Understanding Bolar and Bolar-Like Exceptions in the U.S. and Abroad – Part 1

This is part 1 of our multiple part series examining Bolar and Bolar-like exemptions in U.S. as well as in a number of foreign jurisdictions.

U.S. Bolar Exemption

For most patented products in the U.S., on the day a “blocking” patent expires, a competitor can begin selling what was, up until that point, an otherwise infringing product.  However, for a long time, with respect to pharmaceuticals, this simply was not the case. Because the marketing of pharmaceuticals is strictly regulated by the U.S. Food and Drug Administration (FDA), a drug developer is required to comply with various statutes, regulations, guidelines and requirements before marketing approval is awarded.  It was well known that the marketing approval process is a long, arduous process that takes several years.

Additionally, U.S. law provides a very narrow research or experimental use exemption with respected to patented inventions.  The exemption is so narrow that it is limited to actions performed for “amusement, to satisfy idle curiosity or for strictly philosophical inquiry”.  Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002).  In addition, in 1984, the Federal Circuit decided Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984), holding that a manufacturer could not begin the testing needed to obtain regulatory approval of a drug without infringing blocking patents.  Unfortunately, the Roche decision further delayed the entry of generic drugs into the marketplace by delaying the availability of generic drugs by allowing a patentee to maintain market exclusivity for a period of time after its blocking patent(s) expired.

In response to the Roche decision, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. No. 98-417, 98 Stat. 1585 (codified as amended at 35 U.S.C. §§ 156 and 271(e)), which is often referred to as the “Hatch-Waxman Act”.  The Hatch-Waxman Act overruled Roche and created the Section 271(e)(1), which is often referred to as the “Safe Harbor” or “Bolar” exemption.  The Safe Harbor insulates certain activities from patent infringement.  Specifically, Section 271(e)(1) reads:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

It is important to note that the Safe Harbor is not limited to generic only products.  It is applicable to branded pharmaceuticals, medical devices, biologics and biosimiliars.

The Safe Harbor has been interpreted broadly by U.S. courts and, as a result, exempts a wide variety of activities having an ultimate commercial benefit provided that the conduct is reasonably related to gaining information relevant to the FDA approval process.  The U.S. Supreme Court opined on the Safe Harbor in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).  In this decision, the Court held that the text of Section 271(e)(1) extended to all uses of patented inventions that are reasonably related to the submission of any information to the FDA.  As a result, the Safe Harbor includes preclinical studies of patented compounds that are appropriate for submission in the regulatory process.  Moreover, the Court stated that under certain conditions, the exemption could include:  (1) experimentation on drugs that were not ultimately the subject of FDA submission; or (2) the use of patented compounds in experiments that were not ultimately submitted to the FDA.  Additionally, in a series of decisions subsequent to Merck, the Federal Circuit held that the Safe Harbor can exempt both pre- and post-approval activity.  However, in Momenta Pharms., Inc. v. Teva Pharms. USA Inc., 809 F.3d 610 (Fed. Cir. 2015), cert. denied sub nom. Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 137 S. Ct. 68 (2016), the Court stressed that the Safe Harbor was directed to seeking FDA approval and would only cover limited types of post-approval conduct that are truly required by FDA:

The routine record retention requirements associated with testing and other aspects of the commercial production process contrast with non-routine submissions that may occur both pre- and post-approval, such as the submission of investigational new drug applications (“INDs”), new drug applications (“NDAs”), supplemental NDAs, or other post-approval research results….The routine quality control testing of each batch of generic enoxaparin as part of the post approval, commercial production process is therefore not “reasonably related to the development and submission of information” to the FDA, and it was clearly erroneous to conclude otherwise.

Under Momenta, any type of quality control testing that is a “habitual” or “regular” part of the production process and not related to obtaining FDA approval is not likely be exempt.

