An Overview of the USTR’s 2016 Special 301 Report on the State of IPR in Russia

On April 12, 2016, the Office of the United States Trade Representative (USTR) released its 2016 Special 301 Report (Report) reviewing the state of intellectual property rights (IPR) protection and enforcement in U.S. trading partners around the world. Following extensive research and analysis, the Report placed eleven (11) countries on the priority watch list and twenty-three (23) on the watch list   Russia remains on the Priority Watch List in 2016 as a result of continued and significant chal­lenges to IPR protection and enforcement. The Report indicates that IPR is not a priority for government officials in Russia, and that IPR enforcement continued to decline overall in 2015. In particular, the Report expresses concerns regarding copyright infringement, trademark counterfeiting, and non-transparent collecting society procedures.

Copyright infringement remains a persistent problem in Russia. Specifically, online privacy appears to be a pervasive issue. Although Russia’s antipiracy legislation continues to evolve, Russia remains home to many sites that facilitate online piracy and damage the market for legitimate content in Russia and other countries. The Report indicates that the overall number of raids, criminal charges, and convictions have declined in recent years. The Report further suggests that issuing injunctions against infringing websites does not address the root of the problem, and urges Russia to continue efforts to improve legislative and enforcement efforts that will result in fair, effective, and transparent copyright enforcement. Specifically, the Report suggests that Russia should be investigating and prosecuting the operators of such sites in order to increase efficacy of antipiracy legislation.

In addition to copyright infringement, Russia continues to struggle with a lack of trademark enforcement. This results in an abundance of counterfeit goods, such as seeds, agricultural chemicals, elec­tronics, information technology, auto parts, consumer goods, machinery, and other products, that are manufactured, transshipped, and sold in Russia. According to the Report, the Russian Ministry of Agriculture estimated in 2015 that 10 to 20 percent of hybrid sunflower, rapeseed, and soybean seed used in Russia was counterfeit.   In addition, smuggling of Chinese-origin counterfeit products through Kazakhstan and the Kyrgyz Republic into Russia remains an issue. Although Russia has developed an officially-approved methodology for test­ing pharmaceutical products, counterfeit pharmaceuticals also continue to be manufac­tured in Russia and made available through online pharmacies.

The Report also expresses concern with Russia’s implementation of the commitments it made in the WTO Working Party Report related to the protection against unauthorized disclo­sure of, or reliance on, undisclosed test or other data generated to obtain marketing approval for pharmaceutical products. The report suggests that although Russia has amended its Law on Circulation of Medicines, it has not issued the final regulations and detailed provisions that are necessary to ensure effective implementation of the law.

In conclusion, the Report urges Russia to develop a more comprehensive, transparent and effective legal framework and enforcement strategy to improve the state of IPR in the country. Specifically, Russia should aim to reduce IPR infringement, particularly the sale of counterfeit goods, and the piracy of copyright-protected content. The United States will continue to monitor Russia’s progress on these and other matters through appropriate channels.

In the next post, the BRIC Wall Blog will examine in detail the Report’s findings on the state of IPR in China.

This post was written by Lisa Mueller and Rikki Hullinger of Michael Best.

Foreign Filing Restrictions and Licenses in Russia – Part 4

This is part 4 in our series examining foreign filing restrictions and licenses in the U.S. and in a number of countries throughout the world. To view part 1, foreign filing restrictions and licenses in the U.S., click here.  To view part 2, foreign filing restrictions and licenses in China, click here. To view part 3, foreign filing restrictions and licenses in India, click here.

Foreign Filing Licenses in Russia

According to Article 1395 of the Civil Code of the Russian Federation, if an invention is created in Russia, then an application directed to the invention must be filed in Russia, regardless of the nationality of the inventors involved. This includes inventions made by foreign citizens and jointly by Russian and foreign inventors resulting from any type of collaboration. Also included are inventions made by employees for their employer (regardless of whether or not the employer is Russian). 

