Myriad Beyond The US: Patent Eligibility Of Genes In Australia, New Zealand And South East Asia

by FPA Patent Attorneys
Contact

This article was first published in the September/October 2013 issue of The Patent Lawyer Magazine http://www.patentlawyermagazine.com/myriad-beyond-united-states/

This article discusses the patent protection of isolated, naturally occurring nucleic acids in Australia, NZ and a number of South East Asian countries. In these jurisdictions there is no express exclusion of these molecules as patent eligible subject matter. This suggests that patent strategy for the protection of these molecules commonly implemented before the US Supreme Court in Myriad, should remain applicable in these countries.

Background

On June 13, 2013, Jim Greenwood, CEO of BIO stated in relation to the Supreme Court decision regarding Myriad’s patents: “The United States is now the only developed country to take such a restrictive view of patent eligibility, signalling an unjustified indifference towards our global economic and scientific leadership in the life sciences”.

So what is the legal position in developed countries other than the US? Is a naturally occurring gene, whether isolated or not, patentable eligible? That’s the question that we consider here, at least insofar as Australia, New Zealand and South East Asian countries are concerned.

Australia

The relevant legal principle regarding patentable subject matter is that subject matter that arises from artificial intervention, and that has utility in an economic state of affairs is patent eligible. 

This principle was recently applied by the Federal Court in the Australian Myriad trial1 in which the plaintiff alleged that isolated BRCA1 & BRCA2 genes are not patent eligible. The Court held to the contrary: the genes existing in isolated form were found to be patentable subject matter. The isolation of the genes was seen to be a relevant artificial intervention, and the fact that the genes were claimed in isolated form meant that what was claimed was something more than a discovery or law of nature.

The Australian Myriad decision has now been appealed, submissions have been filed by the parties and we await the outcome of the hearing. The Myriad decision of the US Supreme Court will undoubtedly be considered in the Australian appeal proceedings. However, while potentially persuasive, the Court will not be bound by the US decision.    

Speculation as to the outcome of the Australian appeal can be nothing more than that. On the one hand, apart from an exclusion of human beings and biological processes for production of them from patent eligibility (and plant and animal varieties in respect of innovation patents), there has never been an express exclusion of subject matter from patent protection in the Australian statute. On the other hand, it is clear from the recent Raising the Bar legislation that there is an intention to bring threshold for patentability more in line with the US. We see this in the context of the US -type utility test now in the Australian statute, and we wonder whether the same could be expected on the patentable subject matter ground.

New Zealand

Unlike Australia, New Zealand patent law has carved out certain types of technology that involve methods of medical treatment from patent eligibility. The most recent expression from the New Zealand Patent Office suggests that methods of diagnosis are also likely to be considered patent eligible2

Regarding the question of patent eligibility of naturally occurring nucleic acid molecules, while the relevant facts have not been considered in New Zealand, the decisions of the Australian Courts are influential in New Zealand. In the circumstances, and unless there is further amendment to the New Zealand patents Bill, it is possible that the outcome of the Australian Myriad appeal noted above will apply in New Zealand.

In the meantime, the New Zealand Patent Office will happily allow a claim directed to an isolated nucleic acid, whether or not that molecule is otherwise naturally occurring.

Singapore

The Singapore patents legislation does not expressly exclude gene related inventions from patent protection. A claim to an isolated nucleic acid having a sequence occurring in nature must otherwise be novel, non obvious, industrially applicable, not immoral and something more than a discovery.

The Patent Office explains in the examination manual that the ground of morality (an invention the publication or exploitation of which would be generally expected to encourage offensive immoral, or anti-social behaviour is not a patentable invention) is to be dealt with as it has been by the European Patent Office. In the relevant decision3, the EPO considered that while patenting human life would fall foul of the morality standard, a claim covering an isolated gene did not cover human life. It seems therefore that if the Singapore Court applies the same approach as the Patent Office, a claim to an isolated gene having a naturally occurring sequence is patent eligible subject matter.

