Patent Term Extension is Becoming a Reality in China

On April 12, 2018, the state council of China announced that beginning May 1, 2018, a maximum of 5-year patent term extension will be available for innovative drugs (commonly referred to as branded drugs) seeking market approval within and outside China. This decision by the state council will help move the intellectual property protection system for pharmaceuticals in China closer to that of many countries such as, for example, the U.S., Europe, Japan, Korea and Australia, which have well-established patent term extension systems.  Although the details of the patent term extension system have yet to be specified, it is believed that it will be similar to the U.S. system with respect to the types of products and patents that for which the extension will be applicable as well as how the term for extension will be calculated.

This decision demonstrates that China is serious in implementing more stringent intellectual property protection for pharmaceuticals.  As such, this decision by China to permit for patent term extension is good news to foreign investors, especially foreign pharmaceutical companies.

Please continue to watch BRICS & Beyond for further details on patent term extension in China as it becomes available.

This post was written by Lisa Mueller and Xu Li of Chofn Intellectual Property.

Protecting Life Science Inventions in the Arabian Gulf States – Part 1: Saudi Arabia

Bahrain, Iraq, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates comprise what is known as the Arab States of the Arabian Gulf or “Gulf States”.  Six of these seven countries, the exception being Iraq, form part of the Gulf Cooperation Council (GCC).  The GCC is a regional intergovernmental political and economic union between member countries, the charter of which was established on May 25, 1981. According to Article 4 of the GCC charter, the basic objectives of the GCC are to:

  • Effect coordination, integration and cooperation between GCC member states in all fields to achieve unity between the member countries;
  • Deepen and strengthen relationships, links and areas of cooperation that currently exist between the member countries and their people in various fields;
  • Formulate common regulations between the member countries in various fields such as in economic and financial affairs, commerce, customs and communications, education and culture;
  • Stimulate scientific and technological progress in the fields of industry, mining, agriculture, water and animal resource and establish scientific research; and
  • Establish joint ventures and encourage cooperation by the private sector for the good of the people of all the member states.

Not surprisingly, each of the Gulf States have established their own patent office and unique requirements for obtaining patents.  Moreover, the GCC has established a centralized system for obtaining a single regional patent (a GCC patent) that provides protection in each of the six member states.

In this multi-part series, we will examine the requirements for patenting life science inventions in each of the Gulf States.  Additionally, we will examine the requirements of obtaining a GCC patent.  Finally, we will compare and contrast the benefits of obtaining a patent separately in each of the Gulf States versus obtaining a single patent under the GCC system.

Saudi Arabia

Saudi Arabia is the largest of the Gulf States with a total land area of approximately 2,150,000 km2 (830,000 square miles).  It is the fifth largest country in Asia and the second largest state in the Arab world after Algeria.  Saudi Arabia is about five times larger than Texas and California and about five times smaller than China.

Saudi Arabia is the richest of the Gulf States.  It derives its wealth mainly from its vast reserves of oil (about one-fifth of the world’s reserves) and natural gas, which places the country as the largest exporter of petroleum.  As a result, Saudi Arabia has a leading role in the Organization of the Petroleum Exporting Countries (OPEC).

The Intellectual Property (IP) framework of Saudi Arabia has evolved to protect different intellectual property rights and cope with the rapid globalization and technological change. Both globalization and technological advancement have presented significant economic opportunities and challenges to the IP system. As a result, IP rights have become increasingly important in the country, but many of the challenges facing the IP system have yet to be addressed.

Patent Office

The Patent Office in Saudi Arabia (SAPO) is located at the King Abdulaziz City for Science & Technology (KACST), an independent scientific organization of the Saudi Arabian Government established in 1977.  The main activities and objectives of SAPO are to:

  • Apply the patent law and its implementing regulations, namely, the Law of Patents, Layout Designs of Integrated Circuits, Plant Varieties and Industrial Designs;
  • Grant Saudi patents, Layout Designs of Integrated Circuits, Plant Varieties and Industrial Designs;
  • Establish a Registry for the collection of local and foreign Layout Designs of Integrated Circuits, Plant Varieties and Industrial Designs;
  • Publish the Patents Gazette; and
  • Encourage the inventiveness of Saudi nationals.

SAPO is one of the few patent offices in the region which has developed in-house technical examination capabilities.   Specifically, patent applications are examined in Arabic, which is also the language used during (the entirety of) prosecution.  As a result, the Arabic translation of a foreign patent application is critically important as this document will be used in any future patent litigation.

In 2015, SAPO moved to an all-electronic filing system, thus streamlining the patent procurement process.  As a result, SAPO is considered to be a pioneering patent office, namely, it is constantly developing tools and capabilities that set it ahead of the rest of the patent offices in the region.

