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« Follow-on Biologics News Briefs - No. 12 | Main | Letter to Congressional Leaders Seeks Patent Protections »

February 01, 2010

Comments

There's like, what, at least half a dozen serious universities in and around Boston (MIT, Harvard, BU, BC, Tufts, and Brandeis for starters)? And no small number of biotech and medical device start-ups in the area, as well as a few established players (think Boston Scientific and Perkin-Elmer)? You'd think the Globe could hire at least a few people with a smattering of education and intelligence...or at least ask some of the locals working in the biotech industry what they think about gene patenting before writing dumb editorials.

Well spoken response Kevin. The only real debate about the breast cancer gene patents would be how to reasonably price the testing into public health care treatment. And, oh yeah, Mass. already recently contrbuted their veto vote to any federal plan.

Kevin,

This Boston Globe article just proves that journalism as we once knew it doesn't exist anymore.

Wow. They may be the most confused yet. It is so sad that this is who "explains" tough scientific concepts to the general public... and that the public trusts them!

Thanks, Kevin.

A well written response Kevin. If you read the comments to the globe article, there were (not suprisingly) several intellegent comments setting the record straight and taking the Globe and others who simply don't get it to task. Was that you too?

The "market competition" the Globe envisions would be like the market competition among thieves trying to steal my wallet.

The unsettling thing about journalism is that every time you read about something you know about, irrespective of political issues, you are truly amazed that you believed the rest of what they are saying.

J schools, like college Education departments, teach process, not content. Ergo, we get the equivalent of a chef who knows how to run the oven but hasn't a clue about the role of salt in cuisine.

Great post. One of the many things so infuriating about the position espoused in the Globe's editorial is that they, like so many others in the media, apparently never read the ACLU complaint and so have no idea what they're championing. At its core, the ACLU case is not about patent law. It's about the tenuous theory that Myriad's patents stifle 1st Amendment rights by preventing patients from obtaining second opinions and by setting a price on the patented test that some patients can't afford. Those objections could be raised against any medical technology, not just DNA based products. Moreover, neither has anything to do with the legitimacy of the patent. The "second opinion" complaint focuses on the quality of the test, and the price objection is one for health insurers, not the Patent Office.

Just more irresponsible journalism. It's beginning to seem that the ads in newspapers are better researched than the articles.

"about the tenuous theory that Myriad's patents stifle 1st Amendment rights by preventing patients from obtaining second opinions and by setting a price on the patented test that some patients can't afford."

One thing is for sure, if the 1st amendment protects corps ability to contribute to campaigns then it dam sure well protects this situation as well.

1st amendment protects everything!

Being serious for a moment though, I'm a bit let down about the most recent bit USSC decision. Even if it is lawful (which I have little doubt that it is considering the twists and turns the 1st has been put through). And that decision will cause more hurt or harm than this ACLU one will no matter which way it goes.

Have any of you guys taken a look at that USSC decision and seen what all it said? Any opinions?

Bickering about this ACLU case while the USSC gives control of our gov to corps is analogous bickering over a lit match is dangerous while your house is burning down around you.

Can someone please clarify: does basic research (other than towards developing a diagnostic test for breast & ovarian cancers) of BRCA1 & BRCA2 fall under the scope of Myriad's patents? In other words, can I do other type of research on BRCA1 & BRCA2, even if it involves sequencing the genes? Because any genetic research invariably involves PCR and sequencing. I have been reading conflicting answers. I would need to know that before I make up my mind which side to stand on. Thank you.

Regardless of the answer to my previous question, I am of the opinion that DNA inside a cell and DNA inside a test-tube is one and the same. It's still the same composition of matter. The two may have different (non-common, non-overlapping, whatever you want to call it) utilities, but it's the same thing.
I have heard argument that cDNA is patentable since cDNA does not exist "in nature", but then what about intronless genes - they are the equivalent of cDNA, except for the name.
I'm a scientist, and I understand both sides of the argument, but the idea of a patented DNA sequence is just too tricky.
Thank you.

Dear Sean:

As with most things, it depends. There are plenty of researchers who are doing basic research, and depending on what they are doing it may fall within the scope of one of the claims. That is probably true of many patented inventions.

However, the policy question is whether these researchers are at any risk, and the answer (in this case) is no - what patentees want to exclude is commercial activity, not research.

