Gene Patenting Debate Continues - Round Three

    By Donald Zuhn --

Last week, National Public Radio's Science Friday, which is broadcast nationwide as part of NPR's Talk of the Nation, examined the issue of gene patenting.  The debate over gene patenting reignited in May as a result of the Association for Molecular Pathology v. United States Patent and Trademark Office case, in which a group of patients, physicians, academic researchers, and medical societies filed suit against the U.S. Patent and Trademark Office and Myriad Genetics, among others, over several patents claiming human BRCA1 and BRC2 genes and methods for detecting mutations in these genes to diagnose a predisposition to breast and ovarian cancer (see Patent Docs reports here and here).  Since then, two public radio debates have focused on the issue.

In June, Dr. Hans Sauer, the Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO); Joshua Sarnoff, Professor of the Practice of Law at American University's Washington College of Law; and Shobita Parthasarathy, Co-Director of the Science, Technology and Public Policy Program at the Ford School of Public Policy at the University of Michigan discussed the topic on WAMU, Washington, DC's leading public radio station (see "Gene Patenting Debate Continues").  And last August, Kevin Keenan, Executive Director of the ACLU for San Diego and Imperial Counties; Stacey Taylor, a partner at DLA Piper; and Dr. Leonard Deftos, Professor of Medicine in Residence at the University of California, San Diego, and Adjunct Professor of Law at California Western School of Law tackled the issue on San Diego's KPBS "These Days" program (see "Gene Patenting Debate Continues - Round Two").  This past Friday, Patent Docs author Dr. Kevin Noonan, a partner at McDonnell Boehnen Hulbert & Berghoff, and Daniel Ravicher, the Executive Director of the Public Patent Foundation (PUBPAT), which is serving as co-counsel in the Association for Molecular Pathology case, squared off in a third debate on the topic on NPR's Science Friday.

Science Friday host Ira Flatow (at right) began the program by asking Mr. Ravicher why the lawsuit was brought.  Mr. Ravicher replied that the suit was "about whether or not the government has the right to grant exclusive rights to one company over our genes" as well as the knowledge of gene mutations that might relate to a predisposition for particular types of diseases.  He added that the suit was filed because Myriad Genetics, which co-owns the seven patents-in-suit, had been asserting the patents in a way that "crack[s] down on anyone else doing any research" and "anyone else doing . . . second opinion testing."  After Mr. Flatow noted that the PUBPAT website describes gene patent holders as having "the right to prevent anyone from studying, testing, or even looking at a [patented] gene," Mr. Ravicher declared that "there's absolutely conclusive ownership of the gene by the patent holder."

Mr. Flatow then turned to Dr. Noonan (at left) for a response, asking whether he agreed with Mr. Ravicher's assessment.  Dr. Noonan conceded that Mr. Ravicher was "technically correct," but before he could opine further, Mr. Flatow asked whether it was true that "people aren't even able to look at the gene?"  Noting that "[t]he National Library of Medicine has a list of most of the major scientific journals in the U.S. and abroad," Dr. Noonan revealed that a search of the collection for BRCA references yielded "almost 3,500 papers that have been published about these genes, some as recent as last month."  (In addition, a search of the NCBI PubMed database yields 1,145 references containing "BRCA" in the title or abstract.)  In view of the NLM search results, Dr. Noonan contended that "the idea that people are not doing scientific research on these genes is just wrong," explaining that "[w]hat people are not being [allowed] to do, and what some of the named plaintiffs in this lawsuit are trying to do, is provide clinical testing."  According to Dr. Noonan, it was the commercial use of the BRCA sequences, and not the research use of the sequences, that was precluded.  Mr. Ravicher, however, replied that he represented researchers at the University of Pennsylvania, Emory University, and the University of California-Los Angeles, all of whom had received "very nasty letters" from Myriad saying that "[w]e know that you are doing things with these genes that relate to breast and ovarian cancer, and you shall stop or pay us money."  He added that "BRCA analysis at the University of Pennsylvania [had been] shut down because of Myriad's patent assertion."

