AMP v. USPTO: What Everyone Else Is Saying

    By Donald Zuhn --

Last week, the District Court for the Southern District of New York ruled in favor of the plaintiffs in Association of Molecular Pathology v. U.S. Patent and Trademark Office, finding the claims of several patents directed to the BRCA1 and BRCA2 genes invalid as encompassing non-statutory subject matter (see "Round One Goes to the ACLU").  On Thursday, we discussed the parties' reaction to the decision (see "AMP v. USPTO: What the Parties Are Saying About the Decision").  Today, we take a look at what others have been saying or reporting about the decision.

• In "US Judge Strikes Down Patent on Cancer Genes," the Associated Press reports on comments made by Dr. Mary-Claire King, the University of Washington scientist who demonstrated in 1990 that a single gene on chromosome 17, later known as BRCA1, was responsible for many breast and ovarian cancers.  According to the AP report, Dr. King called the ruling "very good news for women who are potential carriers" of cancer genes and their families, saying that the decision "will open the door to truly competitive testing," and "will allow the science to drive the field instead of the monopolistic approach that has dominated."  In the article, Dr. King contends that gene patenting "makes no sense," and was "like patenting one's thumb."

• In "Judge Invalidates Human Gene Patent," The New York Times reports that Bryan Roberts, a Silicon Valley venture capitalist, believes the decision will push more gene discovery research to universities, saying that "[t]he government is going to become the funder for content discovery because it's going to be very hard to justify it outside of academia."  The Times also notes that Dr. Kenneth Chahine, a visiting law professor at the University of Utah who filed an amicus brief in support of Myriad, predicts that if the decision is upheld, "[t]he [biotech] industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection."

• In a statement released by the Biotechnology Industry Organization (BIO), BIO President and CEO Jim Greenwood notes that "[a]s explained in the ruling [on March 29], the District Court's determination is only a preliminary step in the legal process that does not affect how the U.S. Patent and Trademark Office (PTO) evaluates patent applications relating to DNA-based inventions."  Mr. Greenwood also notes that "[f]rom the mass production of life-saving medicines by cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules have been put to countless uses that have benefited society," contending that "[p]reparations of isolated and purified DNA molecules, which alone can be put to use in these ways, are patentable because they are fundamentally different from anything that occurs in nature."

• In "Is the DNA Patent Dead?", CNNMoney.com opines that while "[b]iotech companies argue that a judge's ruling against DNA patents will slow their life-saving work," they should instead "move quickly to come up with a better, more collaborative way to protect and share findings," arguing that it was "[t]ime to get creative."  The CNNMoney report states that:

The issue of patenting an "isolated" gene, which is a copy of a "real" gene, has always stretched credulity.  For years it has angered researchers and patient groups who want a system that does not create gene monopolies that can hinder further research into the genetic roots of disease, can charge exorbitant prices for tests, and can block attempts by patients to get second opinions on diagnostic tests that remain in many cases experimental.

The report also states that:

The whole framework around grabbing control [of genes] revolved around creative lawyering, with companies over the last few years figuring out ways to adopt intellectual property laws better suited for, say, toasters -- or man-made drugs -- than to biological structures that seem to be more like leaves or sunshine.  Now it's time for that innovative spirit to move away from the general counsel's office and back to the lab.

In an acknowledgement (however slight) of Myriad's position, CNNMoney quotes Myriad General Counsel Richard Marsh as saying that "[t]he patent system works."  Without gene patents, Mr. Marsh asks "who is going to do the work and spend the money to make this product accessible to people?"

• In "The Court Ruling That Says 'You Can't Patent Nature'," the DailyFinance reports on comments made by Daniel Ravicher, the executive director of the Public Patent Foundation (PubPat) and co-counsel for plaintiffs in AMP v. USPTO, who says that "Judge Sweet's decision thoroughly analyzes the law and the science.  You cannot patent nature.  We fully expect the decision will be upheld on appeal."  The report also quotes James Love, co-chair of the intellectual property committee of the Trans Atlantic Consumer Dialogue and director of Knowledge Ecology International, as arguing that Myriad's patents "were anti-science, anti-innovation, and anti-consumer."

