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No One is Patenting Your Genes: The Ripple Effect if Isolated DNA Claims Are Made Patent Ineligible


Written by Eric Mirabel & Suzannah Sundby
Posted: December 14, 2012 @ 11:15 am
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You may have heard about the “breast cancer gene patent wars.”  Most likely, you have heard from various individuals and popular media asking “how can someone patent my genes?”  One can’t and never could patent your genes as they are in you.

One side in the “gene patent war” has nevertheless convinced the Supreme Court to weigh in on the issue of whether DNA sequences derived from the human genome are patentable, in Association for Molecular Pathology (AMP) v. Myriad Genetics, while disingenuously labeling the patents at issue as “human gene patents.”

Myriad (the “other” side) owns several patents with claims directed to “isolated” nucleic acid molecules (e.g., DNA) and fragments thereof which are referred to as either “probes” or “primers,” based on their function.  Probes anneal, i.e., bind, to a particular part of a DNA and are used to detect the presence of certain genes which indicate abnormalities or disease states.  Primers anneal to particular parts of a DNA and are used to make additional pieces of DNA, e.g., make multiple copies of a single abnormal sequence such that it is readily detectable and/or become capable of being utilized in other useful applications, e.g. forensic science.

Following the well-established Patent Law principle that natural products are not patentable, since the dawn of biotechnology in the 1980’s, in order for claims to DNA to be patent eligible, the DNA must be “isolated” or synthesized or modified such that the claimed DNA is not as it is found in nature.  In other words, no DNA patent claim encompasses a gene as it exists in you.

The Biotech Industry was founded upon patent protection for isolated DNA and similar products, which enabled small start-up companies to compete with established Big Pharma.  By now, the Biotech Industry employs millions each year, and more importantly provides life-saving technologies.

In the United States, we enjoy patent rights that are stronger than patent rights elsewhere in the world and because of the strength of US patent rights, many industries, including the Biotech Industry, thrive in the US.  In fact, the US Biotech Industry has become orders of magnitude larger – and concomitantly more productive and employs more individuals– than that in all of Europe, or any other country/region.  Changing the principles of our patent system to exclude patent protection for isolated DNA will likely cause a ripple effect with detrimental consequences on our economy and American interests.

As the public relations prong of their attack in the war, in AMP v. Myriad, AMP and other petitioners have disseminated additional highly inflammatory untruths, including: that isolated DNA is simply a product of nature, patents prevent further research and development, and that such isolated DNA patents prevent access to personalized medicine and care.

Let’s set the record straight.

Personalized medicine is based on the principle that medical treatments can and should be tailored to an individual according to the individual’s biochemical and genetic makeup that is often different from the majority of those afflicted.  This necessarily means researching and developing a variety of treatments for a plurality of small subsets of the population.  No company is going to spend the millions and billions of dollars required to conduct the R&D and obtain FDA approval for such a small subset when, without patent protection (for limited times), that company is unlikely to recoup the millions and billions spent.

A correlation between orphan diseases and drugs can be drawn to personalized medicine and treatments based on genetic diagnostic tests.  Rare diseases are diseases which affect a small percentage of the population, i.e. about 1 in 1,500 people in the US.  The term “Orphan Disease” is often used to refer to a rare disease because of the lack of available treatments and medicines.  The lack of available treatments and medicines for such Orphan Diseases is the result of the fact that only a small percentage of the population is afflicted and, as such, companies (without Government incentives) are unlikely able to recoup the costs of bring the treatments and medicines to the public and keeping them available to the public.  Many Orphan Diseases have known etiologies and known treatments, but the drugs and medicines are not available to the public because of the costs involved in the FDA approval process and commercialization.

Thus, Congress enacted the 1983 Orphan Drug Act which provides various incentives, including exclusivity periods and monetary incentives in the form of grants and discounts on various FDA approval and user fees.  Because of these incentives, companies have found it economically viable to risk millions of dollars in R&D with the hope of bringing treatments, medicines, and even cures to small populations afflicted with a rare disease.

Personalized medicine will likely go the way of treatments and medicines for orphan diseases prior to the 1983 Orphan Drug Act, if patent protection for isolated DNA, biomarkers, genetic assays, and treatments in view of such isolated DNA, biomarkers and genetic assays becomes unavailable.  Although academia may still continue such research, who is going to spend, more appropriately, risk millions to conduct the additional R&D to take that basic research and make a product available to the public so that one can have medical treatment that is personalized for that person?

With the current budget constraints on our Federal government, it’s not likely that we’ll see additional Federal research grants for universities to conduct the basic research that results in potential products, e.g., diagnostic tests, which are essential for personalized medicine.  Additionally, it is not likely that Congress will allocate additional money and resources for setting up incentives, e.g., grants, user fee discounts, and limited exclusivity periods (like that provided for orphan drugs), for companies to run the last 20 yards to bring such basic research to publicly available products that benefit an afflicted minority.

