isolated artificially from the Amazonian cherry tree and is industrially applicable in view of the provided background information.

Analysis of claim 2: Because a derivative has been artificially created from amazonic acid which is industrially applicable in view of the background information, this claim constitutes patent eligible subject matter.

Analysis of claim 3: As currently drafted, this claim does not constitute patentable eligible subject matter. However, this claim would be patent eligible if reformulated into a Swiss-type claim.

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:

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;

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;

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: Because the pair of primers recited in this claim have been artificially prepared, this claim would constitute a statutory invention. Additionally, this claim would be industrially applicable because the primers are useful for the amplification of the target DNA recited in claim 2. Therefore, the claimed pair of primers constitute patent eligible subject matter.

Analysis of claim 2: This claim constitutes patent eligible subject matter because the method is clearly statutory and industrially applicable.

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: Because this claim recites a step that involves the treatment or diagnosis of a human by a physician, this claim does not constitute patent eligible subject matter. Additionally, it appears that it would be difficult to reformulate this claim into a Swiss-type claim. However, according to the Guidelines, if this claim can be reformulated to recite a medical device, system or a method for controlling the operation of a medical device, then such a reformulated claim would be patent eligible.

Analysis of claim 2: As with claim 1, if claim 2 could be reformulated to recite a medical device, system or a method for controlling the operation of a medical device, then such a reformulated claim would be patent eligible.

Analysis of claim 3: As with claims 1 and 2, if claim 3 could be reformulated to recite a medical device, system or a method for controlling the operation of a medical device, then such a reformulated claim would be patent eligible. 

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

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

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

(b) 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: Because this claim recites a step that involves the treatment or diagnosis of a human by a physician, this claim does not constitute patent eligible subject matter. Additionally, it appears that it would be difficult to reformulate this claim into a Swiss-type claim. However, pursuant to the Guidelines, if this claim could be reformulated to exclude the step of treating or diagnosing a human by a physician, then such a reformulated claim would be patent eligible. 

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

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: The recitation in the preamble that this claim is directed to a “method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome” and the inclusion of the step of “determining the risk of Down’s syndrome,” involves the diagnosis of a human by a physician. Thereupon, this claim does not constitute patent eligible subject matter. However, pursuant to the Guidelines, if this claim could be reformulated to exclude the diagnosis of a human by a physician, then such a reformulated claim would be patent eligible.

This post was written by Lisa Mueller of Michael Best and Yuko Noda at Kawaguti & Partners.

The Thorny Problem of Patentable Eligible Subject Matter: Part 9 of a 10-Part Series: South Africa

This is Part 9 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. To view Part 5 (The Thorny Problem of Patent Eligible Subject Matter: Brazil), click here. To view Part 6 (The Thorny Problem of Patent Eligible Subject Matter: Europe), click here. To view Part 7 (The Thorny Problem of Patent Eligible Subject Matter: China), click here. To view Part 8 (The Thorny Problem of Patent Eligible Subject Matter: Australia), click here.

Patentable Subject Matter in South Africa

In South Africa, patentable inventions are regulated by Section 25 of the Patents Act 57 of 1978 (Patents Act) as amended. Section 25 provides:

(1) A patent may, subject to the provisions of this section, be granted for any new invention which involves an inventive step and which is capable of being used or applied in trade or industry or agriculture.

(2) Anything which consists of –

(a) a discovery;

(b) a scientific theory;

(c) a mathematical method;

(d) a literary, dramatic, musical or artistic work or any other aesthetic creation;

(e) a scheme, rule or method for performing a mental act, playing a game or doing business;

(f) a program for a computer; or

(g) the presentation of information,

shall not be an invention for the purposes of this Act.

Additionally, Section 25(4)(a) provides that:

[a] patent shall not be granted for an invention the publication or exploitation of which would be generally expected to encourage immoral or offensive behavior.