There are three ways to file a patent application in Russia:

  1. File a Russian patent application with the Russian Patent Office;
  2. File a regional Eurasian patent application, designating Russia, with the Eurasian Patent Office (this method generally is about twice as expensive as filing directly in Russia with the Russian Patent Office); or
  3. Designate/elect the Russian Federation in a Patent Cooperation Treaty (PCT) application and enter the national phase before the Russian Patent Office.

The requirement for first filing in the Russian Federation exists so that the Russian government can carry out an examination on the patent application to determine if the application contains a state secret. This examination must be carried out before a foreign (non-Russian) patent application is filed.

It is important to note that if the Applicant (such as an entity or individual filing a patent application) is a foreign citizen or a foreign legal entity, then the subject matter of the patent application filed in Russia cannot be classified as state secret.

A patent application can be filed abroad in the case of:

  1. Six months have passed since first filing the patent application in Russia; or
  2. After a foreign filing license is obtained

After a patent application has been filed with the Russian Patent Office, the patent application undergoes examination for six months at no cost to the Applicant. If the Applicant has not been notified by the Russian Patent Office within six months of filing the patent application, then the Applicant is free to file abroad without further approval.

If the Applicant wishes to accelerate this proceeding and file the patent application abroad earlier, then the Applicant can file a request for examination concerning the presence of a state secret. In this case, a foreign filing license can be expected to be granted within three to four months from filing the request for examination.

If an application is filed in violation of the first filing requirement and the application comprised state secret information, this will result in criminal penalties for the Applicant. If a patent application is filed abroad before than six months have passed since first filing in Russia or if a foreign filing license was not obtained—Applicant will be required to pay a monetary fine.

This post was written by Lisa Mueller and Himani Nadgauda of Michael Best and Vladislav Ugryumov of Gowlings.

 

Current State of Data Protection and Exclusivity in Russia

The BRIC Wall Blog is pleased to present the following guest post by Ivan Burkov, Ph.D.

It has been 3.5 years since Russia joined the World Trade Organization (WTO) and implemented the right of data exclusivity for innovative pharmaceutical products. In this short period of time, the definition of data exclusivity has changed and precedent setting litigation has ensued. In this post, I attempt to delineate the most important events to date regarding data exclusivity in Russia and evaluate its protective potential.

Background

Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) specifies that the members of the WTO shall take the necessary steps to ensure the protection of undisclosed proprietary data submitted to obtain the registration of a pharmaceutical product, the origination of which involved considerable effort.

Upon accession to the WTO, Russia documented its agreement to ensure the protection of undisclosed information and test data in paragraph 2 of the Protocol of Accession of the Russian Federation to the WTO. The right of data exclusivity became effective on August 22, 2012, the official date of Russian Federation accession to the WTO. The concept was later introduced into the article 18 of Federal law № 61-FZ “On the Turnover of Medicines”, a central law for pharmaceutical industry in Russia. According to this new law, data exclusivity was defined as follows:

Receipt, disclosure and use for commercial purposes and for the purposes of medicine state registration of the information of the results of preclinical and clinical studies provided by an applicant for the registration of the medicine is not permitted without the applicant’s consent during 6 years from the date of the medicine state registration.

Concept evolution 

The original definition of data exclusivity did not specify the type of protected medicine (whether the medicine had to be an original/first-ever registered medicine or something else) or how the term was to be split between registration (data) exclusivity and market exclusivity. Since implementation of data exclusivity in 2012, the concept has been actively discussed by the industry players, law firms and other interested parties, and most stakeholders agree that data exclusivity protection alters Russian market attractiveness in the eyes of innovative medicines producers. However, no specific court cases had been instituted and it was not known whether any company had successfully used the right of data exclusivity to protect its product(s) from generic competition (as information regarding extrajudicial dispute resolution procedures was not publically available).

