Wednesday, July 31, 2013

Off-Label Mis-Use

The coffers of the United States federal government will swell by $490.9 billion now that Wyeth Pharmaceuticals, Inc. (a division of Pfizer, Inc.), has settled a case brought against it for allegedly violating the Food, Drug & Cosmetics Act.  On July 30, 2013, the settlement was made public in a press release on the U.S. Justice Department's website. The press release outlines the allegations against Wyeth as follows:
The Federal Food, Drug and Cosmetic Act (FDCA) requires a company such as Wyeth to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses. In 1999, Wyeth received approval from the FDA for Rapamune use in renal (kidney) transplant patients. However, the information alleges, Wyeth trained its national Rapamune sales force to promote the use of the drug in non-renal transplant patients. Wyeth provided the sales force with training materials regarding non-renal transplant use and trained them on how to use these materials in presentations to transplant physicians. Then, Wyeth encouraged sales force members, through financial incentives, to target all transplant patient populations to increase Rapamune sales.
The press release summarizes the terms of the settlement between Wyeth and the Justice Department:
Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the U.S. Food and Drug Administration (FDA), the Justice Department announced today. Rapamune is an “immunosuppressive” drug that prevents the body’s immune system from rejecting a transplanted organ.
Details of how the total penalty was calculated are also provided in the press release:
Wyeth has pleaded guilty to a criminal information charging it with a misbranding violation under the FDCA. The resolution includes a criminal fine and forfeiture totaling $233.5 million. Under a plea agreement, which has been accepted by the U.S. District Court in Oklahoma City, Wyeth has agreed to pay a criminal fine of $157.58 million and forfeit assets of $76 million.

The resolution also includes civil settlements with the federal government and the states totaling $257.4 million. Wyeth has agreed to settle its potential civil liability in connection with its off-label marketing of Rapamune. The government alleged that Wyeth violated the False Claims Act, from 1998 through 2009, by promoting Rapamune for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by Medicare, Medicaid and other federal health care programs. These unapproved uses included non-renal transplants, conversion use (switching a patient from another immunosuppressant to Rapamune) and using Rapamune in combination with other immunosuppressive agents not listed on the label. The government alleged that this conduct resulted in the submission of false claims to government health care programs. Of the amounts to resolve the civil claims, Wyeth will pay $230,112,596 to the federal government and $27,287,404 to the states.
There are several possible explanation for why Wyeth decided to settle.  One is that it calculated its odds of prevailing against the Justice Department as unacceptably low.  Another is that Wyeth decided it would be best for its business prospects to remove the shadow the allegations had cast over it.  A final, more fanciful, possibility is that Wyeth felt distracted hampered by the high-profile dispute;  as Shakespeare wrote, "We do not keep the outward form of order, where there is deep disorder in the mind."

Tuesday, July 30, 2013

Sensitive Secrets And The Enemy

Private First Class Bradley Manning was found guilty of several very serious charges in a United States military court on July 30, 2013.  Incarceration looms large for him.  However, Manning was acquitted of the extremely serious charge of "aiding the enemy."  The prosecution's theory in pursuing the latter charge was that the sensitive military information Manning published to the whole world could assist specific enemies of the U.S., including terrorists.  However, the court was not persuaded.  If he had turned the same information over only to specific enemies, the result might have been different.  This may seem inconsequential in the face of the severe penalties facing Manning.  However, if upheld by other courts, the principle of general publication not "aiding the enemy" could be vitally important to other potential wikileakers.

Monday, July 29, 2013

Nosy Dinosaur

A beautiful artist rendition of a dinosaur always deserves recognition.  A recently-discovered late Cretaceous ceratopsian relative of Triceratops, named Nasutoceratops ("large-nosed horned-face"), is depicted in a July 17, 2013, article in Science.

Sunday, July 28, 2013

Vitamin G(ene)

On July 28, 2013, the New York Times published a fascinating article, entitled "A Race to Save the Orange by Altering Its DNA," covering the biggest dilemma currently faced by orange growers:  whether or not opt for genetic engineering to save commercial orange trees from "citrus greening."  The spread of eubacterium Candidatus liberibacter asiaticus has cast a dark shadow over the large orange growing and processing industry.  Market penetration of genetically-modified ("GM") food has grown rapidly around the world.  Although Europe has been a laggard, consumers in the United States have been relatively enthusiastic - or, at least, agnostic - about GM food.  The orange industry may be embracing GM oranges as its salvation.  How long will it be before parents are worrying about their children eating enough "Vitamin G(ene)"?

