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.

Update on Patentability of Diagnostic Claims: Australia (Part 1 of an 8-part Series)

This is an 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.

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, the basic requirements for patentability in Australia are found in section 18(1) of the Patents Act (1990) (Act) which states that a claimed invention is patentable if  it (a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and (b) when compared with the prior art base as it existed before the priority date of that claim: (i) is novel; and (ii) involves an inventive step; and (c) is useful; and (d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee’s or nominated person’s predecessor in title to the invention.

In Australia, the general test for patentable subject matter is that an invention is patentable (i.e. a manner of new manufacture) if it provides something that is industrially useful or provides an “artificially-created state of affairs” in a field of economic significance (National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252). Patentable subject matter in Australia, however, has largely been defined by case law. For example, methods of medical treatment of human beings, including surgery and the administration of therapeutic drugs were deemed patentable inventions under section 18 of the Act in Apotex Pty Ltd v. Sanofi-Aventis Australia Pty Ltd., [2013] HCA 50 (4 December 2013). Recently, however, the High Court of Australia (HCA) ruled in Yvonne D’Arcy v Myriad Genetics Inc., that claims covering isolated DNA are not patent eligible, finding that the creation of this category of important rights is best left to “legislative determination.”  D’Arcy v Myriad Genetics Inc (S28-2015) [2015] HCA 35.

Regarding diagnostic method claims, unlike the U.S., there is no recent Australian decision that negatively impacts the patentability of diagnostic claims. In general, diagnostic claims are considered to be directed to an “artificially-created state of affairs,” as they are man-made processes that produce useful and concrete results.

We at the BRIC Wall thought it would be insightful to update our analysis of subject matter eligibility under Australian 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 Juliti

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 would constitute patent eligible subject matter in Australia. 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:

  1. hybridizing a wild-type probe to a BRCA1 gene isolated from said sample; and
  2. 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:

  1. 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
  2. sequencing the amplified nucleic acids.

Analysis of claims 1, 70, and 80: Claims 1, 70, and 80 would constitute patent eligible subject matter in Australia. 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 Australian patent law is considerably less restrictive to the patentability 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 John Moore and Tony Davis of Griffith Hack.

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

In this post, the BRIC Wall Blog continues to examine the Office of the United States Trade Representative (USTR) 2016 Special 301 Report (Report) released on April 12, 2016.  Following extensive research and analysis, the Report placed eleven (11) countries on the priority watch list and twenty-three (23) on the watch list. Argentina remains on the Priority Watch List in 2016.

The Report indicates that a major challenge in Argentina is the lack of effective IPR enforcement by the national government. Argentine police do not take ex officio actions, prosecutions frequently stall, and cases may languish in excessive formalities. Furthermore, even if criminal investigations reach final judgment, sentences are not sufficient to deter future infringement.

Argentina also continues to struggle with rampant counterfeiting and piracy. The notorious La Salada market in Buenos Aires is one of the biggest open-air markets in Latin America offering counterfeit and pirated goods. The city of Buenos Aires attempted to combat increasing lawlessness in the market in 2014, but received little assistance from the national government and as such the efforts were unsuccessful. In addition, optical disc copyright piracy is widespread and internet piracy is a growing concern in the country. In several content areas internet piracy rates are approaching 100%. For example, the Argentine-run market Cuevana, which offers pirated movies and TV shows, expanded in 2015 to include a mobile streaming application. The Report also indicates a problem with widespread use of unlicensed software by both private enterprises and the Argentine government. In spite of these issues, criminal enforcement for online piracy is nearly nonexistent.

Argentina also faces a number of ongoing challenges to innovation in the agricultural, chemical, biotechnology, and pharmaceutical industries. Argentina fails to provide adequate protection against the unfair commercial use and unauthorized disclosure of undisclosed test data generated to obtain marketing approval for pharmaceutical or agricultural products. Furthermore, Argentina only provides patent protection from the date of grant of the patent and offers no provisional protection for pending patents. There is a substantial backlog of patent applications, which causes long delays in registering rights. In addition, Argentina requires that the process for the manufacture of active compounds must be reproducible and applicable on an industrial scale in order to be patentable. Resolution 283/2015, introduced in September 2015, limits the ability to patent biotechnological innovations based on living matter and natural substances, including biologics. These measures limit the ability of companies investing in Argentina to protect their IPR and appear inconsistent with international practice.

