Monday, April 27, 2009

Giving True Meaning to “Malaysia Boleh”

I attended an MoU signing ceremony between a private research organization and an European based multinational company recently. It was an honour for me to act as a witness for the signing of this MoU, as well as present a talk at that event.  Since the launch of the National Biotechnology Policy in 2005, we see a mushrooming of ‘biotech’ companies in Malaysia where many label their business as ‘biotech’. This is due to the enormous support provided by the government in terms of funds, financial schemes, tax incentives and special status of deserving biotech companies. Thus, there is a rush to share the ‘biotech’ pie. Sometimes, I feel we need to redefine ‘biotechnology’ to be able include all these companies and cluster them under the biotech industry. We often see wide spectrum of companies ranging from manufacturers of herbal concoctions to the ones producing ‘real biotech’ stuff. However, what I saw during this event gave new hope to the biotech industry in Malaysia. It was a testament that the industry is poised to grow and flourish on Malaysian soil.  
What brought a Belgium based company with a marketing network reaching to 70 nations in the field of animal healthcare, and employing over 700 staff who speak 20 different languages to Malaysia? The pull factor here is a private entity based in Tawau, Sabah which has created its footprint in aquaculture products and research. INVE, the Belgium based company saw great potential in an antiviral drug called RetroMAD1 produced by BioSatria Sdn Bhd for use in aquaculture and livestock industry. BioSatria is a spin-off company of Global Satria Group. The product developed by this company is no ordinary anti-viral. It involves genetic transformation which incorporates 3 different genes into recombinant bacteria to produce an oral-delivery multifunctional fusion protein that hits viral entry, fusion, integration and replication! Of course, the protein refolding is the difficult bit and this will become BioSatria’s drug pipeline platform producing ChAMPs or Chimeric AntiMicrobial Peptides. 

One can only imagine the amount of time, funds, and effort BioSatria spent to be able to develop this anti-viral to its ‘Proof of Concept’ phase…. I understand that more research is being carried out on RetroMAD1 to study its efficacy, safety, and other aspects. A number of trials will be carried out on different animal models to prove viral elimination in mammals as well as poultry. Research is also being carried out to upscale its production in bigger bioreactors. BioSatria’s sister company Defensia S/B will be studying human applications for these new drugs with the University of Malaya. 

RetroMAD1 is a product of a paradigm shift - I would say. It has all the elements that I always preach – research in priority area; private-public collaboration; long-term vision and continuity; market-driven research; and strong fundamental research. RetroMAD1 would not have been a reality if not for all these elements. What is more heartening is that such high-tech product and quality coming from a private laboratory. BioSatria has clearly understood the need of the market and the growing aquaculture industry and its challenges and has stepped into the right direction. Its innovation will not only be available to the Malaysian market but also globally which will be made possible by INVE’s global market reach. BioSatria is now planning to set up a pilot-manufacturing plant in Peninsula Malaysia to produce this oral vaccine. This is certainly a new dawn for the Malaysian biotechnology sector. BioSatria will have its share of contribution towards achieving our national biotechnology agenda in terms of creating more jobs for aspiring biotechnologists and increasing the percentage of GDP from the biotech sector. 

Thumbs up to BioSatria and hope its success, innovation and spirit will be emulated by other biotechnology companies. 

By Mahaletchumy Arujanan

Monday, April 20, 2009

April Fools

How many of you were actually fooled on April 1st? What is the nature of the prank? April Fools is a day whereby pranks and jokes are played on the gullible to varying degrees. Elaborate and well-known pranks include BBC's spaghetti trees documentary in 1957, the changing of Big Ben to analogue, BMW yearly pranks etc.

This sounds odd for a topic on a biotechnology website, but then I would like to focus on a prank I pulled on that particular day on many people in an online forum I regularly haunt. Behind the frivolity of the prank, there is a more serious underlying issue at stake whereby it would be important for us as thinking human beings to look at. Look at the following:

Dihydrogen monoxide:
* is called "hydroxyl acid", the substance is the major component of acid rain.
* contributes to the "greenhouse effect".
* may cause severe burns.
* contributes to the erosion of our natural landscape.
* accelerates corrosion and rusting of many metals.
* may cause electrical failures and decreased effectiveness of automobile brakes.
* has been found in excised tumor

Yes, I pulled a fast one with dihydrogen monoxide, aka water. It was very amusing to look at how people who actually supported a blanket ban on the substance without further research in the first place. Similarly, the wording that was shown above, being used in the online poll I set up, was sufficiently alarmist but yet not untrue about water. Looking at the statements, from your knowledge about water, how can one say the above as being untrue? However, despite so, it would also be ludicrous to suppose that water is a dangerous substance that needs to be banned, on the contrary to what is being assumed, water is a life-giving substance which is important to every living being.

