Posts Tagged: "biotech"

As I’ve said before, no one could rightly accuse me of being biased against patents. But, as I also pointed out in this article on Judge Rader’s dissent in Media Technologies Licensing, LLC v. The Upper Deck Company, I don’t believe every patent is “bullet proof,” or to use Judge Plager’s phrase, that some patents aren’t built on “quicksand.” In fact, I agree with Judge Plager’s dissent in the denial of rehearing en banc in Enzo Biochem, Inc. v. Applera Corp., issued May 26, 2010, which argues that the “definiteness” requirement in the second paragraph of 35 U.S.C § 112 needs more “teeth” than Federal Circuit precedent appears to give it.

You just couldn’t make this stuff up. A team of humans creates genetically altered and a self-replicating synthetic cell using a computer. I suspect that computer was running some pretty powerful and sophisticated software. So the anti-patent crowd should be sufficiently whipped into a frenzy over this story top to bottom. It hits all the hot button issues, life, genetics, software, ethics and it rolls them all into one. But while we might relish the anguish of those in the anti-patent community, this type of scientific advance should not be taken lightly because it has the potential to fire up those with an anti-patent agenda and could also fire up religious groups as well. The coming together of such strange bedfellows would result in an alliance with enormous political power. So innovators need to pay attention and be vigilant.

Wednesday was my day to walk through the BIO Exhibit Hall. I had already decided to blow off the Al Gore “media availability.” I am not sure exactly what that is, but as near as I can tell it meant I would get to listen to the first 5 minutes of Al Gore’s keynote address. I’m not a big Gore fan, and there were so many cool innovations to learn about. I love to talk shop and nothing quite captures me like innovation, innovators and those who speak the language of business. So… sorry Mr. Vice President, this nerd decided to join the other nerds in the Exhibit Hall. The decision to skip the Gore media availability was sealed when I learned of an tech transfer iPhone app that needed some investigation. Hey, I can’t help it, I’m an electrical and computer engineer at a BIO Convention?!?! I needed some computer angle somewhere!

What follows are pieces of Director Kappos’ remarks at the session prior to taking questions and answers. While it is probably unfair to call these remarks prepared remarks, it was clear that he referred to his notes as he provided detailed information and statistics. He also seemed to be reading what he said when he spoke about the ACLU case against Myriad Genetics, but who can blame him given the USPTO was a nominal party to the case and it will be appealed to the Federal Circuit. It is also worth mentioning that during the Q&A there were a few interesting things that came up, chief among them was Kappos’ explanation of the long odds facing a small entity claiming to be the first to invent but who filed the patent application second. Kappos likened the odds of such a Junior Party prevailing to the odds of being bitten by a Grizzly Bear and a Polar Bear on the same day. He then went on to say that you have to go back to FY 2007 to find a prevailing small entity Junior Party in an interference.

On Wednesday, April 21, 2010, I had the pleasure of conducting an exclusive, on the record interview with Jim Greenwood, former Congressman and current President & CEO of BIO. It was a treat to chat with Jim Greenwood. Our conversation lasted about 35 minutes, and we talked about his decision to leave Congress to take over at BIO, exciting new technologies BIO companies are working on, healthcare reform, the importance of patents to start-up companies and capital investment requirements. We also learn that he is an avid bird watcher and has started to become a bit of a gym rat.

I do have a suggested alternative on the patenting of gene sequences that is far more sensible (and won’t kill our biotech sector) than the “all or nothing” approach of the new Becerra bill. Instead of banning the patenting of gene sequences, why not provide the U.S. government with something similar to the “march-in-rights” provision that currently exists in Bayh-Dole for patented technology developed through federally-sponsored research that is underutilized? Admittedly, this “march-in-rights” provision would have to be carefully structured so it isn’t abused by the federal government, as well as those who would push for its too frequent use because they feel “entitled.”

Presentation of the third annual George Washington Carver Award will recognize significant contributions by an individual in the field of industrial biotechnology, including applications in biological engineering, environmental science, biorefining and biobased products. The Biotechnology Industry Organization (BIO) is accepting nominations for the 2010 George Washington Carver Award, which will be presented at the 2010 World Congress on Industrial Biotechnology and Bioprocessing, June 27-30, 2009 in Washington, D.C. The deadline for nominations is April 12, 2010.

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.

Coming as no surprise, a majority of the en banc Federal Circuit just ruled in Ariad Pharmaceuticals v. Eli Lilly &Co. that there is there is a separate and distinct “written description” requirement in the first paragraph of 35 U.S.C. § 112. Also not surprisingly, there were multiple concurring (and dissenting) opinions. Judge Lourie (writing the majority opinion) has now won the on-going debate that has raged between him and Judge Rader (who has strenuously argued there is no written description requirement separate and distinct from the “enablement” requirement) since the 1997 case of Regents of the University of California v. Eli Lilly & Co.

Notwithstanding the above, I am conflicted in my feelings. It seems that one of the deals included in the Health Care Bill, provisions aimed at biotechnology, are unquestionably good. This is not the type of deal where residents of Nebraska get the rest of us to pay for them, or where seniors in Florida get to keep prescription coverage courtesy of the federal government while seniors everywhere else lose. The provisions favorable to the biotech community will spur innovation, lead to new cures and undoubtedly prolong life. If only Congress could have passed these provisions and scrapped the rest.

The Biotechnology Industry Organization (BIO) has just announced that David Kappos, Director of the U.S. Patent and Trademark Office and Under Secretary of Commerce for Intellectual Property, will be a featured speaker at the Intellectual Property Super Session taking place during the 2010 BIO International Convention. The May 3 event, entitled “Leveraging IP to Spur Global Biotechnology Innovation, Investment and Jobs,” will examine the role that intellectual property systems play in attracting biotech investment and how some countries are successfully leveraging their patent policies to foster economic growth.

In the end, Ajinomoto, and especially the ‘698 and ‘160 patents, were unable to outrun the “best mode” patentraptor. And like the sequels to Jurassic Park, there are likely to be future instances where this patentivour devours other U.S. patents, including those of foreign applicants who may even be ignorant of this patent monster. But ignorance of the “best mode” patentraptor is equivalent to not being aware that the bioengineered dinosaurs were multiplying in dangerous numbers in Jurassic Park. The message is now clear in the Ajinomoto case: be aware or be eaten by the “best mode” patentraptor.

Now here is what really caught my attention about PARD, on November 13, 2009 the stock was trading at $7.58, and on Monday, November 16, 2009 it dropped like a rock to $1.83, where it has largely stayed in a trading range plus or minus since. So what happened? On November 16, 2009, PARD announced what they called a positive Phase 3 study of picoplatin for use to treat small cell lung cancer patients. Those treated with picoplatin had an 11% reduction in the risk of death compared to patients treated with current best practices, which was not a positive enough result to be statistically significant. As is often the case with companies like this in the biotech sector, bad news is devastating to a stock. It is also true that stocks in the biotech sector also do quite well on good news. Back in March 2009, PARD was trading at about $1.70 to $1.80 before running up to a high of $9.14. So could this positive Phase 2 news of picoplatin and colorectal cancer be the precursor to another run up?

If you are unaware that Massachusetts Republican Scott Brown was victorious last night via special election to fill the remaining term of the Senate seat held by the late Senator Ted Kennedy you must be living under a rock.  Over the last month or so Brown has surged in the polls and took Massachusetts and the nation by storm, claiming…