Changes to the IP Landscape in Turkey – Patents and Utility Models

On December 22, 2016, Turkey adopted a new IP Code of Property no. 6769 (IP Code), which repeals and replaces the Decree Laws on Patents and Utility Models, on Trademark and Service Marks, on Industrial Designs, and on Geographical Indications (Decree Law).  The new IP Code went into effect on January 10, 2017. In this multi-part series, we will address how this new law changes the IP landscape in Turkey. The first part of the series will focus on changes to the codes regarding Patents and Utility Models.

Post Grant Opposition

Previously, the only way to contest a patent under Turkish Patent Code was to file a cancellation action before the courts.  However, under the new IP Code, third party oppositions against granted patents are now possible.  Specifically, the opposition must be filed within six months of the publication of a grant decision.  Once filed, the patentee is notified of the opposition by the Turkish Patent and Trademark Institute (TPTI), and invited to submit an opinion regarding the opposition or amend its patent (namely, the claims and/or specification).  Although the examination board is yet to be established, the board will serve to examine the opposition and patentee’s opinion and amendments, and ultimately decide whether to invalidate the patent or refuse the opposition.  The IP Code and the draft of the Regulation on the Implementation of the IP Code, do not stipulate any oral hearing for the opposition proceedings.  Third parties may oppose a patent on the grounds that the:

  • Subject matter of the invention is not novel / does not involve inventive step / is not susceptible of industrial application;
  • Subject matter of invention is excluded from patentability;
  • Invention is not disclosed sufficiently clear and complete;
  • Invention contains subject-matter which extends beyond the content of the application as filed- the subject-matter of the patent is not patentable;
  • Invention is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art; and
  • Subject-matter of the patent extends beyond the content of the application as filed.

The examination board will examine the opposition, observations and amendments of the patentee and issue a decision on the revocation/amendment of the patent.

Biotech Patents and Subject Matter Eligible

The provision of the IP Code relating to patentable inventions defines the types of inventions which are not patentable.  Specifically, the discovery of any elements of the human body and the human body itself in its natural environment are not patentable.  For example, claims directed to human gene sequences or process for cloning a human being will be rejected as being directed to non-patentable subject matter.  Unfortunately, claims directed to proteins and antibodies are not specifically addressed.  With respect to diagnostic methods, these methods are considered to be non-patentable subject matter in accordance with the European Patent Convention (EPC).

Second Medical Use Patents

The Turkish Supreme Court overruled a 2014 Istanbul IP Court decision which held that the second medical use claims granted by the European Patent Office (EPO) under the European Patent Convention (EPC) 1973 were null and void.  The Supreme Court further emphasized that Turkish law does not exclude second medical use inventions from patentability, and acknowledges the protection of second medical use patents validated through the EPC.  Unfortunately, the new IP Code is silent with respect to the patentability of second (and further) medical indications of a per se already known substance or composition (second medical use inventions).

Swiss-type claims are not allowable before the EPO for an EP patent application having a filing date or an earliest priority date after 29 January 2011 (G 2/08).  However, in practice, the TPTI accepts any type of claims via validation through the EP route without conducting any further examination. Therefore, for effective protection of second medical use patents, it is recommended that applicants proceed through EP validation in Turkey.

Abolition of the Seven-Year Patent System

Under the previous Turkish patent law, a seven year short-term patent could be obtained without an applicant’s having proceeded through substantive examination.  The new IP Code mandates that all applicants request substantive examination of their applications.  Failure to do so will result in the application being considered to be withdrawn.  It is expect that this change will improve the quality of patents and to provide an overall stronger patent framework, particularly for small and medium sized enterprises.

The new IP Code applies to international and national patent applications filed after the enactment of the new IP Code.  What this means is that international and national patent applications filed before the enactment of the IP Code will be treated according to the provisions of the Decree Law.  It is important to note that should a patentee of a seven year short-term patent wish to convert to a twenty year long term patent through a request of substantive examination, such request will be treated in accordance with the Code in force at the date of the filing of the request.

Utility Model System Re-Adapted

A novelty search will now be required for utility model applications and applicants will have the opportunity to file amendments during the registration proceedings.  Although post grant oppositions may be filed against patents, post grant oppositions will not be allowed for utility models.  Moreover, the new IP Code stipulates that no utility model certificate will be granted for:

  • Biotechnological inventions;
  • Chemical processes or products, or any products or processes obtained therefrom; and
  • Pharmaceutical processes or products, or any products or processes obtained therefrom.