Returning from a short break, Dr. Noonan noted that he was on the program to defend gene patenting (and not necessarily Myriad), stating that "it would be a mistake for the United States government -- whether through the courts, through Congress, or through the Patent Office -- to not allow genes to be patented."  When asked why this would be a mistake, he replied that "[b]esides being contrary to 200 years of natural products patenting," a prohibition on gene patenting would adversely impact the disclosure of gene sequences and investment in biotechnology.  Explaining that "in the biotechnology space, investment is critical," Dr. Noonan noted that "[m]ost of the companies that do this are small companies like Myriad, and unless there's some way for investors -- in something that's very high risk and [where] most of the products fail -- to get their investment back, you're not going to have investment."  As a result, "you don't have the drugs and the diagnostics that the biotechnology industry has developed over the past 25 years, and I think that we're in worse shape if we don't have them."

In response, Mr. Ravicher (at right) argued that "[t]here are valid reasons to have patents on many things, but you can have patents on too many things, and there's a line that's been drawn by the Supreme Court, and we fully believe that these patents land on the wrong side of that line."  When pressed by Mr. Flatow to discuss the impact of the lawsuit on investment, Mr. Ravicher noted that "patents have both an incentivizing and a chilling effect," and analogized gene patents with a patent on the law of gravity, stating that "the Supreme Court has said that you can't patent some things [that] are basic laws of nature because that would have such a dramatic, countervailing chilling effect on everyone else -- all 300 million other Americans and any research that they might do on that subject -- that granting a [patent] to that one party isn't worthwhile."

Mr. Flatow next asked Dr. Noonan whether he could patent a cure for cancer discovered in the course of doing research on a patented gene.  After Mr. Flatow outlined a lengthy hypothetical involving Bill Gates, Dr. Noonan observed that "we could spin hypotheticals all day, but it gets down very much to what exactly is it that you're doing."  Dr. Noonan added that "if you isolate [a patented] gene and use it, then you would be infringing," but "whether or not that would be something that you would be sued for . . . would depend on the circumstances."  When Mr. Flatow asked whether a patent holder could bring suit for "any arbitrary reason," Dr. Noonan responded that Rule 11 of the Federal Rules of Civil Procedure precluded such a suit, and "[y]ou have to have a good faith belief that somebody has infringed your patent."  Mr. Ravicher, however, noted that Rule 11 did not apply "to sending nasty letters."  Explaining that a lot of researchers were either universities that have "very skittish university counsel offices" or small businesses that "could never afford to defend themselves," Mr. Ravicher argued that "[m]erely the threat of a lawsuit just through a letter, which doesn't have to meet Rule 11, often chills conduct that most reasonable people would agree would never be covered by a valid claim of any patent."

Turning to the impact of the claim term "isolated," Mr. Ravicher argued that:

[M]ost reasonable people would agree that if the patents were just on the BRCA genes, that would not be valid because that exists in our body -- the genes exist in our body.  It's that these patents say an "isolated gene," and the Patent Office . . . said that . . . if you isolated the gene, then that's patentable.  And we just think that's incorrect.  That's like saying I can go out into nature, I can dig up some gold, I can isolate it from the mountain, and well now I deserve a patent on gold, and that's just not the law.

(Mr. Ravicher also contended that the decision to grant gene patents containing claims reciting "isolated" sequences was related to the "very pro-business, pro-patent Administration" under which authority the Office operated.)  With regard to the patentability of natural products, Dr. Noonan countered that antibiotics made by bacteria and the anti-cancer drug taxol, which is produced in the bark of the yew tree, were both examples of patentable natural products.  As for the BRCA genes, he contended that:

(a) they're not identical to what's in the chromosome, (b) they're not in the chromosome anymore, and (c) they are much more converted [or] changed as the Supreme Court would say by the "hand of man," than . . . taxol from the yew tree.  So if you're going to use the traditional standards of what you have to do to change something that is found in nature to make it patentable, these genes satisfy that criteria hands down.

Acknowledging that "Kevin does an excellent job of presenting our opponent's point of view," Mr. Ravicher noted that the plaintiffs in the BRCA case nevertheless disagreed.  According to Mr. Ravicher, "[a]ll those isolated natural product claims have never been upheld by the Supreme Court, and we think they would be invalid under binding precedent."

