The Race is on! Anxiously Waiting for the First U.S. Biosimilar to Cross the Finish Line

On July 24, 2014, Sandoz Inc. (Sandoz) became the first company to publicly announce acceptance by the U.S. Food and Drug Administration (FDA) of a biologics license application under the biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA). Specifically, Sandoz is seeking licensure for a version of the protein filgrastim. Filgrastim is a 175 amino acid recombinant methionyl human granulocyte colony-stimulating factor used to decrease the incidence of infection caused by febrile neutropenia in patients suffering from non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs. The reference product is Neupogen®, sold by Amgen.

Sandoz has significant experience with filgrastim. Sandoz currently markets a biosimilar version of filgrastim in over 40 countries under the name of Zarzio®. In fact, Zarzio® is the number one filgrastim biosimilar in the world.

Because Sandoz’ application has been accepted, Sandoz and Amgen are required to participate in a series of exchanges beginning as early as 20 days after receipt of FDA’s notification of acceptance to determine which patents, if any, to litigate. It will be interesting to see if any litigation ensues as several key patents covering Neupogen® have expired (namely, U.S. Patent Nos. 4,810,643, 4,999,291, 5,580,755 and 5,582,823).

If Sandoz receives approval for Zarzio®, it will not be the first filgrastim product (other than Neuopogen®) that has received approval by the FDA (although Zarzio® may be the first biosimilar approved under the BPCIA). In August 2012, Teva Pharmaceuticals Industries Ltd. received approval from the FDA of its full biologics application (a Section 351(a) application) for tbo-filgrastim.

Will Sandoz be the first company to receive approval for a biosimilar in the U.S.? Perhaps. However, it appears that Sandoz may have some competition. On March 31, 2014, Celltrion Healthcare Co., Ltd. and Celltrion, Inc. (collectively, Celltrion), filed a complaint for declaratory judgment against Janssen Biotech, Inc. (Janssen), alleging invalidity and unenforceability of three Jansen patents (U.S. Patent Nos. 5,919,452, 6,284,471 and 7,223,396) that are alleged to cover Janssen’s antibody drug infliximab (Remicade®). Remicade® is approved for treating rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

In the complaint, Celltrion states that it has developed a biosimilar version of Remicade®, called Remsima®, and it intends to apply for marketing approval of Remsima® in the first half of 2014. Specifically, on pages 2-3 of the complaint, Celltrion states, “[C]elltrion expects the U.S. Food & Drug Administration (FDA) to approve Remsima® by early 2015 (assuming the approval process is not hindered by interference from Janssen or its affiliates). Remsima® will become the first biosimilar of an antibody drug every approved in the United States.”

So, the race for approval by the FDA of the first biosimilar appears to have started. Who will reach the finish line first? Sandoz? Celltrion? Or, will it be another company that has quietly filed for approval? Hopefully, we will have some answers by early to middle 2015. Stay tuned!

Please continue to watch the BRIC Wall Blog for updates on biosimilars.

This post was written by Lisa Mueller.

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.

The Thorny Problem of Patentable Eligible Subject Matter: Part 4 of a 10-Part Series: Russia

This is Part 4 of a 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries. To view Part 1 (The Thorny Problem of Patentable Eligible Subject Matter: U.S.), click here. To view Part 2 (The Thorny Problem of Patentable Eligible Subject Matter: Canada), click here. To view Part 3 (The Thorny Problem of Patentable Eligible Subject Matter: India), click here.

Patentable Subject Matter in Russia

The national patent legislation in the Russian Federation became fully consistent with the provisions of TRIPS and other international treaties as of January 1, 2008, the effective date of the Civil Code of the Russian Federation (Civil Code). As a result, Russian’s patent law has been harmonized with other international patent laws, including, primarily, the European Patent Convention, particularly with regard to patent protection of pharmaceutical and biotechnological inventions.