Thus, without patent protection for Biotech inventions, no one would be willing to make the substantial investment required to research, develop and bring such small-market products through the multi-year FDA approval process.  So, no patents for isolated DNA and diagnostics means “one size fits all” as the investment in R&D will only be made for what can be sold for the masses.  Say “goodbye” to personalized medicine.

The opponents in AMP v. Myriad Genetics have proposed, however, that Biotech patents inhibit the development of and access to personalized medicine, because universities and other institutions are prevented from doing their own research and testing.  This argument ignores that even if a drug or treatment is available, if the necessary investment has not been made to receive FDA approval, the payors in the system (Medicare, Medicaid and medical insurance companies) will not reimburse for it.  Thus, without patents to enable one to recoup the costly R&D for FDA approval, public availability of newer and better treatment options for various diseases, including cancer, would likely be much more severely limited as a result.

With regard to breast cancer, most women facing the gut-wrenching decision of whether to have a mastectomy want to know whether they have the breast cancer gene in order to make an educated decision about getting a mastectomy.  Without the research and innovation driven by patents, it is unlikely breast cancer gene diagnostics would be available today.  In other words, patents give rise to the innovation that results in the creation of such diagnostics and treatment options based thereon, but access thereto is a question of whether or not insurance will pay for it.

One should note that many insurance plans cover prophylactic mastectomies as a medical necessity where one has a family history of breast cancer or has the breast cancer gene mutation as evidenced by a genetic diagnostic test (which is also covered by many insurance plans).  However, many individuals do not have a family medical history.  Thus, without the breast cancer gene diagnostics at issue in the breast cancer gene wars, prophylactic mastectomies would not likely be available to many as a reimbursable medical expense.

As for patents inhibiting further research and development, the history of the US Biotech Industry and of virtually every other American industry of significance (i.e., those industries where companies hold large numbers of patents), suggests exactly the opposite.  Our Founding Fathers were wise enough to understand that patent protection promotes innovation, and they delegated regulation of the patent system exclusively to Congress, in the Constitution.  Throughout the years, our Congress has been equally wise and enacted laws that put limitations on patent rights so as to promote further innovation.  And US Courts have, until recently, been wise enough to sufficiently reward the innovators without stagnating further innovation.

Patent protection is for a limited time.  After the patent term, the invention is dedicated to the public, i.e., anyone can make, use, or sell it freely.  Moreover, even before patent issuance, most US patent applications are published, and all patents are published and available following issuance.  Thus, anyone can view the patent (or published application) and use it to design around and/or invent a better design, and that person can be rewarded by his inventive efforts with a patent of his own.

With regard to medicines and diagnostic patents, activities which are related to the development and submission of information to the FDA are excluded from being acts of patent infringement.  This means that despite one’s patent rights, another can perform the R&D to bring better products, such as medicines and diagnostics, through the approval process and to the public.  In short, patents promote further R&D.

It seems that everyone wants something for free.  But if everything is free, there will be nothing to be had.  Without the incentives of our patent system, it is quite unlikely that the breast cancer diagnostic test at issue in AMP v. Myriad Genetics would be publicly available today.  If needed tests or medications are too costly to allow wide access, it seems the cost should be borne without crashing the engine of American innovation.

 

Eric Mirabel (left) and Suzannah Sunby (right).

About the Authors

Eric P. Mirabel is an intellectual property attorney practicing in Houston, with extensive experience representing start-up biotechnology companies; both in therapeutics and in diagnostics.

Suzannah K. Sundby is a partner with Smith, Gambrell & Russell, LLP.  Prior to becoming a patent attorney, Suzannah was a cytogeneticist on one of the major genome projects.

The opinions and actions expressed herein are those of the authors and should not be attributed to any other person or client of the authors and Smith, Gambrell & Russell, LLP.

 


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Posted in: Biotechnology, Gene Patents, Guest Contributors, IP News, IPWatchdog.com Articles, Patents, US Supreme Court

44 comments
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  1. “As the public relations prong of their attack in the war, in AMP v. Myriad, AMP and other petitioners have disseminated additional highly inflammatory untruths, including: that isolated DNA is simply a product of nature, patents prevent further research and development, and that such isolated DNA patents prevent access to personalized medicine and care.”

    Eric and Suzannah,

    Thank for boldly stating the “politically inconvenient” truth. The Myriad case has unfortunately become dominated by “pseudoscience,” and “politics, policy, and philosophy,” and that’s largely due to the ACLU/PatPub intentionally manipulating and fabricating the plaintiffs, as well as the issues in this case. As you’re also probably aware, you’ll be “demonized, marginalized, and ostracized” in certain quarters for daring to state the “truth,” as well as the correct law on the “products of nature” doctrine. And I with you, hook, line and sinker.

