tag:blogger.com,1999:blog-59978539994547604712024-02-08T11:34:20.827+01:00Biotechnology PunditA blog relating to biotechnology issues.Unknownnoreply@blogger.comBlogger31125tag:blogger.com,1999:blog-5997853999454760471.post-20519749700881073622016-03-19T01:39:00.001+01:002016-03-19T01:51:15.484+01:00Pharmaceuticals Sports & the Maria Sharapova Case: The Latvian Inventor of Meldonium Defends the Safety of the Allegedly Performance-Enhancing Miracle Drug aka Mildronāts, Mildronate, Quaterine, MET-88, THP (not Available in the USA or Germany) - See more at: http://lawpundit.blogspot.com/#sthash.zq1du45E.dpufThe Latvian Inventor of <a href="https://en.wikipedia.org/wiki/Meldonium#cite_note-31" target="_blank">meldonium</a> (also known as<i> mildronāts, Mildronate, Quaterine, MET-88, or THP</i>) has defended the safety of the allegedly performance-enhancing drug that has brought Russian tennis star Maria Sharapova into an alleged doping crossfire, <a href="http://www.people.com/article/maria-sharapova-nike-potential-resign" target="_blank">very likely unjustly</a>, because, as Ivars Kalvins of Latvia's Institute of Organic Synthesis has stated, there is no clinical evidence that taking meldonium improves athletic performance per se.<br />
<br />
Meldonium is a curious case because the substance was only put on the athletically prohibited list of drugs this year, in 2016, whereas the medication was already invented in the 1980s and used for livestock. Clinical trials on humans were conducted in 2005 for its use as a heart medication. As written by Eric Niiler at Wired (yes, two i's) in <a href="http://www.wired.com/2016/03/meldonium-became-doping-drug-choice/" target="_blank">The Quirky History of Meldonium, From a Latvian Lab to Maria Sharapova</a>:<br />
<blockquote class="tr_bq">
"The [Latvian Institute of Organic Synthesis] demonstrated meldonium’s ability to treat effects of <a href="http://www.ncbi.nlm.nih.gov/pubmed/26850121" target="_blank">heart failure, myocardial infarction, arrhythmia, atherosclerosis, and diabetes</a>, as well as how it boosts <a href="http://www.ncbi.nlm.nih.gov/pubmed/23238051" target="_blank">the sexual prowess of boars</a>."</blockquote>
As Niiler writes further, the World Anti-Doping Authority (WADA) has stated <i>off the record</i> that meldonium was put on the prohibited list because it is allegedly "<span style="color: #0b5394;">an energy efficiency catalyst that increases oxygen uptake, enhancing stamina and endurance.</span>" WADA is being careful in its statements on the record because they are in hot water legally, having no evidence that meldonium improves athletic performance, nor is there any evidence that meldonium is harmful to athletes -- quite the contrary, all available evidence indicates that<b> meldonium, as a CYTOPROTECTIVE SUBSTANCE</b> -- is beneficial for health -- perhaps for everyone!<br />
<br />
In his Wired article, <a href="http://www.wired.com/2016/03/original-users-meldonium-sharapovas-banned-drug-soviet-super-soldiers/" target="_blank">The Original Users of Meldonium, Sharapova’s Banned Drug? Soviet Super-Soldiers</a>, Niiler points out that the drug has been used for many years, and quotes Kalvins, <b>a European Patent Office finalist for the European Inventor Award in 2015 for his work on meldonium</b>, as follows:<br />
<blockquote class="tr_bq">
<span style="color: #0b5394;">"Kalvins says the<span style="color: black;"> [Sharapova]</span> ban is literally a crime. “<b>It’s a violation of human rights</b>,” he says. “The sportsmen should be able to protect their health. We are living in an era of evidence-based medicine, so there are not any other new data supporting the ban.” He calls the prohibition “sudden” and “a surprise.”"</span> [emphasis added]</blockquote>
In fact, meldonium is a registered drug in Latvia, Russia and East European countries and has been prescribed for heart patients for years because -- if taken as indicated under the supervision of a physician -- it has proven beneficial not only for heart indications but for health in general, as detailed at the end of this posting.<br />
<br />
The slow-moving U.S. Food and Drug Administration has not approved it yet. See <a href="http://www.france24.com/en/20160318-inventor-defends-safety-questions-ban-sharapova-drug">Flash - Inventor defends safety, questions ban on Sharapova drug - France 24</a>. It is also not yet approved in Germany, in spite of clinical trials that were published already in 2010 in <a href="http://www.degruyter.com/view/j/semcard" target="_blank"><b>Seminars in Cardiovascular Medicine</b></a>, 2010; 16:3. That failing in the USA and Germany, of course, may have much more to do with big money and pharmaceutical politics rather than the honest attempt to provide the best medicine to citizens via new substances, especially if the patents to those substances are owned by foreign firms.<br />
<br />
At any rate, as a legal matter, it simply can not be the case<b> </b>that substances that are beneficial to the heart and the circulatory system are put on lists of substance prohibitions for athletes -- just because athletes use them beneficially. That is really quite absurd.<br />
<br />
Many athletes surely stress their hearts more than your average person and thus taking vitamins or other medications to protect their hearts and health surely is not "doping" per se at all. We should in fact rather encourage athletes to take supplements which are beneficial to them and their organs and which make them stronger, presuming the drugs are not harmful.<br />
<br />
Better heart health could of course result in better athletic performance in any sport, and especially so in tennis, which puts a lot of stress on the circulatory system, but to ban substances that improve an athlete's overall health can not be the purpose of prohibitory athletic doping laws. That simply goes too far in terms of sports officials interfering with people's free choice and, paradoxically, likely HARMING their health through prohibition.<br />
<br />
There must be a line drawn between permissible supplements that improve the health of athletes as opposed to drugs such as steroids that are used primarily to enhance muscle size and thus to gain an unfair athletic advantage in strength sports. Moreover, <a href="https://www.drugabuse.gov/publications/research-reports/anabolic-steroid-abuse/what-are-health-consequences-steroid-abuse" target="_blank">steroid abuse</a> has been shown to be dangerous to the health of athletes. But what about other "supplements"?<br />
<br />
We ourselves find that eating honey and peanut butter sandwiches prior to tennis matches or other athletic endeavors appears to be beneficial for winning or losing -- for us. Calories to burn as it were. Dehydration can also be a severe problem for athletic performance and we swear by Coca-Cola (R) in such cases. Who is anyone to prohibit us from doing that?! In other words, there must be sensible limits to drug doping law prohibitions.<br />
<br />
The world is constantly moving forward and new discoveries are being made every day that have the potential to improve human health. There is no way that all such new discoveries can be prohibited for athletes. That would be unsupportable <b>discrimination against athletes</b>. Indeed, the athletes may be serving in the course of their competitions as models for the rest of us, who down the road may in fact find ourselves taking the same substances to lead a better life. Meldonium certainly looks like one of those substances.<br />
<br />
Be that all as it may, meldonium is manufactured only in Riga, Latvia by the pharmaceutical firm <a href="http://www.grindeks.lv/en" target="_blank">Grindeks (Grindex)</a>, and prescriptions of the drug have shot up considerably since the Sharapova case became public.<br />