Examples of activities which may fall under the Safe Harbor (provided that there is clear link between such activities and efforts to obtain regulatory approval) include:  supplying active ingredients, stockpiling drug inventory, preclinical studies, submitting regulatory data to a foreign agency where the data was submitted or is going to be submitted to the FDA, using research tools, using FDA data to prepare a patent application, using a patented product to develop an alternative FDA-approved manufacturing process , etc.   Examples of activities that have been found by U.S. courts not to fall under the Safe Harbor include:  manufacturing patented products in the U.S. for shipment to foreign regulatory authorities, use of product for foreign clinical trials where no indication that results would be submitted to the FDA and basic research.

Finally, under U.S. law, it should be understood that the Safe Harbor is an affirmative defense and the defendant has the burden of establishing and proving the defense during litigation.  As a result, a party seeking to rely on the Safe Harbor should keep detailed records regarding its “infringing” conduct to establish the Safe Harbor.

This post was written by Lisa Mueller.

Essential Diagnostics Lists to be Developed by WHO

On June 6, 2017, the 20th World Health Organization (WHO) Model List of Essential Medicines was published containing several important additions.  One important addition was the recommendation by the Expert Committee on the Selection of Essential Medicines (Committee) that WHO develop an Essential Diagnostics List (EDL).  Based on this recommendation, WHO has begun to lay the ground for the preparation of such a list which will contribute to Universal Health Coverage.

The EDL is intended to provide evidence-based guidance to countries to create their own national lists of essential diagnostic tests and tools.  According to the WHO, essential medicines lists have been successful in facilitating access to treatment and promoting affordable prices, especially in low-resourced countries, by prioritizing the most important medicines that countries need to make available to their populations.  It is believed that the EDL will provide the similar benefits for diagnostics, such as providing improved patient care, greater capacity to diagnose diseases during outbreaks, increased affordability of tests, improved regulation and quality of diagnostic tests and the strengthening of capabilities of national laboratories.

According to the Committee, diagnostic tests are essential not only to diagnose disease or subpopulations of patients for which certain medicines may be indicated, but also to monitor the effectiveness or toxicity of drugs. Moreover, diagnostic tests are often very important in the prognosis of disease.  The Committee recommended that the EDL list focus initially on in vitro diagnostics for tuberculosis, malaria, HIV and Hepatitis B and C but should be expanded as quickly as possible to other important conditions such as antimicrobials and non-communicable diseases.

The WHO is creating a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to advise WHO on global policies and the development of the EDL.

Please continue to watch the BRIC Wall Blog for updates on the Essential Diagnostics List.

This post was written by Lisa Mueller.

Amendments to the Grace Period in Taiwan for Novelty and Inventive Step

Amendments to the Grace Period in Taiwan for Novelty and Inventive Step

On May 1, 2017, an amendment to the Taiwanese Patent Act became effective for all new patent applications filed on this date.  In addition, in conjunction with the amendments to the Patent Act, the Enforcement Rules of the Patent Act were likewise amended. 

Under the Taiwanese Patent Act, the requirements of novelty and inventive step for invention and utility model patent applications as well as design patent applications is governed by Articles 22 (applicable to invention and utility model applications) and 122 (applicable to design applications).

Prior to May 1st, a grace period in Taiwan was only available for very limited numbers and types of public disclosures.  These public disclosures were those when the invention was:

a)      Disclosed publicly for experimental purposes;

b)      Published in a printed publication;

c)      Displayed at an exhibition sponsored or recognized by the Government; or

d)      Disclosed without the consent or against the consent of the applicant.

Additionally, applicants wishing to claim advantage of the grace period had to comply with a number of formal requirements, including:

a)      Filing a patent application in Taiwan six months from the date of occurrence of any of the above described public disclosures;

b)      Making a declaration at the time of filing describing the public disclosure as well as providing the year/month/date in which the disclosure occurred; and

c)      Submitting an evidentiary document at the time of filing or within a time period specified by the Patent Office providing the existence of the disclosure.