  2. “The opponents in AMP v. Myriad Genetics have proposed, however, that Biotech patents inhibit the development of and access to personalized medicine, because universities and other institutions are prevented from doing their own research and testing. This argument ignores that even if a drug or treatment is available, if the necessary investment has not been made to receive FDA approval, the payors in the system (Medicare, Medicaid and medical insurance companies) will not reimburse for it. Thus, without patents to enable one to recoup the costly R&D for FDA approval, public availability of newer and better treatment options for various diseases, including cancer, would likely be much more severely limited as a result.”

    Eric and Suzannah,

    You’re also correct on this statement that university research isn’t inhibited but for an additional reason that comes right out of this case: the University of Utah Research Foundation (UURF) (a non-profit research foundation affiliated with the University of Utah) happens to be one of the defendants in this case along with Myriad. So if Myriad’s “ox is gored,” so will the UURF’s. Another “inconvenient truth” which the ACLU/PubPat tries to hide.

  3. EG:

    I think Tina Turner might already have a copyright on that song(**):

    “What’s Truth Got to Do with It, Got to Do with It?”
    (It’s just a second hand delusion)

    ** The song that will be sung by SCOTUS when they decry the patenting of our vital bodily fluids and of our sacred genes.

  4. SB,

    How true. About on par with SCOTUS permitting our federal government to impose the (Un)affordable Care Act upon us, and to tax us for it (but didn’t Congress and the Obama administration say it wasn’t really a “tax”).

  5. “In the United States, we enjoy patent rights that are stronger than patent rights elsewhere in the world and because of the strength of US patent rights, many industries, including the Biotech Industry, thrive in the US.”

    i don’t think so!
    they come for the money and the high damages they can recover(look at the trolls:many of their patents are not strong at all:but they make money in the US, not elsewhere)

  6. Eric and Suzannah-

    Excellent article, which makes the issues vividly clear, as regards to where the incentive to carry on to valuable and life saving diagnostics and treatments is either available or hindered. It seems to echo what has gone before with IT, where Congress was heavily lobbied to reduce patent rights in the long term, to benefit large corporations in the short term. Once the tech has been rendered obsolete eventually, the laws will still remain for who knows how many decades.

    Hopefully the Supreme Court will be a little more careful in the future, in order to keep patent rights strong and not subject to uncertainty. With such large investments of time and finances necessary to come up with the next Penicillin, any uncertainty about patent rights and especially the term will probably cause them to just walk away and not get to things that might benefit the health of millions, let alone the smaller subsets of patients.

    Stan~

  7. By way of a personal example, my mother was afflicted with an aggressive form of cancer, and it was removed, but the traditional types of chemo-therapy seemed to not be working for her to prevent further metastasizing of what remained.

    There was a new type of treatment just newly available at the time though, in the form of Taxol, which was a derivation from the bark of Yew trees, of all things. In only a few months, her white blood cell count went down to very close to normal, and she became healthy again and very happy for many more years.

    How much is That worth? It was worth a great deal from my perspective.

  8. SB-

    I think Tina Turner sang – “What’s Love got do with it, got to do with it…. it’s nothing but a second hand emotion” along with some other verses. EG would thus seem to be free and clear of copyright issues.

    http://www.youtube.com/watch?v=smGG7L_JjSM
    Tina is also an excellent actress, as in Beyond the Thunder Dome

  9. Dude,

    You need to look at our economy and how weak it was before the creation of the Federal Circuit, along with the reasons why our economy and innovation thrived after its formation… As well as Korea’s economy after they revamped their patent laws to be patterned after our patent laws.

    Re: trolls, patents are a property right. Just like land, one can sit on it and not do anything and still require a toll from others. Until our laws are changed to require a “working”, this is not going to change. Nevertheless, this issue of non-practicing entities completely off topic to the Myriad and personalized medicine issue.

  10. of course, there was no product patent for Taxol since it was found largely with federal funds, and was a natural product, though isolated.

  11. the dude-

    Your comment really makes no sense whatsoever. You quote something that is objectively true and then simply say “i don’t think so!”

    You then proceed to make an argument that has nothing to do with the comment that you seem to take issue with. Perhaps you are new to IPWatchdog, so allow me to explain that comments must at all times be on point and be substantive. Your comment about trolls is not related to the biotech industry and hardly disproves the point of the authors.