<br />
As written at <a href="http://www.france24.com/en/20160318-inventor-defends-safety-questions-ban-sharapova-drug" target="_blank">France24</a> about the clever Mayor of Riga and meldonium, and we would not be surprised if tourist traffic to Riga increased as a result:<br />
<br />
"<span style="color: #0b5394;">Meanwhile, the mayor of Riga, Nils Usakovs has turned the controversy over the drug into a cheeky promotional initiative.</span><br />
<br />
<span style="color: #0b5394;">On his Twitter and Instagram accounts, he has mocked up a holiday-style poster, decorated with swimsuit-clad women, with the slogan: 'Welcome to Riga, meldonium home city!</span>'"<br />
<br />
Here is what the pharmaceutical company <a href="http://www.grindeks.lv/en/for-media/latest-news/Grindeks-meldonium-should-not-be-included-in-the-prohibited-list" target="_blank">Grindeks (Grindex)</a> has written recently at its website about meldonium in <a href="http://www.grindeks.lv/en/for-media/latest-news/Grindeks-meldonium-should-not-be-included-in-the-prohibited-list" target="_blank">Meldonium should not be included in the Prohibited list</a> [note that the company is not doing this to INCREASE sales, rather sales of meldonium have increased because of the prohibition]:<br />
<br />
<span style="color: #0b5394;">"Despite «Grindeks»’s submitted arguments, evidence and justifications, the World Anti-Doping Agency (WADA) included meldonium in the Prohibited list. In accordance with the results of the extended research, «Grindeks» has a firm conviction that meldonium should not be included in the Prohibited list. It is unclear to «Grindeks» why the WADA included meldonium in the Prohibited list, because it never gave any explanation of this decision. The company will continue to use all the options and will stand up for to the exclusion of meldonium from the WADA’s Prohibited list.<br />
<br />
Mildronate® is a registered trademark of the JSC «Grindeks». Its active pharmaceutical ingredient (or active substance) is meldonium which is responsible for the pharmacological and therapeutic effects of Mildronate®. It should be noticed that inclusion of meldonium (Mildronate®) in the Prohibited list doesn’t change the fact that it is a medicine of high quality, safety and efficacy. Until now it has been available to everyone, including athletes, to prevent the negative effects caused by physical and psycho-emotional overload.<br />
<br />
Mildronate® is widely used in the clinical practice. During increased physical activity, it restores the oxygen balance of tissue cells as well as activating the metabolic processes that result in lower requirements of oxygen consumption for energy production. Mildronate® is widely recognized by health care professionals and patients, and this may include athletes as well.<br />
<br />
Mildronate® is mostly prescribed for patients to treat heart and cardiovascular diseases, including stable angina pectoris, chronic heart failure (NYHA I-III functional class), cardiomyopathy, functional cardiovascular disorders; also when there are acute and chronic ischemic brain blood circulation disorders, reduced working capacity, physical and psycho-emotional overload as well as during the recovery period after cerebrovascular disorders, head injury and encephalitis.<br />
<br />
Depending on the patient’s health condition, the treatment course of meldonium preparations may vary from 4 to 6 weeks. The treatment course can be repeated twice or thrice a year. Only physicians can follow and evaluate patient health condition and state whether the patient should use meldonium for a longer period of time or not according to the information provided in the patient leaflet and summary of product characteristics.<br />
<br />
Meldonium is a cytoprotective substance, which is used to prevent death of ischemic cells, and not to increase performance of normal cells. The mechanism of action of meldonium is based on limitation of carnitine biosynthesis, which leads to deceleration of fatty acid oxidation and activation of glycolysis. Unlike carnitine, meldonium doesn’t cause increase of muscle mass and physical properties. Meldonium decreases cellular damage from ischemia by reducing accumulation of detergent substances (acylcarnitine and acyl-coenzyme A) in the mitochondria. It means that meldonium reduces the ability of an organism to use fatty acids as its energy source. This is important in the treatment of pathologies associated with heart muscle ischemia (stenocardia, heart failure), because in these cases the heart is not getting enough oxygen and nutrients. Consequently, meldonium is a cytoprotective substance, which is used to prevent death of ischemic cells, and not to increase performance of normal cells. It means that meldonium cannot improve athletic performance, but it can stop tissue damage in the case of ischemia. That is why this therapeutic drug is not a doping agent.<br />
<br />
Good safety profile of Mildronate® should be particularly emphasized. This is one of the key factors explaining its wide recognition among the doctors and patients. The Mildronate®’s safety is confirmed by its periodic safety update records and the results of published clinical studies. Based on available data, no adverse reactions related to Mildronate®’s use in athletes have been registered.</span>"<br />
<br />
Meldonium looks pretty good to us, and WADA has clearly made a mistake in putting a substance on the prohibited list which has not been proven to be harmful nor has it been proven that it confers an unfair advantage in sports.<br />
<br />
Moreover, as a personal matter and on behalf of people who might be helped to lead better lives with meldonium, we want to know why the substance is not available in the USA and Germany, where the local pharmaceutical company monopolies are reaping gigantic profits by providing us with what may turn out to be less effective cardiovascular substances than meldonium.<br />
<br />
Hat tip to CaryGEE. <br />
<br />
Crossposted at LawPundit and SportPundit.<br />
<br />Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-66060227830681893672013-07-04T23:56:00.001+02:002014-01-30T21:38:05.917+01:00Bowman v. Monsanto Co.: U.S. Supreme Court Limits Doctrine of Patent Exhaustion by Prohibiting Purchasers from Making and Marketing Replicas of Patented Soybeans<div dir="ltr" style="text-align: left;" trbidi="on">
As we <b>previously predicted</b> at <a href="http://lawpundit.blogspot.com/2013/02/bowman-v-monsanto-oral-argument-leads.html" target="_blank">LawPundit</a> on the basis of the oral arguments to the case, the U.S. Supreme Court decided unanimously in favor of the patent holder in <a href="http://www.supremecourt.gov/opinions/12pdf/11-796_c07d.pdf">Bowman v. Monsanto Co.</a>, holding as follows in an opinion by Justice Kagan:<br />
<blockquote class="tr_bq">
<span style="color: #0b5394;">"Under the doctrine of patent exhaustion, the authorized sale of a patented article gives the purchaser, or any subsequent owner, a right to use or resell that article. Such a sale, however, does not allow the purchaser to make new copies of the patented invention. The question in this case is whether a farmer who buys patented seeds may reproduce them through planting and harvesting without the patent holder’s permission. We hold that he may not."</span></blockquote>
The Court ALSO stated by way of limitation as follows:<br />
<blockquote class="tr_bq">