• In "AMP's Victory Has 'Very Limited' Legal Effect But Carries 'Far-Reaching Implications'," GenomeWeb reports that Barbara Caulfield, a patent lawyer with Dewey & LeBoeuf who filed an amicus brief in support of the plaintiffs, called the decision "ground-breaking," adding that "[n]ow all naturally occurring gene patents are invalid by the reasoning of this opinion.  This is really a sea change for patents in life sciences."

• In a New York Times article entitled "In Patent Fight, Nature, 1; Company, 0," the newspaper reports that Dr. Wendy Chung, a genetics professor at Columbia University and a plaintiff in the case, opined that "[i]f this holds up on appeal, this is a game changer."

• In "After Patent on Genes Is Invalidated, Taking Stock," The New York Times also reports on comments made by Dr. James Evans, a professor of genetics at the University of North Carolina School of Medicine, who asserts that there is thriving competition with regard to testing for mutations that cause cystic fibrosis or Huntington's disease despite the fact that no biotech company has exclusivity.  Dr. Evans states that "[i]t's quite demonstrable that in the diagnostic area, one does not need gene patents in order to see robust development of these tests."

• In "Could Biotechs Survive Without Gene Patents?" the Palm Beach Post quotes John Ball, executive vice president of the American Society for Clinical Pathology (and another plaintiff in the case), as saying that the decision is "good for patients and patient care, it's good for science and scientists.  It really opens up things."

• In "Judge Rules Gene Patents Invalid," UPI.com reports that Myriad President and CEO Peter Meldrum believes that "[i]f the federal circuit court upholds this decision it, unfortunately I think, would be very bad for the biotech industry."

• In "Myriad Ruling: Just BRCA Genes or Underpinnings of Biotech?" BioWorld reports on a suggestion by Beth Arnold of Foley Hoag LLP that although the District Court's ruling was specific to genes, the rationale in the case could extend to patents covering other biological molecules, such as polypeptides or siRNAs.  BioWorld also reports that JMP Securities analyst Charles Duncan believes, based on discussions he has had with a number of intellectual property experts, that the Federal Circuit is "not necessarily going to support" Judge Sweet's opinion.

• In "Gene Patents Are the Talk of the Town Following Surprise Court Ruling," the Los Angeles Times reports that Dr. Lisa Haile of DLA Piper also believes that the decision is not just about gene patents, but rather suggests that if DNA cannot be patented because it is created by nature, then proteins, enzymes, bacteria, and other biological entities may also be unpatentable natural products.  In the article, Dr. Haile states that "[t]hat's where I think this [decision] could get blown out of proportion."  The Times also reports that American Civil Liberties Union (ACLU) attorney Sandra Park states that the gene patenting issue "is not a partisan issue," arguing that "[a] lot of very conservative religious folks have come out against gene patents because they believe God has given us these genes, and they should not be parsed out for patents."

• In "When One Patent Means So Much," The Motley Fool notes that on the day after the decision, Myriad's stock fell 5%.  On Tuesday, Myriad stock (MYGN) closed at $23.44 after opening at more than $25 on March 29 (the day of the decision).  When assessing potential losers as a result of the decision, The Motley Fool speculates that:

Universities will also be big losers if all gene patents are invalidated because they hold many of the patents, which they license out to drug and genetic-testing companies.  Investors can't buy shares in public and most private universities, but they do indirectly benefit from the royalties that flow into universities.  Much of the basic science is carried out at universities, and the loss of royalty income may affect the ability to perform the basic research that drug companies base their drug discovery on.

For information regarding this and other related topics, please see:

• "'60 Minutes' and 'Newshour' Take Different Apporaches to Covering Gene Patenting Story," April 5, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "Debating Gene Patents - Round Four," February 10, 2010
• "Newsweek = Newspeak on Gene Patenting," February 8, 2010
• "Everybody Knows -- The Boston Globe Weighs in on Gene Patenting," February 1, 2010
• "The USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
• "Top Stories of 2009: #4 to #1," January 4, 2010
• "Gene Patenting: Australian Potpourri," December 28, 2009
• "Science Progress Article Examines Impact of Gene Patents on Research," December 21, 2009
• "Gene Patenting Debate Continues - Round Three," December 17, 2009
• "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
• "The Tragedy of a Bad Idea," August 25, 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

Comments

[Dan Feigelson]

Thanks Don. It's stunning just how deep the misunderstanding of the patent system runs - and how many people who we'd otherwise regard as smart don't get it. I'll be curious to hear what the naysayers quoted above have to say after this decision is reversed by the CAFC.

