Monday, October 12, 2015

Agricultural Data Exclusivity

Now that a draft text of the Transpacific Partnership ("TPP") trade agreement has been published on WikiLeaks for a few days, some of the provisions in the chapter on intellectual property rights are coming into sharper focus.  Section E ("Patents / Undisclosed Test or Other Data"), Subpart B ("Data Protection for Agricultural Chemical Products"), Article QQ.E.13 is remarkable.  It extends the sort of data exclusivity protection usually associated with biologics to "new agricultural chemical products".  Here is the text, sans footnotes:
1. If a Party requires, as a condition for granting marketing approval[] for a new agricultural chemical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product[], the Party shall not permit third persons, without the consent of the person who previously submitted such information, to market the same or a similar[] product on the basis of that information or the marketing approval granted to the person who submitted such test or other data for at least ten years[] from the date of marketing approval of the new agricultural chemical product in the territory of the Party. 
2. If a Party permits, as a condition of granting marketing approval for a new agricultural chemical product, the submission of evidence of a prior marketing approval of the product in another territory, that Party shall not permit third persons, without the consent of the person who previously submitted undisclosed test or other data concerning the safety and efficacy of the product in support of that prior marketing approval, to market the same or a similar product based on that undisclosed test or other data, or other evidence of the prior marketing approval in the other territory, for at least ten years from the date of marketing approval of the new agricultural chemical product in the territory of the Party. 
3. For the purposes of this Article, a new agricultural chemical product is one that contains[] a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.
To owners of biologics, data exclusivity can be more valuable even than patent protection.  Owners of agricultural chemical products may soon enjoy a similar potent right throughout TPP territories.

Saturday, September 5, 2015

Bench, Bar, And Two Smoking Barrels

The annual Eastern District of Texas 2015 Bench Bar Conference will be held in Plano, Texas from October 21st to 23rd.  The program is replete with high-profile patent law speakers, including Judge William Bryson of the Court of Appeals for the Federal Circuit, several of his retired colleagues from the same court, and former United States Patent and Trademark Office Commissioner Q. Todd Dickinson, and panels discussing the most fascinating and important issues bedeviling patent law today.  However, by far the most compelling portion of the program is the "Guns & Golfing Kick-Off" that precedes the proceedings.  Here is the description from the program:
Choose from the refinement of golfing on the beautiful Gleneagles golf course minutes from the conference hotel, or join a bunch of rag tag lawyers taken to calling themselves the Posse for an East Texas cultural excursion at the nearby Frisco Gun Club. If you have never fired a gun, this is your chance. All experience levels accommodated and everything you need provided.
Directly after this teaser is an ominous addendum:  "See Registration Form for Special Registration Details."

With apologies for loaded language, the organizers of the 2015 Bar Bench conference clearly bit the bullet, took aim at some great topics, and, in terms of speakers, shot for the stars.

Thursday, July 2, 2015

Recoordinated Framework

Timed perfectly to be lost amidst the Independence Day weekend celebrations, the White House announced that the regulatory framework that has governed biotechnology in the United States for the past 29 years - the hopefully-named "Coordinated Framework for Regulation of Biotechnology" - will be reviewed over the next year.  The July 2, 2015, announcement was promulgated via both an Office of Science and Technology Policy blogpost entitled "Improving transparency and ensuring continued safety in biotechnology" and in the Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and Department of Agriculture.  The Memorandum announces the purpose of the review as follows:
Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation. This memorandum initiates a process to modernize the Federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system. The objectives are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.
Advances in biotechnology, in general, and in synthetic biology, genetic engineering, genome editing, gene therapy, cloning, embryonic stem cell biology, and, most recently, deextinction, in particular, appear to have raised the level of public anxiety surrounding biology.

One can only hope that any new federal biotechnology regulatory framework resulting from this federal review will ensure as many societal benefits in the future as biology has delivered over the past three decades.  After all, "Better Living Through Chemistry" was long ago displaced by "Better Living Through Biology."  

Monday, June 29, 2015

Good Friday

The United States Supreme Court does not always come to the right decision.  However, they did very much get it right in Obergefell v. Hodges (U.S. 2015).  Arguments by opponents of same sex marriage that biology supported their cause were woefully misguided.  (See previous post, entitled Sex, Biology, and the Supreme Court.)  Congratulations to the Supremes, to the citizens of the United States, and to the cause of civil rights around the globe!

