November 2010 - Tech Transfer Alert! Supreme Court to hear Patent Ownership Dispute
October 2010 - Myriad Files Appellate Brief with the Federal Circuit
Myriad Files Appellate Brief Myriad filed its brief with the Federal Circuit appealing Judge Sweet’s (SDNY) decision that invalidated Myriad’s patents on BRCA1/2. Myriad’s brief is appealing three issues: declaratory judgment jurisdiction, invalidity of the composition claims, and invalidity of the method claims.
Declaratory Judgment Jurisdiction: While declaratory judgment jurisdiction is not as exciting as the invalidity of gene patents, I believe that Myriad does have a strong argument that there is no declaratory judgment jurisdiction. Under MedImmune, a declaratory judgment is allowed if there’s (1) an explicit threat that creates a reasonable apprehension on the part of the declaratory plaintiff that it will face an infringement suit, and (2) present activity that could constitute infringement or concrete steps taken with the intent to conduct such activity. Myriad argues that there was no threat to the plaintiffs that created a reasonable apprehension that the plaintiff would be sued for infringement, and this is because, THERE WAS NO INFRINGEMENT. The plaintiffs were not infringing the patents, but were recruited for this lawsuit.
Additionally, in Hewlett-Packard Co. v. Acceleron LLC, 587 F.3d 1358 (Fed. Cir. 2009), the Federal Circuit explained that declaratory judgment jurisdiction generally will not arise merely on the basis that a party learns of the existence of a patent owned by another or even perceives such a patent to pose a risk of infringement, without some affirmative act by the patentee.
In Innovative Therapies, Inc. v. Kinetic Concepts, Inc., 599 F.3d 1377, 1382 (Fed. Cir. 2010), the Federal Circuit did not find declaratory judgment jurisdiction because the patentee did not make any affirmative act towards the plaintiff. Here, there was no affirmative act by Myriad toward the plaintiffs. Lastly, Myriad argued that there was no controversy of “sufficient immediacy and reality.” “[T]here can be no controversy without a showing that this threat [of suit] was real, imminent, and traceable to defendants.” Prasco, LLC v. Medicis Pharm.Corp., 537 F.3d 1329, 1339 (Fed. Cir. 2008). The plaintiff’s were not infringing Myriad’s patents, nor was there any threat of a law suit from Myriad. I would really like the Federal Circuit to reach the merits of this case. But if declaratory judgment jurisdiction is upheld, this will eviscerate an already low bar for declaratory judgment jurisdiction. Essentially, anyone who MAY be interested in infringing a patent can sue to see if they can invalidate it first. This would create horiffic precident for future patent owners, who could be sued anywhere, for not doing anything. Invalidity of the Composition Claims: Here is where all the excitement is at, are patents on genes valid? It is amazing to me that this determination has not been decided definitively yet. For over 25 years, the PTO has granted patents for isolated DNA molecules, more than 2,645 patents with claims to “isolated DNA,” and over 50,000 patents containing claims to a nucleic acid sequence. Myriad argues that the claims for isolated genes are a composition of matter, not just a sequence of information, but an actual composition of physical matter. This is important because “isolated DNA” is a DIFERRENT physical structure than natural DNA. If you insert an “isolated gene” fragment into another cell, it will not behave the way natural DNA will behave. Additionally, if you take a natural DNA sequence it cannot be used as a probe or a genetic tool as “isolated DNA” may be. The very fact that “isolated DNA” MUST BE ISOLATED should be very telling, it requires the intervention of man. Gene patent owners are not suing people for having genes for which they have patented. But they only sue commercial entities that are using man made discoveries for some utility. The mere fact that MEN want to USE these genes is proof that there is Utility and MAN-MADE discovery. I think that those who oppose gene patents forget is that 101 is only gateway question. An isolated gene is not a natural phenomena, it is only produced and discovered by man. It should be patentable. Any perceived abuses can be prevented by correctly applying the additional requirements of utility, novelty, obviousness, and enablement. Invalidity of the Method Claims: I think Myriad really benefited from the way Bilski came out. Not only did the Supreme Court not completely scrap the machine-or-transformation test, they said that it was not the only test for deciding if something is patent eligible. The Court did not want to limit patent eligibility because innovation itself is changing from the Industrial Age to the Information Age. The Court specifically mentioned “advanced diagnostic medical techniques” as one of those emerging technologies. The method claims involving “analyzing” and “comparing” DNA sequences require extraction and processing of human tissue or blood samples. They are transformative just as the claims involving “determining” were held patent-eligible in the Prometheus v. Mayo opinion. Policy consequences are huge. The entire biotechnology industry of the United States will be affected. Much of the capital investment for biotechnology is secured upon the underlying assumption that a patent will offer protection from others who would just piggy-back off the R&D efforts of others.