For the last portion of the program, Mr. Flatow took calls from listeners.  The first caller stated that while she couldn't "fault the company Myriad, because they are the holders of the patent that was granted legally," and therefore she didn't "see any point in any lawsuits against them," she appeared to favor Mr. Ravicher's argument regarding the claim term "isolated," and thus saw "quite a bit of validity in complaints or suits against the U.S. Patent Office."  Mr. Ravicher noted that he:

[W]ould disagree [with the caller] when she concedes that these patents are legal.  There are many things done under our previous Administration that were not legal.  Just because the Patent Office has granted a patent doesn't mean it's actually valid.  In fact, about half of the patents granted by the Patent Office and that are later litigated in court are found to be invalid.  They were wrongly granted by the Patent Office.  That's because the Patent Office has been created to be a pure patent-issuing Office under previous Administrations.  Under the new Administration, we expect that to change.  So I would not concede that these patents are valid just because they were granted.

Unfortunately, Mr. Ravicher's attack on patent validity has some holes.  As an initial matter, Mr. Ravicher provided no support for his assertion that "about half of the patents . . . litigated in court are found to be invalid."  According to the Patstats.org, however, in cases where patent validity was at issue, the patent holder prevailed 59.8% of the time in 2008.  Mr. Ravicher's comment about patent validity also glosses over the motivation of accused infringers to invalidate asserted patents, as well as the impact of recent Federal Circuit decisions (e.g., KSR International Co. v. Telflex Inc.) on patents that were examined and granted years ago.  With respect to Mr. Ravicher's comment that the USPTO had been "created to be a pure patent-issuing Office under previous Administrations," one hopes that he was not referring to the most recent Administration, as the Office's efforts to push through the claims and continuations rules (among other rules packages) and "reject, reject, reject" mantra contradict such a characterization.

Turning to the cost of Myriad's test, Mr. Flatow asked Dr. Noonan whether there wasn't "something ethically, morally wrong with not allowing someone to come up with a cheaper test that potentially cancer patients can afford."  Dr. Noonan responded that he didn't have "any evidence that Myriad is the most profitable company in the country, or that what they're charging is excessive," adding that if Myriad was "making money hand over fist and w[as] on Forbes' front cover as the most profitable biotechnology company, maybe you'd have an argument."  He argued that Myriad appeared to be charging an amount that merely "justified the investment to [develop] the test in the first place."

The second caller to the program admitted that she was "still a little unclear on this isolating of the gene," and asked:

I have the gene, right?  It's in me?  So they've isolated it, but I have the gene, right?  So, why don't I have the patent on the gene, or why can't I sue Myriad?

Agreeing with the caller, Mr. Flatow exclaimed that Myriad was "using your gene!" and asked Dr. Noonan for comment (while also accusing him of "trying to make light" of the caller's question).  Dr. Noonan argued that he was not making light of the question, and added that the caller's (and Mr. Flatow's) comment was "the emotional crux of the ACLU lawsuit."  He contended that:

[N]obody is going to knock on your door, like Michael Crichton said in a New York Times editorial a few years ago, and give you a bill for using your gene.  That's just -- it's great -- it gets people all excited and all upset, but it's just -- frankly, at the end of the day, it's a lie.

The third (and final) caller observed that "the recommendation typically for women who test positive for the BRCA gene is to have a double mastectomy and their ovaries removed, and it's troubling that you can do this and you can't really get a second opinion," and noted that "[t]here's no other company you can go to get this test done before you have this very radical life changing surgery."  Dr. Noonan replied that he had "spoken with some people at Myriad [who] say nobody ever asked them for the second diagnosis," and therefore speculated that "the second opinion option is one that may still be out there."  Mr. Ravicher, however, asserted that he had "actually written a letter to Myriad on behalf of my client who has already paid [for one test]," and that Myriad had "refused to grant our client in this lawsuit the right to get a second opinion."  Dr. Noonan asked Mr. Ravicher whether this letter had been sent to Myriad after the lawsuit was filed, and Mr. Ravicher acknowledged that it had.