    On IPWatchdog we prefer vigorous but truthful debate. It is 100% correct to say that because of the strength of US patent rights the biotech industry thrives in the United States. While you will not be able to factually disprove that statement you are welcome to interject facts into the discussion, but merely quoting and then saying “i don’t think so!” is not acceptable. There are plenty of places on the Internet where such low-brow commentary is allowed and even encouraged, but not here.

    -Gene

  12. Ken-

    Your comment is misleading. There are many hundreds, if not thousands, of patents that relate in one way or another to taxol. So to say that taxol is not patented is incorrect. It is also incorrect to say that there is no composition of matter claims in patents that relate to Taxol. Anyone who wants to independently verify this can just do a quick patent search using the term “taxol.” For example see:

    http://www.freepatentsonline.com/5415869.html

    http://www.freepatentsonline.com/5916783.html

    http://www.freepatentsonline.com/5461169.html

    http://www.freepatentsonline.com/5760251.html

    http://www.freepatentsonline.com/5496846.html

    http://www.freepatentsonline.com/RE40839.html

    You get the idea. So your comment, which seems directed to Stan’s discussion of his mother, is extremely overbroad. I’m guessing you don’t know Stan or his mother and have no idea whether one of the many taxol patented products were what was given to his mother.

    Furthermore, although the original formulation was not patented Bristol-Myers did receive exclusivity, which largely comes with the same rights that accompany a patent.

    -Gene

  13. I just wanted to point out that

    Until our laws are changed to require a “working”, this is not going to change

    is not going to work with our patent law, and for a very fundamental reason.

    Patents are a “negative right” – an ability to exclude. Patents are also possible on improvements to other things already patented (and likely by someone else). Simply put, a “working requirement” would violate the very nature of the right to exclude when an improvement patent is based on someone else’s main patent.

    For someone to say “Let’s have a working requirement” is also saying “I don’t really understand how patents work to begin with.”

  14. Anon-

    Excellent point!

    So when am I going to be able to convince you to write an article? I’m happy to publish it as “Written by Anon.”

    -Gene

  15. I’m enjoying this thread, I must say. I particularly like the assertions (from trained scientists to boot) that, if event B follows event A then it was caused by event A and, further, that statements that B was caused by A are “objectively true”. Suzannah (Sundby, perhaps) is not talking about the endless exclusive right given by registration of a trademark. She puts patent law “working” in quotes so I suppose she contemplates a compendious definition, that would include the sort of working requirement commonly called “compulsory licensing”.

    Such a requirement was always part of UK patent law.

    Wasn’t there a big debate recently about whether the US Government, in pursuance of the general welfare, and in harmony with its “strong” (another term in want of a definition) would compulsorily license vaccine from Bayer?

    anon is more astute, limiting to improvement patents the violation caused by a “working requirement”. So, yes, an essay from anon, complete with tight definitions of the terms he uses, would be great.

  16. As you know, Gene, most of the patents that relate to Taxol are to analogs that were made, not the original compound that was synthesized to be identical to the one isolated from the Yew tree. The others relate to process claims for synthesizing it in one way or another. The point is that the Taxol case is a poor example to use when claiming that patents on the isolated natural products are necessary to spur innovation. In fact, it’s misleading to suggest the Taxol case shows that patents on synthetic natural products are necessary.

  17. Gene
    “In the United States, we enjoy patent rights that are stronger than patent rights elsewhere in the world and because of the strength of US patent rights, many industries, including the Biotech Industry, thrive in the US. ”

    1-this statement is about “many industries” …”including the biotech industry”(but not limited to…)-this is a fact-
    2-you do not prove that statement, Gene:you just state it: so you are also welcome to interject facts into the discussion, but not merely state appreciation without facts.Imagine a guy stating in a blog i.e.”here in korea, we enjoy patent rights that are stronger than patent rights elsewhere” you may consider to answer”i don’t think so” !(korea is just an example which comes obviously into my mind ;china would be probably another good example)
    3-i would have had no comment if the statement had been”we enjoy a patent SYSTEM which is…” but the patent rights by themselves are not particularly stronger than in many other countries :patent infringement consequences are”stronger than elsewhere in the world” and this is what makes the difference (you could read an excellent article entitled “the enforcement of bad patents is the problem- by Gene Quinn”(particularly the end of paragraph labelled”patent trolls”)).And that difference is not necessarily always “pro-innovation” .
    4- i am reading your blog since almost the beginning of it but rarely make comments, because the exchange of comments are most of the time sterile, as this one is.i am not necessarily a”follower” as you may expect your readers to be if i understand well your answer : as a patent attorney (for almost 50 years) i am used to not necessarily agree with statements made by others on patents.if you do not tolerate comments on your blog from people making statements as you do, then your answer is well taken:anon comments will make you happy probably.
    5- i am sorry if you had a bad day:but i will continue to read your blog, unless you blacklist me.
    have a good day Gene.