[EG]

Don,

Still lots of "Kool-Aid" drinking going on. Academia and government may be able to carry out the basic gene research. But anyone who expects academia or the government to be able to move it to market is out of touch with reality.

Ravicher is also delusional is saying: "We fully expect the decision will be upheld on appeal." The Federal Circuit will trounce Judge Sweet's nonsensical ruling in a heart beat. Like others have said, this so-called "victory" will be short-lived.

[Prior Art]

Me thinks 60 minutes can learn some objectivity from Don. Great summary.

- In "AMP's Victory Has 'Very Limited' Legal Effect But Carries 'Far-Reaching Implications'," GenomeWeb reports that Barbara Caulfield, a patent lawyer..... - I don't think she's a patent attorney, but that's genomeweb's mistake.

[Mpls Mark]

A colleague of mine who is reasonable, well informed, and up to date on patent law, but educated as an electrical engineer, thought it entirely reasonable that a patentability should require more than isolating a molecule from nature. He was surprised to learn that many useful antibiotics are natural products.

I'm not surprised that the news media - and others - like plaintiff's simple story. Understanding of chemistry and biology is difficult to learn and rather rare in the general public. So, I'm really not surprised that understanding of the patent law as applied to chemistry and biology is hard to find, even among the "chattering class".

[patent attorney]

Dear Prior Art,

No disrespect to your colleague, but please ask him if he believes that patents should also be denied for a light bulb or a telephone, since the technology basically is just moving electrons around. Who should be able to own an electron ?

[6]

"will open the door to truly competitive testing"

I have to agree with the good doctor. The things we need patents on, it seems to me, are the technology, like the tests etc, testing machines and all what have you. Not the genes themselves, or cDNA of the genes or whatever. That's how you promote the progress without simultaneously retarding it I'm afraid.

"A colleague of mine who is reasonable, well informed, and up to date on patent law, but educated as an electrical engineer, thought it entirely reasonable that a patentability should require more than isolating a molecule from nature. He was surprised to learn that many useful antibiotics are natural products. "

Exactly.

"The New York Times reports that Bryan Roberts, a Silicon Valley venture capitalist, believes the decision will push more gene discovery research to universities, saying that "[t]he government is going to become the funder for content discovery because it's going to be very hard to justify it outside of academia." The Times also notes that Dr. Kenneth Chahine, a visiting law professor at the University of Utah who filed an amicus brief in support of Myriad, predicts that if the decision is upheld, "[t]he [biotech] industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection.""

Now guys, I have a question relating to this "investment" argument as we might call it. Why on earth would it be hard to justify finding BRAC1/2 (for example) first because you would then be the first people to develop tests etc. that could be patented? I mean, this seems like a fairly simple concept. If I'm the first person to know about BRAC1/2 and I'm skilled in the art then shouldn't I be able to immediately whip up some patentable claims to things that would garuntee me a great big chunk of the testing market without patenting the isolated gene itself?

"The Motley Fool notes that on the day after the decision, Myriad's stock fell 5%. "

I knew I should have shorted them :( Same probably with that company Bilski is associated with.

[Prior Art]

Don - Do you believe that patents should also be denied for a light bulb or a telephone, since the technology basically is just moving electrons around? Who should be able to own an electron?

[Kevin E. Noonan]

OK, 6, we'll do it one more time.

Suppose there exists a chemical produced in a leaf in a plant in the forest. A scientist finds the leaf in the plant in the forest, takes it back to the lab and identifies the chemical. She also discovers that it has great medicinal properties, and is unlike any other chemical known to have similar (albeit much less potent) properties.

Riddle me this, 6: is the chemical patentable? Assume the claim is for "isolated and purified chemical X." What is the rationale if it isn't? Usually it is because it was not "invented." The problem with that argument is that it limits patentable subject matter to the mechanical and electrical arts (and maybe not even these if we take the electron examples).

To what end? The folks who take this position seem to think that a patent is a gold star, a reward, or a carrot for innovation. Wrong - a patent is a tool to give an inventor enough of a competitive edge that she can garner investment and make her competitors do what is less efficient, more expensive, less reliable etc. during the limited time until the patent expires. The price? disclosure - full disclosure, so that less than full disclosure has the consequence of permitting someone to practice the invention during the term of the patent (because the claims don't satisfy 112 for the infringing embodiment), or invalidity based on best mode, or unenforceability based on failure to disclose relevant art.