After Mr. Ravicher suggested that an individual could get a second opinion outside the U.S. "because these gene patents are not allowed in most other countries in the world," Mr. Flatow compared such an option with the dilemma facing women prior to Roe v. Wade.  Mr. Ravicher noted that he had "seen another analogy, which was with respect to patents on human embryonic stem cells in this country, which were granted [in the U.S.] but not granted in other countries."  He suggested that these patents had forced "many researchers . . . to move their labs to foreign countries like Singapore because the [stem cell] patents didn't exist there."  Exposing the flaw in Mr. Ravicher's analogy, Dr. Noonan pointed out that "the reason those labs moved offshore was the Bush Administration's restriction on the cell lines," rather than the assertion of stem cell patents.

While Mr. Flatow's guests found little common ground, they did agree on one thing at the conclusion of the debate:  that the case would likely be appealed to the Federal Circuit regardless of who wins at the District Court level.

For additional information regarding this and other related topics, please see:
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009

• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009
• "Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
• "Science Article Should Help Allay Gene Patenting Fears," December 17, 2008

Comments

[Bartmans]

Kudos to Dr. Noonan for doing a good job in a discussion which is very difficult and can become very nasty.

[EG]

According to Mr. Ravicher, "[a]ll those isolated natural product claims have never been upheld by the Supreme Court, and we think they would be invalid under binding precedent."

Don,

I would frankly like to know what "binding precedent" Ravicher is referring to would render "isolated natural product claims" invalid. It must not include Chakrabarty v. Diamond or In re Bergy.

I'm also not surprised that Ravicher doesn't have his facts straight (witness the gaff on the number of patents invalidated). In my opinion, the ACLU complaint is a gross and deliberate distortion of what these patents cover (speaking of FRCP 11 issues, and I'm not alone in that view).

It is entirely possible that Myriad hasn't acted in the most diplomatic fashion, and may well have overreached on what these patents actually cover; if that's true, the ACLU and others should address Myriad's overreaching conduct without castigating the patent eligibility. But what the ACLU is appealing to here is not facts or the law, but instead "politically correct" hysteria based on bogus (and I do mean bogus) constitutional claims.

[Prior Art]

Link to the program:
http://www.sciencefriday.com/program/archives/200912112

First, I'm shocked that I didn't see the Dec 10 post warning us of this program as I check this site every day.

Second, great job Kevin. Was this your first program?

Third, I'm quite shocked at Ravicher's naive statements regarding patents. Asserting patents grant the patentee a right to use, reference to law of gravity, using someone's gene? He's Associate Director of the Intellectual Property Law Program Benjamin N. Cardozo School of Law.

Kevin, any analysis on the letter that Myriad has sent you?

[Avery]

Thank you, Kevin, for being a public voice in favor of patents and for trying to correct the misinformation that is being flung about by the anti-patent crowd. Unfortunately it seems to be very much of an uphill battle, partly because the issues are complicated to explain but mostly I think because the anti-patent crowd doesn't seem to have any qualms about exploiting the public's ignorance as well as its fears. Thanks, though, for trying.

[EG]

Prior Art,

Thanks for pointing out that Ravisher is Associate Director fo IP Law at the Cardozo School of Law. Wow, someone heading a law school IP program who hasn't a clue what patent law/science basics are.

I've also confirmed that Rivisher isn't a registered patent attorney, although he appears have an undergraduate engineering degree (I don't know if the C stands for Civil or Chemical). "Naive" is an understatement.

[CNS]

With regard to patients' desire for a "second opinion," just what are they looking for another opinion on ... that they should get a double mastectomy, or that they have the BRCA mutation to begin with? The first I can understand. However, the second, which is one of the issues here, isn't even an opinion -- it's a fact. Either a patient has the BRCA mutation or they don't -- another lab's test isn't going to give them a different "opinion."

[Kevin E. Noonan]

Dear CNS:

That is exactly what they are saying - that a patient has the right to a test by another lab to provide the "second opinion." Dan even mentioned that there were some reports that Myriad wasn't using "the best methods," but didn't elaborate.

On the one hand I agree with you, but keep in mind the rather dramatic intervention that a positive result entails - I can understand why a woman would want to be sure before undertaking such a life- and body-altering surgery.

