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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. On a related note, I offered the ICLU my cases against the BLE repeatedly, and sought their amici aid repeatedly as well. Crickets. Usually not even a response. I am guessing they do not do allegations of anti-Christian bias? No matter how glaring? I have posted on other links the amicus brief that did get filed (search this ezine, e.g., Kansas attorney), read the Thomas More Society brief to note what the ACLU ran from like vampires from garlic. An Examiner pledged to advance diversity and inclusion came right out on the record and demanded that I choose Man's law or God's law. I wonder, had I been asked to swear off Allah ... what result then, ICLU? Had I been found of bad character and fitness for advocating sexual deviance, what result then ICLU? Had I been lifetime banned for posting left of center statements denigrating the US Constitution, what result ICLU? Hey, we all know don't we? Rather Biased.

  2. It was mentioned in the article that there have been numerous CLE events to train attorneys on e-filing. I would like someone to provide a list of those events, because I have not seen any such events in east central Indiana, and since Hamilton County is one of the counties where e-filing is mandatory, one would expect some instruction in this area. Come on, people, give some instruction, not just applause!

  3. This law is troubling in two respects: First, why wasn't the law reviewed "with the intention of getting all the facts surrounding the legislation and its actual impact on the marketplace" BEFORE it was passed and signed? Seems a bit backwards to me (even acknowledging that this is the Indiana state legislature we're talking about. Second, what is it with the laws in this state that seem to create artificial monopolies in various industries? Besides this one, the other law that comes to mind is the legislation that governed the granting of licenses to firms that wanted to set up craft distilleries. The licensing was limited to only those entities that were already in the craft beer brewing business. Republicans in this state talk a big game when it comes to being "business friendly". They're friendly alright . . . to certain businesses.

  4. Gretchen, Asia, Roberto, Tonia, Shannon, Cheri, Nicholas, Sondra, Carey, Laura ... my heart breaks for you, reaching out in a forum in which you are ignored by a professional suffering through both compassion fatigue and the love of filthy lucre. Most if not all of you seek a warm blooded Hoosier attorney unafraid to take on the government and plead that government officials have acted unconstitutionally to try to save a family and/or rescue children in need and/or press individual rights against the Leviathan state. I know an attorney from Kansas who has taken such cases across the country, arguing before half of the federal courts of appeal and presenting cases to the US S.Ct. numerous times seeking cert. Unfortunately, due to his zeal for the constitutional rights of peasants and willingness to confront powerful government bureaucrats seemingly violating the same ... he was denied character and fitness certification to join the Indiana bar, even after he was cleared to sit for, and passed, both the bar exam and ethics exam. And was even admitted to the Indiana federal bar! NOW KNOW THIS .... you will face headwinds and difficulties in locating a zealously motivated Hoosier attorney to face off against powerful government agents who violate the constitution, for those who do so tend to end up as marginalized as Paul Odgen, who was driven from the profession. So beware, many are mere expensive lapdogs, the kind of breed who will gladly take a large retainer, but then fail to press against the status quo and powers that be when told to heel to. It is a common belief among some in Indiana that those attorneys who truly fight the power and rigorously confront corruption often end up, actually or metaphorically, in real life or at least as to their careers, as dead as the late, great Gary Welch. All of that said, I wish you the very best in finding a Hoosier attorney with a fighting spirit to press your rights as far as you can, for you do have rights against government actors, no matter what said actors may tell you otherwise. Attorneys outside the elitist camp are often better fighters that those owing the powers that be for their salaries, corner offices and end of year bonuses. So do not be afraid to retain a green horn or unconnected lawyer, many of them are fine men and woman who are yet untainted by the "unique" Hoosier system.

  5. I am not the John below. He is a journalist and talk show host who knows me through my years working in Kansas government. I did no ask John to post the note below ...

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