New guidelines in Brazil give more power to ANVISA in the examination of pharmaceutical patent applications

On March 13, 2017, the board of directors of Agencia Nacional De Vigilancia Sanitari’s (ANVISA) announced that they had reached a new agreement with the Brazilian Patent Office, namely, the Instituto Nacional da Propriedade Industrial (INPI), concerning the prior approval provision under Article 229-C of the Brazilian Patent Statute (For more information about the 229-C article, please see our posts here, here, and here).  On April 12, 2017, after an event with several authorities and President Michel Temer, ANVISA and INPI published a written version of the new joint guidelines #1/2017 (translation enclosed here:  INTERAGENCY ORDINANCE). These guidelines describe the new workflow between ANVISA and INPI involving the examination of pharmaceutical patent applications.

Article 4 of the guidelines establishes that ANVISA will analyze whether a patent application is contrary to public health.  According to Article 4, a patent application claiming a product or process is considered to be contrary to public health when the product or process presents a “health risk”.  The article further states that the “health risk” will be characterized when the pharmaceutical product comprises, or the pharmaceutical process results in a substance that has been prohibited in the country”.    

If a product or process is found to pose a “health risk” (as defined in the Annex I of the Ministry of Health’s Ordinance #344 of 1998), ANVISA will deny prior approval and will send the application back to INPI for further handling. At this point, INPI will publish the definitive dismissal of the application. In other words, the application is denied.

The guidelines contain a new approach in the examination of patent applications claiming pharmaceutical products and processes of interest under the Brazilian government’s drug policies and pharmaceutical assistance of the National Healthcare System (SUS). Under Article 5, ANVISA will examine these applications of interest and prepare a “technical” opinion as to whether the claims meet the patentability requirements under Brazilian law.  This opinion will be sent to INPI for use as a third-party observation under Article 31 of the Patent Statute of 1996.  Once INPI receives ANVISA’s opinion, it is “free” to decide whether or not to agree with it.  In the event INPI disagrees with ANVISA’s opinion and grants the patent application, it will send ANVISA a list containing all granted patents and will continue to make this list available to ANVISA (Article 7 of the guidelines).  

The guidelines do not contain any information as to what ANVISA can or should do with the list of granted patents received from INPI.  Actions that ANVISA could take include filing a post-grant opposition or seeking invalidity of the patent before Federal Courts. 

Article 9 of the guidelines creates an Interagency Group between the two agencies. The purpose of this group is to seek to “harmonize” the understanding between the ANVISA and INPI regarding the application of patent law in “polemic” topics such as Markush claiming, selection inventions, the patentability of new uses, salts, polymorphs and antibodies, as well as other issues relevant to the pharmaceutical industry.  One concern is that such “harmonization” could result in an unlawful administrative ban of claims that are currently being allowed INPI. As such, Article 9 gives ANVISA power to influence the INPI in a multitude of ways. 

Additionally, it is important to note that the new guidelines come after several decisions were obtained against ANVISA by various pharmaceutical companies (See our post here) holding that that the agency lacked the statutory authorization to examine patentability requirements under Brazilian law.  After these early decisions were rendered (which held that ANVISA’s prior approval review was restricted solely to the analysis of potential public health issues and not patentability requirements), ANVISA amended its guidelines to include a provision stating that “the granting of patents that do not fulfil the patentability requirements violates public health”. This change was interpreted by the courts as an attempt by the agency to escape the unfavorable case law and avoid the new guidelines.  

As a whole, the guidelines read like an attempt by ANVISA to revive its ability to participate in the examination of pharmaceutical patent applications.  Interestingly, many the associations representing generic companies in Brazil such as ABIFINA and Pro Generics are celebrating the guidelines as a victory for the local industry. 

Continue to watch the BRIC Wall Blog for continuing updates on these new guidelines in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho from 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.