That has always been the bargain. It's worked pretty well. When Ken Chahine talks about being creative, I suggest he means (in part) helping clients produce products where the inventive component is hard to reverse engineer. I disagree with the commentator who thinks this decision will redound to the benefit of universities - on the contrary, university professors will continue to do research, and publish, but now they won't be able to protect their inventions and universities won't be able to license them.

All because some people think patenting an isolated gene is wrong. Our grandchildren will have to decide whether to laugh or cry at our ignorance.

[6]

"What is the rationale if it isn't? "

Imma have to be 100% honest with you Kev, the rationale is pretty close to that which Sweetie laid out for you. But in other, more simplistic, terminology it is because you didn't invent anything :( At least in so far as that term is used in the patent context. Now, I know, I know, you did a lot of hard, expensive work. And for that reason, if you can then take your extracted, isolated chemicals and make something out of it (like a drug for instance) then you can patent your drug. That is, the drug is your chemical + some other stuff.

It's really the difference between combining old things (which many people swear is what inventing is all about) to make something new and in deriving something "newish" from something already existing. Building up, instead of building down you could say.

In any event, you didn't really speak to my points in the post above and instead seemed to want to start the whole argument about gene patenting in general afresh. I hope that isn't because the points I raised in my previous post above are simply too hard to respond to in such a way that would support your position. Because frankly, even viewing the situation as I do, I'm rather rooting for your side to win, if for no other reason than the patent system itself not having egg all over its face for this activity for the last decade or so. Maybe a technicality that I'm having a hard time grasping will save your side. But dear jebus lets all hope so. I'll be terribly embarrassed otherwise.

"The problem with that argument is that it limits patentable subject matter to the mechanical and electrical arts "

Not at all, there are plenty of things in your bio arts besides the genes themselves as I understand it. Tests, procedures, heck the entire art isn't centered all around gene claims is it? And you know, you guys in bio can make machines too. Electrical and mechanical ones.

"(and maybe not even these if we take the electron examples)."

That "analogy" presented above is a bad one on its face and fails so many different ways I won't even bother to point them out.

"but now they won't be able to protect their inventions and universities won't be able to license them. "

You will not see me shedding any tears that people who aren't inventing aren't able to "protect" and license their non-inventions. Maybe they could go the extra mile and actually invent something based upon their discoveries? Or is that simply asking too much of them?

Look, I've posed a lot of questions above but I don't really want to get into it with ya again, so consider them all rhetorical and not really looking for an answer.

The only thing I really care about at this point is:

Can these big companies not justify their investments by patenting the actual inventions that arise from being the first to discover (for example) BRAC 1/2? It's a fairly simple question since I'm really only looking for your opinion, not a factual statement. The answer could be one of a simple yes/no/sometimes.

"Our grandchildren will have to decide whether to laugh or cry at our ignorance."

During that brief period of time where they were considered patentable. ;)

[saddlepack maker]

I am struck with Judge Sweet's reliance on US Supreme Court case law and his disregard to the CAFC cases (namely, Amgen v. Chugai, In re Deuel, and In re Bell) which held that a gene is a chemical compound. Perhaps, this is likely due to the fact that none of these CAFC decisions had relied on a US Supreme Court case.

[Wallabey]

That is one perspective. I certainly hope there is room for another.

When the members of a group (and you can determine for yourself the size of the group) determine to enrich one of their number, who benefits? Well, the one, of course. For while it is true that whatever the one has discovered may benefit the group, still the group has to pay dearly for that benefit. And in any homogenous group, there will always be those who can not afford to pay, so they will not receive the benefit under any circumstance.

I offer only one example as sufficient to illustrate what I see wrong with the above scenario. When Dr. Salk finally developed an effective vaccine for polio, he could certainly have made himself a multi-billionaire (in the early fifties, no less) by patenting his discovery and licensing it to a pharmaceutical house. Instead, he placed it immediately and irrevocably into the public domain. Furthermore, its existence as his discovery caused it to be prior art, so it was also not patentable by anyone else.

I received the benefit of his discovery when I was in grade school, and although I did not especially appreciate the needles, I did appreciate that I would likely not have to endure polio again. The pain I felt in my leg was more severe than any I have experienced since and one I hope no one will ever have to endure again.

