Patents
“Patents have been seen as more vulnerable to attack on various grounds over the past several years. There has been some backlash against non-practicing entities (“patent trolls”). Newer forums such as inter partes reviews (IPRs) have made it easier and less expensive to challenge issued patents. Also, recent Supreme Court decisions such as Alice v. CLS Bank have made it more challenging to patent software – and this includes medical software. Mayo v. Prometheus has made it more difficult to patent medical diagnostics. Yet another Supreme Court decision, TC Heartland, has limited the venue for patent lawsuits, moving cases out of the Eastern District of Texas – a court that is often said to be very favorable to patent plaintiffs.However, the pendulum may be swinging back the other way. There has been a recent trend at the Patent Appeals Board to strike down fewer patents. The pending Oil States case before the Supreme Court challenging the constitutionality of IPRs could possibly wipe out IPRs entirely, making it more difficult and costly to challenge patents. Also, the proposed STRONGER Patents Act has additional provisions that make challenging patents procedurally more difficult. This could possibly spur innovation further, as medical device companies gain additional confidence in the strength and value of patents.” —Bryan Wahl, partner at Knobbe Martens
Alok Sharma says
In the year 2018, device industry must cohesively work more with Pharma companies to add value to the life of the patients. The disease and the disease patterns are changing & so the long term outcomes. Doctors / practitioners/ Companies & regulatory authorities must look at the side effects of post implantation of a device and prescribe medications so that long term outcomes of the patients are better with low side effects. Not all patients globally have an insurance Cover. Adipose tissue derived autologous Stem Cells treatment must get speedy approvals from regulatory authorities.