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Compilation of herbal plants (description, geographical distribution, taxonomy, line drawings), biodiversity and herbarium.

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Description of herbal and T&CM research, searchable publication and process from medicinal plant discovery to clinical trial in producing a high-quality registered herbal drug.

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Patents

What is a Patent?

Patents are monopoly rights granted by governments for inventions for a minimum of 20 years from the filing date and upon payment of maintenance fees, the patented invention is then released into public domain. The grant of exclusive rights for a limited period serves as a reward and an incentive for inventive activity. By virtue and in return for the patent granted, the patent holder’s invention is securely revealed to the public as a technological advancement to be enjoyed by society. The Patent Offices will lay open the patent holder’s application to public inspection for 18 months from the earlier of either  

  • the filing date in the country of registration; or
  • the filing date abroad under an international treaty (the ‘priority date’). 

While the application lays open, the public may read the full description of the invention but may not make, use or sell the invention without the inventor’s permission. The basic purpose of a patent system is to encourage innovation and the improvement of industrial techniques and to promote the sharing of technological information.   Most countries have their own patent systems which result in different terms of patent protection and types of patents. For instance, in some countries, certain inventions may fail to meet the requirements of an ‘inventive step’ necessary for patentable inventions. Such innovations are still valued and rewarded by recourse to registration as ‘utility innovations’ or ‘utility model’ and because the requirements for their registration are less rigid than patentable inventions, the period of protection given is usually significantly shorter.

 

Patentable Inventions

Emphasis is given to the fact that what may be a patentable invention in one country may not be defined as patentable in another.  For example, the US is relatively relaxed (subject to the conditions and requirements of US law) and anyone who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent.”  Most other countries have a patent system similar to Malaysia, which states that an invention will be granted patent protection, based on the following criteria:

  • It is new, meaning the invention must not have been disclosed anywhere in the world by written publication, verbal disclosure, used or publicly disclosed in any other way. Simply stated, it must be the first in the world.
  • It involves an Inventive Step, meaning the invention must not be obvious to a person having ordinary skills in the appropriate technology, having regard to what was known before the priority date of the application. Simply stated, it must show inventive ingenuity.
  • It is industrially applicable, meaning the invention can be made or used in any kind of industry, including agriculture and service industries. Simply states, it must be useful.

 

 

Patent in the Context of Traditional Medicine

The law states that if an invention is to be patentable, it must generally satisfy three key criteria:

  • The invention must be New/Novel. It should not have previously been made known to the public in any way, anywhere in the world.
  • The invention must involve an Inventive Step. It must be something that represents an improvement over any existing product or process.
  • The invention must be Capable of Industrial Application. It must be useful and have some form of practical application in a particular industry.

Most inventions manage to meet these requirements easily but because herbal medicines consist of crude plant materials, such as leaves, flowers, fruits, seeds, stems, wood, bark, roots and other plant parts which may be in entire, fragmented or powdered form, its chemical entities make it difficult to satisfy the legal criteria of novelty, inventiveness and industrial applicability.  In one US case, the United States Patent and Trademark Office (USTPO) granted US Patent No 5,401,504 in respect of turmeric which was used for many years by the Indians for medicinal and other purposes. This Patent covered the use of turmeric in wound healing. During a re-examination of the patent claims, the claims of the use of turmeric in wound healing were ultimately cancelled for lack of novelty because the claims had been previously documented in Indian publications.

Furthermore, since herbal products are powdered herbal materials or extracts, tinctures and fatty oils of herbal materials produced by steeping or heating herbal materials in alcoholic beverages and/or honey or in other materials, their production process is usually simple, hence falling short of the inventiveness criteria.

The Funk Seed Case serves to remind us that products found in nature are not patentable.

 

 

Patent FAQs

What is ‘patent prosecution’?

Who may apply for patent protection?

If my employee or contractor invents or develops something, do I have the patent to his invention?

If two or more persons work together to make an invention, who is entitled to the patent?

What is a priority date?

Why is priority date important?

What happens to my invention after my patent expires?

When should patenting be considered?

Is there any alternative protection to patenting?

How long is the protection given?

What is the royalty rate for the use of a patented product?

What should I consider before filing an application for a patent?

What do I need to file an application for a patent?

How do I conduct a patent search?

Who are the online information providers?

What is the difference between a patent attorney and a patent agent?

Will my patent granted in a country protect my invention throughout the world?

Can I file just one international application?

If I am granted a patent, can the right be subsequently challenged?

What is ‘patent prosecution’?