The amendments that became effective on May 1st provide good news for most patent applicants.  Specifically, first and foremost, the amendments extend the grace period for filing an invention or utility model patent application from six to twelve months from the date of occurrence of the public disclosure.  Unfortunately, for design patent applications, the grace period remains unchanged, namely, six months from the date of public disclosure.  Second, the amendments expanded the scope of the categories of public disclosure for which the grace period can be claimed.  For example, speaking at a conference, publication of an invention in a product catalog,  a poster presentation and disclosure in a public forum or on the internet can all be claimed under the grace period.   However, there is one exception.  Specifically, the grace period cannot be claimed when the public disclosure is the publication of an issued patent or application that is filed by the applicant or with the applicant’s consent.  Said another way, the grace period is not available if the public disclosure is the publication of an issued patent or published application resulting from the “intent” of the application.  However, the exception does not apply if an issued patent or application published contrary to the inventor’s intent, such as when a patent application is misappropriated or stolen by another person.  If the public disclosure is due to a misunderstanding or negligence, the public disclosure is also deemed against applicant’s intention.  For example, when an applicant understands the party receiving the disclosed information is under confidentiality obligations but later learns that that understanding is not correct.

This post was written by Lisa Mueller and Kate Shu-Yin Chu from Lee and Li.

New guidelines in Brazil give more power to ANVISA in the examination of pharmaceutical patent applications

On March 13, 2017, the board of directors of Agencia Nacional De Vigilancia Sanitari’s (ANVISA) announced that they had reached a new agreement with the Brazilian Patent Office, namely, the Instituto Nacional da Propriedade Industrial (INPI), concerning the prior approval provision under Article 229-C of the Brazilian Patent Statute (For more information about the 229-C article, please see our posts here, here, and here).  On April 12, 2017, after an event with several authorities and President Michel Temer, ANVISA and INPI published a written version of the new joint guidelines #1/2017 (translation enclosed here:  INTERAGENCY ORDINANCE). These guidelines describe the new workflow between ANVISA and INPI involving the examination of pharmaceutical patent applications.

Article 4 of the guidelines establishes that ANVISA will analyze whether a patent application is contrary to public health.  According to Article 4, a patent application claiming a product or process is considered to be contrary to public health when the product or process presents a “health risk”.  The article further states that the “health risk” will be characterized when the pharmaceutical product comprises, or the pharmaceutical process results in a substance that has been prohibited in the country”.    

If a product or process is found to pose a “health risk” (as defined in the Annex I of the Ministry of Health’s Ordinance #344 of 1998), ANVISA will deny prior approval and will send the application back to INPI for further handling. At this point, INPI will publish the definitive dismissal of the application. In other words, the application is denied.

The guidelines contain a new approach in the examination of patent applications claiming pharmaceutical products and processes of interest under the Brazilian government’s drug policies and pharmaceutical assistance of the National Healthcare System (SUS). Under Article 5, ANVISA will examine these applications of interest and prepare a “technical” opinion as to whether the claims meet the patentability requirements under Brazilian law.  This opinion will be sent to INPI for use as a third-party observation under Article 31 of the Patent Statute of 1996.  Once INPI receives ANVISA’s opinion, it is “free” to decide whether or not to agree with it.  In the event INPI disagrees with ANVISA’s opinion and grants the patent application, it will send ANVISA a list containing all granted patents and will continue to make this list available to ANVISA (Article 7 of the guidelines).  

The guidelines do not contain any information as to what ANVISA can or should do with the list of granted patents received from INPI.  Actions that ANVISA could take include filing a post-grant opposition or seeking invalidity of the patent before Federal Courts. 

