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The Latest on Biosimilars: The Federal Circuit Holds that the “Patent Dance” Is Optional

In a previous post, I discussed a district court decision holding that the process for resolving patent disputes under the Biologics Price Competition and Innovation Act (BPCIA) is optional. That post contains extensive background on the BPCIA and its purpose of providing an abbreviated pathway for “biosimilar” drugs to get to market and compete with their branded analogs, resulting in lower prices for consumers. The bottom line is that, under the BPCIA, makers of biosimilar products can rely on the clinical trial data developed for the branded (or “reference”) product in order to accelerate FDA approval. Nevertheless, the BPCIA provides 12 years of data exclusivity to the manufacturer of the reference product. And beyond that period, even if the biosimilar garners FDA approval, the brand owner can try to continue to keep it out of the market by asserting claims of patent infringement. The BPCIA provides for a procedure involving pre-suit information exchange between the brand and biosimilar makers—the so-called “patent dance”—that is intended to apprise the brand of the biosimilar’s manufacturing process and narrow down the number of patents to be be asserted. But the district court, and now the Federal Circuit on appeal, have held that the biosimilar can lawfully refuse to participate in the patent dance.

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BioSci Fi: Asimov on Cognitive Liberty (Sort of)

The CLB blog has an occasional series on BioSci Fi – science fiction involving, at least to some extent, on bioscience. Today’s entry is from a 1955 short story by Isaac Asimov, collected, with a dozen other stories, in a 1968 book called Asimov’s Mysteries. I am addicted to (or at least psychologically dependent on) reading before going to sleep. The other night, looking for something light, I pulled from a shelf my 1969 paperback copy of that book, complete with brittle yellow pages, and started reading it, probably for the first time since 1969.

The story in question, The Singing Bell, is the first in the collection and is one of four featuring Dr. Wendell Urth. Urth is Asimov’s equivalent to Mycroft Holmes, a brilliant, reclusive, scholar who is useful for solving the occasional puzzle. The story – one of murder – is not particularly interesting except for Asimov’s introduction and treatment of an apparent kind of mind-reading device, the never-explained “psychoprobe.” What intrigued me, and led me to write this post, was Asimov’s discussion of the legal limitations that had been put on the use of the device, which included a principle that “the right to mental privacy..is fundamental.” But that plays out in some interesting ways. Here’s the whole passage:

Dr. Urth said “Wouldn’t it be simple to use the psychoprobe, now that its use has been legalized?”

Davenport scowled and the scar of his cheek turned livid. “Have you read the Konski-Hiakawa law, Dr. Urth?”

       “No.”

“I think no one has. The right to mental privacy, the government says, is fundamental. All right, but what follows? The man who is psychoprobed and proves innocent of the crime for which he was psychoprobed is entitled to as much compensation as he can persuade the courts to give him. In a recent case a bank cashier was awarded twenty-five thousand dollars for having been psychoprobed on inaccurate suspicion of theft. It seems that the circumstantial evidence which seemed to point to theft actually pointed to a small spot of adultery. His claim that he lost his job, was threatened by the husband in question, and put in bodily fear, and finally was help up to ridicule and contumely because a news-strip man learned the results of the problem held good in court.”

      “I can see the man’s point.”

“So can we all. That’s the trouble. One more item to remember: Any man who has been psychoprobed once for any reason can never be psychoprobed again for any reason. No one man, the law says, shall be placed in mental jeopardy twice in his lifetime.”

       “Inconvenient.”

“Exactly. In the two years since the psychoprobe has been legalized I couldn’t count the number of crooks and chiselers who’ve tried to get themselves psychoprobed for purse-snatching so that they could play the racquets safely afterwards. So you see the Department will not allow Peyton to be psychoprobed until they have firm evidence of his guilt. Not legal evidence, maybe, but evidence that is strong enough to convince my boss. The worst of it, Dr. Urth, is that if we come into court without a psychoprobe record, we can’t win. In a case as serious as murder, not to have used the psychoprobe is proof enough to the dumbest juror that the prosecution isn’t sure of its ground.”

