Theralase Technologies Inc. V.TLT

RE:RE:RE:RE:Performance and Complaints

[CancerSlayer]

rollthedice10 wrote: Hopefully by the time our patents expire we will be so far out front
catching up to TLT would be quite a chore. Remember a competitor
would have years of trials and FDA as well. And as I opined in a previous
post, I'm sure TLT will be applying for many more patents as well.
A competitor would have to consider TLT market share at the time
as well as any new restrictive TLT patents
before embarking on that long expensive journey. JMHO

Having that first-mover advantage & brand name recognition may be difficult to overcome by any potential generic manufacturer, especially if there is little incentive for generic production due to new pricing not significantly undercutting brand name pricing...jmo.

Although a generic manufacturer doesn't have to reproduce a full clinical trial (to my understanding), it would have to prove bioequivalence using GMP, which is not a simple/slam-dunk task & it could take years to ultimately achieve FDA approval.  If approved, there can also be significant limitations & delays regarding provider/patient/market transitioning & acceptance.

With regards to additional proprietary protection after patent expiration (June 2034), a Theralase NR, dated on June 20, 2016, states:

"Under worldwide exclusive licence agreement with the inventor of the latest patent, Dr. Sherri McFarland has agreed to maintain strict confidentiality on any trade secrets associated with the synthesis or manufacture of TLD-1433 for a period of twenty (20) additional years following the expiry of the last patent covering inventions or improvements in compounds or their methods of use; thereby, increasing minimum proprietary protection of TLD-1433 in the US until June 22, 2054."