In his newly authored article appearing on ThePharmaLetter website, St. Louis patent attorney Doug Robinson discusses the effects that recent patent legislation and changing views about patent rights have had on the pharma industry.
The battle over patent eligibility has two sides: those in favor of looser patent eligibility requirements and those in favor of stricter requirements. The pharma business is in favor of looser requirements. For them, securing patent rights is an important step that makes the long and expensive process to develop new drugs worthwhile.
Some tech innovators, on the other hand, want to keep patent eligibility requirements strict. Some in the computer and electronics industries, in particular, feel that stricter patent eligibility laws will help ward off attacks from non-practicing entities. That view has been winning lately, although the tide may be turning. As Robinson notes, “Like the broader trend in patent law, the law of patent eligibility has swung in favor of stricter eligibility requirements, though the pendulum may be starting to swing the other way.”
Robinson cites the Supreme Court’s Bilski decision in 2010 as the start of the current patent eligibility regime. “In Bilski,” Robinson says, “the Supreme Court found a patent claiming an investment strategy was not patent-eligible because it was directed to an abstract idea.” The 2011 and 2014 decisions in Mayo and Myriad, respectively, extended the stricter regulations into the pharma and then biotech space. Through 2017, the Patent Trial and Appeal Board (PTAB) also did its fair share of axing patents on the grounds of ineligible subject matter.
Recently, however, Andrei Iancu kicked off his tenure as the new Director of the USPTO by requesting more clarity on patent eligibility issues. A number of important decisions, coupled with the USPTO’s new examiner guidance issued in April, have patent owners excited for looser restrictions.
While certain patent laws surrounding pharmaceutical inventions remain murky, there are a number of possible solutions on the table. For example, abolishing section 101. If that sounds drastic, Robinson offers an alternative: “keep section 101, but eliminate it as a ground to challenge an issued patent (meaning it would still remain for examinational purposes).” Other possible solutions are currently working their way through Congress.
While real change is still a ways off, there is new hope for patents and the pharma industry.