Patent prosecution means the preparation and filing of a patent application with the local Patent Registry or Office.

Who may apply for patent protection?

Either alone or jointly, any person may make an application to patent an invention. However, unless the inventor has assigned the rights to the invention to the applicant, or the applicant derives title to the invention from the inventor, the rights shall belong solely to the inventor or inventors.

If my employee or contractor invents or develops something, do I have the patent to his invention?

Yes, if the invention was made in the performance of such contract of employment or in the execution of such work, and there is no agreement to say otherwise.

If two or more persons work together to make an invention, who is entitled to the patent?

This depends on each party's role in the making of the invention.  If each party has contributed ideas to the invention, the law recognises that they are joint inventors, and the patent will be granted to them jointly.  If, on the other hand, only one party provided all of the ideas to the invention, and the other merely executed the former's instructions to make it, then the person who contributed the ideas is the sole inventor and the patent will be granted to him alone

What is a priority date?

 Unless priority is claimed from an earlier application, a priority date normally refers to the filing date of the application. In other words, a priority date is the date of the first application for the patenting of the invention.

Why is priority date important?

Establishing the priority date is important for the following reasons: 

  1. The technical information contained in the application can be published only after the priority date.
  2. Novelty and inventive steps are judged in comparison to information already in the public domain at the priority date.
  3. Foreign applications can be filed within 12 months following the priority date, which means that the foreign application will be backdated to the date of filing of the first application.

What happens to my invention after my patent expires?

Once your patent expires, the protection ends, and your invention enters public domain. This means you will no longer hold exclusive rights to your invention, and it becomes available to commercial exploitation by others 

When should patenting be considered? 

Patents should be filed as soon as possible, but no later than 12 months after disclosure.  Disclosure causes the information about the invention to become public and fall into the realm of prior art which defeats the purpose of a patent application.

Is there any alternative protection to patenting?

The following are alternative protections to patenting:

  1. Protection under the laws of confidentiality
  2. Protection under the laws of trade mark
  3. Protection under the laws of design

How long is the protection given?

Generally, the life of a patent is 20 years from the date the application was first filed. In the case of Malaysia, the life of a patent is 15 years from the date of its grant for applications filed on or before 1 August 2001. For applications filed in Malaysia after 1 August 2001, the life of the patent is 20 years from the date of filing of the applications. To keep the patent in force, payment of maintenance fees throughout its life is required.

What is the royalty rate for the use of a patented product?

There is no standard or average royalty rate, and there are no definite rules about how to determine it. The royalty rate depends very much on the market forces for the patented product, as well as the negotiation skills of the owner of the patent, as well as the licensee.

What should I consider before filing an application for a patent?

Upon developing a new product or process, the following considerations should be observed before filing an application for patent right protection:

  1. A search of previously published patents and patent applications, printed publications and websites to determine whether a ‘prior art’ exists.
  2. Whether there is a market for your invention - It would be futile to spend time and money to patent an invention if there is little opportunity for exploitation.

Once you have determined these two points, the issue of patenting should be considered as an integral part of your overall business strategy, alongside factors such as profit potential, finance, production, and marketing.

What do I need to file an application for a patent?

A patent application must include

  1. an application form,
  2. a description of the invention,
  3. an abstract of the invention,
  4. a claim or claim(s) of its uses,
  5. any drawing referred to in the description, and
  6. the requisite filing fee.

How do I conduct a patent search?

There are different categories of searches:

  1. Novelty search – to determine whether a concept is novel or new, which means the product or process must not be known anywhere in the world.
  2. Assignee search – to discover the rightful owner of the patented product or process.
  3. Infringement search – to uncover any patents that might be infringed by the proposed device or conduct in question.

Searches may be conducted manually, which entails searching at the register of the local Patent Registry or Office (also known as the ‘traditional search’). They may also be conducted online, which means logging in with the online information providers. Either way, these searches will help you avoid costly duplication of R&D.

Who are the online information providers?

  1. One site to consider is the IBM patent searching site, which contains over 26 years of US Patent & Trademark Office (USPTO) patent descriptions, as well as images dating back to 1980. The first entries date back to 5 January 1971. You can search, retrieve and study over two million patents.
  2. The World Intellectual Property Organization also provides free searching of PCT patent applications, from 1998 until the present.
  3. The European Patent Office provides databases consisting of European (EP) patents, PCT (WO) patents, worldwide patents, and Japanese patents.
  4. Another resource is a search site provided by the US Patent and Trademark Office. This site offers two databases - one database containing full-page images, and a second database providing bibliographic content (title, inventor, dates, abstract, citations) which may help with some types of searches.
  5. Others include CompuServe, Lexis, dialog information services, and Derwent.

