“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.
There are a great many people inside the patent industry that are working hard to convince themselves that the Supreme Court decision in Association of Molecular Pathology v. Myriad Genetics is not so bad. The argument goes that the Supreme Court explicitly stated that cDNA is patent eligible and that Chakrabarty remains good law. The trouble with both rationales is that they are incorrect.
It seems to me that anyone who tries to convince themselves that Myriad is anything other than a disaster is just fooling themselves. It does no good to put our heads in the sand and ignore what the Supreme Court said as if by doing so it will make a difference. Anyone who is honest with themselves knows how the district courts will interpret Myriad, and it will not be in a patentee friendly manner.
But before going to far, let me conclusively demonstrate with the Supreme Court’s own explicit language why those who are trying to convince themselves, and others, that the decision is workable are wrong.
UPDATED June 13, 8:24pm ET (see comment #15 & #19)
Earlier this morning the United States Supreme Court issued its much anticipated ruling in Association of Molecular Pathology v. Myriad Genetics. Justice Thomas wrote for a a nearly unanimous Court, only Justice Scalia wrote separately and he concurred in part and concurred in the judgment. The decision is not long, and approximately half of the decision is background, yet at the end of the day much damage has been done to the biotechnology industry, the medical industry and the patent system. Indeed, the assault on patents continues.
According to Todd Dickinson, Executive Director of the American Intellectual Property Law Association, the outcome was fairly predictable given the oral argument, although 9-0 was a bit surprising. Dickinson told me via telephone earlier today the the decision itself is disappointing because it “keeps framing an anti-patent narrative.” He went on: “Patents are terribly useful to incent innovation and necessary to provide funding. If we undermine the patent system further I think we will be shooting ourselves in the foot.” I couldn’t agree more!
Justice Kagan delivered the opinion for a unanimous Supreme Court.
Vernon Bowman is a 75-year-old, recently bankrupt small farmer in Indiana. Monsanto is a multinational corporation that is revered in the industry for its innovations in the field of genetically modified seed technologies, but equally reviled in the American heartland for its staunch protection and ruthless enforcement of its patent rights against small farmers. In a unanimous decision, the Supreme Court sided with Monsanto in finding that Bowman had infringed Monsanto’s patents on genetically altered soybean seeds. This would translate into tens of thousands of dollars in liability for the small farmer. Those reacting purely emotionally to the story will be inclined to sympathize with the small farmer. And recalling Steinbeck’s Grapes of Wrath, they would lament, “The small farmer was weary and frightened because he had gone against a system he did not understand and it had beaten him.” However, the Court’s decision is merely a classical application of basic patent principles.
For years, Vernon Bowman purchased Roundup Ready® soybean seeds from a Monsanto affiliate each year for his main crop of the season. The purchase required Bowman’s assent to a licensing agreement, which prohibited Bowman from saving any of the seeds for replanting. For his late-season second crop, however, Bowman would attempt to skirt Monsanto’s licensing agreement and instead purchase commodity soybean seeds from a grain elevator. The commodity soybean seeds are normally tagged for human or animal consumption only. Anticipating that a batch of commodity soybean seeds would surely contain some Roundup Ready® seeds, Bowman planted the seeds, applied Roundup herbicide to his fields, selectively recovered soybeans exhibiting the Roundup Ready® trait, and saved those seeds for further plantings. Bowman harvested eight late-season crops in this way.
Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases.
The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. At issue is whether federal law preempts such claims from proceeding in state court and if drugmakers can be held liable if they decline to withdraw their medicines from the marketplace.
Of course, the same concept could be applied to brand-name drugmakers, which is why the entire pharmaceutical industry is on edge. In fact, the Obama administration filed a brief in support of drugmakers over concerns the FDA regulatory review process could be undermine if medicines deemd safe and effective could later by considered ‘unreasonably dangerous.’
The court reviewed an appeal by Mutual Pharmaceutical to overturn a $21 million jury award to a New Hampshire woman who in 2004 had taken a generic painkiller called sulindac, but developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. She’s nearly permnanetly blind and suffered burn-like lesions over most of her body, underwent numerous surgeries, and is now unable to read, drive or work, and must use a feeding tube, her lawsuit says.
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