I would be interested to know if insurance routinely pays for such "second opinion" diagnostic tests for any other disease (or for breast cancer, for that matter).

Thanks for the comment.

[Kevin E. Noonan]

All:

Keep in mind that Dan is advocating his position with regard to this lawsuit, not expounding on patent law per se. He has been a civil and engaging counter to our arguments, and he has a defensible position, regardless of whether we agree with it or he had the time or opportunity to explicate it fully on the show.

Also, remember that we avoid the ad hominem stuff here - not that I'm accusing anyone. Just want to keep our traditional tone.

Thanks for the comments, and the kudos.

[Gary Johnston]

Dear Patent Docs authors:

Semantics, semantics, semantics. When people complain about "gene patents," they are, whether they know it or not, almost never complaining about composition claims directed to cDNAs, but rather are almost always complaining about process claims directed to generically analyzing a gene (or part of a gene) for the presence/absence of a specific sequence that is correlated (to some degree or another) with a trait. In fact, a composition claim directed to a cDNA of a gene is, for all practical purposes, worthless in terms of preventing the analysis of that gene for the presence/absence of a specific sequence. You all know this, but you never acknowledge it. Instead, you attack the credibility of the Ravicher's of the world by stating (correctly, I fully admit) that DNAs are nothing more than chemical compounds, and should be treated as such under the patent laws. It allows everyone to ignore (or forget about) the real issue, which is whether processes for "correlating" a biological marker to a trait or condition are or should be patent-eligible. This is the stuff that truly drives people crazy, and it SHOULD drive them crazy. Patents on such processes do not promote the progress of science or useful arts. Deep down, you know this. This is basic science stuff (causes, functions, correlations), and basic science will be done (and commercialized) regardless of patents. In fact, it very well could be done better!

[Kevin E. Noonan]

Dear Gary:

You may well be right, but this has gone beyond talk - the complaint filed by the ACLU on behalf of the named plaintiffs is directed towards the claims to the genes themselves (see our post from this past May), and the ACLU's campaign is directed to these claims expressly ("Do not patent my genes").

Unfortuntely, it isn't just semantics anymore.

As for the method claims, there you (and Dan) may have a point, although I can (and have) come up with a scenario where diagnostic tests could be developed for genes (correctly, a plurality of genes) in such as way that the test could be difficult if not possible to reverse engineer. Under these circumstances, it isn't so much that diagnostic method patents promote progress, but that the alternative does the opposite- the absence of patent protection discourages disclosure and thwarts progress. And in the process, gives the company marketing the test a perpetual "monopoly."

Thanks for the comments.

[Saddlepack Maker]

One of Mr.Ravicher's points was that scientists at the University of Pennsylvania received "nasty" letters from Myriad. I find this interesting because the Regents of the University of Pennsylvania is a co-assignee of at least one of the patents asserted by the ACLU to be invalid. Mr. Ravicher fails to explain whether Myriad's alleged request was an attempt to get the University of Pennsylvania to adhere to the terms of an agreement between Myriad and UPenn or whether Myriad is attempting to assert its rights under the patents.

[6]

Kev,

The 2nd caller just didn't understand that "isolated" meant that she didn't have the gene in her body. She just didn't get the claim properly construed. Your going off about the emotional thing was misplaced.

However, she would be right in pointing out that the mechanism that companies have used to justify their patenting the gene (i.e. saying it is isolated) is hogwash and should have been taken out as such by the courts years ago. Everyone knows it, it is on its face apparent. It simply isn't in the spirit of the patent laws what so ever and we see more and more of these types of limitations popping up every year even in other arts. The USSC will eventually set things proper. Whoa unto us until such a thing happens, and whoa unto those who stake their business on them not setting it right. Hopefully that is nobody.

"Patents on such processes do not promote the progress of science or useful arts. Deep down, you know this. "

I have to give you an amen brother. I didn't read your post until I typed the above portion.