<span style="color: #0b5394;">"Our holding today is limited—addressing the situation before us, rather than every one involving a self-replicating product. We recognize that such inventions are becoming ever more prevalent, complex, and diverse. In another case, the article’s self-replication might occur outside the purchaser’s control. Or it might be a necessary but incidental step in using the item for another purpose. Cf. 17 U. S. C. §117(a)(1) (“[I]t is not [a copyright] infringement for the owner of a copy of a computer program to make . . . another copy or adaptation of that computer program provide[d] that such a new copy or adaptation is created as an essential step in the utilization of the computer program”). We need not address here whether or how the doctrine of patent exhaustion would apply in such circumstances. In the case at hand, Bowman planted Monsanto’s patented soybeans solely to make and market replicas of them, thus depriving the company of the reward patent law provides for the sale of each article. Patent exhaustion provides no haven for that conduct. </span></blockquote>
By so doing, the Supreme Court took the simplest path of decision in this case and applied a clear legal standard to the undenied facts, as the Court should do, without problematical hair-splitting concurrences or dissents. Well done.<br />
<br />
Crossposted from <a href="http://lawpundit.blogspot.com/2013/05/self-replicating-products-in-bowman-v.html" target="_blank">LawPundit</a>.<br />
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-11276162902327104932013-02-26T17:13:00.001+01:002013-02-26T17:13:07.980+01:00U.S. Supreme Court Likely to Hold in Bowman v. Monsanto that Unauthorized Self-Replicated Copies of Patented Monsanto Seeds are Patent InfringementLast week, the U.S. Supreme Court held oral argument on <br />
<a href="http://www.supremecourt.gov/oral_arguments/argument_transcripts/11-796.pdf" target="_blank">Bowman v. Monsanto Co.</a> <br />
<br />
Adam Liptak reported at the NYTimes.com in <a href="http://www.nytimes.com/2013/02/20/business/justices-signal-a-monsanto-edge-in-patent-case.html?_r=0" target="_blank">Supreme Court Hears Arguments in Bowman v. Monsanto</a>.<br />
<br />
It is clear from the questioning during oral argument that Monsanto will prevail on the merits, although it appears to this observer that many commentators underestimate the judicial and legal difficulty of this case, which the Supreme Court took on because it is the first time that the patent rights to progeny of a "self-replicated" product are being decided, i.e. whether successive generations of self-replicating seeds are subject to Monsanto patents on the "original" humanly and genetically-modified non-replicated seed.<br />
<br />
Oral argument suggests quite convincingly that the Supreme Court will not rely on some kind of conditional sales doctrine as representing some form of restrictive "license" as a limitation on the first sale doctrine. As <a href="http://www.supremecourt.gov/oral_arguments/argument_transcripts/11-796.pdf" target="_blank">Justice Breyer</a> said in this regard:<br />
<blockquote class="tr_bq">
<span style="color: #3d85c6;">"Now, they -- they thought, the [Federal C]ircuit, that there's some restriction in a license and they have a doctrine that seems to say that you can restrict licenses -- through licenses the use of a product after it's been sold. And that would seem contrary to the first sale doctrine"" </span></blockquote>
Obviously, the Supreme Court will be sure to set the Federal Circuit straight on its "<span style="color: #3d85c6;">lingering confusion</span>" (quoting Justice Sotomayor) with respect to conditional sales. "Sales" have nothing to do with the coming decision <i>per se</i>.<br />
<br />
Furthermore, the Court will also not rely on contractual limitations as the means by which patent holders must protect their rights. Patent rights as such are rights granted by the patents themselves, and not by contracts.<br />
<br />
Rather, it is quite clear that the Supreme Court will hold that successive generations of self-replicating genetically modified and thus rightfully "patented" seeds are "copies" of the original patented seed, the "making" of which via unauthorized copies is prohibited.<br />
<br />
Such a resolution as above of the legal problem presented by the case may appear by hindsight to be "apparent", but by no means necessarily obvious as a matter of law. Indeed, a strict view of the facts would hold that "God" makes the copies in the case of seed replication, regardless of genetic modification, even if human intervention (planting, fertilizing, watering, etc.) may also be required. In any case, the definition of "copying" here will be extended by the Court to its furthest possible limit for purposes of patent law.<br />
<br />
It must be emphasized here in closing that the patents to the Monsanto soybeans involve the insertion of a genetic sequence into the germplasm of seeds that makes the resulting plants resistant to glyphosate, a herbicide manufactured by Monsanto, that otherwise kills other plants and weeds by inhibiting an enzyme necessary for growth.<br />
<br />
When glyphosate is applied from the air, other plants and weeds in the field are killed while the resistant genetically modified plants survive and grow.<br />
<br />
In other words, contrary to the situation in the upcoming Myriad case decision at the Supreme Court involving human genes, the "seed" here "created" by Monsanto has been truly "humanly" altered, even if the patent incorporates the original soybean seed or other plant seed as the object of the genetic modification. In Myriad, by contrast, there is the attempt to patent "cleaved snips" of actually existing human genes, and that of course will be denied by the Supreme Court, since the genetic code remains as is for its operative part, and is used principally as such, even if in abbreviated form.<br />
<br />
In Monsanto there is a completely new addition to the genetics of the seed. In Myriad, one is merely using a genetics that is already there. <br />
<br />
See the briefs to the Monsanto case at <a href="http://www.americanbar.org/publications/preview_home/11-796.html" target="_blank">americanbar.org</a>.<br />
<br />Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-70066598838305161782012-03-28T23:12:00.004+02:002012-03-28T23:12:46.997+02:00Myriad Patent Case Vacated and Remanded by U.S. Supreme Court in Light of Prometheus<br />
Stanford Law Professor Hank Greely has a quick note in <a href="http://blogs.law.stanford.edu/lawandbiosciences/2012/03/26/quick-note-the-supreme-court-has-gavrilod-the-myriad-case/">The Supreme Court Has Gavrilo’d the Myriad Case</a> writing:<br />
<blockquote class="tr_bq">
"<span style="color: #3d85c6;">Granted, vacated, and remanded in light of... Prometheus.</span>"</blockquote>
We previously posted about Myriad at <a href="http://lawpundit.blogspot.com/2011/08/split-federal-circuit-in-myriad-case.html">Split
Federal Circuit in Myriad Case Partially Reverses District Court and
Finds Isolated Human Genes to be Patentable: Subsequent Supreme Court
Review of this Case is Surely Essential</a>.<br />
<br />
This is
really a toss of the ball back into the Federal Circuit's court, giving
them a chance to apply Prometheus sensibly and, of course, to rule
instead that isolated human genes are not patentable, which is and can
be the only acceptable decision. <br />
<br />
The logic we suggest is: if you cleave an orange in two, you can not claim the two orange halves as inventions, and so it is also with human genes.<br />
<br />
Crossposted from <a href="http://lawpundit.blogspot.com/2012/03/myriad-human-gene-patent-case-vacated.html">LawPundit</a>.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-40909394802280958282012-03-27T23:44:00.001+02:002012-03-27T23:44:56.319+02:00Prometheus Diagnostic Method Claims Not Patentable Says U.S. Supreme CourtText below crossposted from <a href="http://lawpundit.blogspot.com/2012/03/supreme-court-holds-that-prometheuss.html">LawPundit</a>.<br />