Moreover, with respect to medical use claims, Section 25(9) provides that:

[i]n the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practiced on the human or animal body, the fact that the substance or composition forms part of the state of the art immediately before the priority date of the invention shall not prevent a patent being granted for the invention if the use of the substance or composition in any such method does not form part of the state of the art at that date.

Finally, Section 25(11) provides that:

[a]n invention of a method of treatment of the human or animal body by surgery or therapy or diagnosis practiced on the human or animal body shall be deemed not to be capable of being used or applied in trade or industry or agriculture.

It is important to note that South Africa does not have any case law under its current Patents Act concerning the subject matter eligibility of naturally occurring products. In fact, the only case that is partly relevant is a 1961 case under repealed Patents Act No. 37 of 1952. Specifically, Section 10(7) of the repealed Act provided.

[w]here a complete specification claims a new substance, the claim shall be construed as not extending to that substance when found in nature.

In the seminal case regarding this section of the repealed Act, American Cyanamid Co v Continental Ethicals (Pty) Ltd 1961 BP 301 CP, it was found that:

[i]n enacting Section 10(7) the legislature recognized that an absolute product claim is perfectly valid, notwithstanding the fact that the substance covered thereby may also be found to exist in nature. The legislature merely enacted that in such a case the scope of the claim should be restricted…In other words, if the plaintiff claims a new substance then it cannot complain of any dealing with that substance when the other party has merely found it in nature and has taken it from where he found it.

Should the South African Court of the Commissioner of Patents be faced with having to address the question of subject matter eligibility of naturally occurring products and the like, it will most likely turn to like judgments from Great Britain and the European Patent Office (EPO), since South Africa’s law closely mirrors the patent law of the United Kingdom and the European Patent Convention (EPC).

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 South African 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: The subject matter of this claim does not contain excluded subject matter. However, the subject matter of this claim is not novel. Specifically, this claim is not patentable by virtue of the fact that stable energy-generating plasmids, which provide a hydrocarbon degradative pathway, are known.

Analysis of claim 2: The subject matter of this claim does not contain excluded subject matter. This claim is novel since the background states that Pseudomonas bacteria containing a (singular) stable energy-generating plasmid capable of degrading a single type of hydrocarbon are known. Thus, a Pseudomonas bacterium containing at least two stable energy-generating plasmids is novel. However, it will have to be shown that the inclusion of two plasmids involves an inventive step. In Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980), (Chakrabarty) scientists added four plasmids to a bacterium, which enabled it to break down various components of crude oil. In the event that the facts are similar to Chakrabarty, South African courts will likely find that an inventive step is present since further inclusion of plasmids into the bacterium gave rise to certain advantages which were not obvious to a person skilled in the art.

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 of 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: The subject matter of claim 1 is patentable and will be considered novel against the prior art described in the background. Prior to its isolation, it was (presumably) not possible to determine the exact chemical structure of amazonic acid. The background described that the leaf of Amazonian cherry, not the amazonic acid itself, displayed anti-cancerous properties. The fact that amazonic acid was the true active anti-cancerous compound was not known despite many attempts to isolate and determine the chemical composition of the active ingredient. Furthermore, since the amazonic acid has now been isolated from the leaf by the Applicant, it can further be viewed as novel in the sense that it is for the first time separate and distinct from the leaf. However, it should be noted that there is no South African guiding case law regarding whether or not mere “isolation” can impart novelty.

Analysis of claim 2: Because the subject matter of this claim is new, it constitutes patentable subject matter. The addition of a functional group will most likely also be deemed to be inventive since there is no indication in the prior art that such modification will impart hair growth properties and retain the anti-cancerous properties. Predicting the nature of chemico-physical properties of molecular entities remains one of science’s greatest challenges (See, P. Ball, Nature, 1996, 381, 684 and J Maddox, Nature, 1988, 335).

