Comments on: Breaking: District Court Rules Myriad Breast Cancer Patents Invalid

By: Dr. T. Jordan

Dr. T. Jordan — Tue, 24 May 2011 22:45:36 +0000

Ultimately, I think most biotech companies went for the cheap, low hanging fruit to produce “results” to show their investors. Any half-decent master’s student with access to a PCR machine and a sequencer could, in theory, sequence some new gene and patent it. That’s totally ludicrous. Any scientist worth his lab notebook knew it 20 years ago, and now the court system has finally realized it. Soon, investors will realized it as well, and it will change the funding paradigm of biotech. You have to come up with a real compound or method to actually change the phenotype which the gene controls. The sequence will help you do that, but it’s not patentable. Hell, it’s in the public domain at NCBI. Real medicine requires real research, not some tech in the basement with a sequencer. I’m glad this ruling came down. Finally we can get the bull out of the way and real companies looking for real results will survive and prosper, and the pseudo scientists can go home and be lab techs.

By: IPStudent

IPStudent — Fri, 23 Apr 2010 07:02:15 +0000

The information is very useful.
Earlier the isolated and purified gene sequences were patentable subject matter….from this ruling can we say that to be a patentable subject matter….mere purified form of a native DNA without any limitations is not sufficiant?

please explain me if the court decesion directs to any specific limitations.

Regards.

By: Dr. Shyamala Pillai Shah

Dr. Shyamala Pillai Shah — Thu, 08 Apr 2010 13:23:31 +0000

This is really good news for research and all those of us in the biotechnology research community who believe that ultimately, all research should benefit the human race. Monopolistic and restrictive methods being misused by companies claiming to have sunk millions of dollars in research and hence justifying the disproportionate and, in my opinion, almost criminal costs of many of the existing health care diagnostics should really be curbed. A patent is awarded to foster the spirit of research and not to stifle it. Just because a company has been protected under the patent act does not mean it has the right to exorbitantly charge for diagnostic tests and treatments. Many of the clauses of gene patenting seem absurd and if it were not for the fact that they have such far-reaching and disastrous effects on so many lives, we might have laughed at the USPTO actually granting such rights. I sincerely hope that this judgment will pave the way for a more rational and just system of protecting inventors as well as the people for whom the research was intended in the first place. Thank you for featuring the finer points of the judgment. Though I am not from the legal profession I found some of the aspects extremely enlightening.

By: Dan Vorhaus

Dan Vorhaus — Tue, 30 Mar 2010 20:02:35 +0000

1) Austin, re: products of nature and whole-genome sequencing. Prescient comments/questions - they are addressed in the follow-up post but, yes, I think the information content of DNA (which I'm not at all sure will hold up) is the distinction drawn. I further agree that the arrival of whole-genome sequencing is what is creating the fundamental tension that must be resolved. This decision is a step in that direction, but hardly the final word. 2) Neuro-conservative, re: appeal to the Federal Circuit. The summary judgment posture shouldn't really limit what the higher court considers or bases its own decision on. If an issue wasn't raised in the briefs below, it could be considered waived, but even that wouldn't necessarily stop the court from using it as a basis for a decision. I think we can feel comfortable that the Federal Circuit will give this a thorough review. I think I've answered your other questions either in the follow up post or over on the Genetic Future comment string.

By: Neuro-conservative

Neuro-conservative — Tue, 30 Mar 2010 06:08:52 +0000

This decision seems to rely heavily on a recent (2006) dissent by Justice Breyer in the case of Lab Corp v Metabolite, which was ultimately denied cert by SCOTUS.

In that case, the five conservative Justices tacitly supported the lower court ruling in favor of the patent holder in a situation somewhat analogous to the Myriad case.

It seems that Judge Sweet is on weak ground here.

By: Neuro-conservative

Neuro-conservative — Tue, 30 Mar 2010 03:35:46 +0000

Many thanks for this concise summary.

Two questions for you:

1) Looking at Myriad’s patents, I notice that the claims do not include anything specifying that this is a method to detect susceptibility to breast cancer. Of course, this is discussed in other sections the patent(s), but do you think that this was a weakness of the patent? Would explicit claims of “a method for detecting risk of cancer,” with some sort of risk algorithm, have made a difference?

2) Given the nature of the summary judgement, are there any limitations on what the Appeals Court is allowed to consider or rule upon?

Thanks in advance for considering my questions.

By: Jean Jocquet

Jean Jocquet — Tue, 30 Mar 2010 02:01:50 +0000

As a molecular biologist, I find that the ruling is all obvious stuff. The basic principle of patents is that you can patent an invention, not a discovery. The USPTO got really goofy in the 90s and approved patents all sorts of natural phenomena. They’ve been consistently knocked back to sense. I was close to the ridiculous Johns Hopkins broccoli sprout patent, and that hinged on the same issues and resulted in the same conclusion.

By: A Alexander

A Alexander — Tue, 30 Mar 2010 01:16:47 +0000

I always thought that the USPTO was really reaching in its defense of gene patents when arguing that the isolated and purified form of a gene is somehow different from what occurs in nature, but a summary judgement is surprising given that this seems to be overturning precedent set by the patenting of such naturally occurring biologics as adrenaline and even yeast. Is the court effectively overturning those precedents or is it drawing a distinction between DNA as a “physical embodiment of information” and everything else?

Of course, from a practical perspective, the declining cost of direct sequencing should eventually make the whole issue irrelevant for genetic diagnostic purposes.

By: Paul

Paul — Tue, 30 Mar 2010 00:16:52 +0000

This is excellent news! James Watson co-discoverer of DNA was opposed to such patents and when NIH overuled him he left, or was forced out, in 1992. As the judge correctly notes these are products of nature not intellectual products. Now we are in the absurd position of being able to cheaply and rapidly sequence a persons entire genome. Is every single nucleotide polymorphism found in the individual by the testing company open to being patented. The current situation is then akin to buying a microscope and then claiming a patent on whatever components of life found there. What about, again as the judge noted, the problem with stifling scientific advance by not being able to openly study the gene in question. I would go one further and say that no DNA sequence whether created artificially or found through sequencing may be patented. Quite often these sequences end up in self replicating or potentially self replicating organisms. There is an interesting story http://healthjournalclub.blogspot.com/2010/03/astonishing-court-case-of-becky-mcclain.html of a microbiologist who is claiming she was inadvertently infected by a genetically engineered virus. The company however, is refusing to release the sequence of the virus in question. Well what if that virus or a future one turned out to be contagious? Can you even place a patent on a computer virus? How much more foolish to claim there is patent protection on a virus or other component of a self replicating organism that might someday be able to kill you. At the very least, requests by health practitioners or public health officials should over rule patent claims, whether a sequenced part of a genome or one made from scratch. Glad to see this ruling.
Paul
http://healthjournalclub.blogspot.com/