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The merits of medical patents

High-stakes court cases highlight debates in IP law.

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Indiana Lawyer Focus

In April, the U.S. Court of Appeals for the Federal Circuit heard arguments in a case that raises fundamental questions about the patentability of human genes. In June, the U.S. Supreme Court agreed to take on a patent case in which the central issue is the patentability of a medical process. Both cases could have far-reaching effects – in medicine, in law, and in academia.

In Indiana, people who study the intricacies of intellectual property law and medicine are now waiting to learn how the courts will rule on some of the most controversial issues in IP law.

Patenting genes

David Orentlicher, co-director of the William S. and Christine S. Hall Center for Law and Health at Indiana University School of Law – Indianapolis, explained why controversy exists about the patent eligibility of genes.
 

orentlicher-dave-mug.jpg Orentlicher

“We want to reward you for your inventiveness,” he said. “But then when you get to patenting genes, you think, well how much of this is really inventiveness, finding a gene that exists in nature?”

This is the heart of the debate in the case of Association for Molecular Pathology, et. al. v. U.S. Patent and Trademark Office, et. al., No. 10-1406, now under consideration in federal appeals court. In that case, the American Civil Liberties Union and plaintiffs challenged patents on two breast cancer genes, collectively known as BRCA1/2. A judge in the U.S. District Court, Southern District of New York, ruled last year that the defendants – Myriad Genetics and the University of Utah Research Foundation – were not entitled to patent protection for the genes.

Curt Cichowski, associate dean for Valparaiso University School of Law, said the point of contention in this case is not the genes, but rather the method used to reveal them.


Curt Cichowski Cichowski

“It’s the process that’s involved – so even though you can’t patent a human gene, the process of isolating a human gene is patentable,” he said.

Jay Sanders, a partner at Baker & Daniels who specializes in biotechnology patent law, said the U.S. Patent and Trademark Office’s Manual of Patenting Procedure offers guidance about what genetic material is patent-eligible.


sanders-jay-mug.jpg Sanders

“They have chapters about how you go about certain requirements for patenting genes … so it came as a quite a shock to me that there would be a District Court judge questioning whether genes were patentable,” Sanders said. “Some of the caselaw that that judge cited in his opinion was from the 1800s.”

Patenting processes

The U.S. Supreme Court granted a writ of certiorari in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150, in June, agreeing to hear the case for a second time.

Cichowski said that Prometheus Laboratories had been conducting blood tests on patients to determine if medication dosing was correct. Mayo Collaborative Services began using a similar method and Prometheus sued Mayo for infringement. Mayo claims that the Prometheus patents didn’t pass the “machine-or-transformation” test.

That test – as defined by the USPTO – means that a process is patent-eligible if it is tied to a particular machine or apparatus or if it “transforms a particular article to a different state or thing.” Cichowski said that Mayo argues that the human body is the “machine” Prometheus used to gather results, and because the human body is found in nature, the process is not patentable.

“I think we’re going to see what is patentable as a medical process, and that’s what we really need to get to,” Cichowski said.

Mark D. Janis, director of Indiana University Maurer School of Law’s Center for Intellectual Property Research, said that in the 1990s, a few cases caused people to wonder whether doctors who used patented medical processes might be sued for infringement.

“The first reaction was, ‘We should change patent laws to make surgical processes ineligible for patent protection,’” Janis said. Instead, the Ganske Amendment – enacted by Congress in 1996 as the Medical Procedures Innovation and Affordability Act – placed limits on the enforceability of medical process patents.


janis-mark-mug.jpg Janis

“The compromise was a doctor can still get a patent on that process,” Cichowski said. “However, any medical professional who performs that process cannot be held liable for infringement.”

Cost v. benefit

“There’s no question that advances in medical technology is one of the most important factors in health care cost inflation,” Orentlicher said. “A lot of new cancer drugs can cost tens of thousands or hundreds of thousands for a year’s worth of therapy.”

