A Review of Compulsory Licenses in Colombia

During the last two years, there has been a lot of interest and discussion about compulsory licenses in Colombia, particularly with respect a patent covering the beta polymorph of imatinib mesylate (imatinib), which is marketed by Novartis as Gleevec® or Glivec.  In this post, the BRIC Wall Blog looks at compulsory licenses in Colombia and the Glivec case in detail.

Compulsory licenses in Colombia – Background

In Colombia, a compulsory license may be granted:

  1. Three years following grant of a patent or four years following filing of a patent application, whichever is longer, if the patent has not been worked in Colombia or if working of the patent has been suspended for over one year, unless the patent owner is able to provide a valid reason(s) for its failure not to work the invention (such as, for example, force majeure, an act of God, etc.). Additionally, a compulsory license will only be granted if the third party applying for the license has made an effort to obtain a license from the patent owner on commercially reasonable terms and such efforts were not successful (Articles 61-64 of  Decision No. 486 of the Andean Community Commission Establishing the Common Industrial Property Regime (Decision)).
  2. Upon declaration of the existence of a public interest, an emergency, or other national security considerations. When a compulsory license is granted for one of these reasons, the patent is subject to the compulsory license only for so long as the considerations exist.  The Colombian Patent Office (CPO) will establish the scope of the license, specify its duration and the compensation to be paid to the owner (Article 65 of the Decision).  In Colombia, the declaration is made by the Ministry in charge of the subject matter of the patent; e.g. by the Ministry of Health (MoH) for pharmaceutical patents.  Once the declaration is made, the case is handed over to the CPO (part of the Superintendence of Industry and Commerce) to determine the terms of the compulsory license and to process the specific compulsory license request under those terms.
  3. By the CPO ex officio or at the request of a third party and after receiving the consent of the national antitrust authority, in situations where the practices of the patent owner are deemed to be detrimental to the exercise of free competition, particularly where they constitute an abuse by the patent owner of a dominant position in the market (Article 66 of the Decision).
  4. Upon request of a patent owner in situation where exploitation of its patent (the “first patent”) requires a license to another patent (the “second patent”) and the patent owner has been unable to obtain a license to the second patent on commercially reasonable terms (Article 67 of the Decision). Compulsory licenses granted under these circumstances are subject to the following conditions:
    • The invention claimed in the second patent must constitute an important technical advance of considerable economic significance in relation to the invention in the first patent;
    • The owner of the first patent is entitled to a cross-license on reasonable terms to use the invention claimed in the second patent; and 
    • The license authorized in connection with the first patent is non-assignable except when the second patent is assigned.

All compulsory licenses granted in Colombia are subject to the following general conditions:

  1. Before the grant of a compulsory license, the patent owner is notified and provided with a deadline of 60 days to submit arguments;
  2. Are non-exclusive and cannot be sublicensed;
  3. The licensee must work the object of the license within two years after grant, unless reasons of force majeure are proven;
  4. Compulsory licenses do not exclude the patent owner from working the patent;
  5. Are non-assignable, except in connection with the part of the business or goodwill which permits its industrial use. Any such assignments must be in writing and registered before the CPO,  otherwise such transfers shall not be considered legally binding;
  6. Are terminable if and when the circumstances which led to the granting of the compulsory license cease to exist and are unlikely to recur;
  7. The scope and duration of any compulsory license shall be limited to the purposes for which they were authorized;
  8. For patents protecting the semi-conductor technology, a compulsory license shall be authorized only for public non-commercial use or to remedy a practice declared by the competent national authority to be anti-competitive pursuant to Articles 65 and 66;
  9. Must provide for the payment of adequate remuneration pursuant to the circumstances of each case, taking into account the economic value of the license (without prejudice to the stipulations provided for in Article 66); and
  10. Must be used predominantly for the supply of the Colombian market.

Compulsory Licenses Granted on Public Interest Grounds

In Colombia, there have been two compulsory licensee cases on public interest grounds.  In both cases, the compulsory licenses were initiated by the same non-governmental organizations, namely, IFARMA Foundation, Mision Salud and CIMUN (collectively, NGOs).  In both cases, the compulsory licenses were rejected.  However, in both cases, price cuts were implemented or being sought.