The below table shows the number of patent applications filed and granted in the SAPO from 2010-2016.

Year Number of Applications Filed Number of patents granted
2010 931 196
2011 987 252
2012 1061 213
2013 944 233
2014 788 561
2015 2408 764
2016 3266 595

In 2016, the countries that filed the most applications in the SAPO were: (1) Saudi Arabia (1064 applications); (2) U.S. (939 applications); (3) Germany (181 applications); (4) Netherlands (141 applications); and Japan (126 applications).

Patent Details

Intellectual Property Rights Available:  Several different types of intellectual property are available in Saudi Arabia:

  • Patents;
  • Layout designs of integrated circuits;
  • Plant varieties;
  • Industrial designs (or models);
  • Trademarks; and
  • Copyrights

No utility models are available.

Term of Protection:  The term of protection for intellectual property available in Saudi Arabia is provided below:

  • Patents – 20 years from the national date of filing or from the PCT filing date;
  • Layout designs of integrated circuits – 10 years;
  • Plant varieties – 25 years from date of filing for trees and grapevines; 20 years for other agricultural products; and
  • Industrial designs (or models) – 10 years

Legislation:  The main legislation covering patents, layout designs of integrated circuits, plant varieties and industrial models is Law no. 159 on the Protection of Patents, Layout Designs of Integrated Circuits, Plant Varieties and Industrial Models (Law No. 159).  Law No. 159 was promulgated by Royal Decree No. M/27 of 29/5/1425H on July 17, 2004.  This law contains 6 Chapters and 65 Articles.  The chapters are broken out as follows:  Chapter One (Articles 1-42) on General provisions, Chapter Two (Articles 43-48) on Special Provisions Governing Patents; Chapter Three (Articles 49-53) on Provisions Governing Layout Designs of Integrated Circuits; Chapter Four (Articles 54-58) on Provisions Governing the Protection of New Plant Varieties; Chapter Five (Articles 59-60) on Special Provisions Governing Industrial Designs; Chapter Six (Articles 61-65) on Concluding Provisions.

Note:  Saudi Arabia is not a member of the International Union for the Protection of New Varieties of Plants (UPOV).

Types of Patents available: 

  • Patents of invention; and
  • Divisional patent applications.

What types of inventions are not patentable?  Inventions that are not patentable include:

  • Discoveries, scientific theories and mathematical methods;
  • Aesthetic creations (such as literary, dramatic, or artistic works);
  • Schemes or methods for performing a mental act;
  • Games or business methods;
  • Presentation of information;
  • Plant varieties, animal species and biological methods of producing plants or animals, with the exception of microorganisms, non-biological and microbiological processes;
  • Surgical or therapeutic methods of treatment* applied to humans or animals and methods of diagnosis applied to humans or animals, with the exception of products used in any of these methods; and
  • Computer programs (but which can be protected by a copyright).

*Methods of treatment claims cannot be reformulated into Swiss-type claims.  However, such claims can be reformulated into the “product-for-use” type form permitted under the European Patent Convention (EPC) pursuant to the EPC2000 convention.  In addition, second medical use claims are permitted provided that such claims are formulated into the “purpose-limited-product” claim format.

Claims directed to specific dosing regimens are considered to constitute method of treatment type claims and are generally not patentable.  While claims to specific doses or formulations are permitted, claims directed to the frequency of dosing are not permitted.  Depending on the disclosure in the application, certain subject matter relating to dosing regimens may be patentable depending on how such claims are presented.

Additionally, certain subject matter which is considered contrary to public morals is not patentable in Saudi Arabia.  For example, inventions relating to embryonic stem cells (ESC) may fail a review by an ethical committee which evaluates subject matter as part of the examination and granting process. While ESCs or methods/processes of obtaining/using the same may not be patentable, it is possible to obtain patents relating to the use of pluripotent stem cells, their differentiation, and methods or processes thereof.

Moreover, SAPO does not consider patentable naturally occurring products, including genes and proteins.  However, novel methods or processes for isolating, purifying and using such naturally occurring products can be patented.  Modified genes and peptides can be patented as products as well as antibodies or fragments thereof, including primers and/or probes.

Claims directed to the in vitro or ex vivo diagnosis constitute patentable subject matter.  With the lack of any specific guidelines around the patentability of personalized medicine-type patent applications, obtaining in vitro or ex vivo results for developing a medical use are patentable.

Other restrictions on patenting inventions:  Patent protection will not be granted if the commercial exploitation of the invention contradicts the Sharia law or is harmful to human or animal life, public health, or is substantially harmful to the environment.  Examples of such inventions include alcoholic beverages and methods for producing such beverages.