Tuesday, June 16, 2015

Where GRAS Is Leaner

The United States Food and Drug Administration ("FDA") has announced that within three years partially-hydrogenated oils (major sources of trans fats) will no longer qualify to be "generally regarded as safe" ("GRAS"). Often used as a grandfathering mechanism for ensuring light regulation of foods whose wide consumption preceded passage of the Food, Drug, and Cosmetics Act, food designated as GRAS may be legally sold without specific proof of nutritional benefit. In light of overwhelming scientific evidence, the FDA outlined its new policy on June 16, 2015:
Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.
This new policy furthers a previous FDA initiative regarding trans fats:
Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. While trans fat intake has significantly decreased, the current intake remains a public health concern. The Institute of Medicine recommends that consumption of trans fat be as low as possible while consuming a nutritionally-adequate diet.
By 2019, partially-hydrogenated oils will be banned from food unless specifically approved by the FDA:
The FDA has set a compliance period of three years. This will allow companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Following the compliance period, no PHOs can be added to human food unless they are otherwise approved by the FDA.
Whatever its other effects, this new dietary policy will lend credence to the proposition that the GRAS is always leaner.

Tuesday, June 9, 2015

Towards Jurassic World

Like the passenger pigeon, the Tasmanian wolf, and the wooly mammoth, the Jurassic Park franchise has recently been the object of serious resurrection efforts.  Deextinction has been successful in the case of the latter:  Jurassic World hits movie theaters on June 11, 2015.  I had fun being interviewed by reporter Amina Smith of 6News television on the prospects, ethics, and legality of deextinction.

Friday, June 5, 2015

Mother Of Infringements

The Canadian Telecom Summit describes itself as "deliver[ing] thought provoking presentations from the prime movers of the industry...[in a] a structured atmosphere of frank discussion and high octane idea exchange".  Apparently, such frank discussion can include calling j'accuse on alleged copyright infringement by one's own children.  In a keynote address she delivered at the Summit on June 3, 2015, Bell Media President Mary Ann Turcke is reported to have called out her 15-year old daughter for using a virtual private network ("VPN") to watch Netflix' U.S. programming rather than settling for what Netflix Canada offers.  This, Turcke declared, was "stealing".

Not so fast, says Professor Michael Geist, a copyright law expert at the University of Ottawa Faculty of Law.  In an article in the Toronto Star newspaper, Geist questions whether using a VPN to access Netflix' U.S. version of its streaming video content is, in fact, theft.  He notes that such actions might constitute breach of contract or possibly violate Canadian anticircumvention law, but considers "arguments that the subscribers [who access Netflix U.S. via VPN] violate copyright law are very weak". 

One thing is almost a certainty:  any teenager whose parent tattles on her in a public speech will feel very strongly (to euphemize) that her rights to privacy have been egregiously infringed.

Tuesday, April 28, 2015

Sex, Biology, And The Supreme Court

During United States Supreme Court oral arguments today (April 28, 2015) in the case of Obergefell v. Hodges, "biology" and its cognates were uttered 27 times in relation to whether or not there is a federal constitutional right to same-sex marriage.  John J. Bursch, Special Assistant Attorney General for the State of Michigan, opposing same-sex marriage, repeatedly argued variations of the following mantras:  "[W]e want to encourage children to be bonded to their biological mother and father" and "[W]e want to forever link children with their biological mom and dad when that's possible."  Justice Elena Kagan, echoing several other justices, offered this challenging retort:  "[I]t's hard to see how permitting same-­sex marriage discourages people from being bonded with their biological children."  In addition, it was noted repeatedly that many married couples either adopt children born to other parents - as Chief Justice Roberts and his wife have done - or have no children at all.

Bursch leaned heavily on "biology" to support his moral arguments against same-sex marriage.  Yet, biology and morality make strange and unmarriageable bedfellows.  Biology can, indeed, shine considerable light on a number of social issues discussed in the oral arguments, including bases for sexual preferences, means and patterns of procreation, and even why "fathers with the benefits or the requirements of marriage walk away from their children".  However, pair-bonded humans reproduced successfully and prodigiously for aeons before the invention of the institution of marriage.  So, any necessary connection between marriage, bonding, and "biology" remains unsubstantiated at best.

Biological evidence can be useful to support legal arguments.  The use of DNA evidence to convict and exonerate criminal suspects may be a success, but the attempt to use "biology" to deny marriage rights to same-sex couples is a failure.

Monday, April 27, 2015

Mark Lynas On GMOs

Way back on January 4, 2013, in Mark Lynas Recants on GM Agriculture, I discussed high-profile former GMO-critic Mark Lynas' change of heart in favor of genetic modification of agricultural organisms.  In an op-ed entitled "How I Got Converted to GMO Food", published in the Sunday New York Times on April 26, 2015, Lynas offered his impassioned advocacy of the agricultural benefits of genetic engineering.  Here is a remarkable passage from the article:
After writing two books on the science of climate change, I decided I could no longer continue taking a pro-science position on global warming and an anti-science position on G.M.O.s. 
There is an equivalent level of scientific consensus on both issues, I realized, that climate change is real and genetically modified foods are safe. I could not defend the expert consensus on one issue while opposing it on the other.

As I described in Intellectual Property as the Third Dimension of GMO Regulation, the history of opposition to GM food is replete with scientific myths and reversals of rationale and opinion.  Even so, it is remarkable to watch the continuing metamorphosis of Lynas' views from those of sworn opponent to those of passionate proponent.