The first compulsory license case began in 2008 and involved Kaletra®, marketed by Abbott Laboratories.  Kaletra® is an anti-retroviral medicine containing ritonavir and lopinavir and is used in the treatment of HIV/AIDS.  Although the MoH rejected the declaration of public interest and therefore, the compulsory license, the Colombia government cut the price of Kaletra® by 55%.

The most recent case involved Novartis’ Glivec product.  In November 2014, the NGOs began encouraging the MoH to declare access to Glivec to be of public interest with the goal of securing a compulsory license. Glivec costs about twice the average Colombian income of $15,000 per year.

Not surprisingly, the attempt by the Colombian organizations to secure a compulsory license were met with resistance and response from a variety of players including developed countries, Big Pharma and Colombian trade authorities.  As a result, the NGOs sent a letter in May 2016, to the Chairman of the World Health Organization 2016 Consultative Expert Working Group on Research and Development:  Financing and Coordination (CEWG) alleging that the enormous pressure was being applied by those opposing the compulsory license that combined “inaccuracies, distortions of international trade rules and even threats of trade claims under the dispute settlement mechanism”.  Adding more fuel to the fire, also in May 2016, a letter was sent by 28 organizations to President Obama that expressed concern access to medicine and U.S. aid to support peace in Colombia.  Moreover, still also in May 2016, a letter was sent to Columbia President Manuel Santos by lawyers, academics and other experts specializing in intellectual property and health encouraging his administration, the MoH and the Superintendence of Industry and Commerce to proceed with the public interest declaration and grant the compulsory license for imatinib.

On June 14, 2015, Alejandro Gaviria, Health Minister of the MoH, issued Resolution No. 2475 declaring the existence of public interest for imatinib.  However, this resolution did not order the issuance of a compulsory license for Glivec but instead requested that the National Price Pharmaceutical Commission (NPCC) provide a new price methodology for Glivec (which had already been included in the Price Regulation Regime; and, additionally, the price of Glivec, had already been regulated twice in the past). The new methodology, proposed in a NPPC draft circular (directive), stated that the maximum price for a drug subject to a declaration of public interest would be equal to the lowest price of any competitor in any referenced country. A “referenced country” comprises 17 countries. This circular (directive) is still in a preliminary stage.

Please continue to watch the BRIC Wall Blog for more updates on compulsory licenses in Colombia.

This post was written by Lisa Mueller and Alexander Agudelo of Olarte Moure.



Ukraine’s Competition Authority Issues a Major Decision on Drug Pricing Practices

In September 2016, the Antimonopoly Committee of Ukraine (the “AMC”) issued a significant decision holding Alcon Pharmaceuticals LTD (Alcon), a Swiss subsidiary of Alcon, Inc. (Novartis group), and four of its Ukrainian distributors liable for uncompetitive conduct as a result of overcharging for drugs in Ukrainian public tenders.  This decision is important because it sheds light on the AMC’s approach in enforcing Ukraine’s competition policy as it relates to discount and pricing practices in the Ukrainian pharmaceutical market.

Details of the Decision

The main focus of AMC’s scrutiny in this case were the discounts provided by Alcon at the time of drug supply (namely, at the time of importation) into Ukraine and the effect these discounts had on drug pricing for both the Ukrainian pharmacy market as well as the tender segment.  The AMC held that the retroactive discounts granted by Alcon to its distributors via the use of credit notes lacked transparency and also served as a tool to manipulate drug prices for Ukrainian consumers. Specifically, the AMC stated that such discounts effectively decreased the price at which distributors purchased drugs from Alcon.  Moreover, at the same time, the distributors chose not to apply for a reduction in the prices offered for Ukrainian tenders. As a result, the prices for drugs supplied to public sector customers were higher than those available at pharmacies.

Most significantly, the AMC concluded that this discounted structure resulted in the circumventing of the pricing restrictions established by Ukrainian law for supplies of drugs for public procurements, even though these actions did not per se violate the law.  In the AMC’s view, Alcon should have realized that when it officially declared its nominal (namely, before discount) prices in the official Ukrainian drug price register, that distributors might excessively charge Ukrainian public sector customers based on such nominal prices, instead of the real prices after all discounts.  Moreover, considering that distributors regularly report the volume of their sales, price levels, customers, etc. to Alcon, the AMC held that the company was aware of, and contributed to, the resulting price manipulations.  As a result, the AMC found that the actions of Alcon and its distributors constituted concerted anticompetitive practices that resulted in excessive pricing of medicinal products for Ukrainian public tenders.