According to article 1350(1) of the Civil Code, an invention is entitled to legal protection if it satisfies the requirements of patentability, namely, if the invention is “new, involves an inventive step and is industrially applicable.” Accordingly, patentable subject matter is defined broadly to include:

A technical solution in any area, relating to a product (for instance a device, substance, microorganism strain, cell culture of plants or animals) or method (process of affecting a material object using material means) (Article 1350(1) of the Civil Code).

It is important to note that some inventions (such as those claiming the treatment of humans and animals by surgery or therapy, as well as diagnostic methods employed on humans and animals) may be patentable in the Russian Federation, even though such inventions may not be patentable in other jurisdictions (such as in the European Patent Office). Nonetheless, not all inventions are patentable in the Russian Federation. Specifically, subject matter not considered to be patentable includes:

1. Discoveries, as well as scientific theories and mathematical methods, proposals concerning solely the outward appearance of manufactured articles and intended to satisfy aesthetic requirements, rules and methods of games, intellectual or business activities, computer software or ideas on presentation of information (Article 1350(5) of the Civil Code);

2. Plant and animal varieties, and biological methods for producing them, excluding microbiological methods and products produced by microbiological methods or topographies of integrated circuits (Article 1350(6) of the Civil Code); and

3. Methods for the cloning of humans, methods for modifying genetic integrity of human germ line cells, use of human embryos for industrial and commercial purposes, other solutions contradicting societal interests or principles of humanity and morality (Article 1350(4) of the Civil Code).

According to item 3) above, stem cells derived from human embryos and any products produced from such stem cells do not constitute patent eligible subject matter; however, stem cells derived from other tissues (such as, for example, from adipose tissue) 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 Russian 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: A p”lasmid” constitutes patent eligible subject matter in the Russian Federation even if the plasmid exists in nature. Under Russian practice, a plasmid as recited in claim 1 would not be accepted and this claim should be revised to further recite the structural elements of the plasmid (such as its encoding and regulatory sequences, the assemblage of such sequences, etc.).

However, if it is not possible to characterize the plasmid by its structural elements but only by its functional features (such as by reciting that the plasmid provides a hydrocarbon degradative pathway), an Applicant will need to deposit the plasmid in a recognized depositary and provide the deposit number in the specification and claims. 

Analysis of claim 2: A bacterium constitutes patent eligible subject matter in the Russian Federation even if it is isolated from the natural environment. Under Russian practice, the description of the bacterium recited in claim 2 would not be accepted and should be further revised to recite the structural elements of the plasmid (such as its encoding and regulatory sequences, the assemblage of such sequences, etc.) which can be replaced by reference to claim 1 (assuming claim 1 recites such structural elements).

As with claim 1, if it is not possible to characterize the bacterium by its structural elements but only by its functional features (such as providing a hydrocarbon degradative pathway), an Applicant will need to deposit the bacterium in a recognized depositary and provide the deposit number in the specification and claims.

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: Purified amazonic acid constitutes patent eligible subject matter in the Russian Federation even if it is derived from the natural environment. However, claims directed to amazonic acid must further recite the structure of amazonic acid (such as its chemical structure). If the chemical structure has not been established or is unknown, then the amazonic acid can be characterized by other specific features distinguishing the claimed substance from others known in the prior art (such as, for example, by features of a method for producing the substance). 

Analysis of claim 2: Any derivatives of amazonic acids also constitute patent eligible subject matter. As discussed above, this claim must recite the structure of any such derivatives (as discussed above in connection with claim 1).

Analysis of claim 3: A method of treatment constitutes patent eligible subject matter in the Russian Federation. A method of treatment using an isolated active agent also constitutes patent eligible subject matter.

E. 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: In principle, a pair of primers constitutes patent eligible subject matter in the Russian Federation (the primers are considered to be a kit). However, if the target DNA is known in the prior art, claims directed to a pair primers may be rejected as lacking inventive step because designing primers to a known nucleic acid sequence will likely be considered to be a routine technique for a skilled artisan.