Isaac Asimov, The Singing Bell, The Magazine of Fantasy and Science Fiction (January 1955), reprinted in Asimov’s Mysteries, 17, 28-29 (New York: Dell Publishing Co., 1968)

It’s nice to see Asimov endorse (I think) the idea of cognitive liberty – Nita Farahany will, no doubt, want to cite him! But, more concretely, if neuroscience-based mind-reading or lie detection approaches feasibility, the story is a nice warning to think through all the possible consequences of not just the use of such techniques, but of their regulation.

That lesson may be the highest and best use of the volume, other than feeding an addiction to reading before sleep. The stories are not Asimov’s best; they rely heavily on clever puzzles, often with a chemistry connection (his PhD was in biochemistry), and occasional bad to terrible puns. The world’s shortest judicial opinion: “A niche in time saves Stein” is perhaps the worst. And they do not particularly engage the biosciences, though The Singing Bell does hinge on the vaguely bioscience issue of acclimation to the Moon’s gravity. Still, law and the biosciences nuggets may turn up any place or time even in bed, just before turning out the lights.

Hank Greely

Director, Center for Law and the Biosciences

Director, Stanford Program in Neuroscience and Society

From Elsewhere at Stanford Law School – Regulating Sugary Drinks

Stanford Law School has been lucky to add two great new people to our health law group lately, Michelle Mello, whom we stole from Harvard, and David Studdert, whom we imported from the University of Melbourne. Both focus on public health and have collaborated often; Michelle also works in bioethics.

The two combined with Stanford student Jordan Flanders to publish today an article in PLOS Medicine: Searching for Public Health Law’s Sweet Spot: The Regulation of Sugar-Sweetened Beverages. I’m not sure I approve of the title’s pun – though I’ll admit it’s not saccharine – but the paper is an interesting examination of what seems to work, and not work, in regulating sweet drinks, in the real world and in the courts.  Worth a read while downing your (caffeinated) Coke Zero.  There’s also a discussion of the piece in the Medical Center’s blog (we share Michelle and David, happily, with Stanford Medical School), Scope.

New CLB Podcast!

Check out our latest podcast, in which Dmitry talks about the Myriad Genetics settlement, Stephanie discusses “subjective punishment,” and Hank analyzes President Obama’s new precision medicine initiative.

 

 

 

On King v. Burwell and the Survival of the Affordable Care Act

Today is my birthday – and the Supreme Court (or, at least, two-thirds of it) just gave me, most people who follow health policy, and millions of now still-insured Americans a present: King v. Burwell.

There is a lot to say about this decision, but I want to focus on three things: the strength of the conflicting substantive arguments, the possible internal Court dynamics that resulted in the majority and dissenting opinion, and a guess at some deeper meanings of the case for the future of health care in America.

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2014-2015 Workshop Series: Mini-Podcasts with Glenn Cohen and Pilar Ossorio

Mini-podcasts for the last two speakers in the 2014-2015 Law and the Biosciences Workshop series are up! Listen to Hank Greely discuss exceptions to laws limiting abortion rights with Glenn Cohen and data sharing with Pilar Ossorio. The workshop series will resume in September.

Mental Health Month: Is Addiction a “Brain Disease”?

May being mental health month, I thought it timely to discuss one of the most costly mental health issues we face today: addiction.

Addiction exacts a huge toll on our society. In purely monetary terms, the National Institute of Drug Abuse estimates that addiction to alcohol, tobacco, and illegal drugs costs the U.S. $559 billion a year. This price tag results from increased health care costs, decreased productivity, and crime, and does not even include the cost of prescription drug abuse, which is on the rise. And as anyone who has experienced addiction up-close can attest, the personal costs of addiction are enormous. Addiction destroys families and lives.

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Update on the Patent Dance Case – Zarxio® Enjoined Pending Appeal

In an earlier post, I discussed a recent district court decision holding that the “patent dance” provisions of the Biologics Price Competition and Innovation Act are not mandatory. Yesterday, there was a new development in this case. The Court of Appeals for the Federal Circuit entered an injunction pending appeal preventing Sandoz “from marketing, selling, offering for sale, or importing into the United States its FDA approved ZARXIO® biosimilar product.” The oral argument in Amgen v. Sandoz on appeal is scheduled to be held on June 3.