What are the requirements for patentability?  To qualify for a patent, an invention must be:

  • New (Possess Novelty): Absolute novelty is required.  In other words, the invention must not have been made public in any way, anywhere in the world, before the filing or the priority date.
    • Exceptions:
      • If the disclosure of the invention occurred six months prior to the date of filing the application or the priority claim as a result of abusive acts against the Applicant or his predecessor; or
      • If the disclosure of the invention occurred as a result of the displaying of the invention at an officially recognized international exhibition in a country that is a member of the Paris Convention during the year preceding the filing of the application for the patent.
  • Possess Inventive step: An invention involves an inventive step if, when compared with what is already known in the art, it would not have been obvious to someone skilled in the relevant field.  An Examiner will use the closest prior art identified during a prior art search.
  • Possess Industrial applicability: An invention must be capable of being made or used in some kind of industry.

Written Description and Enablement:  According to Article (11) of the implementing regulations of the Saudi patent law, the specification must include a title, an abstract, full description, claims and drawings.  One peculiarity about the Arabic translation of an application first filed outside of Saudi Arabia involves scientific names, abbreviations and references.  Specifically, according to the provisions of Article (12) of the implementing regulations:

  • A scientific term will be written in its original language with the Arabic synonym when used for the first time in an application. Subsequently, the Arabic name will only be given, except in the claims where the term will be repeated in both languages;
  • When abbreviated names are used in a foreign language, the full name in both Arabic and English will be mentioned when used for the first time in the application. Subsequently, the abbreviation only will be given;
  • Symbols, units, names and basic physical constants approved by the International Union for Pure and Applied Physics (IUPAP), the SUNAMCO Committee, published in the Union Document No. 25 will be adopted;
  • Latin letters will be used in accordance with the IUPAC System for writing structural figures and chemical formula, symbols of chemical elements, compounds, and names. If a chemical name appears in the title it will be written in both Arabic and Latin; and
  • References, research papers, articles and scientific books will be written in their original language.

Claiming Priority:  Saudi Arabia has been a member of the Paris Convention since 2004.  As a result, Applicants can claim a right of priority by filing a corresponding Saudi patent application within twelve months of the earliest filed patent application.

Patent Cooperation Treaty (PCT):  Saudi Arabia became a member of PCT on August 3, 2013. SAPO began accepting PCT national phase applications as of February 3, 2015 (for PCT applications filed on or after August 3, 2013). The official fees of national phase applications are the same fees of regular applications. The documents required at the time of filing are the patent text in English and Arabic as well as the details of the PCT application.

Types of Claims Permitted:  Product and process claims are acceptable. When a patent is granted for a process, any product made directly by such a process is also protected.

Patent Application Workflow:  After filing, a formal examination is conducted.  If the application fails to meet the formal requirements, a notice will be issued giving the Applicant 90 days to complete (or correct) the formal requirements.  Once all the formal requirements have been complied with, SAPO will issue a notification, usually within 18 months from the date of national entry, for publication and requesting substantive examination. One peculiarity at this stage is that once this notification is issued, it is no longer possible to file any amendments to the claims or specification until the first search and examination report (Office Action) is issued. Upon payment of the examination fees, the application is transferred to the Examination Department and assigned to the proper art unit.  As mentioned previously, Examiners at SAPO are trained in the various arts.  During substantive examination, the Examiner will assess the application for patentability (namely, determining whether the application possesses novelty, inventive step and industrial applicability).  If the Examiner believes that the invention is not patentable, he or she will issue an Office Action setting a 90 day period for response (with no extensions of time available).  Applicant will be allowed to present arguments and claim amendments in response to an Office Action.  An Examiner will issue up to three Office Actions. If, after the third response filed by the Applicant the Examiner is still not convinced that the claims are patentable, then a final rejection will be issued and the decision published in the Official Gazette.

An Applicant can appeal a final rejection by filing a case with the Patent Committee (Committee), which resides at KACST. The Committee is formed of three law specialists and two technical experts.  Specifically, the Committee has jurisdiction over:

  • All disputes and appeals against decisions issued in connection with protection documents (meaning all intellectual property matters including patents); and
  • Penal lawsuits for violations of the provisions of the Law and its Implementing Regulations.

The Committee’s decision may be appealed to the Saudi Board of Grievances. The Saudi Board of Grievances (the Grievance Board), known in Arabic as “Diwan Al Mazalem”, was established pursuant to Royal Decree No. M/51, 17 Rajab 1402 [10 May 1982] (the “1982 Decree”) as an independent administrative judicial committee responsible directly to the King of Saudi Arabia. The Grievance Board comprises three levels of courts:

  • Administrative Courts – which are the lowest courts and have powers equivalent to those of a first instance court, the decisions of which can be appealed to the Administrative Courts of Appeal;
  • Administrative Courts of Appeal – the decisions of which can be appealed to the High Administrative Court; and
  • High Administrative Court – which is the highest court of the Grievance Board and has powers equivalent to those of a cassation court (no further appeals are available from the High Administrative Court).

