' What will happen to biotech’s patent thickets after Myriad and Prometheus? | MTTLR

What will happen to biotech’s patent thickets after Myriad and Prometheus?

Changing patentable subject matter standards have been on the mind of biotech patent holders for the last few years. A wide range of biotech patents that were widely considered valid have been called into question by the decisions in Mayo v. Prometheus and AMP v. Myriad. Even if the number of patents that are actually ruled invalid proves to be low, the uncertainty could still dampen investment in new technologies.

This uncertainty has been particularly acute in the area of personalized medicine, where the Myriad ruling left a large number of diagnostic patents in question. Since the ability to diagnose individuals based on genetic and other biological information are key to the idea of personalized medicine, the ability to patent tests for specific indicators is important for its long-term growth. Patent holders aren’t giving up without a fight, but the weakening of their patents gives them less leverage in their negotiations.

While diagnostics may be struggling to maintain adequate patent protection, some areas of personalized medicine research have more protection than they need. A recent article in Nature Biotechnology explored the patent landscape that is forming around induced pluripotent stem cells (iPSCs). iPSCs were the basis of a Nobel prize in 2012, and are an exciting area with the potential to completely change the way that some areas of medicine are practiced. iPSCs could theoretically give scientists and doctors the ability to take a person’s existing cells and grow them into any cell type in the body, like new pancreatic cells for people with diabetes or new heart tissue for heart attack patients.

Most of the patents on iPSCs focus on either culturing the iPSCs from other cells or on differentiating the iPSCs into other cell types, raising the question of whether key iPSC technologies may be forming a “patent thicket.” This situation is common in computers and electronics, where different entities have patents on overlapping fundamental aspects of a technology. It is much less common in pharmaceuticals and biotechnology where a product is often protected by one or two patents.

With Myriad and Prometheus upending the existing body of law about patent-eligible subject matter, the entire landscape around iPSCs is uncertain. Distinctions can be drawn between the underlying iPSC technology and those cases, but challenges to the fundamental patents have at least gotten new traction based on the decisions.

iPSCs provide a unique problem for the patent system like many new inventions in biotechnology, but they also provide a challenge to typical conceptions of biological patents. Challenges to the validity of these patents could put some stakeholders in awkward legal positions defending both stronger and weaker patent rights. They could also clear some of the patent thicket around iPSCs. The uncertainty could slow down efforts to bring iPSC technology to market. Or it could prompt patent holders to merge or to work together in pooling their patents for ease of licensing. The conventional wisdom is that weakened patent rights hurt the biotech industry but, in the iPSC area, the effects may be far more complex.

Submit a Comment

Your email address will not be published. Required fields are marked *