High Court Delivers Compromise on Gene Patenting

A U.S. Supreme Court ruling barring the patenting of human genes ostensibly seems like a significant setback to the nation’s biotechnology industry. The decision—superficially, anyway—appears to strike down the DNA patents that anchor numerous business plans.

Indeed, Biotechnology Industry Organization President and CEO Jim Greenwood was quick to express his disappointment with the June 13 decision, releasing a formal statement calling the ruling “a troubling departure from decades of judicial and [U.S.] Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences.”

The U.S. government has granted patents on 4,000 human genes over the last several decades, mostly to companies and universities.

“The Court’s decision could unnecessarily create business uncertainty for a broader range of biotechnology inventions,” he continued. “The term ‘gene patent’ is misleading because patents cannot cover the genes that exist in humans, plants animals or microbes. Patents have never conferred ownership over genes. The past 25 years have seen an unprecedented explosion of research and scientific publication on the human genome and the genomes of bacterial and viral pathogens. New biologic medicines, vaccines and tests have become available to treat previously untreatable conditions, benefit patients and improve medical care. These developments were not impeded by patents—they were aided by patents. The United States is now the only developed country to take such a restrictive view of patent eligibility, signaling an unjustified indifference towards our global economic and scientific leadership in the life sciences.”

The high court’s decision represents a partial defeat for Myriad Genetics, a Salt Lake City, Utah-based company that was awarded patents in the 1990s for genes (BRCA1 and BRCA2) linked to hereditary breast and ovarian cancer. The court invalidated Myriad’s patents because they directly covered DNA isolated from the body. “Myriad did not create anything,” Justice Clarence Thomas wrote in the court’s unanimous decision. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”

The Court did, however, allow legal protections on man-made genetic material, or cDNA. Method patents, which involve technical procedures for conducting certain processes, are not affected by the ruling.

The compromise outcome was recommended to the justices by the Obama administration and is considered a partial victory for patients. Some legal experts contend the decision will foster the sharing of genetic data and help companies freely build open databases of genomes. It also should promote healthy competition among genetic testing companies as well as better, more comprehensive research, patent attorneys claim.
Perhaps more importantly, though, the decision gives biotechnology companies the leeway to develop proprietary innovations that use DNA data in new ways because the court upheld patents on “new applications of knowledge,” or DNA whose sequence has been altered. Genetic insights applied to new processes, methods or algorithms are still patentable.

“The Court has drawn the line between discovery and invention when it comes to the patenting of genes, and effectively raised the bar for genetic inventions,” Jennifer A. Camacho, shareholder and co-chair of the Boston IP Group at international law firm Greenberg Traurig LLP, told Medical Product Outsourcing. “A newly-discovered gene is simply not an invention that is eligible for patenting. However, the knowledge gained by the new discovery may give rise to novel methods or compositions-of-matter that are eligible for patenting. Put otherwise, it is not the gene itself but what you do with the gene that matters in the patent world.”

John Wilbanks, chief commons officer at Seattle, Wash.-based research institute Sage Bionetworks, agrees, noting that creative uses of DNA data rather than the data itself ultimately will give companies a competitive advantage.

“It’s clearly not as terrifying a ruling for the industry compared to what it could have been,” Wilbanks explained to Wired magazine. “It’s a decision that says that data is free and that’s in line with what patent law has always said, which is that you can’t patent data. That’s what a gene sequence is. By making that data free, there is a lot of room for public good and public and private innovation.”

Myriad executives said the Court’s decision left intact 24 different patents relating to its BRACAnalysis test. President/CEO Peter Meldrum said the ruling ensures “strong intellectual property protection for our test moving forward.”