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Getting the appropriate commercial usage rights can make all the difference to the commercial success of your molecular diagnostic assay.
Why are commercial use rights important for innovation?
Your company just finished developing a novel method to assay for a unique gene mutation associated with a rare disease. The patent application is filed, and the team is excited to head full force into the assay development process. Everyone wants to bring this new diagnostic test to market.
As you begin reviewing all the assay’s reagents, a significant decision becomes apparent. Do you incur the cost and time up front to secure a licensing agreement for custom assay components? Or do you save money and effort by sticking with the original catalog reagents?
When it comes to reagent supply choices, a company may neglect the importance of acquiring the appropriate commercial rights for all the individual reagents that may end up in a final product. Not having a complete strategy for commercial use rights can have serious consequences for the future commercial success of a diagnostic assay.
While a company may hold a patent for one technology, the complete commercial product might be integrated with other components, each having their own commercial use case. Failure to understand how all the components of a product or service can be sold or resold for profit can lead to costly legal liabilities. Even worse, a product could be removed from the market completely.
Fortunately, help is available for assay developers seeking to commercialize their innovative new technologies. The Licensing and Commercial Supply (LCS) team at Thermo Fisher Scientific specializes in assisting customers to secure the relevant commercial rights for a vast array of products and services offered by Thermo Fisher.
When is the right time to bring in a LCS expert?
The best time for an assay developer to bring in a LCS expert would be during the assay feasibility phase or early assay development phase of their product development timeline. The earlier commercial usage rights are considered the easier it is to have a risk mitigation strategy in place if something goes wrong.
Say for instance your core assay relies on an enzyme you purchased from a supplier as a catalog item. If the enzyme product’s terms and conditions state a limited use case, the enzyme product may need additional approval to be part of an assay workflow.
Even if commercial use of a catalog product is approved, the catalog product may still cause regulatory traceability issues or have regional use restrictions.
A Thermo Fisher LCS Business Development manager (BDM) can begin working with clients as soon as possible in their diagnostic assay development timeline.
A LCS BDM ensures that a desired Thermo Fisher reagent, instrument, or service is supplied with full determination of legal and commercial usage rights.
How does a LCS BDM help with commercialization?
A catalog reagent may have the appropriate use rights for an assay developer, but certain safeguards may be missing if a licensing or supply agreement isn’t in place. For instance, a supplier can change qualification parameters or substitute like components of a catalog product without notifying customers.
A lack of traceability for reagent changes is a red flag from a regulatory standpoint.
When working with an LCS BDM, assay developers can expect an expert who can provide these benefits for their product commercialization strategy:
- They can help ensure that a Thermo Fisher Scientific product is authorized to be sold in combination with a client’s product through a licensing agreement. The commercial use of a Thermo Fisher product can be granted worldwide depending on regional agreements and supporting intellectual property.
- They can secure a commercial use rights agreement where clients are assured that intellectual property rights are inherent to using a Thermo Fisher product or service.
- They can assist an assay developer in getting a supply agreement in place that includes product or service change notification assurances for regulatory traceability.
- They provide white glove service in facilitating procurement of custom reagents and services that bolsters the reassurance of supply security.
What assay developers can expect from working with a LCS BDM?
A LCS BDM can help an assay developer achieve global impact and success with their go-to-market strategy by removing the concern of not having the appropriate commercial use rights for their innovation.
The additional benefit to an assay developer is having a LCS BDM partner who can leverage the products and services of Thermo Fisher Scientific, a global leader in innovation.
A LCS BDM partner can choose from a comprehensive menu of options and services that include procuring customized reagents, securing professional supply agreements, and finding the highest quality manufacturing facilities for all your business needs.
Key Takeaways
- Commercial use right is a vital piece to the commercialization process.
- Not having the appropriate commercial use rights is a big liability.
- Partnering with a LCS BDM can help alleviate the concern of commercial use rights by acquiring a suitable commercial use rights agreement.
Contact a BDM to assist with a commercialization strategy
Related Links & Resources
- Learn more: Genetic Sciences OEM and Commercial Supply
- Article: How to Avoid the Pitfalls of Diagnostic Assay Development
- Article: Three Steps You Can Take to Navigate the IVDR
- Article: Four Things You Should Know About Customized OEM Solutions
- Article: Nine Questions to Ask When Considering an OEM Partner
- Article: How to Help Ensure Your Supply Chain Security
- Reference: Innovation and Intellectual Property
- Reference: Successful Technology Licensing
- Reference: Medical Device Development Process, and Associated Risks and Legislative Aspects
- Related Link: Partnering & Licensing
- Related Link: Intellectual Property for Licensing
- ←Back to OEMpowered Blog
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