Article 9 of the guidelines creates an Interagency Group between the two agencies. The purpose of this group is to seek to “harmonize” the understanding between the ANVISA and INPI regarding the application of patent law in “polemic” topics such as Markush claiming, selection inventions, the patentability of new uses, salts, polymorphs and antibodies, as well as other issues relevant to the pharmaceutical industry.  One concern is that such “harmonization” could result in an unlawful administrative ban of claims that are currently being allowed INPI. As such, Article 9 gives ANVISA power to influence the INPI in a multitude of ways. 

Additionally, it is important to note that the new guidelines come after several decisions were obtained against ANVISA by various pharmaceutical companies (See our post here) holding that that the agency lacked the statutory authorization to examine patentability requirements under Brazilian law.  After these early decisions were rendered (which held that ANVISA’s prior approval review was restricted solely to the analysis of potential public health issues and not patentability requirements), ANVISA amended its guidelines to include a provision stating that “the granting of patents that do not fulfil the patentability requirements violates public health”. This change was interpreted by the courts as an attempt by the agency to escape the unfavorable case law and avoid the new guidelines.  

As a whole, the guidelines read like an attempt by ANVISA to revive its ability to participate in the examination of pharmaceutical patent applications.  Interestingly, many the associations representing generic companies in Brazil such as ABIFINA and Pro Generics are celebrating the guidelines as a victory for the local industry. 

Continue to watch the BRIC Wall Blog for continuing updates on these new guidelines in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho from Licks Attorneys.

 

 

 

Brazil: Courts confirm preliminary injunction based on pending patent applications

On March 15, 2017, the Sao Paulo State Court of Appeals confirmed a preliminary injunction barring Uniao Quimica, a Brazilian generic company, from launching a generic version of Allergan’s Combigan® (brimonidine tartrate and timolol maleate).  Combigan® is prescribed for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.   

The preliminary injunction was granted in view of three patent applications filed by Allergan and pending before the Instituto Nacional da Propriedade Industrial (INPI) since 2003 (namely, patent application no. PI0302584-5 filed in 2003 as well as divisional application nos. BR1220140116901-9 and BR122014016915-9 filed in 2012).  Application no. PI0302584-5 was rejected by INPI; however, an administrative appeal is pending. 

Allergan argued that the backlog and inefficiency of INPI had been punishing to the pharmaceutical company.  Specifically, Allergan argued that not granting the preliminary injunction based on the pending application would be “allowing third parties to freely infringe the application during its pendency”, and that the “patent owner would be absolutely deprived of effective means to protect its invention during the prosecution of the application, a proceeding the patent owner has no control over”. 

After the Trial Court issued an injunction on September 28, 2016, Uniao Quimica filed an interlocutory appeal challenging the grounds of the decision.  The reporting Appellate Judge, Hon. Francisco Loureiro, stayed the injunction concluding that the patent owner was only allowed to exclude others based on its patent rights after issuance of the patent by INPI. 

However, in a split decision (2-1), other members of the panel dissented from Hon. Loureiro, thus rejecting the interlocutory appeal and confirming the preliminary injunction.  The Hon. Cesar Ciampolini issued the deciding vote, stating that the preliminary injunction should be granted for the following reasons: (i) INPI’s inexcusable delay in examining patent applications; (ii) the rapid pace at which technology becomes obsolete; (iii) counterpart patents has been granted in several countries; (iv)  Uniao Quimica did not deny that its products were copies of Combigan®; and (v) Uniao Quimica’s behavior in launching generic copies was a matter of unfair competition and should not be allowed by the courts.

Although Uniao Quimica may still appeal to higher courts, the decision is an interesting outcome in view of INPI’s backlog in examining patent application.

Please continue to watch the BRIC Wall Blog for updates on the examination of patent applications by INPI.

This post was written by Lisa Mueller, Felipe Mesquita and Roberto Rodrigues Pinho of Licks Attorneys.