If my perspective still eludes you, I offer it in much simplified form: If you are in possession of something that everyone needs, then you should see that everyone gets it regardless of what they can do for you in return. I am not speaking here of things that people simply want like a snazzier car or the latest techno-gadget. Instead, I am speaking of things that people need like information on what gene does what in our bodies as well as what we can learn to do about it.

And if you still do not see the validity of my perspective, then I suggest you think about this: If I were to discover something of potentially great monetary value about one of your organs, then my patenting of the process occurring in your organ would entitle me to force you legally to submit to whatever medical procedures I deemed necessary to further my research. Now does that sound like something you would like to endure? Of course, my patent would not grant me the right to disassemble your body or to cause you any serious physical harm. However, I would be entirely free to take any number of biopsies and to dictate your diet and exercise regimen. And if you did not comply with my dictates, then I could secure the power of a court order to force you to do so.

It just seems a bit too much like slavery to me.

[Dan Feigelson]

Wallabey, you're missing the point. We as a society have decided that we want drugs or vaccines to be safe and efficacious, and we want our diagnostic tests to be accurate. So we put a big regulatory system in place to ensure that that's the case. Meeting the requirements of that regulatory system greatly increases the cost of entering the market versus what it would cost in the absence of that regulatory system. So just because someone discovered a gene doesn't mean that test for the presence of the gene or a therapy based on that discovery is going to make it to the market. Someone has to be willing to invest in developing a commerically viable product. In some cases an entity might be willing to do that in absence of an assurance of a return on their investment, but in most cases it won't. So we give patents for *limited periods of time* to ensure that investors can recoup their costs and make a profit. Ultimately - and this seems to be the point lost on what EG terms the kool-aid drinkers - the patent expires and competitors can start free-riding on the investor's investment. Sure, for a time it will be expensive to administer that test or buy that drug, but eventually the patents will expire and the cost will go down (unless there are other barriers to entry, such as lack of a pathway for approving biogeneric drugs, but if that's the case, then the instances of such drugs have nothing to contribute to the patent discussion). In the big picture, we get many more tests, drugs and vaccines that way than we would in the absence of patent protection, or if all drug development was left to the government. I can live with that.

[EG]

"Suppose there exists a chemical produced in a leaf in a plant in the forest."

Kevin,

May I presume your analogy is to Taxol, originally extracted from the bark of a particular pine tree if I recall it correctly.

[EG]

"I am struck with Judge Sweet's reliance on US Supreme Court case law and his disregard to the CAFC cases (namely, Amgen v. Chugai, In re Deuel, and In re Bell) which held that a gene is a chemical compound. Perhaps, this is likely due to the fact that none of these CAFC decisions had relied on a US Supreme Court case."

SM,

Sweet's heavy reliance on SCOTUS precedent (versus Federal Circuit precedent) suggests to me an unfortunate phenomena which became apparent after the decision in KSR International, namely the Fedral Circuit is losing its position as the primary arbiter of patent law jurisprudence. I also think Sweet must realize that the Federal Circuit precedent more on point than those SCOTUS' cases isn't going to support his ruling in the end. That he quoted from but misrepresented Judge Rich's holding in Bergy is striking in that regard.

A Federal Circuit case even more on point for why Sweet's ruling is dead wrong is In re Kubin. While Kubin deemed the isolated NAIL nucleotide unpatentable, that was based on 35 USC 103, not 35 USC 101. That "isolated" gene sequences are patent-eligible under 35 USC 101 is acknowledged fact by the Federal Circuit. The fact is Sweet's ruling is based on a distorted view of the case law, be it SCOTUS or Federal Circuit case law. The Federal Circuit is going to make mincemeat of it.

[anonymous]

saddlepack maker wrote, "I am struck with Judge Sweet's reliance on US Supreme Court case law and his disregard to the CAFC cases[.]"

In KSR v. Teleflex, were you struck with KSR's reliance on US Supreme Court case law and not the CAFC case law?

[EG]

Kevin,

I was close. Taxol was extracted from the bark of Pacific Yew tree.

[Prior Art]

Maybe Sweet has something against the CAFC? Perhaps he relies on USSC to say "try to get over these USSC cases and reverse me, you group of [something something something]."