What does this mean for pharmaceutical companies doing business in Ukraine?

This decision is believed to be indicative of the approach that the AMC is likely to apply in similar investigations. Accordingly, pharmaceutical companies may wish to consider re-visiting their pricing and discount strategies for Ukraine to ensure that potential competition risks are duly addressed.  Specifically, pharmaceutical companies should consider the following risk factors:

  • Credit notes: Retroactive discounts via credit notes may be viewed as lacking transparency and enabling price manipulations;
  • Level of discounts: Risk may increase proportionally to level of the discount provided;
  • Application of discounts: Discounts granted at the producer-distributor level are expected by the AMC to be adequately applied at distributor-customer level;
  • Pricing regulation: Medicinal products subject to pricing regulations in Ukraine, including those supplied for public procurements, require increased attention;
  • Difference in pricing approaches for retail and tender business: If prices differ substantially, this may be an additional risk factor; and/or
  • Level of detail in distributor reports: Excessive reporting by distributors to pharmaceutical companies may contribute to the qualification of their conduct as anticompetitive concerted practices.

Continue to watch the BRIC Wall Blog for further updates on decisions by the AMC regarding drug pricing policies in Ukraine.

This post was written by Lisa Mueller and Viktoriya Podvorchanska and Oksana Franko of Egorov, Puginsky, Afanasiev & Partners Ukraine.



Accelerated Examination of Patent Applications in Argentina

On September 19, 2016, the Argentine Patent and Trademark Office (ARPTO) issued a resolution that will allow patent applicants the option to request accelerated examination of  a patent application. This resolution will become effective on October 15, 2016.

The resolution applies to any patent applications for which examination has not yet started as of October 15, 2016.  For those applications that qualify, the ARPTO is authorized to consider that the essential requirements of patentability have been satisfied in those circumstances where a patent has been granted outside of Argentina for the same invention (regardless of whether or not priority has been claimed).  In addition, the following requirements must also be met:

  1. The foreign Patent Office which granted the corresponding patent being relied upon must (a) conduct substantive examination; and (b) have the same requirements for patentability as those of ARPTO.
  2. The scope of the patent claims filed in Argentina must be less than or equal to that of the corresponding foreign patent being relied upon;
  3. The subject matter being claimed must not constitute patent ineligible subject matter under Argentine patent law; and
  4. Any objections raised by third parties to the patent application must be considered.

At any time before the start of substantive examination, an applicant meeting the above requirements can file a voluntary request for accelerated examination.  The Argentine Patent and Trademark Office will issue a decision within sixty (60) days of the filing of the request.  In some circumstances, the ARPTO may require an applicant to amend the scope of its claims to be commensurate with those granted by a foreign patent office.  If the ARPTO makes such a request, it will allow the applicant ninety (90) days from the day of notification to make the appropriate amendments.  A request for accelerated examination may be denied by ARPTO for various reasons, including reasons of national defense, internal security,health emergency or for other public interest reasons.

This post was written by Lisa Mueller and Eugenio Hoss of Marval, O’Farrell & Mairal.

Amendments to Indonesian Patent Law Come into Effect

Several fairly significant amendments to Indonesian Patent Law came into effect on August 28, 2016. Some of the key changes include:

  1. Claims directed to second use or second medical use are no longer permitted. This change to Indonesia’s law aligns the country with other countries such as India and Vietnam which also prohibit such claims.
  2. Statement of Ownership. The amendments require the submission of a Statement of Ownership of an invention, signed by the applicant, when filing a patent application. Such a requirement is already in existence for trademarks and industrial designs.
  3. Statements regarding Genetic Resources and Traditional Knowledge. The amendments require that inventions related to and/or derived from genetic resources or traditional knowledge to clearly stipulate in the specification the origin of the genetic resources or traditional knowledge.
  4. Use of patents as fiduciary objects. The amendments allows patents to be used as fiduciary objects (such as a guarantee between a debtor and a creditor). Under the previous law, patents could not be used for such securitization.
  5. Introduction of online filing. Under the amendments, an online filing system will be introduced to allow applicants to file patent applications on the Internet. Previously, applicants had to manually file patent applications at the Directorate General of Intellectual Property’s Office.
  6. Restructuring of the grace period for paying annuities. Under Indonesian patent law, a patent will be considered null and void if annuities are not paid by the requisite due date. However, according to the amendments, an extension of up to 12 months can be requested. Under the previous law, annuities could be paid up to three years from the due date. If annuities were not paid within three consecutive years, the patent would be deemed null and void. Moreover, even if a patent was allowed to lapse due to non-payment of annuities, a Patentee was still obligated to pay the annuities. As a result of the amendments, this obligation to pay outstanding annuities has been eliminated.
  7. Availability of post-grant oppositions. Post-grant oppositions of patents are now available to third parties in addition to pre-grant oppositions.
  8. Expansion of the Appeal Commission Authority. The role of the Patent Appeal Commission (Commission) has been expanded as a result of the amendments. Previously, the Commission only examined appeal petitions of rejected patent applications. Now the Commission has the authority to receive, examine and decide on the appeal petitions of:
    1. A refused application;
    2. A correction of a patent specification, claims, and/or drawings after the application has been granted; and
    3. Notice of a grant decision with respect to a post-grant opposition.
  9. Scope of simple or “petty” patents. The scope of simple patents has been expanded to include new processes or the development of an existing process.
  10. Additional exemptions to patent infringement. Two acts are now specifically excluded from patent infringement. These acts include:
    1. Importation of a pharmaceutical product patented in Indonesia where the product is legally marketed in another jurisdiction without the permission of the patent owner; and
    2. Manufacturing of a pharmaceutical product which is patented in Indonesia within five years before the patent expires, for purposes of licensing and marking after the patent expires (e.g., a “Bolar” exemption).
      The exemption regarding importation of a pharmaceutical product described in a) is intended to help ensure that pharmaceutical products are reasonably priced and that access to such products is widened. This exemption can be exercised if it is proven that the price of a certain pharmaceutical product in Indonesia is very high compared to the price in the international market. The exemption is limited to “pharmaceutical products” and does not allow parallel imports of non-pharmaceutical products.
  11. Expansion of the scope of compulsory licenses. Under the new law, a grant of a compulsory license can be made to:
    1. Produce a pharmaceutical product patented in Indonesia for the treatment of a disease;
    2. Import a pharmaceutical product patented in Indonesia that cannot be manufactured in Indonesia presently for purposes of treating a disease; and
    3. Export a pharmaceutical product patented in Indonesia that is manufactured in Indonesia for the purpose of treating an endemic disease (such as upon request by a developing or least developed country).

Please continue to watch the BRIC Wall Blog for updates on Indonesian patent law.

This post was written by Lisa L. Mueller.

Updates to the Brazilian Food and Drug Administration OTC Drug Guidelines

It has been 13 years since the Brazilian Food and Drug Administration (ANVISA) updated the guidelines regulating which drugs can receive over-the-counter (OTC) status. The much-anticipated guidelines, which issued on August 3, 2016 as Rule #98, revoke the previous Rule #138, which was established in 2003. Rule #138 established which drugs could be sold as OTC medications, according to their therapeutic indications. Drugs currently recognized as safe for over-the-counter use under Rule #138 will continue to be categorized as such until a reassessment can be completed and compliance with Rule #98 evaluated; however the new guidelines allow ANVISA to simultaneously reassess the status of currently available OTC drugs while expanding the number of new products available to consumers.

Rule #98 was previously submitted to Public Inquiry #27 on April 8, 2015. According to ANVISA’s report on the public inquiry, the general feedback was that the new rule will have a positive impact on the market, especially with regards to increasing patient’s access to drugs and the recognition of pharmacists’ roles in healthcare. It is expected that Rule #98 will expand the number of OTC drugs in the Brazilian market, which will increase price competition and marketing efforts towards consumers, rather than physicians.