  18. the dude-

    The statement is objectively true whether you want to accept it or not. On IPWatchdog article after article after article proves the truth. You made a naked challenge to what everyone in the industry knows to be true. You challenge without ANY facts, and really without even a complete thought. It is for YOU to come forth with facts. Merely saying “I don’t think so” is not acceptable.

    Substantively, since the comment you have issue with and the article is about the biotech industry, why don’t you tell us where pharma and biotech protection is stronger than in the U.S. I can’t wait for your answer. I suspect the silence will be quite telling.

    I would also love to know where in the world there is stronger protection for software and computer related innovations.

    I would also love to k now where in the world there is greater support for basic research and discovery based science, and where in the world there is greater support and protection for innovation period.

    If you are a patent attorney for 50 years you have to know that the U.S. is the most dominant player in the world when it comes to patents. There is a reason why the U.S. is the home of the biotech industry for the world. There is a reason why the U.S. is the home of the computer/software industries for the world. There is a reason why the U.S. is the home of the pharma companies of the world. It is because this is where patent protection is strongest. When we cease to provide protections we will lose industry, the same way industry has left other parts of the world.

    With respect to mentioning my article about bad patents… obviously that has absolutely nothing to do with this conversation. You are comparing apples and elephants and pretending there is some core similarity. The fact that there are bad patents that bad people sue on without fear of consequence has absolutely nothing to do with what we are discussing… namely that “many industries, including the Biotech industry” thrives in the U.S. because of strong patent rights.

    As for your ranting about comments in general here, if you are a reader you know that you can comment substantively. Those who offer substantive comments are given wide latitude. There is no latitude, however, for non-substantive comments that don’t forward the discussion. I don’t require people to follow. You either know that or you aren’t really a reader. If you think otherwise that is just fooling yourself and being rather disingenuous.

    Having said all this, if you want to continue to comment please keep your comments substantive. Please also refrain from chasing unicorns by bringing in wholly irrelevant material to the discussion solely for the purpose of misrepresentation and confusion.

    -Gene

  19. Ken-

    We are going to have to agree to disagree on whether Taxol proves the point or not.

    The way I look at the state of patents in the Taxol area is to notice that Taxol was quite an important discovery. I then also notice how there are many innovations relating to synthetic Taxol, innovations relating to compositions that have fewer side effects than what comes from the Yew tree. I also see that there are many use patents that explain how to use Taxol to treat specific forms of cancer.

    It seems completely fanciful to me to suggest that these additional Taxol innovations would have happened absent the patent incentive. Why would anyone have invested the time, money and energy into improving the compound if as soon as they spent the time, money and energy everyone else could have copied? That is the real question that patent critics refuse to answer. In what world does it make any sense to spend your time and money only to allow those who are copy-cats to come in and take what you develop and sell for less? Yes, they could sell for less because there would be no sunk costs for them to recover.

    -Gene

  20. Thanks for seconding an article by me MaxDrei. (Gene, perhaps after the AIA crush has passed…)

    And while I rarely agree with the views you post, I do appreciate the difference in perspective you bring. However, I think that you are one of those that don’t ‘get” US patent law (at least more so than you seem to “get” it).

    In the immediate case, I think you both over and under read my comment.

    I did no such thing as “limit to improvement patents” any violation of US patent law. I did use them (improvement patents) as an example, but the US law is NOT written in separate parts for first, initial, or non-improvement patents and then for improvement patents. The exclusivity nature applies equallly to all patents. So you over-read what I state, and misunderstand US patent law all at the same time. The essence of the patent right, as indicated by our constitution is based on a negative, not a positive basis. Your patent law may be different, but to ignore the very basis of US patent law is to court deliberate ignorance.

    As to “tight” definitions, I fail to see how anything I have posted is not sufficiently “tight” already. Truthfully, I have neither the time nor the inclination to take and give you extensive lessons in US Patent law. Those that have a basic understanding will have no difficulty understanding what I say.

    Re “the dude:” Perhaps I am misreading you, but I can only take your reference to these pages being “sterile” as an insult, and an unfounded one at that. Are you saying this because you disagree with the views expressed? Disagreement is fine – we can discuss. But if you think something said is said in error, then by all means put is plainly and we can discuss exactly what the error may be.

    By the way, Gene does not blacklist anyone from reading the blog. I do note that he has blacklisted several (and several others are on the cusp) when those people post in egregious error and gamesmanship that is allowed (far too much in my opinion) on other blogs. Gene does not tolerate purposeful misrepresentation of law. If you consider yourself as a candidate for being blacklisted, the easy thing to do to relieve your fear is to not misrepresent the law. If your opinion is that the current law should change, expressing that view as an opinion will not get you blacklisted. Of course, you may be asked to defend your opinion, but that shouldn’t bother you, should it?