 Once the Examiner determines that the claims are allowable, the Applicant will receive a decision of grant setting a 90 day period for payment of the grant and publication fees.    After payment, the patent will be granted in approximately 90 days and published in the Patent Official Gazette.  As will be discussed further below, no oppositions are provided under Saudi patent law.

Patent Term Adjustment (for delays in patent examination caused by SAPO):  No.

Annuities:  Payment of a yearly annuity is required, even while the application is pending.  Annuities are due within the first three months of each calendar year following the year the patent application was filed.  There is a three month grace period for late payment which also requires the payment of a surcharge. Annuity payments are also due for PCT national stage entries whereby the 1st and 2nd year annuities will become due the year following the national filing date. In most cases, the 3rd annuity will be due at that time as well.

Divisional applications:  If an application contains two or more inventions (such as where a lack of unity exists), an Applicant may submit a divisional application any time before receipt of a decision to grant or reject the application.  Additionally, it is possible to file a divisional application even if a lack of unity rejection is not raised.  However, depending on the scope of the claims between the parent and the divisional, a double patenting objection may be raised.  A divisional application will have the filing date of the original (parent) application. Divisional applications can only be filed off of a parent application.  In other words, a divisional application filed from another divisional application is not permitted.

Oppositions:  No opposition procedure is provided under Saudi patent law. However, once a patent application has published and issued, any interested third party may request invalidation (nullification) of the patent by filing a petition with the Committee.  The allowable grounds for an opposition include non-compliance with any of the articles of Saudi Patent law (e.g., lack of novelty and/or inventive step, etc.).  An invalidation action can be filed by a third party anonymously and be submitted in name of a law firm or attorney.   Generally, an invalidation action takes approximately six to twelve months, depending on the number of experts used.  If an invalidation action is initiated by a defendant in an infringement suit, the defendant can request that the infringement case be stayed pending the outcome of the invalidation action.

Third party observations:  Not available.  Since patent prosecution in Saudi Arabia is not publicly accessible, it is not possible for a third party know what application is pending or to submit any arguments during prosecution.

Searching for Saudi Arabian patents:  Patent searches are available at the SAPO via a formal request.  It is also possible to search informally using the on-line database. However, searches are limited to granted and published patents.

Working and Compulsory Licensing:  Patents must be worked in Saudi Arabia.  If a patent is not fully exploited, i.e. used, sold, imported, manufactured, filed for marketing approval, etc. by a Patentee within 4 years from the filing date of the application or 3 years from issuance, the patent can be subject to compulsory licensing.  To date, not a single compulsory license has been granted in Saudi Arabia.  A third party wishing to obtain a compulsory license will have to demonstrate that it attempted to obtain a license from the Patentee in good faith and failed.  Alternatively, if, in the opinion of the government, there is a dire need for use of the claimed subject matter of the patent (such as supply, cost, etc.), then a government issued compulsory license may be provided to a capable third party.  Again, an attempt must be made to obtain a license from the Patentee in good faith with no agreement being reached.  A compulsory license may be canceled if the conditions for its requirement are no longer in effect.

Bolar exemption:  Yes; 24 months before patent expiry.

Patent Term Extension:  No.

Data Exclusivity: Yes – 5 years.

Patent Linkage:  Based on circular letter no. 7448 dated February 2, 2013 (1434 Hijri years), the Saudi Food and Drug Authority (SFDA) does not allow generic drug companies to file for marketing authorization (MA) prior to 24 months before the expiration date of a relevant patent that covers the innovator drug in question.  Moreover, the SFDA will not approve any generic drug MA unless any relevant patents covering the drug have expired.  The first applicant for a generic drug must provide a letter from KACST and the Patent Office of the Cooperation Council for the Arab States of the Gulf (GCCPO) stating whether any patent(s) has been granted for the innovator product, if such a patent(s) exists, provide the expiration date.

Miscellaneous:  On April 13, 2018, the KACST and the European Patent Office (EPO) signed a memorandum of understanding (MOU) with respect to various patent activities relating to patent procurement.  The aim of the MOU is to strengthen the patent system in Saudi Arabia by increasing bilateral cooperation between Saudi Arabia and the EPO in the field of patents. Additionally, the MOU contemplates joint activities in the areas of patent procedures, search, examination and automation, as well as the use and exchange of patent data and databases. With this MOU, Saudi Arabia has demonstrated its commitment to develop and establish a robust patent system as well as its awareness of the strategic importance of patents in the country’s economic development.

This post was written by Lisa Mueller and Namir Sioufi of Saba IP.