 

Changes to the IP Landscape in Turkey-Industrial Designs

On December 22, 2016, Turkey adopted a new IP Code of Property no. 6769 IP (IP Code), which repealed and replaced 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 entered into effect on January 10, 2017.  In this multi-part series, we will address how this new IP Code changes the IP landscape in Turkey.  In our second installment of the series, we will examine the changes to the codes relating to industrial designs.  In part one, we examined the changes to the codes involving patents and utility models.

Submission of the Description of the Designs

Under the new IP Code, during examination, the submission of the description of an industrial design is optional.  This is because the information provided in the description does not affect the scope of the protection of the design.  In contrast, the former Decree Law required such a description to be provided during examination.  The new IP Code avoids an obligatory requirement for registering a design.

Industrial Designs will be Examined for Novelty

During examination, a design will now be examined for“novelty”.  Designs found not to be novel will be ex-officio refused.  The former Decree Law did not provide an ex-officio novelty search stage during examination.  In fact, novelty could only be questioned through a post-grant opposition or an invalidity action before the IP Courts.

Visible Parts of a Complex Product

According to the IP Code, only the visible parts of a complex product are protectable.   However, in order for the visible parts of a complex product to be protected, the visible parts must meet novelty and distinctive character requirements.  A design is considered to be novel if before the application date no identical design has been made available to the public anywhere in the world.

A design is understood to have an distinctive character if the overall impression it creates on the informed user is significantly different from the overall impression created on the same user by any design which has been made public (in Turkey or anywhere else in the world) before the application date of the design.  In the assessment of the distintiveness, the emphasis of the evaluation will be on the common features of the design; however, the degree of freedom of the designer in developing the design will also be taken into consideration.

Spare Parts of a Complex Product

According to Decree Law, the owner of a registered design could not assert its rights with respect to a visible part of a complex product until three years after the time period after which the design was first made available to the public. The new IP Code introduces a new derogation stating that the this three year period is not be applicable if the protected spare part design is mentioned among the list of “equivalent parts” issued by the Ministry of Science, Industry, and Technology.

Shorter Opposition Period

Under the new IP Code, the post grant-opposition period is now three instead of six months.  The reduction from six to three months will reduce the total registration time to less than a year.

Non-Registered Industrial Design Rights

In order for a design to be protected as a “non-registered” design, the design must first be made available to the public in Turkey.  The duration of protection for a non-registered design is three years from the date the design was first made available to the public (in Turkey).  Interestingly, non-registered design protection is intended to protect fast changing designs which are not intended to be registered for long periods by the design owner.  This type of protection will avoid registration costs for the designs for which registration is not preferred.  However, the owner of a non-registered design will be requested to evidence of ownership and that the design was first made available to the public in Turkey when enforcing its rights.

Non-registered designs are also protectable without any time limit under the unfair competition provisions of the Turkish Code of Commerce which remain in force.  During the next few years, it will be interesting to watch whether the Courts in Turkey will still allow such unfair competition cases after the completion of the 3 year protection period.

Enforcement of Non-Registered Designs

Under the new IP Code, designs are protectable for three years from the date of first public disclosure, if such disclosure was made in Turkey.  This protection is available for non-registered designs to prevent the use by third parties of identical or similar non-registered designs.  The IP Code also provides a common provision for the compensation of damages arising from intellectual property rights including registered and non-registered designs.  As a result, a design holder can ask for material damages which include actual damages and loss of income.  The loss of income can be calculated pursuant to one of the three (3) options mentioned in the IP Code, namely, the loss of income of the plaintiff, the income of the defendant or in accordance with an exemplary license fee.  Upon request by the plaintiff, the Court can increase the damages for the design holder under specific circumstances.  Moreover, the design holder can also seek moral/reputational damages.

Under the IP Code, a design holder can ask the Court to issue a preliminary and/or permanent injunction, compensation, the confiscation/destruction of the infringing goods and the tools and machinery (such as those used for manufacturing the infringing products), the publication of the verdict in a daily newspaper or any similar award.

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.

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.