On December 22, 2014, the Russian president signed Federal law № 429-FZ, which introduced certain amendments to the Federal law № 61-FZ “On Circulation of Medicines”. One of the amendments (the effective date of which is January 1, 2016) affects data exclusivity. As a result, beginning January 1, 2016, data exclusivity will be defined as follows:

It is not permitted to use for the commercial purposes the results of pre-clinical trials of medicinal products and clinical trials of medicines, provided by the applicant for state registration of the medicine without his consent for the period of six years from the date of state registration of the reference medicine in the Russian Federation.

Compared to the original definition, the new definition limits the opportunities in which pre-clinical and clinical trial data are eligible for protection. Specifically, their use is prohibited for commercial purposes only. Additionally, data exclusivity is now granted to reference medicines, where a reference medicine is defined as:

 …a medicine which previously has never been registered in Russia, whose quality, efficacy and safety have been confirmed by the results of pre-clinical and clinical trials and which is used for the assessment of bioequivalence or therapeutic equivalence, quality, efficacy and safety of a generic (biosimilar) medicine.

The amendments also specify a division of the six year term between registration* (what is often referred to as “data” exclusivity in other jurisdictions) and market exclusivity: four (registration exclusivity) plus two (market exclusivity) years for generic drugs and three (registration exclusivity) plus three (market exclusivity) years for biosimilars.

* Registration exclusivity is determined from the date of registration of a reference medicine and prohibits a generic/biosimilar applicant from using the protected data of the originator for the purpose of seeking a state registration.

Russian company fights off Novartis in data exclusivity dispute

Early in 2015, Russia saw its very first court case involving data exclusivity. Specifically, Novartis Pharma AG (Novartis) claimed that local company Biointegrator LLC (Biointegrator) violated the prohibition against using Novartis’ preclinical and clinical data during state registration of its product “Nescler”, a generic version of Novartis’ fingolimod (sold under the brand name Gilenya®). Gilenya® is approved for the treatment of relapsing-remitting forms of multiple sclerosis in adults. In the suit, Novartis asked the court to cancel Biointegrator’s state registration.

Instead of focusing on the data exclusivity issue itself, the semantic vector of the case shifted towards determining the actual timing of the submission of the generic dossier. Biointegrator argued that cancellation of the registration was not appropriate because the application for state registration of “Nescler” had been submitted by another company (on April 2, 2012) prior to the date of implementation of data exclusivity provisions (August 22, 2012). Subsequent to these events, ownership rights were transferred from the other company to Biointegrator pursuant to a commercial agreement. In view of these facts, the court of first instance agreed with Biointegrator and rejected Novartis’ request for cancellation.

Undeterred, Novartis appealed. The appeal court held that an application for registration of a generic product submitted by another company did not exempt Biointegrator from liability since the generic company’s abbreviated clinical development (bioequivalence studies) relied on Novartis’ protected data and was initiated after the implementation of the data exclusivity provisions. As a result, the court agreed with Novartis’ arguments and canceled the marketing authorization of the generic product.

Unhappy with the appeal court’s decision, Biointegrator appealed to the court on intellectual rights (Intellectual Rights Court), which ruled for Biointegrator and restored the decision of the first instance court, allowing the generic product to return to the market. The arguments of the Intellectual Rights Court in holding for Biointegrator were as follows.

First, both parties agreed that Biointegrator was liable to follow the corresponding provisions of the Federal law, since the state registration application for “Nescler” was submitted after the date when the provisions for data exclusivity concept became effective. Nonetheless, the panel of judges did not agree with the appeal court that Biointegrator had used Novartis’ protected data, holding that the decision was made in violation of substantive norms. Specifically, the Intellectual Rights Court held that the appeal court incorrectly concluded that the right of data exclusivity covered any information relating to the preclinical and clinical trials of the original medicine. More specifically, according to the Intellectual Rights Court, the Federal law “On Circulation of Medicines” provides for a fast-track registration procedure for generic medicines. It requires that information on the clinical trials of an original medicine be published in specialized sources (namely, scientific journals, etc.) and that documented results of a generic’s bioequivalence/therapeutic equivalence studies be provided. Moreover, the court stated that the “…systematic interpretation of the provisions on data exclusivity suggests that the specified prohibition does not apply to publically available information, including scientific publications, and legislator recognizes the use of such information legitimate”.