Crowdsourcing Medicine?

There’s been a lot of talk about crowdsourcing lately. Everything from criminal investigations, to the tax code, to ski resorts have been crowdsourced or considered for crowdsourcing. And now medicine has thrown its hat in this trendy ring. KQED’s “Future of You” recently reported on a company called CrowdMed that wants to be the “Wikipedia of medicine.” (Due to space constraints, this blog post will not engage the important question of whether Wikipedia itself, is, in fact, the Wikipedia of medicine.)

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Do Biosimilar Manufacturers Have To Dance? A District Court Answers “No”

In 2010, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act. BPCIA is, in a broad sense, intended to be the analog of the Hatch-Waxman Act for biologic drugs. Hatch-Waxman provides a pathway for Food and Drug Administration (FDA) approval for small-molecule generic drugs. Vastly simplified, the Hatch-Waxman process comes down to this: if a follow-on (i.e., generic) manufacturer can make an identical copy of the branded drug molecule, it can obtain FDA approval to market the drug without the clinical trials that the drug’s originator had to go through to prove that the drug is safe and effective. This saves costs for the generic manufacturer and, once the generic goes on the market, lowers prices for consumers. Under Hatch-Waxman, a follow-on manufacturer’s act of filing a so-called Abbreviated New Drug Application is an act of patent infringement, and so the originator can try to keep generic drugs off the market using patent law. The Food, Drug, and Cosmetics Act also provides periods of market and data exclusivities even for originator drugs that are not covered by patents. But once those periods end and the generic manufacturer can prove chemical identity to the brand, the generic drug is good to go on the market as far as the FDA is concerned—and the only barrier left is the brand’s potential patent infringement claims.

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Call for Applications!

For those of you who may have an interest in the intersection of Law, Policy, and Neuroscience, we are now looking for our next SPINS (Stanford Program in Neuroscience and Society) fellow. See the call for applications here.

An Off Topic Side Note on Asilomar, the Place

Asilomar is one of my favorite places in the world. It is just on the west side of the northern end of the Monterey peninsula in Central California, between the towns of Pacific Grove and Monterey to the east and Pebble Beach to the south. Although it is used as a geographical designation for that part of the peninsula, the name comes from a conference center created by the Young Women’s Christian Association (the YWCA), which sits on and behind sand dunes, just across the road from the surf and tide pools of the Pacific.

The following history is taken largely from the history page at the Asilomar Conference Center’s web site: http://www.visitasilomar.com/history/asilomar-the-complete-story.aspx. From 1900 the YWCA held annual meetings of its Pacific Coast Field Committee and a Western Regional Conference at a hotel in Santa Cruz, California. That hotel burned down in 1912, leading the committee decided to build its own site.

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On Asilomars

The very long post I put up yesterday about the call for a moratorium on germline genome modification in humans made me think about Asilomar and its parallels. I know that STS (Science, Technology, and Society or Science and Technology Studies) scholars have long debated the value of the “first” Asilomar, the Asilomar Conference on Recombinant DNA held in February 1975, and its lessons for other efforts. I have not looked into any of that research for this post, but instead am putting up my very lightly researched thoughts. I conclude that, at this point, there have been at least two “Asilomars” with several other contenders for the label and two other topics possibly ripe for one.

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Of Science, CRISPR-Cas9, and Asilomar

On Thursday, March 19, 2015 Science published (on-line) a Policy Forum entitled  A Prudent Path Forward for Genomic Engineering and Germline Gene Modification.  The piece had 18 authors, including David Baltimore, Paul Berg, Alta Charo, George Church, George Daley, Jennifer Doudna, Ed Penhoet, Keith Yamamoto, and (as, with Alta, one of only two non-scientists and definitely as one of the lesser lights) me. The Policy Forum recommended that steps be taken to “strongly discourage…any attempts at germline genome modification for clinical application in humans, while societal, environmental, and ethical implications of such activity are discussed among scientific and governmental organizations.”