  21. gene,anon
    thank you for your comments guys:sorry but i see nowhere facts that support your various statements:i am still waiting for a definition of what “strong patent rights ” are (you probably know that terms like strong, weak, high, low,etc..are generally inappropriate in the patent world , unless they are properly defined)
    Anyway i have the impression to watch first grade kids yelling at a third one who dared to tell them he disagreed with their statement: this discussion is thus completely sterile (and if you read this word as an insult anon then it would be an insult to me either because we are at least two in a discussion).And i hardly see “purposeful misrepresentation of law” Anon when i state that i disagree with the statement “patent rights that are stronger than patent rights elsewhere in the world”!
    So please continue your discussions together between people who share the same opinions and do not expect me to continue this chat!
    enjoy!cheers!

  22. May I cross-refer to the various comments made in connection with EG’s recent posting.

    And if you ask the public: “Would you rather pay for innovation or have it for free?” the answer is known in advance. The hard truth is that if we do not pay, we will not have the innovation. Whatever the failings of the pharma/biotech industry (see the Canadian decision in the Sildenafil case, very recently posted), the fact remains that it has saved countless lives and made the lives of many others more comfortable and tolerable even where a cure or remission is not achievable. In the Prometheus case, the result of the patented invention, reportedly, was to make a new treatment with reduced side effects available to sufferers from ulcerative colitis which is a long-term autoimmune disease with distressing symptoms.

    If Taxol is isolated from the yew tree and found to be beneficial in the treatment of cancer, that it not a mere discovery of a principle of nature. It is a major invention, and possibly one which the Nobel prize committee should not altogether overlook.

  23. Perhaps we could distinguish here between software and chem/bio. Let’s ask Bill Gates how much help the strong US patent system was to him, in building his Windows business. Let’s ask the German chemical industry (broken up after the war) how important the strong German patent right was, in building its business early in the 20th century. I doubt either would support the proposition that a US patent right “stronger” than in any other is the explanation of American technological dominance in the 20th century.

  24. “the dude”

    I will take it then that you either have nothing interesting to add (that you can defend), or that you just don’t agree with the opinions generally presented here (and without any particulars from you as to why, well, your opinion, sadly, is the very “sterile” stuff you complain about), or, and more likely, both.

    I guess a “thank you” for adding your sterile opinion is in order??

  25. Paul C-

    You remarks about the reduced side effects of medication being a major benefit was clearly demonstrated when a loved one was switched over to Taxol instead of the more traditional types of treatments. Her appetite improved dramatically, and she was much healthier in only a few months. I believe Taxol was in it’s clinical trial stage, and was offered by Group Health and a few others if the situation seemed to warrant it, circa 1999 if I recall it correctly.

    Also, wouldn’t just a new and novel use of an existing thing render it to be patentable? It seems as if alterations in the original thing would generally be sought as well, to enhance it’s effectiveness for the intended new use. It reminds me of the discovery of some antibiotics, which were originally in the form of rye molds, which had to developed into a usable and safe form. I don’t know if they were ever patented, but it seems as if it should have been possible from my perspective. I can hardly even imagine how many millions of lives they saved over all the decades.

    Penicillin is a good case in point for antibiotics and the diagnostics needed to find the right treatments. For instance, during an extensive test to find out why I was having symptoms when I was about 12 years old, they discovered that it was caused by mold and pollen, and also that I was violently allergic to Penicillin. Soon after that Erythromycin was coming onto the market, which was completely safe for me to be treated with.

    Stan~

  26. Gene,

    How does one factually prove that the patent rights in the US are stronger than patent rights elsewhere in the world?

    TR

  27. TR-

    One clue might be that about 45% of USPTO applications come from abroad. There must be a reason that it is so, or perhaps just because the US economy is very large. It also suggests respect for being allowed a US patent grant. As Max pointed out earlier, German patents were also very strong, depending upon your definition of the term strong. Easily invalidated patents would seem to make the patent right less valuable, making them much less valuable as an effective business strategy.

  28. Max-

    I appreciate your concern about the new European unified patent laws. It is similar to my skepticism about various forms of US patent reform. The AIA is somewhat less damaging than other previous attempts, but it still amounts to a limiting of US patent rights and a public taking of some of my patent/property rights as far as I am concerned.

    Just a point of order, to try to help future inventors to be able to succeed in the face of large companies that would probably like to see them and their patent rights just go away. I tend to agree that it will probably take about 8 years to figure things out, much like the at least 5 years that it will probably take to sort the AIA out and it’s effects, or hopefully change it a bit.