In order to be compliant with Rule #98, drugs must comply with the following seven criteria:

  1. The drug must have been commercially available for a minimum of 10 years (five years in Brazil), as a prescription drug, or five years, as an OTC drug, in countries where regulations are similar to ANVISA.
  2. The drug must exhibit a high level of safety: the causes of the adverse reactions must be well known and easily reversed, the drug must have a low level of toxicity, a safe therapeutic window, and a low level of interactions with other drugs and food.
  3. The clinical condition treated by the drug cannot evolve rapidly, and its symptoms must be easily identifiable by the consumer.
  4. The drug must pose a low risk when used off label or in overdose scenarios.
  5. The drug cannot be indicated for continuous use; rather, it can only be used for a short period of time or a fixed period of time, which must be identified in the drug’s label (except for drugs labeled for prevention).
  6. The consumer must be capable of using the drug without any physical assistance from a healthcare professional.
  7. The drug cannot cause chemical dependency in consumers.

Companies looking to obtain OTC status for a particular drug can do so at any time; status can be applied for with the Marketing Approval Application, or after the drug has already been approved. The OTC status request must be supported by the required documents listed in Rule #98, ensuring compliance with the above-identified criteria. The company must also support its request with a risk reduction plan, which will inform the ANVISA how it will monitor occasional risks arising from the commercialization of the drug as an OTC product. Once the OTC status is approved, the decision will be published by ANVISA in the Official Gazette and be made available online. The publication will include the active pharmaceutical ingredients (API) in the drug. Once published, companies will have 180 days to make appropriate amendments to the drug packaging and label, as well as have the product sales status changed to OTC.

Importantly, Rule #98 defines which products are not entitled to receive OTC status, which includes drugs that require parenteral administration, or drugs that are commercially packaged, as the quantity of the API per package exceeds the maximum limits established by ANVISA.

The enforcement of Rule #98 will begin 30 days after its publication on September 3, 2016.  Please continue to check the BRIC Wall Blog for additional updates on the enforcement of these new guidelines in Brazil.

This blog post was written by Lisa L. Mueller, Caitlin E. Mac Nair of Michael Best, Ricardo Campello and Roberto Rodrigues of Licks Attorneys.

Upcoming Michael Best Events

Michael Best is pleased to announce two upcoming, complimentary events:

Best Summit for Life Sciences, University and Higher Education – How Does the Legal Landscape Affect Your IP Portfolio?
September 8, 2017

The day will begin with a welcome by attorney, Chair of Michael Best’s Life Sciences and Chemical practice, and BRIC Wall Blog founder, Lisa L. Mueller, followed by five presentations led by Michael Best attorneys and several guest panelists from the Midwest, across the United States and throughout the world. Sessions include:

  • IP and Strategic Alliances
  • Patent Protection and Enforcement for Life Science inventions in the Middle East and North Africa
  • Presenting Oral Arguments at the PTAB – Mock Trial
  • Patent Term Extension, Supplementary Patent Certificates and Other Ways to Extend a Patent Term
  • FDA Predictions

For more information, click here.

Stop, Breathe, and Think! A Mindful Approach to Work and Career
September 7, 2017

Featuring speaker Lauren Pagenkopf of Laurus Consulting, LLC, will discuss how in the 24/7, hyper-connected world in which we live and work it can sometimes feel as if we have no control, life is happening, and a work/life balance is an impossible goal. Mindful thinking helps us become aware of the thoughts and behaviors that hold us back, gives us the space to make choices and trade-offs, and empowers us to redefine what success looks like. Lauren will also discuss myths and truths about mindfulness and how to cultivate an intentional approach to work and career.

For more information, click here.

Update on Patentability of Diagnostic Claims: Brazil (Part 2 of an 8-part Series)

This is the second update to our 2014 10-part series “The Thorny Problem of Patentable Eligible Subject Matter.” Since that series, the U.S Patent and Trademark Office (USPTO) issued further guidance on December 16, 2014, updated in July 2015 and May 2016 (May 2016 Update), for evaluating subject matter eligibility under Section 101 (Guidance). The new Guidance superseded the March 4, 2014 Guidance.  Part 1 – Update on Patentability of Diagnostic Claims: Australia can be found here.

On July 16, 2016, the USPTO issued a memo commenting on recent decisions by the U.S. Supreme Court (Supreme Court) and the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in two subject matter eligibility cases directed to life sciences method claims: Sequenom v. Ariosa and Rapid Litigation Management v. CellzDirect, (Rapid Litigation Management) respectively. The memo concludes that neither decision changes the subject matter eligibility framework and that the existing Guidance and training examples are consistent with these cases; however, the memo also notes that the Rapid Litigation Management decision further clarifies the inquiry involved in determining whether a claim is directed to a judicial exception. In particular, the Federal Circuit stated that the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole, was a patent-ineligible concept.”

