Update on Patentability of Diagnostic Claims: Canada (Part 3 of an 8-part Series)

This is an update to our 2014 10-part series “The Thorny Problem of Patentable Eligible Subject Matter” and our July 2015 post regarding new guidance in Canada for examining diagnostic method claims.

Impact of Practice Notice PN2015-02

As discussed in our July 2015 post, the Canadian Intellectual Property Office (CIPO) released Practice Notice PN2015-02 (Practice Note), which instructed examiners to use an application’s description and the common general knowledge to identify an unaddressed “problem” and its proposed “solution”.

A determination of whether a diagnostic method claim is patent eligible is made based on the essential elements as determined through a purposive construction of the claim. A proper purposive construction is a two-step analysis requiring an Examiner to identify (1) the problem the inventors set out to solve; and (2) the solution disclosed.

For diagnostic methods, only two types of mutually exclusive problems are recognized: data acquisition problems and data analysis problems. “Data acquisition” problems involve, for example, identifying, detecting, measuring, etc., the presence or quantity of analyte X in a sample, while “data analysis” problems involve, for example, analyzing the significance of the acquired data (such as how the presence, increase/decrease in quantity, etc., of analyte X correlates to condition Y).

The Practice Notice indicates that the “essential elements” of a claim are limited to those that work together to solve this restricted problem.  Other “non-essential” claim elements are said to “merely define the context or the environment of a specific working embodiment, but do not actually change the nature of the solution to the problem…”  These non-essential elements are excluded from later analysis.

The Practice Notice suggests that “data analysis” solutions will generally be viewed as unpatentable, particularly when the identified solution is only provided by an element or set of elements associated with the analysis or significance of acquired data. The CIPO views that the recitation of only data analysis elements that are disembodied (e.g., mental process, lacking physicality, or having no physical application) is insufficient to meet the subject matter eligibility criteria of the Patent Act.

In contrast, the Practice Notice indicates that a claim having a physical step of data acquisition as an essential element likely will be found patent eligible.  The Practice Notice provides the following examples as to elements expected to be characterized as “data acquisition”:

  • detecting protein X in a subject sample;
  • measuring the concentration of substrate X;
  • determining the expression levels of genes A, B and C;
  • contacting a urine sample with antibody A and determining the optical density; and
  • incubating a sample with a nucleic acid probe consisting of SEQ ID NO: 1 and detecting hybridization between the probe and target sequence A.

The application of these restrictive guidelines had created what some Canadian practitioners see as a hostile situation for diagnostic claims in Canada.  Indeed, Access to Information requests from the biotechnology industry reveal significant discord within the biotechnology examining division in CIPO, leading to examination of hundreds of diagnostic patent applications being placed on hold as CIPO works to develop its policy.  These developments suggest that CIPO’s position may be challenged in court.  In the meantime, applicants should argue against objections raised by CIPO under section 2 until clarity is obtained from the courts.

USPTO Subject Matter Eligibility Guidance

In view of the restrictive climate at CIPO, we at the BRIC Wall thought it would be insightful to update our analysis of subject matter eligibility under Canadian patent law for diagnostic method claims based on the USPTO’s May 2016 updated Guidance and Life Science examples for evaluating subject matter eligibility under Section 101 (Guidance).

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 concerning life sciences method claims: Sequenom v. Ariosa and Rapid Litigation Management v. CellzDirect, 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 previous USPTO Guidance.

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:  Claims 1 and 2 would likely constitute patent eligible subject matter in Canada, although an Examiner may require the recitation of a specific anti-JUL-1 antibody (e.g., by SEQ ID NO).  However, one caveat is that the “obtaining” steps in claims 1 and 2 might be considered a medical treatment step thus rendering the claim ineligible on that basis alone.  In the event such a rejection were raised, it could be overcome by removing this step or making the step of obtaining the plasma sample inactive (such as by reciting a specific anti-JUL-1 antibody).

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:  Claim 1 would not constitute patent eligible subject matter in Canada (relates to a “data analysis” problem), while 70 and 80 would constitute patent eligible subject matter in Canada (relate to a “data acquisition” problem).  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, it is clear that the current standard for determining patent eligible subject matter in Canada based on CIPO’s Practice Notice is similarly restrictive to the patentability of diagnostic method claims as compared to U.S. patent law. The BRIC Wall Blog will continue to monitor the fate of diagnostic claims in Canada.

This post was written by Melissa Kolom & Lisa Mueller of Michael Best and Trevor Newton of Gowlings WLG (Canada)

 

New Requirements in Brazil for Plant Variety Protection Applications in View of Brazil’s Biodiversity Law

Brazil’s Biodiversity Law No. 13,123 (Biodiversity Law) was signed into law on May 20, 2015.  Decree No. 8,772 (Decree) was issued on May 11, 2016 to implement the statute which repealed provisional measure 2,186-16 adopted by President Fernando Henrique Cardoso in 2001 (2001 Provisional Measure). The 2001 Provisional Measure has been criticized as overly complex and bureaucratic.  Nonetheless, one of the consequences of the Biodiversity Law and the Decree was the creation of several new obligations relating to the research and development of plant varieties in Brazil, particularly those resulting from the access to national genetic heritage and associated traditional knowledge.