In spite of these issues, the report states that the United States is hopeful that the recently elected government of President Mauricio Macri will engage more productively to improve the protection and enforcement of IPR in Argentina, thereby creating a more attractive environment for investment and innovation.

 

Written by Lisa L. Mueller and Rikki A. Hullinger.

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

In this post, the BRIC Wall Blog continues to examine the Office of the United States Trade Representative (USTR) 2016 Special 301 Report (Report) released on April 12, 2016.  Following extensive research and analysis, the Report placed eleven (11) countries on the priority watch list and twenty-three (23) on the watch list. Thailand remains on the Priority Watch List in 2016.

The Report indicates that although steps have been taken to improve IPR protection and enforcement in Thailand, including the launch of the National Intellectual IP Center of Enforcement in 2013 and several legislative measures passed since 2014, these attempts have proven ineffective and unsuccessful.  For example, in 2014 the Thai government introduced several amendments to the Customs Act and Copyright Act in an attempt to decrease the volume of illegal goods transiting through the country and to diminish unauthorized cam-cording in Thai theaters.  Unfortunately, the government failed to consider concerns expressed by foreign governments on prior drafts of the amendments.  As a result, the amendments omitted a much-needed landlord liability provision, failed to provide proper enforcement against unauthorized camcording, and did not set forth adequate protections against the circumvention of technological protection measures (TPMs).

In addition to the above issues, another Copyright Act amendment designed to introduce an option for right holders to obtain a court order to force online service providers to take down infringing content has resulted in a lack of clarity in the operation of the notice-and-takedown procedures. Right holders also express concerns regarding pending legislation imposing content quota restrictions and are concerned about potential unintended effects of pending data and cyber security laws.  The Report indicates that it will be critical for Thai authorities to engage closely with foreign governments and industry to ensure that these and future legislative measures effectively improve IPR protection and enforcement in the country.

Other concerns include a backlog in pending patent applications, widespread use of unlicensed software in both the public and private sectors, growing Internet-based copyright piracy, rampant trademark counterfeiting, lengthy civil IPR proceedings and low civil damages, and extensive cable and satellite signal theft.  Furthermore, Thailand continues to struggle to provide an effective system for protecting against the unfair commercial use and unauthorized disclosure of data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.

In conclusion, the Report urges Thailand to do more to prioritize IPR enforcement and to address longstanding organizational challenges in the country.

This post was written by Lisa L. Mueller and Rikki A. Hullinger, Ph.D.

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

In this post, the BRIC Wall Blog continues to examine the Office of the United States Trade Representative (USTR) 2016 Special 301 Report (Report) released on April 12, 2016. The Report reviewed the state of intellectual property rights (IPR) protection and enforcement in U.S. trading partners around the world.   After extensive research and analysis, Venezuela remains one of eleven (11) countries on the priority watch list for 2016. 

The Report indicates that the combination of Venezuela’s formal withdrawal from the Andean Community, the reinstatement of its 1956 Industrial Property Law, provisions set forth in Venezuela’s 1999 constitution, and international treaty obligations still in effect has created legal ambiguity for IPR in the country.  Venezuela’s Autonomous Intellectual Property Service (SAPI) has not issued a new patent since 2007, and has substantially increased patent filing and maintenance fees since May of 2015.  Brand owners further report that SAPI regularly approves and publishes applications for trademarks that are similar or nearly identical to registered marks, and that trademark opposition procedures that do exist to combat these issues are slow and ineffective.   Additionally, Venezuela lacks an effective system for protecting against the unfair commercial use and unauthorized disclosure of data generated to obtain marketing approval for pharmaceutical products. 

Venezuela also continues to struggle with widespread counterfeiting and online piracy.  In the past year, infringing copies of movies found to be contributing to online piracy were traced back to unauthorized camcording in Venezuelan theaters.  In spite of these problems, prosecution of IP crimes is rare and penalties in place are insufficient to deter counterfeiters.  In view of these issues, The Property Rights Alliance’s 2015 Intellectual Property Rights Index ranked Venezuela 125 of the 129 countries evaluated and the World Economic Forum’s 2015-2016 Competitiveness Report ranked Venezuela last among all 140 countries evaluated with respect to IPR protection.  Despite these consistently low rankings, Venezuela has made no effort to improve IPR in the country in 2015 and as such remains on the priority watch list for the 2016 Special 301 Report.      

This report was written by Lisa Mueller and Rikki Hullinger.