The Intellectual Rights Court determined that the effectiveness of the generic product in the treatment of multiple sclerosis was based on information contained in previously published articles describing the results of clinical trials involving Gilenya® (specifically, the articles entitled “A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis” and “Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis”). At the same time, the definition of data exclusivity under the Federal law “On Circulation of Medicines” prohibited the use of the “results of pre-clinical trials of medicinal products and clinical trials of medicines, provided by the applicant for state registration of the medicine. Unfortunately, Novartis was unable to prove that Biointegrator used undisclosed data from Gilenya®’s registration dossier, which led to the unfavorable decision by the Intellectual Rights Court.

Impact on the industry 

Data exclusivity and intellectual property protection in general are essential for the pharmaceutical industry, where extremely large sums of money are invested in developing highly risky health care solutions. At the same time, maintaining the transparency of clinical trial data is of great significance and is expected by patients, healthcare providers, companies and health authorities around the world. For example, the European Medicines Agency (EMA) bases its scientific opinions on the results of clinical trials carried out and submitted by pharmaceutical companies. Since January 1, 2015, the EMA has been proactive publishing clinical reports submitted as part of marketing-authorization applications for human medicines.

The Novartis case demonstrates that Russian authorities treat the right of data exclusivity only in connection with undisclosed, non-public information of the results of preclinical and clinical trials of an original medicine. Thus far, a very limited number of original medicines have undergone their first-ever clinical development in Russia. Rather, in most of the cases, information on the clinical trials for a medicine is already publically available from a number of sources at the time the originator seeks local registration in Russia. Therefore, the Novartis case may open the way for generic companies to bypass the legal right of originators to protect its data.

Although the Novartis case has its own unique set of facts and stare decisis is not officially practiced in Russia, innovative companies should take note of this case and its implications as an additional risk for their original products in the Russian market. At the end of the day and in the long term, the lack of intellectual property protection in Russia may affect generic producers themselves, as the attractiveness of a market which does not guarantee sufficient protection for innovators will decrease.

This post was edited by Lisa Mueller.

This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances. The opinions expressed herein are those of the author. Comments or questions on this article can be addressed to the author (vanyaburkov@gmail.com) or Lisa Mueller (llmueller@michaelbest.com).

A New Beginning? The Brazilian Patent and Trademark Office has a New President.

Mr. Luiz Otávio Pimentel has been appointed as the new president of INPI (the Brazilian Patent and Trademark Office – BRPTO). The official notice for the nomination was published yesterday, July 28, 2015, in the Federal Register. On April 10, 2015, President Dilma published an official notice dismissing the former president, Otávio Brandelli, who had been in charge of the office for less than one and a half years. Since then, vice-president, Ademir Tardelli, acted as interim head of the BRPTO. There is strong speculation on the reasons for Mr. Brandellis’ departure. Mr. Brandelli had a strong background in Intellectual Property and, while in office, took a series of measures to expedite prosecution and to reduce the BRPTO’s backlog.

What do we know about Mr. Pimentel? He is a professor with expertise on International Law and Intellectual Property. He holds a Masters in Law from the Federal University of Santa Catarina (UFSC) and a Ph.D. in Legal Sciences from the National University of Asunción – Paraguay. He is also an arbitrator at the Ad Hoc Arbitration Court of Mercosur.

Mr. Pimentel faces numerous challenges in his new position as the BRPTO requires strong leadership by an intellectual property expert with the ability to take drastic measures to restore a high-quality management at the office. In addition to having the fortitude needed to fight the battle against the huge backlog, Mr. Pimentel will need to lead the BRPTO with transparency, allowing applicants to have advance knowledge of which guidelines and rules the examiners will adopt during prosecution.

Other important goals that need to be achieved are the acceleration of the examination process and signature of the main international agreements to simplify prosecution, such as the Patent Prosecution Highway.