Analysis of claim 3: The claim will need to be amended since claims directed to methods of treatment of the human or animal body by surgery or therapy or of diagnosis practiced on the human or animal body are not patentable under the Patents Act. However, claims directed to a first medical use of a known (or novel) substance or composition are allowable under Section 25(9) of the Patents Act. Claims directed to a second or subsequent medical use of a known substance or composition are not allowable, unless framed in the “Swiss form.” Nonetheless, while “compound for use” claims for a second or subsequent medical use of a known compound are accepted in Europe pursuant to EPC 2000 and the recent changes to the EPO rules, such claims are not acceptable in South Africa.

Since the use of amazonic acid in the treatment of cancer is not previously known, claim 3 will need to be revised to a first medical use claim having the general structure “amazonic acid for use in the treatment of cancer.” While there is no case law in South Africa on whether or not a dosing regime is patentable, the courts are likely to follow the position of Great Britain Patent Office and/or EPO with respect to the patentability of such claims. In Great Britain, in the matter of Actavis v. Merck ([2008] EWCA Civ 444), the court stated at paragraph 29, “Research into new and better dosage regimes is clearly desirable, and there is simply no policy reason why, if a novel non-obvious regime is invented, there should not be an appropriate patent reward.” This is substantially in line with the Enlarged Board of Appeal decision in G02/08 EPO.

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:

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;

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;

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: Under the current Patents Act there is no case law concerning the subject matter eligibility of naturally occurring products. As such, subject matter eligibility will be determined from a novelty and inventiveness aspect taking into account exclusions of “method of treatment” claims. With respect to this claim, there is no indication of the extent of the prior art. As such, the claimed pair of primers are considered novel.

Analysis of claim 2: In this case, there is no indication of the extent of the prior art. As such the claimed method is considered novel.

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: The claim is not patentable pursuant to Section 25(11) of the Patents Act. While amending this claim to a first medical use claim is theoretically possible, this presents certain issues as will be discussed in more detail below. Moreover, amendment of this claim to a second medical use type claim is not readily possible.

Claim 1 can be rewritten as a first medical use claim to read as follows: “Sunshine for use in a method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, the sunshine being for exposure to the patient, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder.”

This rewritten claim will not be considered novel, since it is known that sunshine treats mood disorders. Moreover, this claim may be deemed as contra bones mores since it would afford the Applicant a monopoly over sunshine. As discussed previously herein, the Patents Act provides, at Section 25(4)(a) that a patent shall not be granted for an invention the publication or exploitation of which would be generally expected to encourage offensive or immoral behavior. Additionally, a “Swiss form” claim having the general structure, “Use of sunshine in the manufacture of a medicament to treat mood disorder” would not be possible since the manufactured medicament would need to comprise sunshine.

Analysis of claim 2: As with claim 1, this claim would have to be amended to a first medical use claim. Such a claim could read: “Synthetic white light for use in a method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, the synthetic white light being for exposure to the patient, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.”

Since “it is a well-documented natural principle that white light affects a person’s mood” the mere fact that the white light is synthetic does not distinguish itself from the prior art. Therefore, this claim cannot be seen as novel.

Analysis of claim 3: The claim will also need to be amended. An amendment to a first medical use claim could read: “Filtered white light for use in a method of treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, the filtered white light being for exposure to the patient at a distance between 30-60 cm from a source of the filtered white light 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.”

There is no indication that filtered white light for use in the treatment of mood disorders is known in the prior art. Thereupon, this claim is arguably novel, however, it could be attacked for a lack of clarity, which is a ground of revocation under Section 61(f)(i) of the Patents Act. Because there is no case law regarding dosing regimens in South Africa, it is not possible to ascertain with any degree of certainty whether or not this claim will be seen as novel.

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

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

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

(b) 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: Because claim 1 is a method of treatment claim, it will need to be amended into an acceptable format under South African law. There is no case law regarding dosing regimens, and in such cases we shall typically follow the decisions of the United Kingdom and EPO.

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

  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: Under South African law this claim will contravene Section 25(11) of the Patents Act and will need to be amended. The simplest amendment is to introduce the term “ex vivo” such that the claim is directed to “[a]n ex vivo method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome.” In principle, an “ex vivo” method claim will be patentable subject matter as long as the claim is novel and inventive over the prior art.