Analysis of claim 2: This claim constitutes patent eligible subject matter in the Russian Federation. However, as discussed above in connection with claim 1, inventive step objections may be raised if the target DNA is known in the prior art.

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: Claim 1 constitutes patent eligible subject matter in the Russian Federation. However, this claim most likely will be rejected as lacking inventive step in view of well-documented principle that white light affects a person’s mood. 

Analysis of claim 2: Claim 2 constitutes patent eligible subject matter in the Russian Federation. However, this claim may have similar inventive step issues as claim 1.

Analysis of claim 3: Claim 3 constitutes patent eligible subject matter in the Russian Federation. The additional elements included in this claim compared to claims 1 and 2 increase the likelihood of this claim being recognized as involving inventive step. 

Additionally, it should be noted that only the method of treatment type claim format would be allowable for this type of invention in the Russian Federation. It is not possible to secure protection for this type of invention using Swiss-type or German-type claims. 

Diagnostic claims from Mayo

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: The type of claim directed to a method of optimizing therapeutic efficacy constitutes patent eligible subject matter in the Russian Federation.

Claim from U.S. Patent No. 6,573,103 

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: Diagnostic methods constitute patent eligible subject matter in the Russian Federation. However, this claim may be rejected as being too broad and indefinite because the screening markers are not defined in the claim. Additionally, an inventive step rejection may be raised if the screening markers and their use in diagnosing Down’s syndrome were known in the prior art.

This post was written by Lisa Mueller of Michael Best & Friedrich and Elena Kondakova and Vladislav Ugryumov of Gowlings (Russia).

 

 

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

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

Patentable Subject Matter in India

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Analysis of Examples under the U.S. PTO Guidance

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

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

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

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

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

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

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

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

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

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

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

Claim 1: Purified amazonic acid.

Claim 2: Purified 5-methyl amazonic acid.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Patent Troll Update: Brazil

As an update to our postings on Patent Trolls: A Global Perspective, Patent Troll Update: Japan and Patent Trolls: A View from Europe, we have learned of recent patent troll activity in Brazil.

As originally reported by NASDAQ®, on April 14, 2014, Vringo Infrastructure, Inc. (Vringo) filed a lawsuit against ZTE Corporation and ZTE Brazil (ZTE) in the 5th Business Court of Rio de Janeiro (Court) alleging patent infringement of Brazilian Patent No. PI0013975-0 (‘975 patent). The ‘975 patent issued on August 27, 2013 and covers an operation called “relocation,” an essential part of the handover performed by equipment referred to as a “network control” used in the 3rd and 4th generations of mobile phone (known as 3G and 4G networks). On April 15, 2014, the Court granted a preliminary injunction restraining ZTE from manufacturing, using, offering for sale, selling, installing, testing or importing the infrastructure of 3G and 4G networks without Vringo’s authorization under penalty of a daily fine of R$20,000 (US$9010). Furthermore, on April 17, 2014, Vringo posted a bond of R$2,000,000 (US$901,000) with the Court to enforce the injunction.

On May 9, 2014, ZTE filed an interlocutory appeal. On May 26, 2014, the Court denied ZTE’s request for a stay of the injunction pending the interlocutory appeal hearing. On June 11, 2014, the 4th Civil Panel of Rio de Janeiro State Justice Court unanimously denied the appeal. As a result of this denial, the injunction will likely remain in place until a decision of the merits has been reached. Presently, a trial date has not yet been scheduled and a final decision could take anywhere from two to four years.

This is not ZTE’s first encounter in court with Vringo. In fact, in addition to Brazil, Vringo has sued ZTE for patent infringement in at least Great Britain, Germany, France, Australia, Spain, India and the Netherlands.

Please continue to watch the BRIC Wall for further updates on global patent troll activity. 

This post was written by Lisa Mueller of Michael, Best & Friedrich.