One thing I should clarify in the piece I wrote is that the Myriad patents weren’t invalidated in their entirety, only the 15 claims that the plaintiffs put in issue in the suit. Stil enough to make Sweet’s ruling ghastly.

What do you call someone who relies upon made up evidence, findings of fact made for the first time, findings not based upon substantial evidence, twisted distortion of the law? The answer is “an Examiner.” When it happens at the BPAI, you get glorified examiners.

I’ve personally known a few former BPAI APJs in my time. Some extremely talented people. However, the new hires they put in place since around 2005 have … what I could call … Dudasitis. It is an affliction whereby all patents are considered evil and if you can twist the law and/or fact to reject an application, then it is your duty to do so. This affliction of Dudasitis has reached epidemic portion in the 3600 group where attempting to allow more than 3 patents in a 24 month period can be considered grounds for dismissal.

It is bad enough that the BPAI mangles the law and/or the facts. What is even worse is that certain APJs just want to re-examine the application — like back when they were an Examiner. They make findings of fact that are not on the record and proceed to reject the claims on these new findings of fact. Also, heaven-forbid that actually label any of these new findings as new grounds of rejection. I had one case in which the BPAI agreed with me that the Examiner screwed up on both the facts and the obviousness analysis. However, examiner error was not establish and the application was affirmed. WTF is that?

I have one case where the BPAI screwed up on one of the most basic concepts of patent law. After the BPAI’s Decision, we ultimately filed a RCE and presented evidence that the Examiner’s and BPAI’s inferences were royally in error. Anyway, it looks like we’ll have that rejection withdrawn. Several years later and the claims have yet to be amended, and I’m getting a new office action — priceless. After I retire, this particular case will be the first one I will point to as example of the BPAI’s incompetence — or at least the incompetence of the BPAI to thoroughly screen new APJs for knowledge of patent law.

Rich, I would beg to differ – I think most patent lawyers will point out that since patents promote the inventions and discoveries in the first place, that it is those who are anti-patent that dismiss the moral component. The fact of the matter is that without the patent system, especially in the bio and pharma arenas, mankind would be far, far worse off.

Rich,

I’m a patent attorney and I’m definitely not dismissing the moral component here. I’m certainly not going to say that Myriad hasn’t created a PR issue with their approach to marketing the BRCA1 and BRCA2 gene sequence technology. In fact, many drug companies are quite sensitive to the PR impact of the affordability of the drugs they market, and even note prominently in their ads how those who are struggling to pay for those drugs can get help.

But what the ACLU and Judge Sweet have done here amounts to negating somebody’s property rights (which is what patents are) by “judicial fiat.” That’s especially true as the Becerra bill, which would have achieved the result that the ACLU and Judge Sweet desired was never enacted. Instead, the ACLU, as well as Judge Sweet, have grossly distorted and misrepresented the applicable patent law precedent, as well as what the Myriad’s patents actually cover. Doing that because they consider those property rights to be “immoral” is a very slippery slope, and not one I’m going to stand by and let pass.

Mike’s reference to the Kelo v City of New London case is a horrible example of SCOTUS exerting such an improper “judicial fiat” mentality. And what’s trully ironic is that the City of New London who pushed for this “emminent domain” nonsense (that has now turned our 5th Amendment on it’s head) is out of pocket $78 million. Why? Because Pfizer (for whom this “emminent domain” nonsense was pushed) decided not to move some of its operation to New London. Yes, there are consequences to relying upon “judicial fiat.”

One thing I can tell is that it is almost guaranteed that the Federal Circuit will trounce Sweet’s decision. If they don’t, the impact of Sweet’s decision will be grave indeed on the development of future biologic drugs, mediical diagnostics, etc., and eveny more serioulsy, American business growth and job creation. Companies, especially American small businesses, are not going to invest in high cost, uncertain technology (which biotech is) which is unprotectable to the extent that the ROI is unsustainable. In fact, it would be ironic if future development of medical diagnostics like those developed completely dried up because no one is willing to invest the money because it’s too much for too great a risk for the ROI.

