Posts Tagged: "myriad"

Unlike many in the biotech community I do not think the Prometheus decision will break the biotech industry or even seriously affect it. Much like the car mechanic in a small Caribbean island told me when my engine light came on in my rental car, “no worries, no problem!” I believe the holding in Prometheus prevents what could be a future legal quagmire, where overly-broad patents could serve to block entire fields of practice and create an enforcement nightmare in which ghosts of legal uncertainty and licensing ambiguities would haunt hospital hallways, R&D labs, boardrooms, and investment entities throughout the country. If the Prometheus decision would have gone the other way, it would not have been status quo, but rather been fairly harmful to future innovation.

The basic argument in Myriad is whether DNA that is isolated from the chromosomes is statutory subject matter, or whether it is a product of nature. The stakes are high in the Myriad case, since the isolated DNA claimed by Myriad encodes mutated BRCA1 and BRCA2 proteins that can be used to detect breast cancer. Myriad has the only test offered in the United States because of its aggressive enforcement of its several patents. The numerous plaintiffs in the case speak to the core of the patent versus non-patent debate: whether patents actually “promote the progress of science and useful arts” as required in the U.S. Constitution. Myriad and other companies heavily reliant on biotechnology patents, would support the argument that strong patent enforcement allows companies which have invested millions or billions in assay or drug development for clinical use to recoup their investment and provide a return for investors. The plaintiffs would argue that such patents not only hinder the useful arts, but also endanger lives and/or drives up the cost of providing potentially life-saving testing and treatment.

After much anticipation, the United States Court of Appeals for the Federal Circuit earlier today issued a decision in Association for Molecular Pathology v. Myriad Genetics. The decision on first glance will seem to be a split decision, particularly by Federal Circuit standards. The majority opinion was written by Judge Lourie, Judge Moore wrote a concurring opinion and Judge Bryson concurred in part and dissented in part. Having said that, the outcome largely seems to be what was predicted by the patent community. On the major substantive issue — are isolated DNA molecules patent eligible subject matter — the Federal Circuit reversed the decision of the district court and ruled that isolated DNA molecules do constituted patent eligible subject matter. The Federal Circuit also ruled that methods relating to the screening for potential cancer therapeutics are, likewise, patent eligible subject matter. All three Judges also found the “comparing” and “analyzing” claims to be ineligible for patent protection because they were not transformative, and thus were merely abstract mental steps.

The ACLU lead plaintiffs have a real predicament relative to standing. It does not sound as if the Federal Circuit believed any single plaintiff could satisfy both prongs required to bring a Declaratory Judgment Action, and rather were trying to say we have some plaintiffs with first prong evidence and some with second prong evidence. Simply put, that dog doesn’t hunt, at least not under current law relative to standing. Thus, there seems a real chance that the entire case could be thrown out because no plaintiff has standing.

Richard M. Marsh, Executive Vice President and General Counsel for Myriad Genetics is on the panel. He started off his presentation explaining that he really wants to talk about the case and the issues, but given that the case is ongoing and the future is uncertain regarding whether it will continue to be appealed, go back to trial or be dismissed altogether he might be unable to answer all questions. He did say clearly that the biotechnology industry “is under attack.” Marsh explained that the industry needs to be proactive because “if we sit back and idly do nothing there could be grave consequences.” Marsh explained that Myriad was able to do what it did thanks to the patents by giving it the time, money and incentive to innovate. I couldn’t agree with him more.

At this time of the year all typically sit back and reflect on the year that has been, spend time with family and friends, watch some football and set a course to follow into the new year. So here are the top 10 events that shaped the patent, innovation and intellectual property industry during 2010 — at least according to me, and with a heavy patent emphasis. What did you expect?

On Monday evening, November 1, 2010, David Kappos, Undersecretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, told the Dow Jones news service: “The USPTO at the present time is maintaining the status quo. We’re continuing with current procedures as they are.” This could set up a contentious and public policy battle between the United States Department of Commerce and the United States Department of Justice. This battle of agency titans — DOJ v. DOC — comes as a result of the Department of Justice filing an amicus brief in The Association of Molecular Pathology v. The United States Patent and Trademark Office, which actually does not take the side of the USPTO, but rather says that what the USPTO is doing is wrong. Thus, in an extremely odd twist the DOJ is supporting the plaintiffs’ against the United States Patent Office.

Like it or not, the patent system is a great motivator, and used appropriately to incentivize the type of behavior we want to encourage it is a powerful tool in the government arsenal. To fundamentally alter what is considered patentable subject matter will not only negatively impact cutting edge biotechnology research, but it will also have a chilling effect. Uncertainty causes business paralysis and forces investors to the sidelines. The uncertainty that would be created by the curtailing of patentability would not be isolated to the biotechnology sector, and is exactly the opposite of what our economy presently needs.

On Friday, October 29, 2010, practically on the eve of a national election that will in all certainty be an enormous rebuke of the Obama Administration and the Democrats’ agenda in general, the Department of Justice filed an amicus brief at the United States Court of Appeals for the Federal Circuit that would destroy the U.S. biotechnology sector. In an astonishing and irresponsible policy shift that directly contradicts the long-standing policy of the United States federal government and a variety of agencies, the Department of Justice is promoting the dialing back of what is considered patentable subject matter and is urging the Federal Circuit to rule that “isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.”

One reason I was quite interested in Bilski was because the Supreme Court (not surprisingly) ruled that the Federal Circuit’s “machine or transformation” test was too inflexible, much like the “teaching, suggestion and motivation” (TSM) test in KSR International v. Teleflex. So why my intense interest in the Supreme Court (aka the Judicial Mount Olympus) relegating the “machine or transformation” (aka MoT) test to “second class status” in Bilski? Besides the inanity of MoT as the sole test for patent-eligibility, I am interested because of Judge Sweet’s ill-advised reliance on MoT (now smitten by the thunderbolts from our Judicial Mount Olympus in Bilski) for invalidating Myriad’s method claims using its BRCA1 and BRCA2 gene sequence technology.

There are few things in this world that irritate me more than hypocrisy. Did you know that since 1976 Duke University has had 716 issued US patents, 266 of which in some way, shape or form relate to genetics and 156 of which relate in some way, shape or form relate to both genetics AND cancer. While Duke University throws Myriad Genetics under the bus over its patents on the BRCA1 and BRCA2 genes tied to breast and ovarian cancer, Duke has its own patent on identification and sequencing of the BRCA2 cancer susceptibility gene. How convenient!

Unfortunately, the ACLU appears to have found an “ally” in Judge Sweet, who is the district court judge handling the AMP case. In my view, Judge Sweet has either been duped by the ACLU, or is more likely complicit in accepting the ACLU’s warped view of what these patents cover. That became evident when Judge Sweet denied the motions by Myriad and the USPTO to dismiss this case for lack of subject matter jurisdiction, lack of personal jurisdiction, and failure to state a claim upon which relief can be granted.

Recently I received an e-mail with a link alerting me to something posted on the 271 blog relating to Bilski. The video (viewable on the 271 blog) is taken from a movie about World War II that focuses at least in part on Adolph Hitler. The video posted is from a scene that appears to be taking place in Hitler’s…