If the merits are reached, it will likely go to the Supreme Court.
March 2010 - S.D.N.Y. Invalidates Myriad's BRCA1/2 Gene Patents
Judge Sweet, in the Southern District of New York, made headlines by invalidating Myriad’s patents on the BRCA1/2 genes. These genes have a known mutation that is linked to a high frequency of breast cancer.
Judge Sweet ruled that “The patents at issue directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 USC 101.”
While I think that this suit is ridiculous, I also think it is interesting that after more than 25 years of the PTO allowing patents on isolated DNA molecules and the issuance of more than 2,645 patents with claims to “isolated DNA,” and over 50,000 patents containing claims to a nucleic acid sequence, that this issue has not already been definitively decided.
I have to think that the Federal Circuit will reverse this decision and that ultimately it will go before the Supreme Court. I think the arguments for patentability and public policy behind patenting genes (as the backbone of our biotechnology industries) are better and I believe that the SCOTUS will rule in favor of gene patents.
The strongest argument in favor of patentability is the fact that "isolated DNA" is not natural. These isolated sequences are not found in nature. The isolated DNA is not just information but it is a different composition of matter than natural DNA. In fact, if an isolated DNA sequence were inserted in to a cell, it would not have the same properties as natural DNA. And natural DNA cannot be used as isolated DNA can as probes and genetic tools.
It has been suggested that Judge Sweet just passed the buck because he did not want to address the more difficult issue in the case, a first amendment issue. Well, at least for now, this case will be decided by wiser minds.
August 2009 - “Evolution of the IP Market”, Intellectual Asset Management, Sept./Oct. 2009
of the IP Market”, Intellectual Asset
Management, Sept./Oct. 2009
The article is a summary of the hearings that the US Federal Trade Commission conducted addressing Evolution in the IP Market.
The Value of a Patent The hearings confronted many important IP issues. One issue that particularly concerned the Commission was how to value a patent. Economic harms could result in undervaluation and overvaluation. If a patent is undervalued, then there will be more infringement because there will be less deterrence to infringe them. However, if a patent is overvalued, that would lead to inflated damage awards in litigation. What is of greatest concern is that we want to foster an environment friendly to innovation.
The IP Market Exists Economic slowdown aside, there still is a market for many different IP services. "Innovation is what drives the economy."
Role of Patents in Raising Cash Patents continue to play an important role in providing security for investors. Additionally, there is a strong market for secondary patents.
Lack of Transactional Transparency One of the problems associated with transferring IP is the lack of transactional transparency. It is difficult to know how much some of these patents are worth. It is also difficult to determine if some of these issued patents really could be found invalid if challenged.
Circuit Has Created an Unworkable Abstract Idea Test for Determining
Patentability that will Unduly Suffer Like the Vague Copyright Idea/Expression
"The Federal Circuit’s holding creates a further undefinable standard that brings the once concrete patentable subject matter analysis an unfixable boundary similar to that between abstract idea and expression that currently haunts copyright law."
2. A Broad, Judicially-Made § 101 Test will Preclude
Patents and Stifle Innovation for New Technology in the Unpredictable Fields
"When patents are so important to the growth of entire industries, the determination of patent eligibility—a gateway question—must be clear."
3. Ambiguity in the Federal Circuit’s New
Machine-Ortransformation Test has Already Fostered Harmful Confusion and
Uncertainty in the Case Law and USPTO Appeals that have Followed
"The Federal Circuit may be wary of emerging technologies and unsure as to whether the USPTO can successfully adapt to avoid issuing patents for inventions that are anticipated, obvious, or overly broad."