<br />
BRAVO to the United States Supreme Court! The <a href="http://www.forbes.com/sites/danielfisher/2012/03/21/two-unanimous-supreme-court-rulings-two-pleas-to-congress/">unanimous</a> (who would have believed that!) U.S. Supreme Court decision in <i><a href="http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf">Mayo v. Prometheus</a></i> (and also the unanimous decision in <a href="http://www.scotusblog.com/case-files/cases/sackett-et-vir-v-environmental-protection-agency-et-al/"><i>Sackett vs. EPA</i></a>) have restored our faith that the nation's highest court can be counted upon to see past the hype, spot the <a href="http://www.scotusblog.com/2012/03/court%E2%80%99s-biotech-case-sends-stern-warning-to-federal-circuit-and-software-designers/#more-141232">major legal issues</a> facing the world, and decide them correctly. In the past, we have spent so much time at LawPundit battling against insanity in the patent sector (see <a href="http://lawpundit.blogspot.de/2011/12/mayo-collaborative-services-v.html">here</a>, <a href="http://lawpundit.blogspot.de/2011/07/prometheus-v-mayo-coming-soon-again-at.html">here</a> and <a href="http://lawpundit.blogspot.de/2010/02/did-federal-circuit-misapply.html">here</a>), that I am happy here just to pass along to you the following email which I received today. As a Paul, Weiss alum, I ask the people at Paul, Weiss to overlook my posting their letter in entirety, since the letter is covered by all kinds of copyright protection, but this is <b>a very important case</b>, and so it is probably better to let one of the world's top law firms give you the scoop, rather than my commentating it again from my admittedly biased point of view. The text of the Paul|Weiss email is given below, while the full text of the Client Memorandum summarizing the Prometheus decision (only 4+ pages in the memo, beautifully written) is accessible by clicking the link in that email:<br />
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<table border="0" cellpadding="0" cellspacing="0" style="color: #333333; font-family: verdana; font-size: 10pt;"><tbody>
<tr valign="top"><td><b>Client Memorandum</b><br />
March 21, 2012</td>
<td align="right"><b>Paul, Weiss, Rifkind, Wharton & Garrison LLP</b><br />
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<span style="color: #333333; font-family: verdana; font-size: x-small;"><span style="font-size: small;"><b>The Supreme Court Holds That Prometheus’s Diagnostic Method Claims Are Unpatentable Under 35 U.S.C. § 101</b></span></span></div>
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The United States Supreme Court issued a significant, unanimous decision yesterday in <i>Mayo Collaborative Services</i> v. <i>Prometheus Laboratories, Inc.</i>,
No. 10-1150 (2012), holding that certain diagnostic patent claims were
invalid for failure to recite patent-eligible subject matter under 35
U.S.C. § 101. The Court determined that the “steps in the claimed
processes (apart from the natural laws themselves) involve
well-understood, routine, conventional activity previously engaged in by
researchers in the field,” and noted that “upholding the patents would
risk disproportionately tying up the use of the underlying natural laws,
inhibiting their use in the making of further discoveries.” In so
holding, the Supreme Court reversed a Federal Circuit decision that the
method claims were patent-eligible under the machine-or-transformation
test, and do not impermissibly claim natural phenomena.</div>
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The Supreme Court’s opinion
is of interest to pharmaceutical and biotechnology companies because the
decision leaves a large number of therapeutic and diagnostic patent
claims vulnerable to challenge, especially those that concern
correlations resulting from natural body processes. The Supreme Court’s
decision states, however, that new drugs and new methods of using
existing drugs remain patentable subject matter. And the decision
suggests that certain patents covering diagnostic tests directed at the
measurement of new or previously unknown analytes would withstand
challenge under § 101.</div>
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A link to the memo is
attached. If for security reasons your e-mail system does not enable web
links, please copy and paste the link into the address window of your
Internet browser.</div>
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</tbody></table>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-63858669807977609712012-03-27T23:40:00.000+02:002012-03-27T23:40:19.807+02:00Stanford Law Prof Greely Blogging on Obamacare Oral Arguments Before the U.S. Supreme Court: Day One<br />
Professor <a href="http://www.law.stanford.edu/directory/profile/27/" target="_blank">Hank Greely</a> of Stanford Law School is blogging at the <a href="http://blogs.law.stanford.edu/lawandbiosciences/2012/03/27/the-supreme-court-on-health-reform-day-one/">Law and Biosciences Blog</a> on the oral arguments before the U.S. Supreme Court, Day One.<br />
<br />
He is suggesting that the court will find that the Anti-Injunction Act will not apply, prohibiting as it does, cases on taxes to be brought to the courts before the tax has been assessed.<br />
<br />
This issue should not be underestimated because the U.S. Supreme Court can not permit a situation where every time some political faction does not like a new law of Congress, they turn to the Supremes.<br />
<br />
Now, it is clear that Obamacare is not a direct tax, but there is in our mind no question that the Affordable Health Care Act is a form of indirect taxation and passed as it was to spread the costs of health care more equitably and to make affordable health available for all.<br />
<br />
Hence, after all is said or done, it is not guaranteed that the court will not rule this an indirect tax to which the Anti-Injunction Act applies.<br />
<br />
The Court has to be careful that it is not put into direct confrontation with Congress, indeed, be put in a position of second-guessing Congressional legislation before the actual act of implementation. Simply put, you have to have a harm to allege a harm. You can not be theorizing about the future.<br />
<br />
We agree with Greely that that the Anti-Injunction Act will be held not to apply because this is not a direct tax, but also agree that if the Court can not reach a sensible consensus on the merits, they will always have this option available as an escape hatch.<br />
<br />
Even if the Court does not use this escape hatch, they should direct some strong words at all the people who are pushing this case for POLITICAL reasons rather than actually being concerned about the Act's Constitutionality, which has been raised merely as an excuse to challenge legislation that is not liked by one political extreme.<br />
<br />
A Supreme Court acting as a political referee would be in deep trouble down the road. <br />
<br />
Congress, for better or worse, makes the laws, not the Supremes.<br />
Hence, the Supreme Court Justices can not play legislator here.<br />
<br />
<br />
Crossposted from <a href="http://lawpundit.blogspot.com/2012/03/stanford-law-prof-greely-blogging-on.html">LawPundit</a>.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-85468088469340860792011-10-15T00:00:00.003+02:002011-10-15T00:00:32.118+02:00Law and Science Combined in a Career: Biotech Patent Law<h3 class="post-title entry-title">
</h3>
<div class="post-header">
</div>
<br />