Saturday, July 27, 2013

Open Drug Data

Pharmaceutical firms possess two major methods for shielding their products from competition.  The first is patent protection, although it expires 20 years - slightly longer with patent term extension - after the priority application is first filed.  The second method is the secrecy of much research and clinical trial data.  Even after a patent claiming a particular drug has expired, how precisely to manufacture that drug may remain opaque to aspiring competitors.  Competition tends to lower prices and raise quality.  Thwarting competition is thought to harm social welfare.

On July 18, 2013, the two largest trade groups representing drug companies, the European Federation of Pharmaceutical Industries and Associations ("EFPIA") and the Pharmaceutical Research and Manufacturers of America ("PhRMA"), announced their strengthened commitment to data openness.  According to the joint press release issued by EFPIA and PhRMA,
[u]nder the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.
  • Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data will be encouraged to publish their findings.
  • Companies will work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials.
  • The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration, European Medicines Agency, or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.
  • Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
This kinder, more open strategy may be designed to soften current antipathy towards drug companies.  An anagram of the two organizations' acronyms may be prophetic of the industry's hopes:  "Ah, IF PAMPER."

Thursday, July 25, 2013

Canadian Supreme Court Patent Decisions

Patent law is meant to promote technological innovation.  This should be as true for Canada as it is for other countries.  Yet, it is a challenge to locate a list of Supreme Court of Canada patent law decisions outside of the Hughes & Woodley on Patents treatise.  So, here is a list:
Term of Chief Justice Beverly McLachlin
Teva Canada Ltd. v. Pfizer Canada Inc. (November 8, 2012) (Disclosure)
Apotex Inc. v. Sanofi‑Synthelabo Canada Inc. (November 6, 2008) (Novelty, nonobviousness, double-patenting)
Monsanto Canada Inc. v. Schmeiser (May 21, 2004) (Patentable subject matter)
Apotex Inc. v. Wellcome Foundation Ltd. (December 5, 2002) (Utility, claiming, inventorship)
Harvard College v. Canada (Commissioner of Patents) (December 5, 2002) (Patentable subject matter)
Free World Trust v. √Člectro Sant√© Inc. (December 15, 2000) (Claim construction)
Whirlpool Corp. v. Camco Inc. (December 15, 2000) (Claim construction, double-patenting)
Eli Lilly & Co. v. Novopharm Ltd. (July 9, 1998) (Utility, sufficiency)
It will become more complete in the fullness of time.

Wednesday, July 24, 2013

Salmon Tale SLAPP

On July 22, 2013, the Court of Appeal for British Columbia overturned a trial court decision that had supported the legal rights of the Global Alliance Against Industrial Aquaculture ("GAAIA") to carry out an aggressive publicity campaign against Mainstream Canada, which operates salmon farms on the coast of Canada's Pacific Southwest.  According to its website, GAAIA is
an international network dedicated to advancing environmentally and socially responsible aquaculture. GAAIA recognizes that salmon, shrimp, tuna and 'Frankenfish' farming jeopardizes sustainable and safe seafood production. By highlighting worst aquaculture practices, GAAIA will lead the fight against standards-setting and certification schemes for farmed salmon and shrimp farming in particular.
The Court of Appeals summarized the events leading up to the appeal as follows:
The appellant sought general and punitive damages for allegedly defamatory comments made by the respondent in various publications, as well as a permanent injunction restraining him from publishing similar words and images in the future. The trial judge found the defence of fair comment applied to the defamatory comments and dismissed the action. In holding that the defence applied, the judge found that a determined reader could have located the facts upon which the comments were based.
The Court then explained its decision to side with Mainstream Canada, and grant it substantial damages:
The trial judge erred in finding the test for the defence of fair comment was satisfied. The defamatory publications did not identify by a clear reference the facts upon which the comments were based that were contained in other documents. The trial judge’s order dismissing the appellant’s claim is set aside, and the permanent injunction is granted. As it is in the interests of justice for this Court to assess damages rather than order a new trial, the appellant is awarded general damages of $25,000 and punitive damages of $50,000. The respondent is punished for his misconduct during the trial by awarding the appellant special costs of the action.
It is now likely that GAAIA will petition to appeal the British Columbia Court of Appeals' decision to the Supreme Court of Canada.  The Supreme Court may be tempted to accept such an appeal to help clarify the conditions under which the defence of fair comment should succeed against an allegation of defamation.  However, even if GAAIA is granted leave to appeal, its journey to vindication in the Supreme Court, against its deep-pocketed opponent, may be just as difficult as the upriver odyssey made by the wild salmon the organization hopes to protect. 

