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« "60 Minutes" and "Newshour" Take Different Approaches to Covering Gene Patenting Story | Main | Patent Profile: Kylin Therapeutics Receives Patent Covering pRNA Technology »

April 06, 2010

Comments

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.

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.

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.

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".

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 ?

"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.

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?

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.

"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. ;)

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.

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.

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.

"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.

"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.

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?

Kevin,

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

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?

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.

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.

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.

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."

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.

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

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.

"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".

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.

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