Replies to post #113352 on Biotech Values

[genisi]

Unfortunately, The Supreme Court expressly declined to decide whether the exemption is available for use of patented research tools so this is yet to be dealt with in future cases. Enjoyed addressing the issue with you guys from the legal department :-)

[biomaven0]

All uses of "compounds". Which is exactly what Bolar stated. Certainly an argument can be made that this can be extended to all uses of any patented process as well as a compound, but that is a very large expansion of the doctrine.

If you read the link I posted earlier, you will see that this has even been extended to medical devices - a long way from compounds:

The courts have since determined that the manufacture and sale of devices to a hospital, which are then used to generate data for the FDA, are exempt from infringement. In addition, continuing to sell patented devices to hospitals even after the submission of an application for pre-market approval falls under the Section 271(e)(1) exemption since a company may need further data to satisfy the FDA requirements. Consumer studies consisting of focus groups and interviews, when undertaken to provide information as to the design of the product, are considered to be directed towards developing information necessary to obtain FDA approval. Similarly, displaying devices at medical conferences to non-physicians and promoting the progress of clinical trials to raise money from investors are exempt activities. However, selling devices for further clinical trials after FDA approval has been obtained would not fall under the safe harbour exemption since the information obtained would no longer be necessary to satisfy FDA requirements.

My overall point here is that a MNTA patent suit against Teva is by no means a sure winner. At the end of the day I doubt if the suit is something most investors will place much value in, although clearly it has the potential for a huge (perhaps billion dollar) payout.

Peter