Thursday, November 17, 2011

Alkemy 101 Newsletter - November 2011

Is your Intellectual Property protected by your Vendor?
- What is in your Confidentiality Agreement or Service Agreement?

- Are you getting a deal for the price you are paying or being taken advantage of?

- What are the potential gaps in your IP development and protection strategy?

Intellectual Property comes in all shapes and sizes, and sometimes companies don't know they even have any IP to protect other than a copyright. At an economic time when companies must adapt their position to best leverage their brand and grow sales, we are finding out quite often that the back door is left wide open.

Case in point, a small company selected a particular Contract Manufacturing Organization (CMO) vendor that has an industry recognized seal of GMP compliance and a recognized brand name. After working with the CMO to get the ideal formulation and manufacturing the first several production batches, the company opted for a third-party investigative analysis of their finished product due to a small discrepancy. It was then that the company realized "things" were not what they seemed i.e. their formulation had been changed without their prior approval. Furthermore, because the CMO partner didn't charge the company for development on the final formulation, they would not support the investigation or disclose any details of the ingredients or testing of the product because it was "proprietary" the CMO!

In another case, a start-up company engaged in development of Botanical Drug products and related IP sought out a laboratory to contract the isolation and characterization of some new compounds. The contract lab they selected offered the company to do the work at a great rate including delivery of nearly twice the amount of the desired compounds. With compounds in hand, the company went on to the next stages of developing their product. They did not realize the lab they contracted also had their own business interest in the compounds. Because of opting to conduct the work at a lower price compared to some other bids received, they inadvertently waived the rights to the isolation and purification processes, the characterization IP and ultimately the exclusive use of the isolated compounds because these were outside of the Scope of Work. By the time the package was submitted, the various compounds were already on the open market.

To help understand, identify and protect your IP, the folks at Ingredient Identity can help!