The May 2016 Update provided more detailed instructions for Examiners regarding the formulation of a rejection under Section 101 and evaluation of an Applicants response thereto. Specifically, Examiner’s must identify the exception to patentable subject matter (referred to as a “judicial exception”) that is being claimed, explain what is recited  in the claim and why it is an exception, and identify any additional elements that define claim features/limitations/steps that are beyond the exception. The Examiner must then explain why the additional elements individually AND in combination do not result in the claim as a whole amounting to “significantly more” than the exception.

The May 2016 Update also provided additional examples for application of the Guidance to specific types of life science claims, which were not well represented in the December 2014 Guidance.

As discussed in our 2014 series, Article 10 of Brazilian Intellectual Property law (IPL) defines what is not considered to be an invention or a utility model and thus, patent ineligible subject matter.  In fact, Article 10 may be considered the counterpart of 35 U.S.C. § 101 in the U.S. According to Article 10, the following are not considered 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 Intellectual Property 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.

Additionally, on July 15, 2016, the Ministry of Development, Industry and Foreign Trade, National Institute of Industrial Property (INPI) published Part II of its guidelines for the examination of patent applications relating to patentability (Guidelines).  According to Paragraph 1.38 of the Guidelines, a diagnostic method is not considered an invention when the series of steps that comprise the method are applied “in a human or animal body”.  Specifically, Paragraph 1.39 states that:

A diagnostic method for application in the human or animal body in accordance with the provisions of item VIII of Article No. 10 of IPL falls within, when it meets the following criteria:  (i) it has direct application in the human or animal body, such as, for example, in the base of determining the allergic conditions by diagnostic examination applied in the body, or requires the presence or participation of the patient for its interpretation; and (ii) allows the conclusion of the clinical state of the patient, or indicate various possible clinical states, just based on data processing, analysis or interpretation, information and/or clinical results associated with the patient.

The following is an example provided in the Guidelines of a diagnostic method not considered to be an invention (and hence not patentable):

  1. Automated diagnostic method of a patient, characterized in that it comprises the steps of:
    1. examining the patient to provide at least a first symptom element having a first relative degree of importance to the symptom;
    2. examining the patient to provide at least a second symptom element having a second relative degree of importance to the symptom;
    3. apply the relative degrees of importance for the symptoms, in order to obtain a diagnostics core for the conclusion of a medical condition.

Paragraph 1.41 of the Guidelines makes it clear that methods consisting of in vitro tests that are carried out on blood samples or other tissue removed from the body are considered to be an invention because such tests are not applied to a human or animal body and thus do not “conclude regarding the clinical state of the patient”.  However, this same paragraph also notes that diagnostic methods may include a combination of in vivo and in vitro steps.  In these instances, “…if the claimed method includes technical steps carried out in vivo, which are inseparable from the in vitro step, the method as a whole will be regarded as being applied on the body and, therefore, it will not be considered invention.  In addition, the treatment of tissues, cells or body fluids after they have been removed from the human or animal body, or methods applied onto them, such as methods in vitro, are considered entitled to protection.  The methods of measurement of enzymes and blood glucose, complete blood count, serology tests, among others, are included in this case.”

Paragraph 1.42 of the Guidelines further specifies that methods of obtaining information from a human or animal body where the data collected is just an “intermediate result that, by itself, is not enough for defining a diagnosis, are not considered diagnosing methods.”  Therefore, such methods are considered to be inventions and thus entitled to protection.

We at the BRIC Wall thought it would be insightful to update our analysis of subject matter eligibility under Brazilian patent law for diagnostic method claims based on the May 2016 updated Guidance and Life Science examples.

Analysis of Life Sciences Examples from May 2016 Update to USPTO Guidance

Example 29 – Diagnosing and Treating Julitis

Background:  Example 29 of the May 2016 Update relates to a hypothetical situation relating to an autoimmune disease called “Julitis.”  An Applicant for a patent discovered that Julitis could be diagnosed by detecting the presence of the hypothetical “JUL-1” protein in patients’ plasma, skin, hair and nails.  Applicant has disclosed detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody named “mAb-D33”).