So if you want to lobby for a "basic research exemption" in patent law, be my guest - a similar exemption was enacted 15 years ago, concerning doctors practicing medical techniques (I think the impetus was eye surgery).

The consequence in that case was fewer surgical method claims, and that's fine. In view of the existence of thousands of papers and hundreds of researchers doing basic research unimpeded by any patent holder of any gene, I don't think anyone would notice the effects of a similar ban regarding enforcing gene patents against basic researchers.

With regard to your second comment, there are several differences between DNA in a cell and DNA in a test tube. For example, the DNA in a cell is covalently linked to other DNA sequences. Further, 1 ug of genomic DNA comprises maybe 1 pg of the particular DNA of interest. Also, it is impossible to use the DNA in a cell to produce useful amounts of the encoded protein.

So these are related to the DNA's utilities, but frankly you could make the same argument for any naturally-occurring product. If that is your position, then many antibiotics and other drugs are not patentable, since there is "no difference" between the drug in nature and the drug as purified (in the drug molecule; there are certainly fewer contaminants, but the molecule itself doesn't change.

Now, I understand that there are those who think that permitting gene patents is "wrong," and insofar as this is human exceptionalism, or vitalism, or any other ism, I can't argue - people are entitled to their opinion. But I think that the consequence of such a ban is less disclosure, less investment, fewer drugs and fewer diagnostic tests. I don't think placating people's isms are worth the cost. And I don't think a position that advocates this outcome is ethical, since it will directly translate to human suffering and loss of life.

Thanks for the comment.

Kevin:
Thank you for coining a phrase aligning with my position - basic research exemption lobbyist. This is the stance I intend to take.
As far as patenting genes go, firstly, "DNA patent" sounds better than "gene patent". I understand your purified DNA-drug analogy, and I may be willing to concede (but the SCOTUS might not - wood paper patent). But specifically, for the BRCA patents (I'm sure you must have read them), I would opine that they do not involve inventive step. PCRing DNA (genomic, cDNA etc.), sequencing, comparing sequence with BRCA SNP database, and "diagnosing" cancer propensity based on the sequence look like 103 (if not 102) pitfalls. And I believe Myriad had to include a composition of matter i.e. the DNA sequence and not just a method or use (PCR, sequence etc.) to ensure strength of their patent application.
Anyway, I wonder whether the US should come up with some other way to patent DNA sequence without having to exclude others using it (for any purpose) - like an omnibus claim that would leave the actual sequence out. Do you think that could be feasible - at least for the sake of argument?
Also, I genuinely ask myself whether banning DNA patents would cause what you claim - less investment, fewer drugs, and fewer tests. Would it really?
Thank you.

Dear Sean:

I'm with you for the basic research exemption - it pulls the teeth from some of the ACLU's facially attractive (but ultimately specious) arguments.

I think the Wood Paper patent cases support my position - the court expressly did not decide that patents on purified natural products were not patent-eligible, but rather that a new method for making purified cellulose did not permit the patentees to claim purified cellulose, which was known in the art (they didn't quibble about whether the new method made it more purified).

Now, the parts of the claims you mention are parts of the diagnostic method claims, and those are different from gene claims per se. At least two members of the current Court don't like diagnostic method patents very well, but mostly on dogmatic lines. Since one of those members (Stevens) will likely retire after this term, the Court's inclinations on this topic are very up on the air.

As to your final question, I think there would be a reduction in biologic drug investment, but the most pernicious threat would be development of diagnostic methods where the genetic bases were not disclosed. For multigenic ailments (i.e., most ailments) where the genetic bases have not been fully elucidated, this would involve genetic identification and bioinformatics using platforms that would be very hard to reverse-engineer. But the advantage to the company would be no disclosure, and no expiration of de facto exclusivity. Not the best outcome, in my opinion.

Thanks for the comment.

Dear Kevin:
I do believe ACLU's complaint on constitutional grounds is a bit severe.

In the wood paper patent case, I thought the court ruled that while method of purification may be patentable, but not the purified extract. "A process to obtain it from which it has never been taken may be the creature of invention, but the thing itself when obtained cannot be called a new manufacture...." I was trying to say that something existing in nature in a crude form or with contaminants may not be patentable in a purified form (while the purification method may very well be). For example, General Electric Co. v. De Forest Radio Co., 28 F.2d 641 (3rd Cir. 1928).