Again, I’m not saying that we shouldn’t address the moral impact of these property rights. But letting that be done by the “judicial fiat” of one judge is the worst way to do it. Instead, this is and should be a public policy decision that is best left to the legislative branch.

MM,

Interesting that you should assert the above.
Did you come up with that line as an original work of creativity on your own or are you merely mimicking the behavior of others around you?

Why did you not vary it a little bit by saying for example:

Secondly, a million PARROTS with a million typewriters will eventually produce all of Shakespeare’s works given enough time, …

But of course, as we know, parrots parrot each other. Or so we are told and believe. So once a first parrot pecks out some nonsense on his typewriter all the other parrots will plagiarize and peck out essentially the same thing. It might not be 10^6 years till they reproduce the works of Shakespeare. It may be never. Because they are all just plagiarizing each other’s nonsense.

We have all of course heard the saying:

Monkey see, monkey do.

Shakespeare would recognize this latter saying as merely a rose by another name but smelling out the same idea of parrots parroting each other. Mimicry is a basic hard-wiring in mammalian and other brains. Even small brained fish mimic one another. They call it being in school (swimming as a school).

Human beings are not far removed from monkeys and parrots and schools of fish. Humans mimic each other all the time. (Some even make a good living impersonating others.)

All this brings us full circle to the notion that originality and clear vision are not all that common in human beings and many of us merely parrot the words of others without questioning them or truly understanding all their implications.

You said, in parroting mode: “a million monkeys with a million typewriters will eventually produce”. I said , No. It will never happen because none of the monkeys is Shakespeare and all of the monkeys are copy parrots (what? did you expect me to say copy cats? how about copy cougars? a cougar is a form of cat. )

Judge Sweet appears to be yet another parrot cat. He pays great homage for appeal to authority in the first 100 pages of his lengthy dissertation and then parrots the position of one side in the dispute while giving no weight or understanding to the opposed view. In this, I don’t mean to say that Judge Sweet is evil or ignorant or something else along that line. It appears that he has done a commendable job as a lay person trying to come to grasp with some complicated scientific ideas. In the end he gets it all wrong. But hey, don’t blame him, blame all the monkeys he is copying from.

At the same time, why is everyone here blaming the patent system? Are you just copying each other?

The patent system didn’t make Myriad opt for the business model they chose.
Blaming the patent system is like blaming firearm technology for the fact that someone acquired a firearm and then chose to use it in a manner that others might consider immoral. If you want to say that Myriad “abused” its patent rights, then say that and prove it. But saying that all gene patents are invalid because we don’t understand basic chemistry is indeed inane.

(An BTW, relax. No one said all of Gene’s patents are invalid. That’s a toucan of a different color.)

BRAC analysis is probably the most widely publicized genetic test simply because of Myriad’s advertisements. It is relevant to a select portion of the population, women who have a family history of breast cancer. Will everyone who needs a BRAC analysis get one? NO. Will everyone who learns of a propensity for cancer via BRAC analysis get a masectomy? NO. Are there other options out there? YES. No one is upset at the insurance companies, but shouldn’t they make sure their clients have access to the care they need?

I agree, a doctor’s second opinion, especially about such a big decision is important. I agree that it is not available here, in this instance. Other genes have been under patent protection and come into the public domain without issue – insulin, etc. Why should the entire biotechnology industry be thrown around at the whim of an emotional NY judge? This case LEGALLY should have been tossed as frivolous – regardless of the MORAL issue. If you are offended by the morals of it you should push that one up to congress in a bill to modify the realm of patentable subject matter. Meanwhile, DNA patents are naturally getting narrower as the field matures. In this instance, if allowed to stand, one judge and one group of people have decided the morals for a nation based on the flawed business practices of 1 business. Leaving the rest of us with a shattered biotech industry in a time of economic turmoil.

How many biotechs lost value today? How many are going to survive? Are the best, latest, greatest innovations going to be the ones knocked off by this soapbox grandstanding? I’m Judge Sweet, look at me, the CAFC is going to review my case and remand it telling me I don’t understand patent law, but my daughter will be so proud of me because I gave those Myriad bullies a black eye.