Tuesday, July 23, 2013

Copy It Again, Sam!

In the 1942 classic film Casablanca, Rick pleads with Sam, "You played it for her, you can play it for me."  On June 27, 2013, less that 250 km to the south, in Marrakesh, international negotiators concluded negotiation of the Marrakesh Treaty to Facilitate Access to Published Works for Persons who are Blind, Visually Impaired, or otherwise Print Disabled, an agreement that might be loosely summarized as "You copied it for her, you can copy it for me."  In general, the Marrakesh Treaty is intended to strike a mutually-acceptable balance between the rights of the visually impaired and copyright owners.  As the Preamble states, the Treaty
Recogniz[es] the need to maintain a balance between the effective protection of the rights of authors and the larger public interest, particularly education, research and access to information, and that such a balance must facilitate effective and timely access to works for the benefit of persons with visual impairments or with other print disabilities.
Article 4, Section 1(a) provides for the availability of literary and artistic works for the visually impaired:
Contracting Parties shall provide in their national copyright laws for a limitation or exception to the right of reproduction, the right of distribution, and the right of making available to the public as provided by the WIPO Copyright Treaty (WCT), to facilitate the availability of works in accessible format copies for beneficiary persons. The limitation or exception provided in national law should permit changes needed to make the work accessible in the alternative format.
Article 6 allows importation of literary and artistic works readable by the visually impaired:
To the extent that the national law of a Contracting Party would permit a beneficiary person, someone acting on his or her behalf, or an authorized entity, to make an accessible format copy of a work, the national law of that Contracting Party shall also permit them to import an accessible format copy for the benefit of beneficiary persons,without the authorization of the rightholder.
A number of other provisions encourage, or, in some cases, mandate, that signatories improve availability of literary and artistic works for the visually impaired.  Although at least 20 countries must sign the Marrakesh Treaty before it enters into force, it has already attracted a very prominent supporter.  Stevie Wonder, a highly talented musician who also happens to be visually impaired, enthusiastically endorsed the results of the negotiations.  To adapt one of Wonder's own songs, "Here is the Marrakesh Treaty, signed, sealed delivered, it's yours."

Tuesday, July 16, 2013

For Whom The Bell Trolls

Public concern over "patent trolls" or "patent pirates" - more bloodlessly termed "non-practicing entities" ("NPEs") or "patent assertion entities" ("PAEs") - has reached a fevered pitch.  Companies whose business is to acquire patent rights from others, and then to sue (or threaten to sue) companies that produce goods or services, are now firmly in the sights of the United States federal government.  On July 16, 2013, the New York Times published an article entitled "Inventive, at Least in Court," by writer Edward Wyatt, that chronicles the new legal scrutiny into patent trolls.  As the article points out,
[t]he explosion in lawsuits [many apparently filed by patent trolls] has prompted not only the F.T.C. but other parts of the government — notably the White House — to question whether the activity of patent trolls violates antitrust law or fair competition regulations.
Courts may be the first to determine whether or not the activities of patent trolls - especially those with the most massive patent portfolios - violate the law.  Whatever courts may decide under current law, it may not be long before new laws are passed to curb patent trolling.  Our understanding of the costs and benefits of the patent system remains rudimentary.  Until we better grasp the social utility of patents, knowing how best to regulate NPEs will be mere surmise.    

Friday, July 12, 2013

Remarkable Research Use Exemption

Myriad Genetics, Inc., owner of a large portfolio of patents claiming various aspects of testing patients for gene variants indicative of heightened risk of developing breast or ovarian cancer, announced on its website its new "Pledge to Our Patients and the Research Community."  Part II of its "Affirmation and Pledge" states that
Myriad has supported and continues to support research institutions in the advancement of scientific and technological knowledge, and we will not impede non-commercial, academic research that uses patented technology licensed or owned by us. [Emphasis added.]

