Monday, November 9, 2015

Canadian Pollution Dilution Solution

Catherine McKenna, the newly-minted Canadian Minister of Environment and Climate Change, is learning just how dirty governing can be.  In her first major decision as a member of Justin Trudeau's Liberal Cabinet, she held her nose and effectively gave the city of Montreal permission to release 8 000 000 000 litres of raw sewage into the Saint Lawrence River.  Staying true to the second part of her ministerial title, her approval is sure to change the downstream climate of this great river, especially for the unfortunate birds, fish, seals, and cetaceans who will be inundated with human waste.  As the new Liberal government of Canada has already begun to learn, sometimes government stinks.

Monday, November 2, 2015

Battle Royal

Early this morning (November 2, 2015), the Kansas City Royals bested the New York Mets by exploding for five runs in the 12th inning.  When I was a kid, the Royals were the enemy for beating my beloved Toronto Blue Jays in 1985, denying my home team its first opportunity to win a World Series championship.  When the Jays won not one, but two, World Series back to back, in 1992 and 1993, forgiveness began to take root.  This year, I found myself cheering both the Jays and the Royals.  In the end, I was delighted to watch the Royals win their second World Series championship, showing more grit, determination, and sheer joy than I remember seeing in any professional baseball team.  My Royal pain transformed into Royal treatment.  Congratulations, Kansas City Royals, on being 2015 World Series champions!

Friday, October 16, 2015

Book 'Em, Google!

Google Books, a gigantic searchable repository of published books, has become the default resource for searching the contents of books.  A number of parties sued Google to challenge their chutzpah in scanning books and making them available on Google Books without permission from their authors and owners.  After a decade of litigation, the influential Second Circuit Court of Appeals has decisively sided with Google in its opinion in Authors Guild v. Google, Inc.:
The Court of Appeals concludes that the defendant’s copying is transformative within the meaning of Campbell v. Acuff-Rose Music, Inc., 510 U.S. 569, 578-585 (1994), does not offer the public a meaningful substitute for matter protected by the plaintiffs’ copyrights, and satisfies §107’s test for fair use.
Unless the United States Supreme Court decides to add its voice to this debate over copyrights and copywrongs - not an improbability - the Second Circuit's decision will be a bitter pill to swallow for those who champion stronger copyright protections for authors.  On the other side of the social welfare ledger, this outcome ensures that the world of published books will remain a mere Google search away.  Over to you, Supremes!

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.