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Introduction

In my 14 years as an intellectual property attorney (1986 to 2000), I have helped researchers in their quest to protect the fruits of their research. The task of seeking protection of intellectual property rights (IPRs) created in the course of research and the commercialization of inventions can become costly, tedious, and, at times, not even viable because of the time lag from the bench to the marketplace.

Unlike their counterparts in other countries, most Asian researchers generally regard IPR protection as an afterthought rather than as an important consideration in research planning. With the lack of understanding there is usually no proper IPR strategy, which includes proper documentation of all invention. IPR protection becomes very tedious and costly and at times impossible due to prior disclosure or filing by third parties.

What Are Intellectual Property Rights?

In Singapore, IPRs can be classified into patents, copyright, trademarks and tradenames, confidential information, registered designs and geographical indications, and circuit layouts. In the context of biotech inventions and discoveries, the two most relevant forms of IPRs are patents and confidential information. Patent protection can only be secured by filing and obtaining an official patent in each and every country around the world. Confidential information, on the other hand, can only be protected by contractual obligation. The owners of any confidential information must sign an agreement generally known as an NDA (Non-Disclosure Agreement) to ensure that any confidential information is protected.

Biotech Patenting in Singapore

Under the patent laws of most countries, only new and nonobvious products and processes are patentable. Scientific discoveries are not patentable per se. Vague distinctions, particularly in the area of gene discoveries, have led to much controversy in the biotech industry. Some have argued that genetic information is part of nature and therefore not patentable. Under the common law regime of which Singapore is a part, it is very doubtful that the patent office will grant a patent for any specific gene.

Singapore does not have an examination office like in the United States. The Intellectual Property Office of Singapore (IPOS), a new statutory body formed by the government, is only a receiving office. It receives applications filed in Singapore and sends these for examination in Australia or Austria. An applicant may choose to have their application examined by the U.S. Patent and Trademark Office if there is a U.S. interest. In the absence of U.S. connectivity, an applicant may only proceed with a U.S. direct filing if a waiver is obtained from the IPOS to do so.

Is Patent Filing Essential for Biotech Inventions?

This depends primarily on two considerations: the nature of the invention and the commercialization strategy. Keeping the information confidential may best protect certain biotech inventions such as a specific formulation of a new compound because in a patent application, the formulation must be fully disclosed. With the disclosure and publication of the patent, others can easily copy it. In the particular case of formulation, it is generally very difficult to establish conclusively whether a rival product is a copy of your formulation in a patent litigation. However, if the commercialization strategy is to license the formulation to others for manufacturing and sales, it may be prudent, and at times necessary, to file for a patent as the licensees may request that applications be filed for protection.

Cost may be an additional consideration. The estimated cost of filing and securing a single patent in major markets is approximately US$100,000 to US$200,000 for a simple, uncomplicated patent. This cost will be incurred over a period of 3 years from the date of filing. If you do not have the budget to file, in most markets it may be advisable to keep the invention confidential instead of fully disclosing it and allowing competitors to have full access.

IPR Issues That Researchers and Biotech Start-ups Should Address

IPR issues must be addressed from very early days. In fact I would recommend that they be addressed from DAY ONE!!

The following are important issues:

a. IPR survey

If the objective of the researcher is to address a problem or seek scientific discoveries with a view to commercialize them, it is imperative that a world IPR survey be conducted. The survey should be conducted in commercial, research, and patent databases. In the case of a commercial survey, the most cost-effective way is to search through a good search engine. My favorite is Copernic.com. Commercial biotech sites, such as www.biospace.com, provide excellent information on areas of interest as well. Survey of research communities for published papers, articles, and press releases of researchers may be conducted at various Web sites of key biotech research institutes such as the U.S. National Institutes of Health, or sites of key biotech publications such as Nature and Science . The patent survey is the most crucial of the three. Searches should be conducted at the databases of the key examination offices; in particular, the U.S. Patent and Trademark Office, the World Intellectual Property Organization, and the European Patent Office. In Singapore, searches can be conducted at http://www.epatents.gov.sg/PE/. In the case of a patent search, it should be noted that the search is only for published/granted patents. As there is generally a 2-year lag time in the grant process, one may not be able to get the latest technology scene from the search. Thus a combination of the searches mentioned above is prudent.