We see that nonsense popping up in other arts as well. So many inherent things used as limitations that they claim they've discovered about something that already existed in the prior art (or in your body). It's time for a decision like In re King to take these people to pound town. Preferably delivered by Rader. "Ok, so you say you discovered this new thing about something old, fine, no patent", "oh my bad, you were saying you 'detected' this new thing, fine, no patent".

And I do hope Rader gets this instant case when it gets up to a panel.

Kev you did a good job arguing for your side, but I really think you should be on the other side. And I think if you were seeing clearly you would. It is one thing for us pointy headed ivory tower patent people to tell people that parts of living things (and seeds, don't even get me started on monsanto) are patent eligable, it's quite another to face the consequences of doing so. Especially when we all know good g od dmn well they probably aren't eligable in the first instance. We can pretend that such things are a "product" within the meaning of the word in the statute, or even a composition of matter, within that term in the statute, but we know very good and well that the way the words were used in the statute were never intended to include things such as an isolated gene, an isolated piece of mined gold ore, an isolated piece of log cut from a tree, etc. etc. etc. We're practically pretending to be ret arded in even thinking about stating otherwise.

Just as an aside, I was recently made aware that it has recently become standard practice in the printer arts to claim a printer in combination with "novel" toner. That is like claiming a car in combination with it having gas in the tank where the formulation of the gas is the novel feature. The mixing of stat categories (car/printer is apparatus or product and the gas/toner is a composition of matter) and the bludgeoning of the fact that this phrase is used in the singular "any new and useful process, machine, manufacture, or composition of matter" is horrendous. We're just more and more turning the system into a big joke. Every year. And the courts need to state in no uncertain terms: "enough already, get this sht under control or we will wreck your 'industries' that you build around these shinanigans". KSR and Bilski are not powerful enough no matter the outcome of Bilski. The years of neglect need to be made up for.

[Kevin E. Noonan]

My dear 6:

We have had this debate before, and it will be more efficient if I don't reiterate it all again, but I'll hit the highlights.

What is claimed isn't just "an isolated gene," although I would argue that, to be intellectually consistent, banning genes because they are isolated on the grounds that they are natural products gets us into even more trouble. Most of the drugs that have been developed during the 20th Century were "natural products" - vitamins, hormones, antibiotics, steroids, the list goes on. If we are not able to patent genes, then we should not be patenting these either, and that would be tragic - tens of thousands of penicillins not developed because there is no patent protection (it took the 2d World War to develop penicillin - not a good model).

So, one more time, if you go back to the "Lies" post from a few months ago, there is a graphic that shows that genes are not just isolated but are in fact changed in form to be something that never existed before. That is a cDNA copy of the gene - something only made by the hand of man. Contrast this with most of the other natural products, which are not changed much at all (simply separated from contaminants).

Those who dismiss this argument focus on the wrong thing - that the information (at least the important information, the coding sequence) isn't changed. But the information isn't patented - in fact, the depository of gene sequences in the world's patent offices contains millions of bases of information that anyone can use without liability to the patent owner. But the isolated gene, as a chemical, is new and, under controlling Supreme Court precedent, patent-eligible (being the product of the hand of man).

I would note that most people aren't stupid, and most arguments have pros and cons that can be argued - one of the things that is great about discussing these issues with Dan is we disagree fundamentally but we can have a reasoned debate that isn't predicated on the assumption that either one of us is an idiot.

And I would be careful about "wrecking" industries based on your (or my) concept of morality, what is right or more importantly, whether something is wrong. Look at the pros and cons - genes have been patented for 25 years, and have resulted in new diagnostics and therapeutics unknown and unattainable beforehand. These patents have supported investment in these industries and disclosure of a wealth of genetic information, both of which I believe are net benefits for society. Besides the thrill of having the PTO and the courts agree with you, what would be the benefit of having a ban on gene patenting?

Thanks for the comment.

[David Koepsell]

Amen, 6.
And Kevin, 6 is right... you're a good guy, your moral stance ought to overcome your perceived debt to the industry.

[Donald Zuhn]

David:

When 6 (or any "gene" patenting opponent) starts and ends the conversation with the claim term "isolated," he conveniently ignores all of the other arguments that proponents have made in support of "gene" patenting. Instead of simplifying the issue so he can try to win the argument (and we all know how much 6 likes to win an argument), 6 should heed Kevin's advice and read his June 15, 2009 post (the link to this post was provided at the end of the Science Friday post).