Joking aside, clearly intellectual property rights are crucial to maintaining discoveries in a marketable fashion. However, there is definitely a moral component here that so many patent lawyers seem apt to dismiss, attempting to justify the “no-second-opinion” quandary as mere business practice. There is obvious human suffering attached to Myriad’s business practice. The fact that there’s so much controversy attached seems an indicator that something is wrong with the way the current system is working.

Why haven’t we seen a newly synthesized solution equitably considering both sides of this issue rather than 30-year-old regurgitated analyses or festering opinions from either side?

Not true, a gene sequence could not exist on it’s own because A) it would not have the proteins to maintain structure, B) it would not replicate, and C) it requires an entire organism for the DNA to exist within an entire genome. Even viruses have a series of proteins, coat proteins, equipment to initiate replication, and equipment to invade a host. Their is no evolutionary selection to generate a stand alone gene (a unique chemical entity, more unique than penecillin, aspirin, or taxol on an atom per atom basis).

Secondly, a million monkeys with a million typewriters will eventually produce all of shakespeare’s works given enough time, therefore copyright shouldn’t exist either. It has been demonstrated over time that there are two ways to generate new products – government funded research and free market. Government funded research did not generate as many novel drugs/medical devices as the free market -hence Hatch-Waxman. Although universities and research institutes are great at very early technologies, academic research, and other more theoretical investigations, they have shown an inability to generate marketable products without patent protection and start-up companies to carry the torch between for the period between the initial discovery and a marketable product. Start-up companies typically do the majority of clinical trials to identify legitimate leads, test efficacy, determine dosage, track side effects, and complete FDA approval. This takes specialized training in the FDA process and an ability to hurdle through government red tape. Then, if promising, the drugs are typically snatched up by a major pharmaceutical with a marketing team, mass production and distribution experience. After that, generics jump on board to join in the mass production and distribution without needing additional efficacy, dosage, or side effects studies to get FDA approval. This is a complex process, not something that universities have any training, experience or funding for. Because of the current patent system, the universities are able to license their inventions and get more research dollars in the process.

Just ask the Cancer Institute , the initial developer of BRCA1 and BRCA2 research, if they would like to take on development, FDA approval, marketing and distribution. I think they’d prefer just to receive royalties and continue their research. They don’t seem to be volunteering to license their technology or offer alternatives for the BRAC analysis, interesting, maybe they’re not interested in cancer patients health.

Pop – in a perfect world – we can all do altruisitic endeavors and all will be happy. The scientists do good work – I should know – I was a scientist in a former life – but scientists cannot bring a product to market. The cash that is needed to get the drug developed and into the hands of Physicians, will not be invested with out some assurances that the product is protected. Without patent protection, the BRCA1 gene would make some good scientific publications, but that is about it. No patient could afford any therapies based upon the scientific work because the therapies would not be available. Public funding – out of your pocket – cannot possibly provide the resources that would be needed. Public policy would dictate that the pipeline stay open. Judge Sweet’s decision would effectively cut off the pipeline to a slow trickle.

“because they don’t exist in nature and cannot exist without significant human intervention.”

I have to disagree with you here. If you look at things from an evolutionary perspective, then all things are possible given time. The range of possibilities is infinite, and we happen to live in a very small slice of time where things are just the way they are. It may be that specific combination wouldn’t exist right now without human intervention, and if all life, as we know it is destroyed, it may never exist., but life is constantly changing and it has an infinite amount of space to do so, which makes all life inevitable given time and without human intervention.

I have no doubt that your legal position is accurate, but this is more of a moral issue to me than a legal one. We need ways to encourage spending on research, but patents seem to me to be the wrong way to go when it comes to genetics and other biological methods.

A patent isn’t worth fighting for if it isn’t going to make you money, and that means it has to be useful, so perhaps we could set up a system where useful research is directly compensated by the government, or we could increase government grants for research, or both, but letting the public sector do research and then giving them patents on it is just wrong.

This is a similar issue to health care and we shouldn’t let the monetary interests of corporations direct the research and usage of anything that directly involves life forms. The scientists aren’t the ones laughing all the way to the bank, the shareholders are, so why can’t we cut out the middle man, save some money, keep the scientists who are doing the real work active and let this kind of progress be made available to everybody?