What is the difference between a patent attorney and a patent agent?

In the United States, a patent attorney is defined as someone who is

  1. Admitted to practice before the courts of at least one state in the US, and
  2. Admitted to practice before the US Patent Office.

A patent agent in the United States, on the other hand, is someone who is admitted to practice before the US Patent Office, but has not provided any proof to the US Patent Office that he or she is admitted to practice before at least one court in the United States. 

In Malaysia, only a registered patent agent may represent a client in a proceeding before the Intellectual Property Corporation of Malaysia. In order to be registered with the Patent Registration Office, this person shall have to satisfy three criteria:

  1. He is domiciled in or is a permanent resident of Malaysia.
  2. He is an Advocate and Solicitor of the High Court of Malaya, or has a relevant degree or its equivalent in an appropriate branch of engineering or science from an approved institution of higher learning, or has qualifications entitling him to graduate and have a membership of an approved professional engineering or scientific institution.
  3. He has passed the examination set by the Board of Examiners established under the Patent Regulations 1986.

Will my patent granted in a country protect my invention throughout the world?

Each country has its own patent system, which makes patent right protection territorial.  Thus you would have to apply for and obtain patent protection in each country where patent protection is sought. 

Can I file just one international application?

Yes, if you are a national or resident of a Member State of the Patent Cooperation Treaty, which simplifies and reduces the cost of obtaining international patent protection; otherwise you will need to file separate applications in each required country.

If I am granted a patent, can the right be subsequently challenged?

A search by an examiner will be made of previously published technical literature. These are available in patents documents in the local Registry or Office and other major overseas Registries or Offices such as the US Patent and Trademark Office, United Kingdom Patent Office, the Patent Cooperation Treaty and European Patent Offices. Subsequently, if ‘a prior art’ is discovered following the grant of the patent, the patent in question may be invalidated. A Court can declare a patent invalid upon a successful challenge by a third party.

 

Non Patentable Inventions

Generally, patents are available for all fields of technology.  However, some countries exclude certain fields of technology from their federal laws.  The following are some examples:

  • Discoveries of materials or substances already existing in nature
  • Scientific theories or mathematical methods, abstract principles, fundamental truths, calculation methods, and mathematical algorithms
  • Plant or animal varieties, or essentially biological processes for the production of such, other than microbiological processes
  • Laws of nature, newly discovered or otherwise (for example, the law of gravity)

In Malaysia, the following inventions are specifically not patentable:

  • A discovery, scientific theory, or mathematical method
  • Plant or animal varieties, biological processes for the production of plants or animals (other than man- made living micro-organisms)
  • Schemes, rules or methods for doing business
  • Performing purely mental acts or playing games
  • Methods for the treatment of human or animal body by surgery or therapy
  • Diagnostic methods practised on the human or animal body (Australia and United States are among the few jurisdictions that protect such methods)

A discovery of nature is not patentable.  The US case law Funk Bros. Seed Co v. Kalo Inoculant Co 75 USPQ 280 (1948) is the first major case to deal with this issue.  In this case, the product claimed in the patent was a composite mixture of six strains of bacteria packaged for use to inoculate leguminous plants.  The Supreme Court held that claims to the mixture of bacteria, as a product, were not patentable because each of the bacteria existed in nature before, and moreover, their combination was a mere discovery of nature.  Thereafter theFunk Seed Casebecame the landmark case, expounding the general rule that products found in nature are not patentable.

 

International Patent Protection

Patents protection is territorial in nature. It is applicable only in the country of their registration, and there is little recourse against infringers under foreign laws.

Nearly every country has its own patent laws. Anyone who seeks a patent in a particular country must file separately the necessary application in each country desired, prior to which, a  written approval must be obtained from the local authority. For example, under US law, if an invention is conceived in the United States, it is necessary to obtain a license from the Director of the United States Patent and Trade Mark Office before applying for a patent in a foreign country. Similarly, all residents in Malaysia must obtain a written authority from the Intellectual Property Corporation of Malaysia before they may file an overseas application for the same invention.

To ease this process, various international agreements have been concluded such as the Patent Cooperation Treaty (PCT), which simplifies the patenting of the same invention in more than one country. Countries which are members of the Paris Convention will allow a foreign patent application to be filed within 12 months of the date of the first application, and the date of first filing in the original country will be taken as the priority date.