    I heard one report that it might cost practitioners a few billion nationally here in the US, because they will have to change their practices and literature, and even their continued training as regards the new law. I would submit that it was the wrong thing to do right now, with the US and world economy being so shaky lately. I seemed to get the sense that Senator Leahy needed to get it done before he retired, for whatever reasons. When he introduced the AIA to the Senate floor, he had this big sign to announce the name of the bill, which was truly pathetic. He didn’t seem to have a clue about what he might be doing to the future of innovation here in the US.

    PS- Part of the innovation comes from a very diverse and well-educated population. Like Australia, we were an up-start colony originally, where many from Europe and elswhere came to find a better life, and we had to be somewhat creative to make things better.

    Happy Christmas-
    Stan~

  29. TR-

    There are all kinds of metrics one can use and all kinds of facts one can look to. Not trying to be exhaustive I will point out a few.

    First, multinational corporations seek patents in the U.S. for all of their innovations. Few other countries are absolute must file countries.

    Second, multinational corporations enforce patents in the U.S. Sometimes foreign corporations battle foreign corporations in U.S. courts with no U.S. company involved.

    Third, in many, if not most, countries intellectual property rights are ignored. In the U.S. the court system provides recourse for infringement without having to pay off local officials.

    Third, in the U.S. far more is patent eligible than in virtually any other country. In the U.S. software is patentable, business methods are patentable, pharmaceuticals are patentable, living matter is patentable, biotech innovations are patentable and the list goes on and on. In most other countries there are significant limitations on the patent eligibility of one or more of the foregoing categories of innovation. Thus, when one cannot get a patent on a particular innovation but can get that type of patent in the U.S. then it is quite easy to conclude that U.S. patent rights are stronger than non-existent patent rights abroad.

    -Gene

  30. Max-

    In the case of Germany the key is freedom. For most of the 20th century Germany was not free. So it really didn’t matter whether Germany had the best in class patent system. Even assuming equivalence of patent system and patent strength, investment was not going to run from abroad into Germany at the levels it would rush into the U.S.

    As for Bill Gates, perhaps you should ask Microsoft why it is that they spend so much money to obtain so many patents if a patent is not worthwhile? If patents are not worthwhile and Bill Gates knows that to be true there is one heck of a shareholder derivative lawsuit there for the wasting of hundreds of millions of dollars over the years, perhaps billions of dollars between patent acquisition and enforcement.

    But why don’t we talk about how the UK used to dominate the biotechnology sector but now the U.S. dominates. Any guess as to why that is? Broad protection for innovations in the U.S. compared with Europe is the key.

    Let’s also talk about why India has only a generic drug industry and how and why those generic drug companies in India have been pressing the Indian government first for pharma patent protection and then for the protection given to actually be meaningful.

    Perhaps we can also discuss why so much stem cell research has left the U.S. in favor of China and elsewhere. It is all about incentives and welcoming climate for research, development and innovation in a particular technological area. The patent system is one of the biggest drivers, although not the only driver as the stem cell situation shows.

    -Gene

  31. the dude-

    You are still waiting? Really? I’m still waiting. You are the one that challenged a clearly correct statement and have offered not a single fact that even remotely proves your point.

    As for you not continuing the chat, that is fine. When folks are defeated and unable to point to facts they tend to disappear.

    -Gene

  32. Gene we agree on some things and disagree on others.

    A strong patent system is necessary but not sufficient on its own for technological innovation to flourish. Agreed.

    As to patent-eligibility, Europe allows signal claims and the US doesn’t. Agreed?

    And as to MS, tell me, did the MS patent horde come before or after WINDOWS became a world-famous trademark, and Microsoft a global titan? Big Corp does what it can, these days, to protect itself against jealous competitors. Patents are vital for biotech start-ups but not for software developers.

    As to enforcement of duly issued patent rights, we should compare pharma and design patent litigation in England and in the USA, and motor industry and medical device litigation in Germany and the USA. You think you can ignore patents or bribe judges in these countries? Is that what you tell your clients? Better first ask Apple how long it takes, and how much it costs, to get an English or German court to grant injunctive relief from infringement of issued patents.

    Look, I’m not saying the the US lacks a “strong” system of patents, just that every country thinks its system is the “strongest”.

  33. “In the case of Germany the key is freedom. For most of the 20th century Germany was not free. So it really didn’t matter whether Germany had the best in class patent system”WAOOOOH!

    this one is pretty good ,Gene.You definitely “deafeated” me.German people will be glad to learn that.
    i understand this is probably what you call a fact!it’s hard to “combat” at that level.

    but you’re right:i will be careful now when reading your blog and not take what i read for granted.

  34. and MaxDrei, as usual, made it clear.!

  35. the dude,

    It is interesting that you add the note “as usual” – see my comment at 20 and note that you place your reliance on a particular viewpoint on someone that does not get the US patent law system.