Companies depend on patents to protect the costly research that’s behind medical innovation, Sanders said. If not for the incentive of patent protection, Myriad may have never pursued the work that led to the discovery of the BRCA1/2 genes.

“For every success that they have, there’s probably a lot of work that just gets thrown in the garbage can,” Sanders said.

The patent office pressures researchers to narrowly define discoveries, he explained, but if the patent claim is too narrowly defined, it won’t prevent a competitor from developing a similar technology.

Janis said that in pharmaceutical development in particular, the cost of clinical trials, research, and the lengthy Food and Drug Administration approval process can be prohibitive. Yet, a competitor could replicate a medicine cheaply, if not for patent protection.

This year, Pfizer’s patent on its cash cow cholesterol drug Lipitor will expire, Cichowski said, opening up the market to generic versions. “But the price of Lipitor while it was still covered under patent was enormous,” he added.

“We do need to have some sort of a system that rewards the inventor for making advancements in medicine that we all want,” Cichowski said. But the patent process was designed at a different time, with different ideas in mind, he continued.

“Patenting human genes – I don’t think the Founding Fathers ever thought that was gonna happen.”•

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  1. I have been on this program while on parole from 2011-2013. No person should be forced mentally to share private details of their personal life with total strangers. Also giving permission for a mental therapist to report to your parole agent that your not participating in group therapy because you don't have the financial mean to be in the group therapy. I was personally singled out and sent back three times for not having money and also sent back within the six month when you aren't to be sent according to state law. I will work to het this INSOMM's removed from this state. I also had twelve or thirteen parole agents with a fifteen month period. Thanks for your time.

  2. Our nation produces very few jurists of the caliber of Justice DOUGLAS and his peers these days. Here is that great civil libertarian, who recognized government as both a blessing and, when corrupted by ideological interests, a curse: "Once the investigator has only the conscience of government as a guide, the conscience can become ‘ravenous,’ as Cromwell, bent on destroying Thomas More, said in Bolt, A Man For All Seasons (1960), p. 120. The First Amendment mirrors many episodes where men, harried and harassed by government, sought refuge in their conscience, as these lines of Thomas More show: ‘MORE: And when we stand before God, and you are sent to Paradise for doing according to your conscience, *575 and I am damned for not doing according to mine, will you come with me, for fellowship? ‘CRANMER: So those of us whose names are there are damned, Sir Thomas? ‘MORE: I don't know, Your Grace. I have no window to look into another man's conscience. I condemn no one. ‘CRANMER: Then the matter is capable of question? ‘MORE: Certainly. ‘CRANMER: But that you owe obedience to your King is not capable of question. So weigh a doubt against a certainty—and sign. ‘MORE: Some men think the Earth is round, others think it flat; it is a matter capable of question. But if it is flat, will the King's command make it round? And if it is round, will the King's command flatten it? No, I will not sign.’ Id., pp. 132—133. DOUGLAS THEN WROTE: Where government is the Big Brother,11 privacy gives way to surveillance. **909 But our commitment is otherwise. *576 By the First Amendment we have staked our security on freedom to promote a multiplicity of ideas, to associate at will with kindred spirits, and to defy governmental intrusion into these precincts" Gibson v. Florida Legislative Investigation Comm., 372 U.S. 539, 574-76, 83 S. Ct. 889, 908-09, 9 L. Ed. 2d 929 (1963) Mr. Justice DOUGLAS, concurring. I write: Happy Memorial Day to all -- God please bless our fallen who lived and died to preserve constitutional governance in our wonderful series of Republics. And God open the eyes of those government officials who denounce the constitutions of these Republics by arbitrary actions arising out capricious motives.

