How A Pro-Software Patent Bill Could Affect The Medtech Industry
Though it didn’t even get to committee, a bill to make it easier for tech companies to patent software – including medical software – has a good chance of getting passed in Congress this year, bill proponents and legal experts say.
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While the mobile health sector and digital health in general is poised for a major boom, a 2014 case, Alice Corp. v. CLS Bank International, continues to be a major hurdle for manufacturers wanting to patent their software. While there are some recent positive trends, attorneys recommend caution and proactive steps to make the best of the current patent environment.
The agency has codified its over-the-counter ECG software class II classification, which means sponsors can continue to benefit from filing for such apps through the less burdensome 510(k) pathway.
The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.