CPA & Business Advisory Blog

Good Medicine: Pharma Industry Seeing Positive Steps From the Top Down

With Northeast Ohio strengthening its foundation in the bioscience space, we’ve kept a close eye on patent law developments that may impact or impede a company's road to progress.

In a recent article in Crain’s Cleveland Business, Susan M. Hopkins stated: the “U.S. Supreme Court answered a longstanding question in intellectual property law: Can a human gene be patented? The court's answer in Association for Molecular Pathology v. Myriad Genetics was a resounding no.” Read the full article here.

Firm colleague, Dan Smola, a patent and trademark attorney with Akron-based law firm Hahn Loesser & Parks, LLP and I discussed this decision; here are his thoughts:

“This was a landmark decision for the Supreme Court and many believe they got it right (this has not always been the case with the complex subject of patent law). This dispute arose out of the question of what is patentable subject matter. It has long been held that laws of nature, natural phenomena and abstract ideas are not patentable, and these three exceptions were created by the courts. However, pharmaceutical and biotech research and innovation has blurred the lines on whether such inventions fall under any of these exceptions."

As stated in Crain's, the Supreme Court held that isolated forms of naturally occurring DNA are not patentable. However, synthetically created DNA, or cDNA is patent eligible. Therefore, the Supreme Court was conducting a balancing act. Dennis Crouch, a patent attorney, raised the question on whether the reduced coverage of patent law will still provide sufficient incentive to invest in biotech focused research. Johnathan Masur, a law professor, says yes: “This is the rare case in which the Court’s reflexive tendency to split the baby worked well. Biotech companies should have sufficient research incentives going forward, without firms like Myriad exerting too much control over consumers and future R&D.”  Hopkins expressed similar views in her article:

“The court’s decision has given companies access to all patented naturally occurring gene sequences coding, for example, cancer tumor makers. Accordingly, this decision will drive competition as biotechnology companies and pharmaceuticals invigorate their R&D of diagnostics and testing of naturally occurring genes. The winners of these R&D battles may well be those institutions that take the most aggressive approach to patent filings and applications.”

Based on the above, I believe the Supreme Court’s decision will benefit the biotech and pharmaceutical industry by allowing R&D on human genes but still protecting methods of testing and methods of using human genes, among others.”

Are you ready to learn about the patent process or our Life Sciences and Innovation niche practice group?  Post a comment below or email

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