We know the USSC has "admonished" CAFC over and over, so perhaps Sweet is just challenging them.

Was Sweet or any other SDNY judge heavily criticized by CAFC recently?

[Gary Johnston]

Full-length cDNAs should be patent-eligible as compositions. Fragments should not. Generic methods for predicting/diagnosing a disease/condition based on the presence of a marker (mutation, SNP, variant, whatever you want to call it) that is associated/correlated with the disease/condition should not be patent-eligible.

A marketing exclusivity scheme should be adopted for new tests just as is available for new chemical entities/orphan drugs. This will allow the first party to bring a test to market some time to recoup its investment.

There, I have solved the problem.

[saddlepack maker]

The reason that I was struck by Judge Sweet's choice of case law to support his decision is because usually you would anticipate that a judge would show deference to the appellate body to which the case will be appealed. This was a bold move on his part.

I agree with EW in that Judge Sweet misapplied prior case law (including Funk Bros Seed Co. which dealt with whether the invention was patentable and not with whether the subject matter was patent eligible).

Judge Sweet did use Bilski but discounted Prometheus.

Anonymous, I was not struck with KSR's reliance on US Supreme Court case law. I would have been struck with the district court's reliance on such and not on CAFC case law.

[Kevin E. Noonan]

Dear Gary:

Your solution has some good points (it certainly is preferable to the "overturn all gene patents" argument, particularly with regard to biologic drugs), but it has this flaw. The patent system is at least as concerned with disclosure as with incentive, since the progress is promoted only if the inventor is required to disclose. Otherwise, Congress could enact a law providing patent protection for "inventions" that were obtained merely by soliciting the grant without the quid pro quo of disclosure. (After all, patents in England were granted to British subjects who brought technology from abroad (usually France) - not really invention in the modern sense.)

So if we say that any particular type of invention is not patent-eligible, we are saying that the IP involved in those inventions will be protected in other ways - trade secret, for example. This was the norm for business methods until State Street; indeed, the prior user rights provisions of the AIPA expressly recognized that many companies had hit upon these same methods but had not disclosed them or patented them (because it was generally accepted that such methods were not patent-eligible).

In the medical diagnostics context, this means that a system that precludes diagnostic method claims, particularly in the genomics field that is just being developed, would promote non-disclosure. That isn't a big problem with BRCA-related breast and ovarian cancer, or Huntington's disease, muscular dystrophy or even cystic fibrosis, because these are one-gene type diseases and thus once the gene is identified it is (relatively) easy to perform the diagnosis.

But most diseases (particularly those of aging) are multigenic. In your system, it would be profitable for a company to identify a population (for example, African American men) who are known to be more prone to certain diseases than other men (like prostate cancer), and to do intensive bioinformatics studies on the hundreds of thousands of clinical samples present in hospital and other tissue banks in the U.S. Especially as the cost of sequencing and computing goes down, it would be feasible to identify the genetic polymorphisms that are consistently associated with the propensity to develop prostate cancer. And these retrospective studies might be easily applied prospectively in a clinical trial to validate a diagnostic method for prostate cancer.

Then, in your regime, any company with this test could (and would) employ it in a way that the genes involved, or the diagnostic polymorphisms, or the pattern of polymorphisms, would be very difficult to reverse engineer - on a gene chip, for example. A dozen sequences, comprising diagnostic and controls alike, on a 10,000 sequence chip, with the positions of the relevant sequences encrypted uniquely on each chip. Almost impossible to reverse engineer (particularly if "false positive" sequences were included that were also or separately encrypted) and thus providing perpetual revenue - no dedication to the public upon expiry of the prohibited patent, and no requirement to disclose.

Besides the obvious disadvantage to the public in higher costs, there is no promoting the progress here, since everything is kept as a secret. While there are also obvious disadvantages to the company (risks of trade secret misappropriation and successful reverse engineering, for example), the public harm is much greater. This is because full disclosure has effects not only directly applicable to the problem at hand but to workers in related (and sometimes even unrelated) arts. All that is sacrificed in a regime where diagnostic methods are not patent-eligible.

The question becomes, then, what would be the benefits of the scheme? There may be a short-term benefit, with regard to existing disclosed technology, but that would dry up quickly. Unfortunately, the negative consequences would persist, since even if later (and wiser) generations were to reverse this course, there would still be no incentive to disclose the technology.