William J. Simmons has the real deal at the journal Science in discussing the intersection of law and science as a career:<span style="text-decoration: underline;"><br />
<br />
</span><a href="http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2011_10_14/caredit.a1100114">In Person: A Career in Biotech Patent Law - Science Careers - Biotech, Pharmaceutical, Faculty, Postdoc jobs on Science Careers</a>.<br />Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-9083260339020361532010-08-30T03:00:00.000+02:002010-08-30T03:00:08.739+02:00Sanofi Offers $18.5 Billion for Genzyme - NYTimes.com<a href="http://www.nytimes.com/2010/08/30/business/global/30deal.html?_r=1&nl=todaysheadlines&emc=globasasa1">Sanofi Offers $18.5 Billion for Genzyme - NYTimes.com</a>: "- Sent using Google Toolbar"Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-90500398533806263982010-08-22T16:38:00.000+02:002010-08-22T16:38:25.478+02:00Judge Rules that Genetically Altered Biotechnology Sugar Beets Not Kosher Until Thorough Environmental Review by the GovernmentMichael Liedtke, AP Business Writer, in his August 15, 2010 article <a href="http://abcnews.go.com/Business/wireStory?id=11403445">Judge's Ruling Uproots Use of Biotechnology Beets</a> reported that Federal U.S. District Court <a href="http://en.wikipedia.org/wiki/Jeffrey_White">Judge Jeffrey S. White</a> of the Northern District of California has invalidated government approval of genetically modified biotech sugar beets and has barred all future planting pending a full environmental impact review by the government (see the order in Case3:08-cv-00484-JSW Document570 Filed 08/13/10, in <span style="font-style: italic;">Center for Food Safety v. Vilsack</span>, at the <a href="http://graphics8.nytimes.com/packages/pdf/business/20100813Order.pdf">New York Times</a> and at <a href="http://www.docstoc.com/docs/50526810/US-District-Court-Order-Center-for-Food-Safety-v-Tom-Vilsack">DocStoc</a>).<br />
<br />
Andrew Pollack covered the story at the New York Times in <a href="http://www.nytimes.com/2010/08/14/business/14sugar.html">Judge Revokes Approval of Modified Sugar Beet</a>s.<br />
<br />
See <a href="http://www.treehugger.com/files/2010/08/federal-judge-bans-genetically-modified-sugar-beets.php">Federal Judge Bans Genetically Modified Sugar Beets</a> at Treehugger.com<br />
<br />
Crossposted from <a href="http://lawpundit.blogspot.com/2010/08/judge-rules-that-genetically-altered.html">LawPundit</a>.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-91215966864112479712010-08-22T16:12:00.002+02:002010-08-22T16:12:48.033+02:00Federal Circuit Judge Dyk in Intervet v. Merial Dissent Questions Whether Isolated DNA is Patentable Subject Matter: Relevant to Myriad Case AppealAt the Genomics Law Report from Robinson Bradshaw & Hinson in <a href="http://www.genomicslawreport.com/index.php/2010/08/18/swine-still-soaring-federal-circuit-judge-expresses-sympathy-for-myriad-analysis">Swine Still Soaring: Federal Circuit Judge Expresses Sympathy for Myriad Analysis</a>, John Conley and Allison Williams Dobson report that Federal Circuit Judge Timothy B. Dyk in his <a href="http://www.genomicslawreport.com/wp-content/uploads/2010/08/Intervet-Merial-opinion.pdf">Intervet v. Merial</a> dissent raises the cardinal question as to whether isolated DNA is patentable subject matter.<br />
<br />
Dyk's dissent is important as a member of the Federal Circuit to whom the <a href="http://www.genomicslawreport.com/index.php/2010/06/17/myriad-genetics-appeals-ruling-invalidating-gene-patents/">Myriad case</a> has been appealed, challenging a <a href="http://www.genomicslawreport.com/wp-content/uploads/2010/03/Myriad-SJ-Opinion.pdf">ruling</a> by Judge Robert W. Sweet in the U.S. District Court for the Southern District of New York, according to which an isolated DNA sequence is not patentable subject matter.<br />
<br />
Given the ill-considered U.S. Supreme Court (SCOTUS) decision in Bilski finding business methods to be patentable subject matter, we have become somewhat skittish and skeptical about what the courts will decide in this legal arena.<br />
<br />
Our own view is that if a company isolates a particular DNA sequence and can figure out a way to commercially exploit that knowledge and know-how, more power to them, but we would never give them a patent for what is essentially a law of nature.<br />
<br />
If a DNA sequence is "part" of any living organism, human, swine or otherwise, then why should any man-made enterprise be given a monopoly to exploit that particular God's work?<br />
<br />
My understanding of the U.S. Constitution is that an inventive PRODUCT which encompasses such a DNA sequence could of course be patented, but not the DNA sequence itself. Why do the courts have such a hard time with this?<br />
<br />
Crossposted from <a href="http://lawpundit.blogspot.com/2010/08/federal-circuit-judge-dyk-in-intervet-v.html">LawPundit</a>.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-17337796470600210052010-05-25T00:56:00.000+02:002010-05-25T00:56:05.362+02:00Betting on Bilski: The Supreme Court and Biotechnology Patents<a href="http://www.genomicslawreport.com/index.php/2010/05/21/betting-on-bilski-the-supreme-court-and-biotechnology-patents/">Betting on Bilski: The Supreme Court and Biotechnology Patents</a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-81557990751182896332010-05-18T01:50:00.000+02:002010-05-18T01:50:52.164+02:00First large-scale formal quantitative test confirms Darwin's theory of universal common ancestry<a href="http://www.sciencedaily.com/releases/2010/05/100512131513.htm">First large-scale formal quantitative test confirms Darwin's theory of universal common ancestry</a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-5922099894219216352010-05-03T21:23:00.000+02:002010-05-03T21:23:32.400+02:00FDA Approves First Cancer Vaccine, Heralding a New Era in Treatment | Popular Science<a href="http://www.popsci.com/science/article/2010-04/fda-approves-cancer-vaccine-heralding-new-era-treatment">FDA Approves First Cancer Vaccine, Heralding a New Era in Treatment | Popular Science</a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-54934795973618279702010-04-03T00:15:00.000+02:002010-04-03T00:15:25.691+02:00Dr. Philip Neches: DNA Is a Preexisting Condition<a href="http://www.huffingtonpost.com/dr-philip-neches/dna-is-a-preexisting-cond_b_520252.html">Dr. Philip Neches: DNA Is a Preexisting Condition</a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-43611860952642696082010-03-08T15:18:00.000+01:002010-03-08T15:18:47.245+01:00Bill Gates - What I'm Learning - The New Science of Feeding the World - The Gates Notes<a href="http://www.thegatesnotes.com/Learning/article.aspx?ID=117">Bill Gates - What I'm Learning - The New Science of Feeding the World - The Gates Notes</a><br /><blockquote style="color: rgb(153, 102, 51);">"Agricultural biotechnology is controversial but essential, Bill believes, to ease the plight of the 1 billion impoverished people who live with chronic hunger. He reviews a provocative book on the realities of farming today – and its future."</blockquote>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-84275682056314606732010-03-08T14:51:00.000+01:002010-03-08T14:51:44.094+01:0070% of Antibiotics in the USA are Fed to Healthy Livestock<a href="http://mobile.nytimes.com/article?a=561416"><blockquote></blockquote>The Spread of Superbugs</a><br />by Nicholas D. Kristof, March 7, 2010, at the New York Times Mobile<br /><blockquote style="color: rgb(153, 102, 51);">"A study by the Union of Concerned Scientists found that in the United States, 70 percent of antibiotics are used to feed healthy livestock, with 14 percent more used to treat sick livestock. Only about 16 percent are used to treat humans and their pets, the study found.