    But to the larger point, you still do not address the points that Gene raises – that it is you that needs to provide support for your stated opinion.

    You are engaging in the very rhetoric you condemn and once again it is your own comments that are sterile.

    Instead of backing up your viewpoint, you engage in a pedantic “combat facts at that level” type of rebuttal that is really meaningless. I don’t know if you think this type of writing is compelling, but when you are criticizing someone else for writing in a style of “this is fact because I say so” and you merely do the thing that you accuse the other person of doing, I am not moved by your response.

    Rather, I am alerted to the fact that there is no real interchange going on at all.

    I highly doubt that you ever read this blog and took anything here “for granted.” On the contrary, it seems obvious that your viewpoint was pretty much solidified before you engaged in any reading of anyone else’s writings.

    It’s a pity then, that you do not, as Gene points out, defend your viewpoint. I might learn something if you were to actually say something.

  36. Anon
    Max Drei is always making clear comments with a lot of sense(on other blogs where you comment too the same way you do here),even though i do not always share his views.that’s why i said on purpose “as usual”.

    “on someone that does not get the US patent law system.”;the way you consider others not sharing your opinions spread some doubts on”I might learn something if you were to actually say something”(particularly in the context of the “strength of patent rights”throughout the world which was the aim of my first comment-see 5!).You definitely know it all Anon.

  37. I have read your comment three times “the dude,” and aside from accusations (which you seem really good at), I cannot determine any intelligble point that you are trying to make.

    Even your comment at 5!) is nonsensical, as part of strong patent rights include the money and high damages that you try to separate out.

    I certainly do not know it all – but I do know when someone else does not know what they are talking about.

    And again, thank you for your sterile comments. If anything, I appreciate you proving my points.

  38. the dude-

    So are you going to pretend that Germany was free during the 20th century? Perhaps you have heard of World War II and the Berlin Wall and Communism? Once again you challenge and mock something that is undeniably true.

    Regardless, I don’t care any more. I told you to keep your comments substantive and you are unable to do that. Mockery is unacceptable and you are no longer welcome to comment on IPWatchdog.

    -Gene

  39. again, read Watson’s Federal Circuit amicus brief. it says all that’s needed

    http://www.wileyrein.com/professionals.cfm?sp=bio&id=865

  40. The suggestion that a “strong” patent system is evidenced by high damages awards is interesting.

    Consider a wealthy society with 360 million consumers and another equaly wealthy country with only 60 million nationals. There is fierce competition in both countries, between the products of a patent owner and those of a competitor. There is litigation. Validity is put in issue. Infringement is found, in both countries. The attacks on validity fail, in both countries. The infringer is enjoined, in both countries.

    Now, in which country will the quantum of damages be higher? Might it have something to do with the size of the market (how many profitable sales were lost because of the infringement) rather than the “strength” of the respective patent system?

    Now suppose the little country has a “Loser Pays” English rule about legal costs, and the larger country doesn’t. Which has the stronger patent system?

    And suppose that the litigation in the smaller country is done and dusted within 15 months (or less). Decisions rendered on both infringement and validity with the prospects of a successful appeal very poor. Despite its lower damages quantum, is that country really the operator of a weak patent system? How come?

  41. I wrote #39 before I saw today’s news on Patently-O, that Apple is refused injunctive relief against Samsung’s infringing products.

    You will understand if I use this event to support my argument.

    Where I am, the owner of a duly issued claim, not invalid, and found to be infringed, gets injunctive relief. So, from where I stand, I’m still having difficulty accepting as an “objective fact” that the American patent system is “stronger” than mine.

    Perhaps it depends what you, Gene, mean by “strong”? The greater the expense and the level of legal uncertainty in patent litigation, for example, the greater power to intimidate lies in the hands of the owner of a duly issued patent. But that surely is not your measure of “strength”, is it?

  42. MaxDrei,

    Strength is a relative term and not measured only by one factor (and not separable as it appears to be so driven with the points on damages). Your intimations of “intimidation” indicate a bias against one important factor of strength (a subjective hand on an otherwise objective scale, as it were).

    As to the case you wish to use as an example – be careful. Hopefully, this is but an outlier. The case actually better represents a victory for those in the States pushing for a weaker patent system. To that extent, the traditional view (now diminished), is what I would suspect be the basis for the strength comparison.

  43. JDW-

    Watson’s Federal Circuit brief says all that needs to be said if you are interested in reaching the wrong conclusion. Watson is simply flat wrong. I know that will come as a shock to those who revere him as a god, but he doesn’t understand the law and would be better suited to something he has shown an aptitude for.

    -Gene

  44. [...] See No One is Patenting Your Genes. [...]