When the Supreme Court hands down a decision bearing on a hotly contested area of law, it means the work has just begun for any agency tasked with administering its consequences. Last term, the Court rendered such a decision in Association for Molecular Pathology v. Myriad Genetics, adding a new wrinkle to the already confounding question of patentable subject matter under §101 of the Patent Act.
As companies consider current cases related to patents before the Supreme Court, they would be wise to learn from the challenges the USPTO faced in implementing the Myriad decision. And for the reasons set forth below, we believe that the USPTO and the entire business community are well served by engaging in rigorous public debate about the guidelines that should be established to implement the decision from the Supreme Court.
Recently IPWatchdog.com published an article that cited the work we do at the Infectious Disease Research Institute (IDRI) as an example of how dedicated individuals and corporations can work together to transform science into global health solutions. By integrating capabilities, we strive to create an efficient pathway to bring scientific innovation from the lab to the people who need it most.
I write today to explain more about what IDRI does and why leveraging spin-out companies supports global health initiatives.
One of the most important engines in populating and growing the life sciences sector within the United States is the practice of universities spinning out new technologies into startup biotechnology companies. This, in turn, drives the development of new drugs, vaccines and other much-needed health products.
A team of law students, who are members of the Intellectual Property Law Fellowship at the Thomas Jefferson School of Law in San Diego, California, are working on a Research Project directed toward aiding patent practitioners in developing international patent filing strategies for biotechnology and pharmaceutical companies. The team is working to amass statistically significant survey data on the countries patent practitioners are filing patents in for their biotechnology and pharmaceutical clients most often, and the factors considered when making the decisions to file.
As countries modernizes their economy, and more particularly the life science industry keeps growing, the demand for biotech and pharmaceutical products will likely increase. With increased demand, the market competition and incentive for companies to patent their research and products will likely increase as well. Once the results of the survey are published, policy makers will have more information on the factors patent attorneys from different countries consider most important when making their filing decisions. The results will also give life-science patent practitioners better information as to where in the world they can promote their legal services and partner with foreign law firms for patent applications being filed.
The survey is open to patent practitioners from any country who prosecute patents in the biotechnology or pharmaceutical sectors. The survey can be found by following the hyperlink below. All personally identifiable information will be kept confidential. It should take approximately 15 minutes to complete. We will appreciate if you take the survey prior to March 7, 2014.
James Madison, father of the Constitution and proponent of strong patent rights.
As the end of 2013 approaches and I look back on what has transpired I am saddened to see that through the year patent rights have continued to erode. It is difficult to comprehend just how far the pendulum has swung. At one time strong patent rights were viewed by our Founding Fathers as obviously necessary. Now any patent rights are ridiculed as a relic of the past that simply stands in the way of innovation. The reality, however, is that patents don’t stand in the way of innovation; patents foster innovation. But so many won’t even take the time to inform themselves. Rather they equate “innovation” with a new consumer product. But to innovate is to do something new. Innovation has nothing in and of itself to do with a new products or services.
What those urging a weaker patent system want is the ability to release products and establish services regardless of whether they are infringing others. But those who infringe are not innovators, at least not in the most broad sense. Sure, they may have improved something, but if they are infringing then what they have done is copy an innovator. How and why that isn’t self-evident is a mystery. Copying is not innovating!
And if patents were getting in the way of innovation then why aren’t we seeing a standstill in the smartphone industry? The arguments made by the anti-patent crowd are ridiculous on their face, yet decision makers just nod their head in agreement as if they speak the gospel. The truth is the smartphone industry started with the iPhone in late 2007. It is just 6 years old! The phones from 2007 look and function nothing like the smartphones do today, and every new version has new improvements, better battery life, stronger structural integrity, glass that is harder to break, operates faster, has better cameras, etc. etc. For an area that is allegedly being suffocated by patents there sure is a lot of readily apparent improvement.
“It’s never good news when your area of the law is on 60 minutes,” says Courtenay Brinckerhoff, partner at Foley & Lardner LLP at the 2013 AIPLA Annual Meeting. It’s no secret that the Association for Molecular Pathology v. Myriad Genetics case had more than its fair share of media buzz. The decision, holding that isolated DNA was not patent eligible, left many of us wondering how to best address the needs of our biotech clients going forward.
The main claims at issue in this case are the isolated DNA claims. Claim one is broad enough to cover naturally occurring DNA, and claim two is specific to synthetic DNA. In 2010, the district court came out with a decision holding that DNA was not patent eligible subject matter, which was a bit of a shock to us. Most of the rationale was focused on the idea that DNA embodies information, and regardless of what the actual molecule looks like, Myriad’s claim is for that defining characteristic. The case went up to the Federal Circuit where former chemist Judge Lourie held that technically the isolated DNA is different than natural DNA, because you have to break the covalent bonds to isolate the methylated gene. There were, of course, also policy reasons to uphold the claim like the reliance of the biotech industry on the USPTO already having granted these sorts of patents for nearly 20 years.
Ten years ago if you said that patent eligibility would become one of the most important, hotly debated issues in the patent field most in the industry probably would have thought you simply didn’t know what you were talking about. Five years ago some saw the issues percolating, but still many in the trenches with their day-to-day practice life would likely still have raise a cautious eyebrow and questioned why you thought even the Supreme Court might turn its back on a solid generation of well established patent law. The tone was perhaps cautious, but most couldn’t imagine that the Supreme Court and the Federal Circuit would cease their expansive view of patent eligibility.
Oh how times change!
Today, after several years of substantial turmoil, patent eligibility in a variety of economically significant technologies is extremely uncertain, including software, natural products, medical diagnostics and personalized medicine. It is with great irony that one of the few things we know with any degree of certainty is that business methods are patent eligible. We likewise know that at least some cDNA is patent eligible, except that man-made cDNA that happens to be identical to what occurs in nature. Of course, that raises more questions than it answers.
Last month a coalition of farmers, seed sellers, and agricultural organizations (i.e., hereafter “farmers”), recently received an unfavorable but hardly shocking decision from the United States Court of Appeals for the Federal Circuit. See Organic Seed Growers v. Monsanto. These farmers filed a declaratory judgment action seeking a determination of non-infringement and invalidity with respect to twenty-three patents owned by Monsanto Co. and Monsanto Technology, LLC (collectively, “Monsanto”). The twenty-three patents-in-suit relate to technologies for genetically modifying seeds. The patented technologies are used to incorporate various traits into soybeans, corn, and other agricultural crops, including traits conferring resistance to the herbicide glyphosate (the active ingredient in Monsanto’s product Roundup).
The farmers do not want to use or sell transgenic seed incorporating Monsanto’s technologies. They also oppose the use of glyphosate and do not use it on their crops. So what is the problem then? If they don’t want to infringe and don’t plan on infringing Monsanto patents how could they possibly support a declaratory judgment action against Monsanto? They say they were concerned that if they do indeed become contaminated by transgenic seed Monsanto may come knocking and assert claims of infringement despite the fact that they have done nothing affirmative, unlike farmer Bowman, to infringe the Monsanto patents.
Such a generalized fear, without any preparations to engage in potentially infringing activity, has never been enough to support declaratory judgment jurisdiction. Neither would it be found to support declaratory judgment jurisdiction in this case simply because Monsanto is one of the most hated corporations in the world. Thus, unrealistic hatred and irrational fear of a patent holder, as it turns out, is insufficient to support declaratory judgment jurisdiction.