Employee Inventions System for Universities

Under the new IP Code, any inventions made by scientific staff (including Ph.D. students and non-Ph.D. students) as part of their university employment, belong to the university under certain conditions.  This new requirement removes the previous “professor’s privilege”, provided under the Decree Law that provided that researchers and academicians working at universities could automatically own the invention subject to the patent.  The new IP Code also states that at least 1/3 of the income generating from use of the patent will belong to the inventor researcher/academician.

Compulsory Licensing

The new IP Code provides new grounds for the granting compulsory licenses.  Specifically, the patentee can be requested to grant a compulsory license if the patentee breaches competition such as to block, restrict or destruct the competition in the market.  The patentee may also be asked to grant a compulsory license if the use of the patent does not meet the local market needs of the country.

Burden of Proof in Process Patents

Under the previous law, the burden of proof in process patent infringement cases was provided in two Articles.  Specifically, the first article, Article 84 of the Decree Law No. 551 stated that where a process patent claimed the manufacture of new products or substances, unless there was proof to the contrary, any product or substance having the same properties (as the product produced by the patented process) were automatically deemed to have been obtained using patented process.  Under this situation, the burden of proof was with the person claiming the contrary.

The second article, Article 136, provided that where a process patent claimed the production/preparation of a product, all products possessing the same properties (as the products produced by the patented process) were deemed to have been manufactured by the patented process. A defendant claiming that it manufactured/produced the product without infringing the patented process had the burden of proof.

In the new IP Code, Article 141/2 states that where a process patent claims the production/preparation of a product or a substance, the court may request that the defendant prove that its product (having the same properties as the product produced by the claimed process) has been produced/manufactured without infringing the patented process.  Where the patent claims a process for the production/preparation of a new product or substance, all products possessing the same properties as the product produced by the patented process, will be considered to have been produced/manufactured by the patented process.  A defendant claiming that it manufactured/produced a product without infringing a patented process will have the burden of proof.

Please continue to watch the BRIC Wall Blog for the remainder of the series on changes to the intellectual property landscape in Turkey.

This post was written by Lisa Mueller and Kate Merath of Michael Best and Okan Can of Deris.

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.

Biologics and Biosimilars Bits and Bytes – January 8, 2016

Revised Indian Biosimilar Guidelines Expected Soon

According to reports, the Indian Ministry of Health is planning on releasing revised guidelines on the approval of “similar biologics” sometime in February/March 2016. India’s biosimilar guidelines became effective on September 15, 2012. It is believed that the revised guidelines will address a host of items including increased requirements regarding comparability testing with a reference drug product, as well as various ethical questions.

U.S. FDA Approves a “Similar” but not a “Biosimilar” version of Lantus®

On December 16, 2015, the U.S. Food and Drug Administration (FDA) announced that it had approved Eli Lilly/Boehringer Ingelheim’s (Lilly) Basaglar® product as the first “follow-on” insulin glargine product for use in improving glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.  Basaglar® is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. Specifically, Lilly submitted a 505(b)(2) application for Basaglar® that relied, in part, on the FDA’s finding of safety and effectiveness of Sanofi’s Lantus® for its approval. While similar to Lantus®, Basaglr® was not approved as a biosimilar. In contrast, in Europe, on September 9, 2014, the European Medicines Agency approved Lilly’s product as a biosimilar under the brand name Abasaglar (originally approved under the brand name Abasria).

While Basaglar® received tentative approval from the FDA in August 2014, a 30-month hold was placed on its market entry because of a patent infringement dispute with Sanofi which was settled in September 2015.

This post was written by Lisa Mueller.

Brazil: Strategies and Trends on Intellectual Property Technology Law and Litigation

On July 28 and July 29, Licks Attorneys and Quinn Emanuel Urquhart & Sullivan, LLP will be hosting a seminar in California on strategies and trends in intellectual property law in Brazil. With respect to the biotech, pharmaceutical and life sciences sectors, this seminar will examine topics such as intellectual property protection, the regulatory environment in Brazil, price control and reimbursement and legal issues for both the private as well as public market and PDP. To learn more, please find the conference invitation here: Brazil – Strategies and trends on IP Tech Law and Litigation