A bit more than forty years earlier, on Monday morning, February 27, 1975, David Baltimore opened the famous Asilomar conference on recombinant DNA. That conference had been called after a letter in Science from the leaders in the field called for a moratorium on recombinant DNA research until important safety issues could be worked out. The three and a half days of the Asilomar meeting produced safety guidelines which led the group to lift their (totally informal and non-binding) moratorium – and ultimately led the NIH Recombinant Activities Committee; to federal (and foreign) biosafety regulations; in some tellings the wildly successful application of recombinant DNA techniques to research and medicine; and, undoubtedly, the most famous story in modern scientific self-regulation. (An excellent, non-speculative, memoir of the Asilomar meeting by George Frederickson, head of the Institute of Medicine at the time of Asilomar and director of NIH a few months later, can be found here.)

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Stanford’s SCOPE Blogs on Hank Greely and Genome Engineering

Our own Hank Greely has co-authored an article, published yesterday in Science, discussing the opportunities and challenges presented by genome engineering technologies. Krista Conger, writing for SCOPE, the Stanford Medical School’s blog, discusses the article in a recent post.  Read Krista’s post here.

In The Spirit Of Spring Break

It’s almost spring break here at Stanford, and in that vein, I thought I’d talk about a topic that is likely to be on at least a few spring breakers’ minds: marijuana.* Last week, a bipartisan trio – Senators Booker, Gillibrand, and Paul – proposed the Compassionate Access, Research Expansion, and Respect States (CARERS) Act, which has been described as the “first ever” Senate bill to “legalize” medical marijuana.

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This is Your Brain on Politics

It is a tautology to say that our political views affect our attitudes toward various societal issues. If I knew in advance whether you were a conservative or a liberal, for example, I could probably predict with better-than-chance accuracy your views on climate change, teaching evolution in public schools, or genetically modified foods.

But did you know that our political leanings can also alter our perceptions of reality?

This may seem surprising, but it’s true. A growing body of research shows that our political beliefs can influence not only the way our brains interpret and remember scientific information, but even our subjective perceptions of our physical environments.

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2014-2015 Workshop Series: Mini-Podcasts with Nathan Cortez & Margaret Foster Riley

Mini-podcasts for the latest two speakers in the 2014-2015 Law and the Biosciences Worshop series are up! Listen to Hank Greely discuss mobile health with Nathan Cortez from SMU and bioengineered meat with Margaret Foster Riley from UVA.

Three Reasons I’m Excited About Arctic® Apples

Malia McPherson

In mid-February, the USDA approved the first genetically engineered (GE) apples. These apples will be marketed as Arctic® apples, and have been modified to stall browning after cutting or bruising. In an interesting Q&A sheet, the USDA explained its approval process. It is required to approve (technically, to “deregulate”) a crop once sufficient evidence shows that the crop meets pest safety standards set by the USDA Animal and Plant Health Inspection Service (APHIS)—the crop must be unlikely to be a pest to other agricultural crops or plants. The Arctic® Apple passed these pest tests conducted in both Washington and New York states, which combine produce almost 70% of all apples grown in the United States.

The FDA is also involved. Although it considers deregulated biotech crops similar to their conventional counterparts, it provides a voluntary consultation process to help ensure food safety. The biotech company, Okanagan Specialty Fruits, is apparently still waiting for the FDA’s approval through this voluntary review process.

There has been, and will continue to be, controversy surrounding these apples. Characteristic of the larger food genetic engineering debate, the USDA stated that the majority of public comments received, “did not raise any specific disagreement with APHIS’ analysis of the pest risk of this GE apple. Rather, they expressed general opposition to GE organisms or GE apples.” The company has conceded that many stores might be hesitant to stock GE apples for fear of customer backlash. And other apple growers oppose the new technology, citing concerns that customers will associate all apples as GE apples (although in the age of organic, I’m skeptical about this complaint).

Despite these fears, concerns, and doubts, I’m optimistic that GE apples could be good for both consumers and for reframing the GE debate.