And I partly agree on your innovation point. This is an educated guess, but a majority of implicated genetic variants come out of academic research labs who publish in peer-reviewed journals, as with the BRCA sequences. My issue with Myriad is that they just built the diagnostic tests on sequences that were already known and characterized.

Anyway, it will be interesting to see who Obama nominates and how that goes.

Thank you.

Dear Sean:

Sometimes I think it helps to be a Talmudic scholar when reading 19th Century Supreme Court cases, but my reading of the case is different. If you read the entire case, the Court believed that cellulose purified from rags was already in the prior art, and although the new process enabled cellulose to be isolated from wood pulp, it was the same cellulose after all. (I may have reversed the order of prior art/invention, but the point is the same.)

So the Court was saying that a new process of making something couldn't convert an old thing into something patentable. A modern-day example illustrates the point. Erythropoietin was known in the prior art when Amgen isolated the human EPO gene. Thus, Amgen could patent the novel DNA and cells expressing it, but not the EPO itself. Indeed, when Amgen did patent EPO itself, the claim was limited to EPO that did not have a glycosylation pattern of human urinary EPO (i.e., the prior art).

So I don't think the Wood Paper Patent cases say that purified naturally-occurring material wasn't patentable.

I know you can find cases from some of the regional circuits that contradict me, but 1) the reason we have a Federal Circuit is that some regional circuits were violently anti-patent and 2) these decisions were prior to Diamond v. Chakrabarty, where the Court enunciated the modern test interpreting the scope of the current statute.

Finally, to clear up a misconception, Myriad didn't build a diagnostic test on sequences that were already known. Scolnick, the founder of the company (or its predecessor) identified the mutations that are at the heart of the Myriad test. And since this involved identifying point mutations in a genetic sequence centiMorgans in length, I'd say it was a patentable achievement.

Thanks for the comment.

Dear Kevin:
This is really good for me. I am just entering this field and such discussions help me formulate my views or recognize my existing views in patent law.
So, if I may ask you: are there any cases in CAFC or SC where they have ruled against patentability of a purified version (product) of a crude naturally occurring substance? Because I am afraid in this case, CAFC or SC might defer to precedence.
I am totally fine with Diamond v. Chakrabarty. Patenting genetically engineered bacterium that was generated via recombinant DNA technology is, I believe, different from the piece of that DNA itself. That piece of DNA is not new and patentable until it is put a new and patentable use. Now I understand that uses and methods are difficult patents to enforce, but this DNA patents issue is still stuck on me. And thank you very much for clearing the Myriad misconception.

"I'd say it was a patentable achievement."

Achievements don't fall within a statutory category Kev :(

Dear Sean:

The rogue's gallery of Supreme Court cases have been significantly misinterpreted. They are:

the Wood Paper Patent cases, where the court said that the product of a new process was not patentable because it was known in the prior art (and it also said that the Court was not deciding whether a purified product of nature was patentable or not);

the alazarine case, where a new process of making a known dye did not make the dye made by the process patentable, since it was exactly the same dye known in the prior art (these two cases stand for the same thing); and

Funk Bros., where a patent on a mixture of two types of bacteria was not patentable, since the claim encompassed any combination of two type of Rhyzobium bacteria and the only limitation was a functional one (Justice Douglas properly objected that what was being claimed was the biological property of being able to co-culture any two of these bacterial strains).

There is one other case, where oranges were coated with Borax, but it was still an orange after all.

There are several regional circuit court cases that say yea or nay on the topic, but they are no more than persuasive authority; the most persuasive (based on the writer) is Judge Learned Hand's decision that purified adrenaline was patentable.

I think Chakrabarty gets you to the right answer, but the Court has never expressly stated that an isolated nucleic acid encoding a protein is patentable or not. Hence the debate, and the lawsuit.

Thanks for the comment.

Dear 6:

True; I was speaking metaphorically, please forgive me.

How does "manufacture" or "composition of matter" strike you as a basis?

Thanks for the comment.

I know Kev I'm just pullin' your leg.

Dear Kevin:
I don't know why I think a patent for purified adrenaline is okay, but that for purified DNA isn't. Anyway, thank you for bearing with my back my back and forth.

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