Two representative claims from this Example are analyzed below.

Claim 1. A method of detecting JUL-1 in a patient, said method comprising:

  1. obtaining a plasma sample from a human patient; and
  2. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

Claim 2. A method of diagnosing julitis in a patient, said method comprising:

  1. obtaining a plasma sample from a human patient;
  2. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and
  3. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

Analysis of claims 1 and 2:  Both claims 1 and 2 would constitute patent eligible subject matter in Brazil. In the U.S., claim 1 constitutes patent eligible subject matter, while claim 2 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the claim is directed to a judicial exception (i.e., the correlation between the presence of JUL-1 and the presence of julitis in the patient) and as a whole does not amount to significantly more than the exception itself.

Example 31 – Screening for Gene Alterations

Background:  Applicant discovered the “wild-type” sequence of the human BRCA1 gene (i.e., the typical sequence of the gene in humans), and has also discovered naturally occurring alterations from the wild-type sequence that are correlated with an increased likelihood of developing breast or ovarian cancer. Applicant’s disclosure provides methods of screening patients for alterations in the BRCA1 gene by comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences.

At the time the invention was made and the application was filed, scientists routinely compared DNA sequences using two-data generating techniques:  (1) hybridizing two different DNA molecules (e.g., a probe and DNA isolated from a patient sample), and detecting whether the molecules bind to each other and form a hybridization product and (2) amplifying (making copies of) at least part of a DNA molecule such as DNA isolated from a patient sample, by using a set of primers to produce amplified nucleic acids, and then sequencing the amplified nucleic acids.  The probes and primers used in these techniques are short single-stranded DNA molecules that typically have a naturally occurring nucleotide sequence.

In one embodiment, Applicant discloses using a computer-implemented micromechanical method known as Scanning Near-field Optical Microscopy (SNOM) to detect hybridization of a single probe to its target. At the time the invention was made and the application was filed, the use of SNOM to study DNA hybridization had been discussed in several articles in widely-read scientific journals. However, scientists were not commonly or routinely using SNOM to study DNA hybridization at the time the invention was made and the application was filed.  Instead, scientists at the time typically used autoradiography to detect hybridization products.

In another embodiment, Applicant discloses using Cool-Melt polymerase chain reaction (Cool-Melt PCR) to amplify BRCA1 DNA from the patient sample. Cool-Melt PCR uses lower melting and annealing temperatures than conventional PCR, which results in Cool-Melt PCR having a 20-fold higher sensitivity of mutation detection than conventional PCR.  At the time the invention was made and the application was filed, Cool-Melt PCR was known and used by a few scientists in the field.  Several years after filing the application, Cool-Melt PCR became a standard laboratory technique that appeared in virtually every laboratory manual and was conventionally used by most scientists in the field to amplify mutant nucleic acids.

Three representative claims from this Example are analyzed below.

Claim 1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

Claim 70. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:

  • hybridizing a wild-type probe to a BRCA1 gene isolated from said sample; and
  • detecting the presence of a hybridization product by measuring conformational changes in the probe that are indicative of hybridization to the BRCA1 gene with scanning near-field optical microscopy.
  • Claim 80. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:
  • amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids; and
  • sequencing the amplified nucleic acids.

Analysis of claims 1, 70, and 80:  Claims 1, 70, and 80 would constitute patent eligible subject matter in Brazil.  In the U.S., claim 1 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the “comparing” amounts to an abstract idea, which is a judicial exception, and the claim as a whole does not amount to significantly more than the exception itself.  In contrast, claims 70 and 80 are patent eligible in the U.S., as each claim recites additional elements that distinguishes the claim from well-understood, routine, or conventional techniques in the field (i.e., SNOM and Cool-Melt PCR, respectively), and, therefore, each of claims 70 and 80 as a whole amounts to significantly more than the exception itself.

In view of the above, Brazilian patent law is less restrictive concerning the eligibility of diagnostic method claims as compared to U.S. patent law, at least for the foreseeable future.

This post was written by Lisa L. Mueller and Melissa E. Kolom of Michael Best, and Roberto Rodrigues and Anna Carolina Correa of Licks Attorneys.