Thanks for the comment.

[Kevin E. Noonan]

Before we anoint Jonas Salk to sainthood (which may be deserved), let's not forget that he tested his vaccine on mentally-retarded children at a nearby sanatorium, without any informed consent from their parents.

Putting aside the (im)morality of that activity, it certainly didn't require him to incur the kinds of clinical trial costs associated with drug development today.

And while Dr. Salk and other scientists may have little use for the patent system (yet a plethora of opinions about it), it isn't scientists who commercialize inventions. No one involved in the biotechnology industry who has actually brought a product to market espouses no patents (however much them may criticize the current system). The reason is simple: no ability to exclude others from practicing an invention that is readily reverse-engineered means no (or very little) likelihood of attracting the kinds of investment required to bring a new drug or vaccine to market.

Thanks for the comments. The information about Dr. Salk is from the biography "Patenting the Sun."

[Kevin E. Noonan]

Dear Wallabey:

While there is certainly room for alternative views (and sometimes I wish I lived in the world you describe), I must take issue with your last paragraph on a number of levels.

First, the patent right is a right to exclude, not a positive right to do anything. Thus, your assertions that a patent holder has the right to compel biopsies, etc. is simply incorrect.

Second, nothing that happens in a human body is patent-eligible per se - a patentee who has a claim to a method or composition relating to how the body works cannot impose royalties on an individual having an organ containing those constituents or performing those methods. That was Michael Crichton's "big lie" in a New York Times op-ed piece, where he envisioned a gene patent holder presenting a citizen with a bill for "using" a patented gene. Not true then, not true today and not true ever.

Finally, your last comment is right on the mark, which is one of the reasons your hypothetical fails. Slavery is ownership of a human being, and patents are a form of ownership. The 13th Amendment to the U.S. Constitution precludes anyone having an ownership interest in a human being, and thus no U.S. patent can do so.

Thanks for your comment.

[patent attorney]

Let's not forget that Jonas Salk is the co-inventor of 7 US patents, 6 of which relate to an HIV vaccine.

[Gary Johnston]

Kevin:

Make every single test, including laboratory-developed tests (a.k.a. "home brew" tests) undergo a pre-market authorization, and the problem of disclosure is solved. Diagnostic companies may not like it, but it's frankly overdue.

My exclusivity idea isn't that crazy. The FDA incorporated it into its draft guidance for in vitro diagnostic multivariate index assays.

[6]

"let's not forget that he tested his vaccine on mentally-retarded children at a nearby sanatorium, without any informed consent from their parents."

Seems reasonable to me. This was a long time ago, and I'm not too sure people really had and understanding of medical responsibility like we do today.

"Putting aside the (im)morality of that activity, it certainly didn't require him to incur the kinds of clinical trial costs associated with drug development today."

So what you're telling me is that what the pharma industry really needs is a nearby sanitorium?

"it isn't scientists who commercialize inventions. "

Then why are we patenting things that scientists produce?

"No one involved in the biotechnology industry who has actually brought a product to market espouses no patents "

What does that have to do with patenting genes? Are genes the products they're bringing to market? No. So why are they at all worried about this? We'll let them patent their products and they're all happy right?

You make a lot of fairly decent points Kev, but there's a snide come back that moots them all :(

But even ignoring that, allow me to supplement your example of Salk with one Arthur C Clarke, inventor of the comm sat. He came up with the first conceptions of it, and constructively reduced it to practice surely. A little bit later you had people building them. A decade later you had a flourishing industry, in large part because the basic jist of the sat was published by Clarke before anyone patented it. Ol Clarke got some bad patent advice where his patent attorney either told him he couldn't, or shouldn't bother to, patent it. Of course, he'd have been a billionaire (or multi-million) and we wouldn't have half the comm sats we have today if he had, and even in his old regretful age he still saw the good that came out of his not patenting his comsats.

As that story shows, even with things that are clearly an invention, such as the comsat, patenting them (and subsequent enforcement) retards the field somewhat. I just don't see the justification for spreading patentability to things that are "inventionish".

[Wallabey]

I'm sorry I intruded on your conversation. Although I've searched diligently, I seem nonetheless to have misplaced my sources. Therefore, I can not substantiate what I have said.

I will, however, make a prediction. The decision currently under scrutiny will most likely be overturned. I will not bother to say why I believe this to be true.