  3. From back in the day before secularism got a stranglehold on Hoosier jurists comes this great excerpt via Indiana federal court judge Allan Sharp, dedicated to those many Indiana government attorneys (with whom I have dealt) who count the law as a mere tool, an optional tool that is not to be used when political correctness compels a more acceptable result than merely following the path that the law directs: ALLEN SHARP, District Judge. I. In a scene following a visit by Henry VIII to the home of Sir Thomas More, playwriter Robert Bolt puts the following words into the mouths of his characters: Margaret: Father, that man's bad. MORE: There is no law against that. ROPER: There is! God's law! MORE: Then God can arrest him. ROPER: Sophistication upon sophistication! MORE: No, sheer simplicity. The law, Roper, the law. I know what's legal not what's right. And I'll stick to what's legal. ROPER: Then you set man's law above God's! MORE: No, far below; but let me draw your attention to a fact I'm not God. The currents and eddies of right and wrong, which you find such plain sailing, I can't navigate. I'm no voyager. But in the thickets of law, oh, there I'm a forester. I doubt if there's a man alive who could follow me there, thank God... ALICE: (Exasperated, pointing after Rich) While you talk, he's gone! MORE: And go he should, if he was the Devil himself, until he broke the law! ROPER: So now you'd give the Devil benefit of law! MORE: Yes. What would you do? Cut a great road through the law to get after the Devil? ROPER: I'd cut down every law in England to do that! MORE: (Roused and excited) Oh? (Advances on Roper) And when the last law was down, and the Devil turned round on you where would you hide, Roper, the laws being flat? (He leaves *1257 him) This country's planted thick with laws from coast to coast man's laws, not God's and if you cut them down and you're just the man to do it d'you really think you would stand upright in the winds that would blow then? (Quietly) Yes, I'd give the Devil benefit of law, for my own safety's sake. ROPER: I have long suspected this; this is the golden calf; the law's your god. MORE: (Wearily) Oh, Roper, you're a fool, God's my god... (Rather bitterly) But I find him rather too (Very bitterly) subtle... I don't know where he is nor what he wants. ROPER: My God wants service, to the end and unremitting; nothing else! MORE: (Dryly) Are you sure that's God! He sounds like Moloch. But indeed it may be God And whoever hunts for me, Roper, God or Devil, will find me hiding in the thickets of the law! And I'll hide my daughter with me! Not hoist her up the mainmast of your seagoing principles! They put about too nimbly! (Exit More. They all look after him). Pgs. 65-67, A MAN FOR ALL SEASONS A Play in Two Acts, Robert Bolt, Random House, New York, 1960. Linley E. Pearson, Atty. Gen. of Indiana, Indianapolis, for defendants. Childs v. Duckworth, 509 F. Supp. 1254, 1256 (N.D. Ind. 1981) aff'd, 705 F.2d 915 (7th Cir. 1983)

  4. "Meanwhile small- and mid-size firms are getting squeezed and likely will not survive unless they become a boutique firm." I've been a business attorney in small, and now mid-size firm for over 30 years, and for over 30 years legal consultants have been preaching this exact same mantra of impending doom for small and mid-sized firms -- verbatim. This claim apparently helps them gin up merger opportunities from smaller firms who become convinced that they need to become larger overnight. The claim that large corporations are interested in cost-saving and efficiency has likewise been preached for decades, and is likewise bunk. If large corporations had any real interest in saving money they wouldn't use large law firms whose rates are substantially higher than those of high-quality mid-sized firms.

  5. The family is the foundation of all human government. That is the Grand Design. Modern governments throw off this Design and make bureaucratic war against the family, as does Hollywood and cultural elitists such as third wave feminists. Since WWII we have been on a ship of fools that way, with both the elite and government and their social engineering hacks relentlessly attacking the very foundation of social order. And their success? See it in the streets of Fergusson, on the food stamp doles (mostly broken families)and in the above article. Reject the Grand Design for true social function, enter the Glorious State to manage social dysfunction. Our Brave New World will be a prison camp, and we will welcome it as the only way to manage given the anarchy without it.

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