Why Biotech Ventures Lose Value
We Protect What the Science Is Worth
Biotech ventures are built on intellectual property and destroyed by ambiguity about who owns it. A research collaboration with a university that never allocated background and foreground IP. A publication that disclosed the invention before a patent was filed. A material transfer arrangement with no restriction on downstream use. A founder-scientist whose earlier employment contract may have already assigned the very thing the company was built around. The science is often excellent. The paperwork around it decides whether anyone can commercialise it.
How We Support Life Science Ventures
IP, collaboration and regulatory pathway.
We structure research and development collaborations with clear IP allocation, handle confidentiality and material transfer arrangements, advise on the biosafety and access approvals your work requires, and prepare the corporate and fundraising documentation a research-stage venture needs to raise money.
Choose Where You Are Now
Select the service your venture needs next.
IP, collaboration, approvals or fundraising. Pick where you are and we will start there.
Biotechnology in Malaysia is governed by several regimes depending on what you work with. Activities involving living modified organisms fall under the Biosafety Act 2007, administered by the Department of Biosafety and the National Biosafety Board. Access to biological resources and associated traditional knowledge is governed by the Access to Biological Resources and Benefit Sharing Act 2017. Healthcare products face registration and good manufacturing practice requirements through the NPRA before market authorisation.
What approvals does work with modified organisms require?
The Biosafety Act 2007 regulates the release, import, export and contained use of living modified organisms and the release of their products. Regulated activities require risk assessment and formal approval or notification, depending on the activity, from the National Biosafety Board.
The practical point for a venture is timing. Approval processes have their own timelines that need to sit in the project plan and in whatever you tell investors, rather than being discovered after a funding round assumed a faster path to trial.
What is the benefit sharing regime about?
The Access to Biological Resources and Benefit Sharing Act 2017 implements Malaysia's obligations under the Convention on Biological Diversity in relation to access to biological resources and traditional knowledge, and the sharing of benefits from their utilisation. For a venture whose research draws on Malaysian biodiversity or on traditional knowledge, this is not a background policy consideration — it affects whether the access was lawful and what obligations attach to commercialisation downstream.
Establish the position before the research programme is designed around a resource, not after a product exists.
Who owns the IP in a research collaboration?
Whatever the agreement says — and where it says nothing, the answer is often unhelpful. A collaboration agreement should separate background IP each party brings, foreground IP created during the work, and improvements to background IP, and it should deal with each differently.
Issue | Why it decides the venture's value |
|---|---|
Background IP | Identified and listed at the outset, or it becomes contested later |
Foreground IP | Sole ownership, joint ownership or licence — joint ownership is usually worse than it sounds |
Publication rights | Academic partners will want to publish; you need review and delay rights before filing |
Field of use | Licences limited to a field leave the rest of the value with the other party |
Improvements | Who owns what is built on top, and on what terms |
What kills a patent position?
Disclosure before filing, most often. A conference presentation, a poster, a grant application that becomes public, or a discussion with a commercial partner under no confidentiality obligation can each compromise novelty. Research cultures reward disclosure and patent systems penalise it, and ventures built out of academic environments feel that tension acutely.
Get a confidentiality regime in place before conversations start, and coordinate filing with publication rather than the other way round.
Frequently Asked Questions
Do we need approval for contained laboratory work with LMOs?
The Biosafety Act 2007 covers contained use alongside release, import and export, with approval or notification requirements depending on the activity. Confirm the applicable category with the Department of Biosafety for your specific work.
Can we patent something we already presented at a conference?
Prior public disclosure can compromise novelty, and the position depends on what was disclosed, when, and the jurisdictions concerned. Get advice quickly — some options may still exist, but they narrow with time.
Who owns IP created by a founder who is also a university employee?
It depends on their employment or engagement terms with the institution and the institution's IP policy. This needs to be established before the venture is built on the assumption that it owns the science, because investors will check.
Where to start
For collaborations, see research and development collaboration agreements and the non-disclosure agreement. For brand and rights, see trademark registration and brand protection. For the corporate side, see company incorporation and structuring and investor readiness legal audit.
This page is general information about Malaysian law and does not constitute legal advice. Licensing requirements, thresholds and guidelines change. Confirm the current position with the relevant authority or your adviser before acting on any part of it.