Malaysia acceded to the Patent Cooperation Treaty (PCT) on 16 May 2006 and the PCT system came into force on 16 August 2006. Hence, effective from 16 August 2006, one can file a PCT international application by completing form PCT/RO/101 accompanied with patent specifications and payment of a prescribed fee. at the Intellectual Property Corporation of Malaysia (MyIPO) Office.

The PCT is an international treaty, administered by the World Intellectual Property Organization (WIPO). The PCT makes it possible to seek patent protection for an invention in more than one country (which are members of PCT) through a single patent application only, thus doing away with the strenuous exercise of filing several separate national patent applications. The PCT is a patent filing system, and does not offer universal protection or grants international patents in each member country. The granting of patents remains under the exclusive control of the individual national patent Office of each member country.  

Briefly, the PCT application procedure requires at its initial stage, the filing of an international application (complying with the PCT formality requirements) and payment of a prescribed fee with the Receiving office. In Malaysia the Receiving Office is the Intellectual Property Corporation of Malaysia (MyIPO). The international application is then subjected to an "international search” by the International Search Authority (ISA). In Malaysia, an applicant can elect either the Korean Patent Office, the European Patent Office or the Australian IP Office as the ISA. The applicant is required to indicate in the application form the preferred ISA to conduct the “international search”. The ISA will then issue an International Search Report (ISR) with a listing of published documents that may affect the process of the international application. The report also includes a written non-binding opinion on patentability of the invention.

The international search report will then be published by the International Bureau of WIPO shortly after the expiration of 18 months from the earliest filing date. The written opinion will not be published.

The next stage of the PCT filing is known as the “national phase” which must be entered before each of the selected designated Offices by paying national (or regional) fees and complying with requirements of the respective national laws. The applicable time limit for entering the national phase can be 20, 21, 30 or 31 months,   from the priority date or any other time limit depending on the requirements of the national laws of each of the designated Offices. The applicable time limit for entering the national phase is availabe from WIPO’s Internet site at http//www.wipo.int/pct/en/index.html.

Monopoly Rights

A patent holder is generally given the exclusive right to stop others from making, using, selling, offering to sell, or importing the patented invention in question, as long as any of these take place in the country of protection, during the term of the patent.  In most jurisdictions, patent infringement is a civil action and infringers can expect civil action to be taken against them by the patent holder.  

Once a patent is obtained, it gives the patent holder the right to

  • sell his patent rights or license some or all of his patent rights, granting him royalty payments and also an initial license fee to him;
  • stop others from making, using, selling, or importing his invention without his permission; and
  • take legal action against others for infringement of his invention, and to demand compensation from the unauthorised use of his invention.

Patents are granted to an inventor or inventors if there is no bar to such registration.  For instance, an inventor will be barred from receiving a patent if the rights to the invention have been assigned to another party such as the inventor’s employer or someone else with a title from the inventor.  Where two or more persons are jointly granted a patent, then subject to any agreement to the contrary, each of them is entitled to separately assign or transmit their rights in the patent application or patent, exploit the patent invention and take action against an infringer.  However, subject to any agreement, none of them may withdraw the patent application, surrender the patent or grant a license under the patent without the consent of the other joint owners.

IPR laws make use of certain systems and they vary across the continents.  In the US, the first person to invent the claimed subject matter will be granted the patent, even if he was not the first to file a patent application (‘first-to-invent system’).  In other countries, the adverse holds true when, provided with fulfillment of the statutory criteria, the patent will be awarded to the first person who files the patent application, regardless of whether he was the first to invent the subject matter (‘first-to-file system’).

 

International Application Process

There is no such thing as a 'world patent' but there is an ‘international’ patent application.

To file an international application, there are generally two choices:

  • To file separate patent applications in each country (Paris Convention Application)
  • To file a single international application (Patent Cooperation Treaty Application) and select the countries (including one’s own) where one wants to file for patent protection

A Patent Cooperation Treaty (PCT) international application is useful when applying for patents in a number of different countries simultaneously. Remember, it is important to file the foreign application within 12 months of the priority date, as failure to do so may jeopardise the application.

Explore Further

Consumer Data

Consumer data including medicinal herbs, dietary supplement monographs, health condition monographs and interactions and depletions.                                    

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Professional Data

Professional data organized into medicinal herbs, dietary supplement monographs, health condition monographs, T&CM herbs, formulas, health conditions, interactions and depletions.

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International Data

We offer International linkages to provide extensive content pertaining to many facets of T&CM as well as Integrated Medicine. Please register for access.    

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