<br /><br />More antibiotics are fed to livestock in North Carolina alone than are given to humans in the entire United States, according to the peer-reviewed Medical Clinics of North America. It concluded that antibiotics in livestock feed were "a major component" in the rise of antibiotic resistance."</blockquote>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-13581873386439841272010-02-05T01:17:00.001+01:002010-02-05T01:37:33.264+01:00Genetic Privacy : Genetic Testing in New York : Newborn DNA Samples in Texas : German Genetic Diagnosis Act Went Into Effect on February 1, 2010As reported in numerous German-language sources, the German Genetic Diagnosis Act <span style="font-style: italic;">(Gendiagnostikgesetz, GenDG)</span> - <a href="http://www.eurogentest.org/uploads/1247230263295/GenDG_German_English.pdf">English translation at eurogentest.org</a> - took force on February 1, 2010. This law is of interest for many disciplines, especially in view of the recent "<a href="http://www.wnd.com/index.php?fa=PAGE.view&pageId=119916">genetic privacy</a>" <a href="http://www.privacydigest.com/2010/01/21/texas%20destroy%20baby%20blood%20taken%20without%20consent">decision in Texas</a> and the pending passage of <a href="http://www.privacydigest.com/node/7174">Katie's Law</a> in New York.<br /><br />A summary of the German law is found at <a href="http://www.drze.de/themen/blickpunkt/gentests-en?la=en">DRZE - Predictive Genetic Testing</a> - this is an excerpt:<br /><blockquote style="color: rgb(153, 102, 51);">"<span style="font-weight: bold;">1. The German Genetic Diagnostics Act (GenDG)</span><br /><br />... The German Genetic Diagnostics Act will come into effect on 1st February 2010 (§ 27).<br /><br />The Act explicitly aims at defining the prerequisites for genetic testing and genetic analysis performed in the context of genetic testing, as well as for the use of genetic samples and data, and at preventing discrimination on grounds of genetic predisposition, in order to ensure the state's commitment to respect and to protect human dignity and the right to informational self-determination. (§ 1)<br /><br />The scope of the Act is not limited to predictive genetic testing: it extends, in fact, to genetic testing carried out on (born) human beings (i.e. postnatal) as well as to genetic examination of embryos and foetuses (prenatal; see special provisions in § 15), covering different contexts and purposes of application (§ 2 para. 1). Besides the use of genetic testing for medical purposes, the Act regulates the use in the field of insurance (§ 18) and in working life (§§ 19-22), as well as genetic screenings (§ 16), and also covers tests to determine parentage ('paternity tests', §17). However, it does not address the use of genetic testing and analysis or the handling of genetic samples and data for research purposes (§ 2 para. 2 no. 1). Moreover, the Act does not apply to measures carried out under provisions relating to criminal proceedings, international mutual assistance in criminal matters, and the Federal Criminal Police Office Act (BKA-Gesetz) (§ 2 para. 2 no. 2 letter a), or relating to the Protection against Infection Act (IfSG) (§ 2 para. 2 no. 2 letter b)."</blockquote>Read the <a href="http://www.drze.de/themen/blickpunkt/gentests-en?la=en">full summary here</a> and the <a href="http://www.eurogentest.org/uploads/1247230263295/GenDG_German_English.pdf">full English translation of the text of the law here.</a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-57442821440745079752010-02-05T00:51:00.000+01:002010-02-05T00:51:06.340+01:00EuroGentest - What is EuroGentest?<a href="http://www.eurogentest.org/">EuroGentest - What is EuroGentest?</a><br /><blockquote style="color: rgb(153, 102, 51);">"EuroGentest is an EU-funded Network of Excellence (NoE) with 5 Units looking at all aspects of genetic testing - Quality Management, Information Databases, Public Health, New Technologies and Education. Through a series of initiatives EuroGentest encourages the harmonization of standards and practice in all these areas throughout the EU and beyond."</blockquote>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-15638865621777411772010-01-29T21:11:00.000+01:002010-01-29T21:11:42.873+01:00Biogen Idec, Genzyme and the Struggles of Big Biotech - Health Blog - WSJ<a href="http://blogs.wsj.com/health/2010/01/29/biogen-idec-genzyme-and-the-struggles-of-big-biotech/">Biogen Idec, Genzyme and the Struggles of Big Biotech - Health Blog - WSJ</a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-48415047973549896172010-01-22T10:54:00.000+01:002010-01-22T10:54:13.493+01:00Venture Funding Moves from Clean Energy to Efficient Lighting and Energy-Management Software : Biotech Leads the Pack<a href="http://www.businessweek.com/news/2010-01-22/venture-funding-stabilizes-shifts-to-biotech-shuns-energy.html">Venture Funding Stabilizes, Shifts to Biotech, Shuns Energy - BusinessWeek</a><br /><br />Biotech is on the rise as drug companies seek to offset expiring patents and as investments are being made in new technologies such as genome and cancer research. Less money is going into clean energy and more into projects for efficient lighting and energy-management software.<br /><br />Tim Mullaney, January 22, 2010 (Bloomberg) , writes:<br /><blockquote style="color: rgb(153, 102, 51);">"Venture-capital funding for startup companies stabilized in the fourth quarter, with investor interest shifting toward drug development and away from clean energy....<br /><br />Biotech was the largest industry for the quarter."</blockquote>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-80324122490432534932009-11-11T00:39:00.001+01:002009-11-11T00:39:38.021+01:00What is Patentable? Bilski Patent Case Oral Argument Heard at the United States Supreme Court : We Hope for Adoption of the Transformative StandardOn Monday, November 9, 2009, the U.S. Supreme Court heard oral argument in the Bilski patent case, the judicial resolution of which is bound to have far-reaching consequences on the way that the United States and the rest of the world view and treat patents (see the <a href="http://www.supremecourtus.gov/oral_arguments/argument_transcripts/08-964.pdf">original transcript of the arguments here</a> - hat tip to Kevin E. Noonan at PatentDocs in <a href="http://www.patentdocs.org/2009/11/supreme-court-bilski-argument.html">Supreme Court Bilski Argument</a>).<br /><br />Although the Supreme Court may decide the case narrowly with respect to the particular facts of the Bilski business method patent case, the reasons which the Supreme Court sets out as the basis for its decision will nevertheless have broad application in law, for the Supreme Court can not duck the pressing legal patent issues and must provide a flexible standard NOW, inserting stability into a system currently ruled by chaos.<br /><br />Joe Mullin at The American Lawyer in <a href="http://www.law.com/jsp/tal/PubArticleTAL.jsp?id=1202435316698&Supreme_Skepticism_Over_Bilski_Claims_Puts_Method_Patents_on_Shaky_Ground&slreturn=1&hbxlogin=1">Supreme Skepticism Over Bilski Claims Puts Method Patents on Shaky Ground</a> writes in this regard that:<br /><span style="color: rgb(153, 102, 51);"></span><blockquote><span style="color: rgb(153, 102, 51);">"For the first time in almost 30 years, the U.S. Supreme Court on Monday considered the issue of what types of technology should be eligible for patent protection when it heard oral arguments in Bilski v. Kappos.