After enduring withering criticism from many quarters over its patents claiming isolated human gene variants, suffering the loss of several important claims in the United States Supreme Court decision AMP v. Myriad, and watching its stock price dip precipitously, Myriad may be hoping for redemption from the public and the medical community.  Its new pledge may or may not accomplish this goal, but it does suggest a template for a more general research and experimental exception to patent infringement, and is likely to influence patent policy far beyond Myriad itself.

Thursday, July 11, 2013

Medicine, Morality, And Myriad

On July 10, 2013, The New England Journal of Medicine published an article entitled "Gene Patenting - The Supreme Court Finally Speaks" that describes the United States Supreme Court decision in AMP v. Myriad as "a careful balancing act."  The authors, Aaron S. Kesselheim, Robert M. Cook-Deegan, David E. Winickoff, J.D., and Michelle M. Mello, characterize the decision as
an important symbol for those who seek to foster scientific discovery by protecting and expanding the public domain [and containing] symbolic resonance with the ideal that our common humanity cannot be owned.
[T]he law [does not] allow courts to consider whether patenting human genes — or anything else — should be disallowed on grounds of morality. There is a disconnect, then, between the reasons the Supreme Court articulated for its decision and the rich set of ethical and policy concerns that have animated much of the public interest in the case.
Yet, morality most certainly did play a role in the Myriad decision, even if not an explicit one.  Moral repugnance at the patenting of human beings has long influenced court decisions regarding the patentability of human-related inventions, as I argued on SCOTUSblog in "Nothing Under the Sun that is Made of Man."  Patent law is not the amoral field some fashion it to be.  Rather, its moral compass can be followed in the empirical patterns, rhetoric, and dicta of court decisions, statutes, and regulations.

Wednesday, July 10, 2013

Hot Politics

President Barack Obama recently announced his intention to use his presidential power to issue Executive Orders to combat climate change.  Some applauded;  others lamented.  On July 4, 2013, Charles Krauthammer, a Pulitzer Prize winner, and one of the most eloquent voices of American conservatism, published his views on combating climate change in The Washington Post.  In his article, entitled "Obama's global warming folly," Krauthammer reiterated his support for a global treaty to limit carbon dioxide emissions, but opposed any unilateral approach by the United States as futile. This summer has turned into a hot one for the politics of climate change.

Tuesday, July 9, 2013

Duff Beer Brewhaha

The wonderful British intellectual property blog The IPKat featured a July 9, 2013, article about reverse product-placement and attempts to register "Duff Beer" as a trademark.  Homer Simpson would surely push for a quick solution in this case of beer imitating art imitating beer because, as he once eloquently phrased it, "Homer no function beer well without."

Monday, July 8, 2013

Teaching Evolution And Climate Change

The international science journal Nature reports that five U.S. states - Rhode Island, Kentucky, Kansas, Maryland and Vermont - have become the first to agree to adopt the Next Generation Science Standards.  Based on the Framework for K–12 Science Education developed by the National Academy of Sciences, these new Standards embrace scientific topics like evolution and climate change that, despite consensus within the scientific community, remain oddly controversial in some states.  As views evolve, the learning climate changes.

Friday, July 5, 2013

Maddaddam

One day soon, the Nobel Prize in Literature will likely be awarded to Canadian writer Margaret Atwood.  She richly deserves it, having consistently written masterpieces over the past decades.  She achieved a high point of her creativity with Oryx and Crake and The Year of the Flood, which describe a dystopian near-future in which human civilization has collapsed in the face of massive climate change and a deliberate biotechnological apocalypse.  These novels transcend science fiction, or any other genre.  They are brilliant, eloquent, and deeply disturbing in how realistic a vision of societal and ecological collapse they evoke.  What Jared Diamond did for the concept of collapse in nonfiction, with his book Collapse:  How Societies Choose to Fail or Succeed, Atwood has equaled with fiction.  Atwood has now announced that the final book in her trilogy, entitled Maddaddam, will be published on September 3, 2013.  Everyone should read and ponder this trilogy.  Perhaps Atwood should win Nobel Prizes in both Literature and Peace.