It is important to note that there are organisations out there who are thriving on such inherent alarmist tactics to create fear and generate revenue in turn. These are organisation breeding on the inherent good intentions of people who yet are gullible and able to believe things without further verification. Especially with current media trends, where people are being bombarded by information which may or may not be biased, it would be very hard to verify on a first glance. If was an organisation, with the level of support for the bans, I would think that the human race would have to move to a desert planet.

The prank which was perpetrated by Eric Lechner, Lars Norpchen and Matthew Kaufman of UC Santa Cruz in 1989 signifying a greater issue at stake, where science facts are being overlooked and replaced by alarmist accounts which are probably true but worded in a way to give a false negative. As such as the above box. Referring to the Wikipedia article on the subject, the hoax is still alive and well, with people from all walks of life, including MPs being duped.

My contention is this. Google! Anyone with a computer can Google up DHMO or dihydrogen monoxide and find out it was a prank. But how many actually did take the effort to verify that the cause was worthy? How many actually would take the time to check whether petitions are for a worthy cause, instead of something frivolous, or worse, simply pure alarmist? All I am trying to convey right now is the importance of verification and understanding both sides of the debates, and that information being provided for consideration on issues should be factual and science-based. Probably only then will the DHMO issue be able to lay to rest, and my cup of water is not being threatened by organisations with vested interests.

Monday, April 6, 2009

No Two Patents Are The Same

“The research has been completed. These are the results. I want you to obtain a patent for me” – a typical instruction we receive from a research institution or a university. “I have made a proto-type of my invention. I want you to file a patent application for this product” – another typical instruction from an inventor from the industry. How to handle such type of instructions? There are two options available to a patent draftsman – either to draft a patent description and claims based solely on the information provided, OR to treat the information provided as just a working solution of a bigger concept of the invention.

Before we look at which option to adopt, one has to understand the function of a patent. Without knowing the specific reason of the university or the company to obtain a patent, it is not possible to draft a patent specification that meets the objectives of the university / company. The main reason to obtain a patent is to obtain exclusive rights to the invention, so that no one can exploit the claimed invention. Another reason is to licence or assign the invention to a third party for monetary or other valuable consideration.

A patent application will face serious critical examination from patent examiners and is likely to face oppositions from third parties, often competitors. After grant of a patent, if the product or process covered by the patent is successful in the market, the patent will likely be attacked for invalidity for any number of reasons by competitors. Alternatively a competitor may adopt the teachings of the patent and yet argue that it is not infringing the patent.

Therefore if a patent application is to survive objections by the patent examiner and/or a patent is to survive an attack on the validity, or if the patent is to cover a broader scope of patent claims that are attractive to a potential licence or investor, then proper care and attention must be paid at the drafting stage of the patent application. Failure to observe these basic rules may result in no patent or a worthless “paper patent”.

A researcher in a university or an inventor in the industry often sets out to solve a technical problem which is usually narrowly defined. The inventor is said to have a “tunnel vision”. Let’s look at some examples.
Example 1

Say in a novel chemical process, the following ingredients and parameters are used by the researcher.

H2 S04 – 2M  
 NaOH – 1M
 Temperature – 27°C
 Pressure – 1 atm  
 Catalyst – Mg

A patent claim can be drafted to cover the above ingredients and parameters. But the granted patent will be extremely narrow and it is very easy not to infringe the patent and yet follow the teachings of the patent. To obtain a patent with broad scope of claims all the ingredients and parameters must be challenged.

 Why H² S04? Can other acids such HNO3, HCL etc can be used?
 Why NaOH? Can other alkali be used?
 Why 2M H2 S04? Any other concentration? 
  Why 27°C? Can other temperature give acceptable results? Similarly pressure and nature of catalyst must be challenged.

Remember many processes are not discrete, yes/no process but are continuous process.

It is a fundamental principle of Patent Law; all claims must have support in the body of the patent description. It is not generally possible to have a broad claim if there is no support for the claim in the description. Therefore if the researcher wants to obtain a patent with broad scope of claims, then he may have to do further research to find support for the claims.

Example of a narrow claim: A process to make product X by the addition of A to a solution of B where the operating temperature is between 27°C.
Example of a broad claim: A process to make product X by the addition of A to a solution of B where the operating temperature is between 24°C - 30°C  

Of course, it may be possible to obtain a patent with narrow set of claims claiming the exact parameters shown in Example 1. But a third party can easily use the technology and yet not infringe if he just changes any of the claimed ingredients or operates outside the quantified parameters!

Would a potential licensee or investor be interested in such a narrow patent? (In a crowded or matured field of technology, there is no choice but to accept narrow set of claims to overcome objections on novelty and/or obviousness).

To be continued...

Article by P. Kandiah (B.Sc (Hons)) (LLB (Hons))
Member of Chartered Institute of Patent Attorneys U.K (CIPA)

Distinguished fellow of MABIC
KASS International Sdn Bhd
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