</span><br /><br /><span style="color: rgb(153, 102, 51);">Across the board, the justices indicated a deep skepticism toward the invention described in the patent application at issue, which was rejected by the U.S. Patent and Trademark Office and describes a method for trading commodities. Some of the justices went even further--expressing both a fair amount of disdain for the idea of granting broad "method" patents and a concern that ruling in favor of the petitioners would lead to patent grants on fundamental ways of conducting business or organizing human behavior. "</span></blockquote>We have posted about the landmark Bilski case from the very beginning and our line of reasoning - prior to the court decisions - anticipated what the courts decided:<br /><br /><a href="http://www.lawpundit.com/blog/2009/01/in-re-kubin-hitting-nail-on-head.htm">In re Kubin : Hitting the NAIL on the Head : Sequencing Poor Federal Circuit Court Decisions out of the Biotechnology Patent Genome via KSR and/or Bilski Reasoning</a><br /><br /><a href="http://www.lawpundit.com/blog/2008/11/in-re-bilski-patentable-subject-matter.htm">In re Bilski : Patentable Subject Matter : Federal Circuit Overturns Pure Business Method Patents : Requires Machine Process / Physical Transformation </a><br /><br /><a href="http://www.lawpundit.com/blog/2008/03/federal-circuit-to-review-business.htm">Federal Circuit to Review Business Method Patents for Future Viability : There is a Great Likelihood of a New Upcoming Legal Standard </a><br /><br /><a href="http://www.lawpundit.com/blog/2008/03/patentability-of-business-methods-and.htm">The Patentability of Business Methods and the Upcoming Federal Circuit Hearing en banc in Ex parte Bilski</a><br /><br />For our part, we hope that the standard adopted is the transformative one. Transformation is the operative element that is common not only to patents but also to copyright law, for it is "transformation" which is the inventive step.<br /><br />A copyrighted work is after all - in most cases - simply a unique transformation of commonly used words of the language or languages written. Since nearly every word is in a sense "copied" from prior art, and since many elements of any written work are common to many works due to the linguistically identifiable rules of grammar and syntax, almost any truly transformative work still necessarily contains many copied "elements". It is therefore the transformative nature of a work as a whole which must be judged and not its individual parts per se.<br /><br />As far as patents are concerned, the same reasoning applies. Any transformation of "matter" or of a more abstract element of technology such as software or medical knowledge necessarily "copies", i.e. it relies on many elements of prior art to reach a new discovery. An inventive step is never taken in a vacuum and can therefore as good as never be divorced from the environment in which it takes place.<br /><br />An invention is the whole work and it is entirely conceivable to imagine a fantastic new written work or invention made up totally of otherwise copyrighted or patented parts - for which the copyright or patent holders of those parts should in the case of such an invention nevertheless get nothing, because a transformation has taken place in the new whole.<br /><br />A transformative standard can also be equally applied to software products (as a whole) or to new medical advances (as products), i.e. the transformative software (as a product) should be patentable, but NOT elements of the software code, and similarly, transformative medical discoveries should be patentable, but NOT the methods used to achieve them, e.g. transformative new ways to synthesize a gene should be patentable, but not the gene itself.<br /><br />In the case of business methods, a transformative software product implementing a particular business method should be patentable - but NOT the business method itself. Until a business method is APPLIED, no transformation has occurred. Therefore, only a product which performs such a transformation can be patented.<br /><br />We see no serious problems with a transformative standard - which need not be tied to machines or any other technology. The inventive step should be universally recognizable as a reproducible transformation.<br /><br />The view voiced by some commentators and also expressed by some judges and also U.S. Supreme Court Justices that the Bilski patent might be rejected as being merely "an abstract idea" is an intellectual cop-out and begs the question of drawing the necessary line between "an abstract idea" and "an inventive step". WHERE that line is to be drawn is the job of the U.S. Supreme Court to determine and the Supremes therefore can not avoid the establishment of a standard simply by rejecting Bilski's business method as "an abstract idea".<br /><br />The question is, when does a non-obvious abstract idea become an invention? And that question, the Court must answer. They have little choice.<br /><br />We suggest that the only viable answer is the transformative standard.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-24199250002900565252009-10-21T23:20:00.002+02:002009-10-21T23:22:43.065+02:00Pharma and Biotech Twitter at @LaxPatLawMan<a href="http://twitter.com/LaxPatLawMan">@LaxPatLawMan</a> twitters about biotech and the pharmaceutical business, including patents and regulatory issues.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-63953663929687910442009-10-21T20:49:00.002+02:002009-10-21T20:52:16.758+02:00A Biotechnology Blog at Patently BIOtech<a href="http://patentlybiotech.wordpress.com/">Patently BIOtech</a> is a biotechnology blog at WordPress.com which covers "<span style="color: rgb(0, 102, 0);">intellectual property, technology transfer, biotechnology, gene patenting, global health, economic growth, sustainability, green jobs....</span>"Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-89811951507857047982009-10-21T20:46:00.001+02:002009-10-21T20:48:11.068+02:00BIO Technology Transfer Symposium, Wednesday, October 28, 2009 at the Palace Hotel in San Francisco<span class="status-body"><strong></strong><span class="entry-content">BIO Technology Transfer Symposium, Wednesday, October 28, 2009 at the Palace Hotel in San Francisco <a href="http://www.bio.org/ip/techtransfer">bio.org/ip/techtransfer</a> <a href="http://4l372.tk/" class="tweet-url web" rel="nofollow" target="_blank">http://4l372.tk</a><br /><br />Tweet at </span></span><span class="status-body"><strong><a href="http://twitter.com/Law_Pundit" class="tweet-url screen-name" title="Andis Kaulins">Law_Pundit</a></strong> </span>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5997853999454760471.post-91944333946865470312009-05-11T00:01:00.000+02:002009-05-11T00:02:48.917+02:00Comparing Pharmaceutical and Biotechnology Innovation in the United States and Europe : The Key Player is Venture Capital Financing and not PatentsIt is often claimed that the liberal granting of patents is essential for the development of the pharmaceutical industry, especially modern biotechnology. The facts do not support that view.<br /><br /><a href="http://www.ngpharma.eu.com/article/Issue-3/Clinical-Trials/Mind-the-gap/">NGP's Mind the gap?</a> writes:<br /><br />"<span style="color: rgb(153, 102, 51);">Fast facts</span><span style="color: rgb(153, 102, 51);"><br /><br />For most of the past century, Europe has been leading the world in pharmaceutical innovation. But over the last decade, the US gradually overtook Europe both in terms of innovative efforts (R&D investment) and in terms of the output of its innovative activity (New Molecular Entities).</span><span style="color: rgb(153, 102, 51);"><br /><br />Europe is still leading the world in pharmaceutical production, which has risen fivefold in value over the last 20 years, with exports accounting for 60 percent of total production.