As a result, on October 24, 2016, the Brazilian Plant Variety Protection Office (PVP Office) implemented several new procedures relating to the filing and examination of PVP applications in order to comply with the provisions of the Biodiversity Law and Decree.  These new procedures can be found in English here: englishpvpprocedures.

One of the new procedures is the requirement of a declaration of access or non-access to national genetic heritage samples or associated traditional knowledge (access declaration) that might have occurred during the development of a new plant variety.  An access declaration must be submitted for any new plant variety that resulted from research where access to Brazilian genetic heritage or associated traditional knowledge might have occurred as of June 30, 2000.  For new applications, an access declaration will be required at the time of filing of an application.  The same applies for pending applications. The PVP Office will issue an Office Action requiring the submission of the declaration before granting protection.

The PVP Office has proposed two different wordings for an applicant’s access declaration:  (i) “The applicant declares that a genetic heritage or a traditional knowledge were accessed for the present protection request”; and (ii) “The applicant declares that neither a genetic heritage nor an associated traditional knowledge were accessed for the present protection request”.

In those instances where access to national genetic heritage samples occurred during the development of a new variety, the applicant must register the new variety at the Board of Management of Genetic Heritage – Brazilian Ministry of Environment (CGEN) prior to the filing of a PVP application.  Failure to do so will result in the shelving of the application by the PVP Office (Article 110 of the Decree).  Moreover, information relating to the registration at CGEN must be submitted at the time of the filing of the application along with the access declaration.  Despite having an integrated system, the Ministry of Agriculture’s CGEN electronic filing of documents is not yet available. The PVP Office has stated that Articles 37 and 38 of the Biodiversity Law will be disregarded and applicants will have more time than the one (1) year transitional period to provide the registration information to the office.

Any use of associated traditional knowledge requires prior and informed consent from the native community providing such knowledge (Article 9 of the Biodiversity Law).  Specifically, the community must be made aware of the social, cultural and environmental impact of providing such knowledge and must also be informed that it has the right to refuse the users access request (Article 16 of the Decree).

Applicants must comply with every requirement of the Biodiversity Law and Decree. Violations can result in several administrative sanctions, including fines, cancellation or shelving of an application, product seizure, interdiction of the offending applicant, etc.  Specifically, the fines provided by the Decree are as follows:

  1. Accessing traditional knowledge without the community’s prior approval:  From approximately USD 30,000 to approximately USD 3 million (Article 83 of the Decree);
  2. Failure to notify the CGEN of the marketing of finished products or reproductive materials:  From approximately USD 9,000 to approximately USD 3 million, which can be doubled in case of international marketing (Article 78 of the Decree);
  3. Sending genetic heritage abroad (outside of Brazil) without previous registry:  From approximately USD 30,000 to approximately USD 3 million, which can be tripled in the case endangered species are used (Article 79 of the Decree);
  4. Filing for patents in Brazil or abroad without previous registry:  From approximately USD 6,000 to approximately USD 3 million (Article 80 of the Decree);
  5. Disclosing results without previous registry:  From approximately USD 15,000 to approximately USD 150,000 (Article 81 of the Decree); and
  6. Failing to register the access before the marketing of intermediary products:  From approximately USD 15,000 to approximately USD 150,000 (Article 82 of the Decree).

Access and benefit sharing (ABS) agreements are required for any economic use of varieties originating from access to genetic heritage or associated traditional knowledge. ABS agreements are mandatory, even if the new variety is manufactured abroad.  The ABS agreements fall into two categories:

  1. Financial:  Requirement of payment to the National Fund for Benefit Sharing (FNRB) of 1% of the annual net income originating from the economic use of the genetic heritage. This amount may be reduced by up to 90% (0.1% of the net income) by filing a petition before the Environment Ministry (MMA); and
  2. Non-financial: Technology transfer, disclosure of the product to public domain, royalty-free licensing, etc.

Continue to watch the BRIC Wall Blog for continuing updates on Brazil’s Biodiversity Law.

This post was written by Lisa Mueller and Brenno Telles from Licks Attorneys.

 

 

 

BRIC Wall Blog Nominated for 2016 Best Legal Blog Contest

The BRIC Wall blog has been nominated for The Expert Institute’s 2016 Best Legal Blog Contest. This year, more than 500 finalists have been identified as the “most exciting, entertaining, and informative legal blogs online today,” by The Expert Institute, and the BRIC Wall Blog has been included as a leader in the Best AmLaw Blogs category.

Readers can vote for the BRIC Wall Blog to be named the 2016 Best Legal Blog Content winner! To vote, please click here: https://www.theexpertinstitute.com/legal-blog/bric-wall/

Polls are open until Monday, November 14, 2016. Thank you for your support!

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.