Also, trying to win the argument by suggesting that Kevin (or any biotech patent practitioner) is biased because he represents biotech companies involved in "gene" patenting is akin to trying to win the argument by suggesting that an individual who lacks an advanced degree in molecular biology (or similar technical background), hasn't prosecuted a patent application in his career, or isn't a registered patent practitioner is unqualified to opine on the legal and scientific issues at the heart of the "gene" patenting debate. We haven't gone there, and we would hope that opponents could focus on the issue rather than dwell on supposed and contrived biases that have no relevancy to the arguments being made.

Don

[Noise above Law]

If ever there was a "slam-dunk" argument for something, it is when 6 and Dave K align on the opposite side.

[David Koepsell]

Jeez, I guess you're right. Money and power never influence anyone's notions of right or wrong.

I've seen Kevin waver on this issue publicly, I've seen doubt in his eyes, and even heard him express it directly when discussing Myriad's actions, I know he knows they should modify their behavior, and that behavior is enabled by what many of us feel is an erroneous and/or immoral application of the law.

Now, your continued allegations about the ignorance of those who oppose you does nothing to undermine the essentially moral arguments underlying their position, just as our moral arguments do nothing to contradict your steadfast perception of the logic of your position. 6 is spot-on when outlines the distinction between the application and intention of the statutes.

Anyway, happy holidays to all.

-dk

[Kevin E. Noonan]

Now, now, now, David - let's not mix apples and oranges.

In all of our talks and postings, we have not taken a position on Myriad or its activities per se (although we have no reason to believe they have done anything wrong). Our point has always been about whether genes are patent-eligible, not whether patents on genes (or anything else) are always exercised properly. As I recall, the only caveats we have ever voiced is that we don't represent Myriad or any other parties to the lawsuit, and we can't speak for any issues other than whether genes are patent-eligible subject matter.

And let's be clear - I think it is immoral to advocate a position that (I believe) will encourage perpetual monopolies and hinder public disclosure. And I think that is a more defensible position than the "moral" arguments against gene patenting, which at the end of the day amount to a belief that "it's just wrong."

The more difficult it is to protect intellectual property the more our services will be needed. So opposing gene patenting might be in our best financial interests, and in the best interests of corporate clients (while harming our university and small start-up clients).

Finally, please keep in mind that money determines someone's actions mainly when they don't have any. And money isn't the only motivator - careerism can be an even greater impetus to take a position that will get you noticed.

Happy holidays to you too.

[6]

Kev before we continue would you mind telling me if indeed a cDNA is different structurally from the DNA it is based upon? And if it is, perhaps you would be good enough to tell me how specifically it is different structurally in brief fashion.

I looked the Lies post over yet I can find no such discussion of this particular thing.

[Donald Zuhn]

6:

Check out the fourth paragraph and the graphic that follows.

Don

[6]

Don, the fourth paragraph mentions cDNA but the graphic that follows does not show a cDNA. It shows Gene DNA, primary RNA, mRNA and protein. From this am I supposed to infer that the cDNA is the exact same as the DNA except made in a lab?

[Donald Zuhn]

6:

Good question. The graphic shows (a) how a gene is transcribed (converted into a primary transcript), (b) the primary transcript is spliced (converted into a mature transcript, or messenger RNA (mRNA)), and (c) the mRNA is translated (converted into a protein). Thus, the graphic shows how a gene is converted into a protein in a cell.

A cDNA molecule is prepared from the mRNA in a test tube using the enzyme reverse transcriptase (an enzyme used by RNA viruses such as HIV). It is the cDNA sequence that is being claimed in a "gene" patent, as the cDNA sequence can be expressed recombinantly (i.e., used to produce a protein in a cell that but for the intervention of a researcher, would not exist in nature).