</span><span style="color: rgb(153, 102, 51);"><br /><br />More than 400,000 Europe-born scientists are estimated to have crossed the Atlantic, where they account for 40 percent of scientists working in the US.</span><span style="color: rgb(153, 102, 51);"><br /><br />About 40 percent of the new active substances launched nowadays on the world market have been discovered and developed in Europe, whereas 30 years ago Europe’s share of pharmaceutical discoveries was 65 percent.</span>"<br /><br />The reason for the mass exodus of pharmaceutical scientists from Europe to the USA is the lure of more money, enabled by exorbitant U.S. pharmaceutical profits as engendered by a failed and exploitative patent policy. As written by Marcia Angell in <a href="http://www.cmaj.ca/cgi/content/full/171/12/1451">Excess in the pharmaceutical industry</a>:<br /><br />"<span style="color: rgb(153, 102, 51);">Although the pharmaceutical industry claims to be a high-risk business, year after year drug companies enjoy higher profits than any other industry. In 2002, for example, the top 10 drug companies in the United States had a median profit margin of 17%, compared with only 3.1% for all the other industries on the Fortune 500 list. Indeed, subtracting losses from gains, those 10 companies made more in profits that year than the other 490 companies put together. Pfizer, the world's number-one drug company, had a profit margin of 26% of sales. In 2003, for the first time in over 2 decades, the pharmaceutical industry fell slightly from its number-one spot to third, but this was explained by special circumstances, including Pfizer's purchase of another drug giant, Pharmacia, which cut into its profits for the year. The industry's profits were still an extraordinary 14% of sales, well above the median of 4.6% for other industries. A business that is consistently so profitable can hardly be considered risky.</span><span style="color: rgb(153, 102, 51);"><br /><br />Excess profits are, of course, the result of excess prices — and prices are excessive principally in the United States, the only advanced country that does not limit pharmaceutical price increases in some way. Of the top 10 drug companies in the world, 5 are European and 5 are American, but all of them have the US as their major profit centre. In the US, uninsured patients (of which there are many) are charged more for drugs than those who have large insurance companies to bargain for them, and the prices of prescription drugs are generally much higher to start with than in other advanced countries. Moreover, the prices of top-selling drugs are routinely jacked up in the US at 2 to 3 times the general rate of inflation.</span>"<br /><br />In reality, biotechnology patents are not an issue of health, invention or patent law, but rather a matter of greed for money, as discussed in the Journal of Intellectual Property Law & Practice by Katherine A. Helm in her article, <a href="http://jiplp.oxfordjournals.org/cgi/content/abstract/jpn208v1">The battle over global drug markets: enforcement of pharmaceutical patents in the United States, Europe, and Japan</a>.<br /><br />The facts also tell a different story about the alleged relationship of patents to innovation. Margaret Sharp and Pari Patel, SPRU, University of Sussex, write as follows in their article <a href="http://cordis.europa.eu/eims/src/eims-r32.htm">Europe's Pharmaceutical Industry: An Innovation Profile: Summary</a> as part of EIMS (European Innovation Monitoring System):<br /><br />"<span style="color: rgb(153, 102, 51);">For the 20 largest R&D spending pharmaceutical firms, there is little correlation between measures of innovation such as R&D spending, patenting, the number of new drugs under development (in R&D), or the number of top-selling drugs, except for a positive correlation between R&D intensity and the number of new drugs as a percentage of sales....</span><span style="color: rgb(153, 102, 51);"><br /><br />Biotechnology offers a new route to drug discovery that could potentially reduce R&D costs and development times. A large number of small, dedicated biotechnology firms (DBFs) have been established in the United States in response to a conducive environment characterised by a developed venture capital market, lenient stock exchange rules, and a well-funded research base in the life sciences (Irvine et al, 1990). In contrast, few DBFs have flourished in Europe, while Europe's large pharmaceutical and chemical firms were latecomers to biotechnology, although several built up research teams in the early 1980s in order to keep abreast of developments. Since the late 1980s an important route for European firms to access biotechnology expertise has been through the purchase of American DBFs or the establishment of research laboratories in the US. However, case-study research shows that there is no systematic tendency for leading-edge biotechnology research by European firms to move to the United States (Senker et al, 1996). On the contrary, European firms are building up strong research capabilities in biotechnology, using links with American DBFs in areas where Europe is weak.</span><span style="color: rgb(153, 102, 51);"><br /><br />Few DBFs have been able to become fully integrated pharmaceutical firms and as of 1993 only about 3.9% of all pharmaceutical sales were due to biotechnology drugs (Ernst & Young, 1994). Most DBFs survive through a synergistic relationship with larger firms, where the DBF supplies potential new products to a large firm which in turn takes them through clinical trials and helps defend patents. This has meant that there has been a shift over the past decade from R&D agreements to alliances based on marketing and licensing.</span><span style="color: rgb(153, 102, 51);"><br /><br />Conclusions</span><span style="color: rgb(153, 102, 51);"><br /><br />Innovation in the pharmaceutical industry is difficult to measure. Too much R&D is devoted to duplicating the work of other firms and much patenting is defensive. Counts of drugs under development is not a satisfactory innovation indicator because they can reflect poor management as much as real innovation. The best measure is perhaps to take the number of top-selling drugs, but the drawback with this measure is that it measures past rather than present innovation. By this measure German firms have been lagging while British firms are the leading innovators in the EU. All EU firms have been rather slow at making the shift from a drug development paradigm based on chemistry to one that also includes biotechnology, although most are now moving in this direction, partly through establishing links with American DBFs.</span><span style="color: rgb(153, 102, 51);"><br /><br />The priority for European policies to support innovation in this sector is to create an environment conducive to innovation. Several policy measures would assist the European pharmaceutical industry: continued substantial support for the public research base in the life sciences; encouraging the full exploitation of that base by Europe's major firms (who still tend to know too little about what lies beyond national boundaries); the reinforcement of the single market and in particular the construction of a European rather than a national regulatory system, the easing of financial restrictions on venture capital financing; and finally, the promotion of other mechanisms to support and fund new, technology-based firms.</span>"<br /><br />Accordingly, the surely short-lasting biotechnology edge that American firms obtained in the last decade was largely a product of more lenient American venture capital financing practices. Biotechnology innovation has had little to do with patents and patent law.Unknownnoreply@blogger.com0