On May 20, 2013, the United States Supreme Court granted cert. in Medtronic v. Boston Scientific, a case that will answer whether the licensee in a declaratory judgment challenge bears the burden of proving that the alleged non-infringing product does not infringe, or whether the responding patentee must prove infringement. To read the Federal Circuit decision in the case, click here.
The Supreme Court explained the question presented as follows:
In Medlmmune, Inc. v. Genentech, Inc., 549 U.S. 118, 137 (2007), this Court ruled that a patent licensee that believes that its products do not infringe the patent and accordingly are not subject to royalty payments is “not required … to break or terminate its … license agreement before seeking a declaratory judgment in federal court that the underlying patent is … not infringed.”
The question presented is whether, in such a declaratory judgment action brought by a licensee under MedImmune, the licensee has the burden to prove that its products do not infringe the patent, or whether (as is the case in all other patent litigation, including other declaratory judgment actions), the patentee must prove infringement.
Over the past several days, the United States Supreme Court has issued several important decisions that will impact the patent system.
First, on June 13, 2013, the Supreme Court issued a decision in Association of Molecular Pathology v. Myriad Genetics, which has sometimes been referred to as “ACLU v. Myriad” in recognition of the fact that it was the American Civil Liberties Union that was responsible for bringing the challenge in the district court and pursuing the matter through the judicial system.
In Myriad, Justice Thomas wrote for a nearly unanimous Court. Only Justice Scalia wrote a brief separate opinion in which he concurred in part and concurred in the judgment.
The majority decision in Myriad is not long, and the first 10 pages are background. Despite not giving much detailed attention to the significant legal issues presented, the Supreme Court did manage to do real and serious harm to much of the biotechnology industry.
Justice Thomas summarized the Court’s decision by saying:
“[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”
The decision has widely been reported as the Court recognizing that cDNA is patent eligible, but the ruling is far more nuanced. In fact, Justice Thomas specifically recognized that some cDNA is not patent eligible. He wrote:
“cDNA is not a ‘product of nature’ and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.”
I have spoken with a number of people who are in the biotech industry and they all seem to think this decision means that cDNA is patent eligible and I shouldn’t make too much out of Thomas specifically saying that at least some cDNA is not patent eligible. Personally, I think this is misplaced hope; we all know how the district courts will respond, and it won’t be to an expansive reading of patent eligibility. While the USPTO seems poised to say that cDNA is patent eligible, the fact that some has been determined not patent eligible will be used by challengers and likely successfully so. Further, it seems clear that Thomas is saying that if something is man-made but identical to what appears in nature, it is not patent eligible. This fundamentally undercuts the most important aspects of Chakrabarty and would effectively kill research into such important areas as artificially grown organs, which by their very nature must be identical to what is produced in nature to be transplanted into the human body, for example.
On Monday, May 13, 2013, the United States Supreme Court, in a unanimous decision, ruled that a farmer who buys Monsanto’s patented seeds cannot then propagate new seeds for future use without infringing the underlying patent.
The opening paragraph in the Court’s decision, which was delivered by Justice Kagan, succinctly captures the essence of the ruling. Justice Kagan wrote:
Under the doctrine of patent exhaustion, the authorized sale of a patented article gives the purchaser, or any subsequent owner, a right to use or resell that article. Such a sale, however, does not allow the purchaser to make new copies of the patented invention. The question in this case is whether a farmer who buys patented seeds may reproduce them through planting and harvesting without the patent holder’s permission. We hold that he may not.
Monsanto invented a genetic modification that enables soybean plants to survive exposure to glyphosate, the active ingredient in many herbicides (including Monsanto’s own Roundup). Monsanto markets soybean seed containing this altered genetic material as “Roundup Ready” seed. Farmers planting that seed can use a glyphosate-based herbicide to kill weeds without damaging their crops. Two patents issued to Monsanto cover various aspects of its Roundup Ready technology, including a seed incorporating the genetic alteration.
By: Gene Quinn (IPWatchdog.com)
Last week, the United States Supreme Court heard oral arguments in the matter of Bowman v. Monsanto. For a recitation of the facts and procedural history, see Argument Summary. For purposes of this article suffice it to say that the case is about a farmer who did not want to buy Monsanto’s patented seed. He acquired seed from a grain elevator knowing that at least some would be Monsanto patented seed. He planted all the seed and applied Roundup® to kill everything but the Monsanto crop. He then harvested the progeny seeds for future use.
Patent law heavyweights will convene for what looks to be two very special days in New York City at PLI’s 6th Annual Patent Law Institute on February 16-17th.
Chief Judge Randall Rader of the Federal Circuit will participate in an all-star dialogue panel between the bench and bar along with United States District Judge William Young and nationally-recognized expert practitioners Donald Dunner, Seth Waxman and Dean John Whealan of the George Washington University Law School.
Robert Stoll, who recently retired as Commissioner for Patents at the USPTO, is slated to open the program with a PTO keynote address. Commissioner Stoll is expected to report the latest developments regarding the PTO’s on-going implementation of the America Invents Act and other critical PTO developments.
Co-Chairs Scott M. Alter (Faegre Baker Daniels LLP), Douglas R. Nemec (Skadden, Arps, Slate, Meagher & Flom LLP) and John M. White (Berenato & White; Director of Patent Professional Development, Practising Law Institute) will navigate attendees through 6 exciting plenary sessions that discuss the practice impacts of recent Supreme Court and Federal Circuit decisions, AIA changes, current critical patent issues from the corporate counsel perspective, views from the District Court bench, the never-ending PTO changes and for good measure, an hour of legal ethics credit! (more…)