Thus, the nucleic acid sequence that is being claimed (a) is "isolated" from the rest of the chromosome, (b) lacks introns (which can sometimes be quite large; in addition, alternative splicing presents the possibility that the same gene can be spliced to produce multiple, different mRNA transcripts), and (c) is produced from an mRNA molecule in a test tube using a non-human enzyme. The claimed cDNA molecule is therefore not present in the cell from which it is derived (probably a more accurate characterization than to simply call the claimed molecule "isolated").

Don

[6]

So basically Don what you're saying is that the cDNA is not structurally the same as DNA because it is isolated, i.e. lacks the non-coding and regulatory elements found in genomic DNA. Basically this is just the long winded explanation of the "but it is isolated" argument. Stating that the "but it is isolated" actually means it is structurally different and made in a lab. Alright, that being assumed I'll have more later.

[David Koepsell]

Kevin,

Fair enough, but you have said that Myriad's actions aren't necessarily good PR... an understatement if I ever heard one. Moreover, the notion that there would be "permanent monopolies" due to secret-keeping is not at all realistic in light of the numerous scientific groups doing sequencing work who would, and do, in time discover useful genetic sequences (witness the Sanger Institute's recent discovery of the SNPs involved in skin and lung cancers). Finally, there is no cDNA involved in the Myriad patent, in which claims 1 and 2 cover naturally-occurring mutations to naturally-occurring sequences.

and, Secular Jew though I am, may I refer to 1 Timothy 6:10 regarding my personal attitude about money.

all my best,
David

[Kevin E. Noonan]

Dear David:

And as a prolapsed Catholic, I refer to Shakespeare regarding citations to scripture:

Shakespeare Merchant of Venice i. iii. 93

All the best to you, as well.

[Kevin E. Noonan]

Dear 6:

A little more background. The distinction is not only that a cDNA is isolated. First, the mRNA is single-stranded - it is not a double helix like DNA, it is just the coding strand, so it is 1/2 the molecule that the DNA is. Second, there are large chemical differences between DNA and RNA, including the use of different bases (uracil in RNA, thymine in DNA), and there being a ribose sugar in RNA versus a deoxyribose sugar in DNA. Ribose is much more sensitive to acidic conditions and also more labile - there are a lot of enzymes that destroy RNA and very few than attack DNA. Finally, compared with what is done to most "natural products" to isolated them (essentially, purifying them from contaminants), preparing cDNA is a complete chemical conversion.

Two last points. First, a cDNA of a gene never existed until the inventor prepared it - it isn't even like an antibiotic produced by a bacteria, which existed before it was purified and can be claimed only in its purified state. Second, the genetic information in the cDNA isn't patented - claims to the cDNA do not preclude anyone from using the sequence information to interrogate a database of sequences for ones that are 80% identical (for example) or using the sequence for detecting a disease-associated mutation. And most of the gene claims require the full-length cDNA, not fragments.

Hope this helps.

[Gena777]

While I'm generally pro-IP, I must agree that patent law can have both an incentivizing and a chilling effect. Many of the ethical issues involved are quite apparent to us now, in part as a result of Myriad. Perhaps, however, there is a middle ground. For instance, it might be advisable to start seriously discussing patent pools as a potential (partial) solution, particularly when addressing treatments for life-threatening diseases. Of course, line-drawing can quickly become an issue with patent pools. I'd like to hear some of the pros and cons of this and similar proposals.
http://www.GeneralPatent.com

[Kevin E. Noonan]

Dear Gena:

We may ultimately need to consider something like this, as the number of traits associated with diseases increases and personalized medicine becomes more of a reality. With regard to Myriad, at least some of the patents expire between 2014 and 2015, so it is probably too late for that solution in this instance.

Another possibility is having HHS, through NIH, work on regulations for licensing this type of technology. "March-in" rights under Bayh-Dole are also available. However, we should keep in mind that these types of regulations can be expected to have their own effects on investment, particularly if the tests in question must satisfy strict regulatory requirements or are otherwise costly to market.

Thanks for the comment.

[saddlepack maker]

I just got around to reading all of the comments and would like to add one more. The issue of bias struck me as odd. So, biotech patent attorneys are biased in their pro gene patent stands?!

I haven't heard anyone suggest that David K is biased - an ethicist taking an anti gene patent stance based on moral grounds while selling a book on the same subject.

Interesting...