This post was written by Lisa Mueller of Michael Best and Dario Tanziani (Partner) and Charl Marais (Senior Associate) of Adams & Adams

The Thorny Problem of Patentable Eligible Subject Matter: Part 8 of a 10-Part Series: Australia – Update

This is an update to our post last week on “The Thorny Problem of Patentable Eligible Subject Matter: Australia.” Today, September 5, the Full Court of the Federal Court of Australia (Full Court) handed down its decision in Yvonne D’Arcy v Myriad Genetics Inc, unanimously holding that isolated DNA and RNA are patent eligible subject matter.

The case involved Australian Patent No 686004 (Patent) covering the BRCA1 gene. Claim 1 recites:

An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

The key issue for the Full Court was whether the claimed isolated nucleic acids, including isolated DNA and RNA, constituted a “manner of manufacture” under section 18(1)(a) of the Patents Act (1990) (Act) which provides:

… an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim.

(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b) when compared with the prior art base as it existed before the priority date of that claim:
(i) is novel; and
(ii) involves an inventive step; and
(c) is useful; and
(d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee’s or nominated person’s predecessor in title to the invention.

At first instance, Justice Nicholas found that the Patent valid holding that the claimed invention constituted a “manner of manufacture.” The Federal Court of Australia dismissed the application to revoke the patent. The Full Court agreed with Justice Nicholas finding that the Patent was valid and dismissed the appeal. The Full Court confirmed the test set out in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC) for determining whether or not an invention constitutes a manner of manufacture. Specifically, according to the test, an invention is a manner of manufacture if it resulted in an artificial state of affairs providing a new and useful effect that is of economic significance. In concluding its decision, the Full Court stated:

This case is not about the wisdom of the patent system. It is about the application of Australian patent law, as set out in the Act and as developed by the courts since the Statute of Monopolies.

It is not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability. That has been considered by the ALRC and by Parliament and has not occurred. It is not a matter for the court, but for Parliament to decide. Parliament has considered the question of the patentability of gene sequences and has chosen not to exclude them but to make amendments to the Act to address, in part, the balance between the benefits of the patent system and the incentive thereby created, and the restriction on, for example, subsequent research.

Interestingly, the Full Court had some strong criticism of the U.S. Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc. stating:

The U.S. Supreme Court rejected the claim over isolated nucleic acids for much the same reasons as those pressed by the applicant in this case. It is difficult to reconcile that Court’s endorsement of the reasoning in Chakrabarty, with its rejection of isolated nucleic acid as eligible for patentability. With respect, the Supreme Court’s emphasis on the similarity of ‘the location and order of the nucleotides’ existing within the nucleic acid in nature before Myriad found them is misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful.

The fact that, hypothetically, if the isolated DNA sequence were replaced into the cell it would express the same proteins is irrelevant. Following Chakrabarty and NRDC, the isolated nucleic acid has ‘markedly different characteristics from any found in nature;’ Myriad did not merely ‘separate that gene from its surrounding genetic material.’ It should make no difference that in  Chakrabarty there was an “addition” (of the plasmids) to the natural product (the bacterium); this is not the appropriate test. Myriad’s claim, properly considered is not, as the U.S. Supreme Court considered, concerned ‘primarily with the information contained in the genetic sequence [rather than] with the specific chemical composition of a particular molecule.

The reasoning of Lourie and Moore JJ of the Federal Circuit is persuasive. It accords with the High Court’s reasoning in NRDS and Microcell. The U.S. Supreme Court accepted that cDNA is patentable. It rejected the isolated nucleic acid of claim 1 because it accepted wrongly, with respect, that the isolated nucleic acid is a “product of nature.” In any event, that exclusion is not in accordance with the principles of patent law in Australia and has been specifically rejected as a reason for exclusion in NRDC.

Please watch the BRIC Wall for further updates on patent eligible subject matter. This post was written by Lisa Mueller.