Andrew Beckerman-Rodau was not surprised at the U.S. Supreme Court's recent ruling that naturally occurring human genes cannot be patented.
The landmark case never would have been brought if patent-eligibility criteria were more specific and consistently applied, says the co-director of Suffolk University Law School’s Intellectual Property Law concentration.
He outlined that criteria in the article “What Should Be Patentable?” in The Wake Forest Journal of Business and Intellectual Property Law.
Beckerman-Rodau's list of criteria includes the preemption test used previously by the U.S. Supreme Court, which states that a claim is ineligible “if it essentially preempts all meaningful use of a law of nature or something that is naturally occurring” -- such as DNA
The Supreme Court invalidated Myriad Genetics' patent claim for the BRACA1 and BRACA2 genes, which predict of ovarian and breast cancer risk, in its June 13, 2013, decision in Association for Molecular Pathology v. Myriad Genetics. The court also ruled that modified genes, known as cDNA, could be patented.
“The validity of many existing gene patents may now be suspect,” says Beckerman-Rodau. Among known human genes, 41 percent are patented. “But most such patents are nearing the end of their patent term, so they will soon enter the public domain.”
The need for patent-eligibility criteria reform goes beyond human genes, according to Beckerman-Rodau.
“The Court did not provide any clear rules that can be applied to other types of technology, such as software and business methods, so the issue of patent-eligibility is still largely unclear,” says Beckerman-Rodau.
Patent eligibility “is an issue that even the Supreme Court hasn't been able to get its hands around” despite the Myriad decision, he says. “Everyone agrees there’s a line, but no one has figured out what test we should use.”
This vagueness may have economic implications, according to Beckerman-Rodau.
“The importance of predictability in patent law jurisprudence is clear,” including its impact on a range of business decisions.
Myriad Genetics, for instance, claims it spent $500 million discovering that BRACA gene mutations were predictors of cancer risks.
The case percolated to the high court because Myriad, unlike the owners of other gene patents, aggressively kept anyone else from using the BRACA genes.
Beckerman-Rodau’s proposed criteria are not new.
They are gleaned from the Constitution, patent law and court decisions.
However, they have not been applied routinely by either courts or the Patent & Trademark Office, which Supreme Court Justice Elena Kagan referred to as “patent happy.”
Room for interpretation
Beckerman-Rodau argues that having a clear and standardized set of criteria may not eliminate interpretation -- and probably some “bad” decisions. But it would enhance the predictability of a patent’s initial – and continued – legitimacy.
All patented inventions must be novel and “non-obvious” – representing a significant advance in the technology. Beckerman-Rodau proposes adding the following tests to determine if a discovery – even if novel and non-obvious – is eligible for patent protection:
- Preemption: A claim is not eligible if it essentially preempts all meaningful use of a law of nature, natural phenomena or an abstract idea
- Insignificant limitation: A claim is not eligible if its scope is too wide and claim limitations on that scope are insubstantial window dressing
- Equation: A claim is not eligible if it amounts to no more than a disguised attempt to claim a formula, equation or mathematical relationship
- Human intervention: A fundamental discovery -- new plant species, mineral, compound -- is patent-eligible only if it is altered … and has properties not exhibited in its naturally occurring form
- Data comparison: Claims that simply compare data are not patent eligible