The next few months will be crucial for the BRPTO’s future and for the development of Intellectual Property in Brazil.

This post was written by Lisa Mueller and Licks Attorneys law firm.

Third Party Submissions in Russia – Part 2 of an 8 Part Series

This is Part 2 of an 8-part series examining post-grant review proceedings, oppositions, and third party observations in the U.S., BRIC and several non-BRIC countries. To see Part 1, Post-Grant Oppositions in Japan, click here.

Third Party Submissions in Russia

One of the most fundamental amendments to Russia’s Civil Code (Code) part IV “Rights to the Results of Intellectual Activities and Means of Individualization” relates to Article 1386.5 concerning third party observations of the patentability of an invention. This amendment, signed into law on March 12th, 2014 by Russian President Vladimir Putin, provides formal acceptance of observations to be submitted to the Russian Patent Office effective October 1st, 2014.

Under Article 1386.5, after publication of a patent application in Russia, any third party (who may use a straw man) may submit to the Russian Patent Office arguments regarding the compliance of the claimed invention with respect to the patentability requirements provided in Article 1350 of the Code.  The patentability requirements provided in this article are novelty, inventive step and that the invention be industrial exploitable.  There is no limit on the number of type or kinds of references that can be submitted (only that the references must be prior art). Such third party observations can be submitted up until the day the application is allowed by the Examiner. Finally, there is no official government fee for filing such observations.

Although third party observations were not previously prohibited and thus submissions were made to the Russian Patent Office, the enactment of this amendment means observations will at the least be considered during the examination of the challenged application.  Similar to other countries, a third party has neither the right to participate in the examination of the invention for patentability nor the right to communicate with the Examiner.

The primary obstacle that remains for Russia’s allowance of third party observations is the lack of public access to prosecution files, which renders it difficult to ascertain which challenged claims are on file.  The submission of such observations has played a significant role in opposition trials worldwide and it is yet to be seen what effect the legal acceptance of third party observations will have in Russia.

This post was written by Lisa Mueller and Kate Merath of Michael Best and Vladislav Ugryumov of Gowlings (Moscow).

Is compulsory licensing of generic medicines coming to the Russian Federation?

As discussed in previous posts, at least twelve countries have issued compulsory licenses for a variety of pharmaceutical pharmaceuticals (See, Part 1 and Part 2 of our series on compulsory licensing in India).  On December 19, 2014, S. Kalashnikov, the Chairman of the Committee of the State Duma for Health Protection, sent to D. Medvedev, the Prime Minister of the Russian Federation, a letter regarding compulsory licensing.  Given the current geopolitical and economic situation, the State Duma Committee for Health Protection is considering implementing compulsory licensing for certain high-tech and biotech medicinal products for the treatment of orphan diseases and disease having the greatest impact on mortality in the Russian Federation.  A translation of the letter is provided below.

To: PrimeMinister of the Russian Federation

D.A. MEDVEDEV

Dear Dmitry Anatolyevich!

Currently, some countries began to actively use the mechanism of compulsory licenses for the production of generic medicines before the expiration of patent protection for the original medicinal product (India, Brazil, Indonesia, Thailand, etc.). The governments of the aforementioned countries are supported by the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Doha declaration on the public health. According to these documents, compulsory licensing mechanism is applied in the case of severe social requirements and is used for the production of medicinal products to treat common serious diseases in the country such as AIDS, hepatitis, cancer, and also in the event of an epidemy.

In the current geopolitical and economic situation, the State Duma Committee for Health Protection deems it necessary to consider the implementation of compulsory licensing mechanism for the production of some high-technological and biotechnological medicinal products for the treatment of orphan (rare) diseases and diseases that have the greatest impact on mortality in the Russian Federation.

Sincerely  yours,

Chairman of the Committee

S.V. Kalashnikov

Please watch the BRIC Wall Blog for updates on compulsory licensing in the Russian Federation.

This post was written by Lisa Mueller.

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).