The Singapore legislation does not exclude discoveries from patent protection although a decision of the Singapore Court of Appeal4 stated "the fact that a discovery is made does not mean there is invention". The examination manual refers to 19th century UK litigation as potentially explaining the meaning of 'discovery' likely to be applied by the Court.

In conclusion, currently there is no legal decision on patent eligibility of isolated naturally occurring nucleic acids, although it seems that the Patent Office will continue to allow these claims and there is some indication as to why the Singapore Court would follow this practice.

Malaysia, Philippines, Vietnam, Thailand & Indonesia

These countries are all signatories to the TRIPS agreement, and a close inspection of the relevant statutory provisions will reveal that each more or less contains some elements of the wording of Art. 27.3 of the TRIPS agreement, which allows signatories to the agreement to exclude patents in specific technical fields:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals, (other than non-biological and micro-biological processes).

Importantly, there are some differences in the wording of the relevant provisions in relation to exclusion of diagnostic methods. As explained in the Table below, for some countries the exclusion seems to be for a diagnostic method, (ie no matter how applied), whereas for others, diagnostic methods practiced on the human body are excluded.

Country

Provision

Text

Malaysia

s. 13(1) (d)

The following shall not be patentable: methods for the treatment of human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body. Provided that this paragraph shall not apply to products used in any such methods.

Indonesia

Art. 7 b.

A patent shall not be granted to an invention regarding: any method of examination, treatment, medication, and/or surgery applied to humans and/or animals.

Philippines

s. 22 (3)

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. This provisional shall not apply to products and composition for use in any of these methods.

Thailand

s.9 (4)

The following inventions are not protected under this Act: methods of diagnosis, treatment or cure of human and animal diseases.

Vietnam

Art. 59 (7)

The following subject matter shall not be protected as inventions: Human and animal disease prevention, diagnostic and treatment methods.

What becomes clear is that the exclusion of various forms of diagnostic methods (and as stated, therapeutic methods) from patent protection, highlights the importance of obtaining patent protection to the products of diagnostic processes, or the reagents that are used in these processes or therapeutic methods. This would seem to be the only way to monopolise a diagnostic or therapeutic method where the relevant method itself cannot be protected by patent. 

It is clear in the above Table that the relevant Malaysian and Philippine provisions do not preclude patenting of products used in diagnostic and therapeutic methods (which would seemingly leave open the potential to obtain patent protection for isolated naturally occurring gene sequences), and none of the statutes expressly state that an isolated naturally occurring gene sequences is patent ineligible. 

Having said this, many of these statutes preclude patenting of ‘discoveries’ and many contain the wording of TRIPS Art 27.2. The latter enables signatories to exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment.

Presently there is no case law on whether a claim to an isolated form of a nucleic acid is likely to take the relevant molecule outside the realm of discovery. There is an indication in the Malaysian Patent Examination Manual5 that this is likely to be so. 

Further, there is no case law on the likelihood of patent protection for an isolated form of a naturally occurring gene sequence being considered contrary to the ordre public. The Malaysian Patent Examination Manual6 identifies various examples of such subject matter, but none relate to biotechnology innovations. Further, according to the Manual: “this provision is likely to be invoked only in rare and extreme cases”.

Finally, presently  the relevant patent offices continue to allow claims directed to isolated nucleic acids having naturally occurring sequences. Given the paucity of litigation, it is too early to know whether this subject matter is patent eligible in these countries, but there are some indications that that this may be so.

  1. Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65
  2. Biosite Incorporated’s Application 532625 (P31/2007)
  3. Howard Florey Institute [Relaxin], V8/94 Relaxin, OJ EPO 6/1995
  4. Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] SGCA 39
  5. MyIPO Guidelines for Patent Examination, paragraph 3.1
  6. MyIPO Guidelines for Patent Examination, paragraph 4.1

 

Written by:

FPA Patent Attorneys
Contact
more
less

FPA Patent Attorneys on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.