b. Ownership issue

Ownership is a very important issue, especially if the researcher intends to embark on commercialization at a later date. I have come across numerous cases where inventions of good commercial potential were not exploited due to an unclear or unfair ownership situation. Under the provisions of the Patents Act of Singapore, inventions created by employees, especially inventions in the areas of the employee's expertise, belong to the employers. As researchers mostly work as employees in research institutions and establishments, they generally do not have a share of the IPRs in the inventions unless otherwise agreed. Until very recently, most of these institutes and establishments have not had clear policies and guidelines on the sharing of benefits of such inventions. In the case of Ph.D. students, the position is even less clear as they are not employees of the educational institutes. Unless the terms and conditions of enrollments have specified otherwise, it can be argued that inventions created by the student belong to the Ph.D. student instead of the institute.

c. Burden of proof

In the process of seeking protection of inventions, the burden is on the inventor/owner to prove creation. At times proof is also needed in the patent application process. Many inventors may find difficulties producing proper documentary evidence when required to do so several years after the commencement of research. Such inabilities may prove fatal to any claims. Hence it is important to establish proper procedures and documentation processes to avoid such problems. Important research data should be properly logged and signed by the parties involved and stored securely. Any signed agreements relating to the disclosure, collaboration, or licensing of the IPRs must also be kept and treated as important assets of the company. Having proper documentation of the inventions, in particular the research methodologies and protocols, will render the job of professionals like patent attorneys much easier and hence allow significant cost savings in IPR audits or patent filings.

d. Disclosure and access policy

This should be considered as well to ensure that there is no unauthorized access or disclosure under circumstances that may be detrimental to the protection of the IPRs. The best approach may be to have a standard operating procedure dealing with all matters relating to IPRs. Many companies have suffered damaging IPR thefts because access to important IPRs was not properly controlled or because employees of the company disclosed information. It is common practice that employees, consultants, and agents of a company sign an NDA and IPR agreement before being allowed access to the company's IPRs.

e. IPR audits

As most researchers are not legally trained and may not be well versed with IPRs, it is wise to constantly educate the researchers on such issues. Trained professionals can be brought in to conduct regular audits of the research results and ensure that no worthwhile inventions are inadvertently neglected or lost. The audit frequency can be timed with the business and funding milestones of the company. In this way, the economic value of the company can be enhanced as it is able to show a progressively growing IPR portfolio.

f. IPR expenses budgeting

A biotech company may spend up to 20% of its capital handling IPR protection issues. Such expenses include the IPR survey, audits, legal fees, advice on IPR, hiring of an in-house attorney, and patent filings. As the quantum involved is fairly significant, the company should prepare a separate budget. Since IPR protection is a continuous process, it is advisable to prepare a 3-year budget plan. With the proper budget, the company will not be caught with insufficient funds for this very crucial aspect of the company.

Conclusion

I believe that for Singapore and many Asian countries to succeed in this race to become successful biotech players in the international market, a change in mindset of the entire value chain is necessary. The researchers must pay more attention to IPR protection in addition to science. The institutions have to be more generous with the sharing of IPRs created by the researchers with the researchers and the private industry. Most important of all, the Asian investment communities must place greater value in IPRs and accord sufficient funding to biotech start-ups in order for them to secure international IPR protection.

*Alex Thian is a co-founder and chairman of Research Biolabs, which is a fully integrated life science biomedical company, focusing on products distribution, genomic services, and molecular diagnostics. Alex Thian practiced as an advocate and solicitor in Singapore from 1987 to 2000, specializing in intellectual property and technology practice. His main areas of practice were international protection of intellectual property rights, corporate structuring of technology investments, and commercialization and exploitation of inventions. Mr. Thian was the external legal advisor to the Singapore Productivity and Standards Board from 1990 to 2000. He was also legal advisor to the Institute of Materials Research and Engineering (Singapore) and 1-Net Singapore Pte Ltd.