Posts Tagged: "myriad genetics"

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.”

I am in beautiful San Diego, California today, enjoying the beach and near perfect weather. Last night I spoke at the San Diego Intellectual Property Lawyers Association monthly meeting. The topic was “The Perils and Profits of Patent Blogging: How to stay out of trouble while still being read and still generating clients and connections.” Look for more on that next week when I get back to the office and into full swing. In the meantime, in the latest edition of News, Notes & Announcements, IBM enters the blogosphere with an IP blog, Myriad Genetics files it appeal brief and Patent Docs have some excellent early analysis, UCLA Professor Doug Lichtman interviews Chief Judge Randall Rader and the USPTO will host the 15th Annual Independent Inventors Conference at the end of next week. Two more days out of the Office for me attending, speaking at and reporting live from the USPTO Conference. A busy week no doubt.

So now what does SCOTUS’ ruling in Bilski “really” mean to us “mere mortals”? First, we’ve got two “wild cards” to deal with as noted above: (1) Stevens has retired; and (2) what does Scalia’s refusal to join Parts II B-2 and C-2 of Kennedy’s opinion for the Court signify. Some aspects of “wild card” #2 are dealt with above, but as also noted, there are still some aspects which are unclear or at least ambiguous as to how this refusal by Scalia should be viewed. This lack of clarity/ambiguity will require some sorting out by the Federal Circuit, which may come as early as the reconsideration by the Federal Circuit of Prometheus, Classen, or even the appeal in AMP v. USPTO involving the gene patenting controversy. In AMP, District Court Judge Sweet’s invalidity ruling regarding the method claims for determining a pre-disposition to breast/ovarian cancer using the BRCA1 and BRCA2 genes relies at least in part upon the “M or T” test which, as noted above, SCOTUS unanimously relegated to “second class” status in Bilski as not the only test for patent-eligibility.

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!

It will likely come as a surprise to many, but I really don’t think the ACLU victory in the Myriad Genetics litigation is a big deal. Hakuna Matada is what I say. It’s actually a wonderful phrase. It means no worries for the rest of your days, and is a problem-free philosophy… blah blah blah… Picture begins to wiggle out of focus and fades to black in three… two… one… You are about to begin a journey through space and time, into another dimension. On this odyessy into a wondrous land whose boundaries are that of the surreal, the vastness of the timeless infinity forms a middle ground between light and dark, between science and superstition, and it lies at the heart of humanity’s fears and the pinnacle of understanding. You are about to enter the Twilight Zone…

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.

For many months we have been hearing about the government attempts to “reform” health care in the United States, and this weekend the United States Senate is actually working, yes Senators working on a weekend, as the contentious debate continues. Even a relatively rare Presidential visit to Capitol Hill is scheduled for later this afternoon, presumably so President Obama can…

In the ACLU v. Myriad case, the ACLU has alleged that the patents involved in the case cover genes found in nature. This statement is so patently (pun intended) false, that the ACLU either purposely deceived the court or is guilty of gross negligence about the facts plead in the case. As Gene points out in his post, Fired up:…