(1) The Technology

When a normal apple is cut or sliced, the enzyme polyphenol oxidase (PPO) is produced and is responsible for the immediate apple-enzymatic browning. But this pathway can be silenced when copies of low-PPO genes from other apples are inserted. This modification silences the normal PPO gene. The modified Arctic® Apples end up producing only 10% of PPO amounts compared to traditional apples, which is not enough to cause browning. PPO does not affect other apple pathways and Arctic® Apples will still undergo normal rotting.

For some opponents to GE technology, could this type of engineering be an acceptable form of GE? There might be less fear about crossbreeding or “Frankenfruits” or fear that these apples are “unnatural,” since they still only contain apple genes. There could be less confusion about what is being added to the fruits since it is a relatively easy process, and gene, to explain. Even without genetic modification, consumers could imagine a similar mutation happening naturally after years of DNA replication, and then continued through selective breeding.

(2) The Public Health

Apples are healthy. Kids (generally) like apples. Kids (generally) like apple slices even more. Cheaper, more appetizing, and easier to package fruit could help transform cafeteria lunches and reduce cafeteria waste. And apples that don’t turn brown as quickly or as often meet all those criteria.

Additionally, as with Golden Rice, the public understands that we need nutritional solutions both in developing and developed settings. These apples provide another example of biotechnology that could help with obesity and poverty. It is inherently easier to support something that is healthy, compared to something like corn that is used in high fructose corn syrup or even the GE potato (which might be the next approved new GE crop).

(3) The Small Company

Monsanto didn’t create this! Okanagan Specialty Fruits is just a small company, without a reputation for profit seeking or pesticide advocating products. As cynical as this sounds, it is great that a smaller biotechnology company created this apple—not just for public perception, but also for opening the field of genetic possibilities to smaller companies. Biotechnology doesn’t always have to be associated with Big Agriculture!

There are still many challenges regarding public acceptance of GE fruits before Arctic® Apples go mainstream. McDonalds and Gerber both announced that they had no plans to sell or use Arctic® Apples. But I do hope that products like these will help further meaningful and informed conversations about what types of technology we are willing to accept in our foods.

For more information about the company, the products, and what these apples are all about, visit Okanagan Specialty Fruits.

Malia McPherson is a 2L at Stanford Law School

Cloned, Cloned Horses, We’ll Ride Them Today (With Profuse Apologies to the Rolling Stones)

The American Quarter Horse is a breed that excels at sprinting over short distances—Quarter Horse races may range from 220 to 870 yards. It is the most popular breed in the United States, and the American Quarter Horse Association (AQHA), headquartered in Amarillo, TX, is the largest horse breed registry in the world. Because of the interest in this breed, Quarter Horses have become the subject of commercial efforts at reproductive cloning. One company, Viagen, has produced over 150 cloned foals. The cloning is achieved via somatic cell nuclear transfer (SCNT), the technique that famously created Dolly the Sheep. As some readers may be aware, Dolly was the focus of In re Roslin Institute (Edinburgh), 750 F.3d 1333 (2014), an important patentable subject matter eligibility case decided by the Federal Circuit last May.

While Roslin dealt with animal cloning and patent law, a recent Fifth Circuit case, Abraham & Veneklasen Joint Venture v. American Quarter Horse Association, No. 13-11043, 2015 WL 178989 (Jan. 14, 2015) (Fifth Circuit Opinion), addresses antitrust law issues raised by animal clones. AQHA registry is essential for the owners of Quarter Horses to have profitable horse breeding businesses. According to the Fifth Circuit, “[w]ithout access to AQHA’s breed registry, . . . the cloned horses cannot participate in the lucrative racing, breeding or horse shows.” Id. at *1. AQHA registers horses born from in vitro fertilization and artificial insemination techniques, but it does not allow the registration of clones. Interestingly, the Jockey Club, which is the breed registry for Thoroughbred horses in the United States, Canada, and Puerto Rico, does not allow registration of horses produced by any assisted or artificial reproduction techniques. In contrast, cloned polo ponies are allowed to compete in events alongside their natural-born counterparts. So AQHA is somewhere in between.

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