Wednesday, December 14, 2016

Tuesday, December 13, 2016

Patients Lose Patience

Although December 13, 2016, would not seem the most propitious of dates, it may go down as an important one in the history of United States drug and medical device law.  Today, President Barack Obama signed into law the "21st Century Cures Act", which substantially amends the Food, Drug, and Cosmetics Act ("FDCA") in response, at least in part, to a growing chorus of criticism by patient advocates demanding faster approvals of, and access to, new drugs and medical devices.  Among the highlights are formal recognition by the Food and Drug Administration ("FDA") of "patient experience" data as part of the drug approval process, accelerated decisions on drug approvals, reevaluation of clinical trial design (including consideration of "real world evidence"), enhanced access by patients to information on experimental drugs, accelerated approvals for regenerative medicines (including, presumably, stem cell therapies), and accelerated approvals for medical devices.  The 21st Century Cures Act is one of the most substantial amendments to be made to the FDCA in years.  It may prove one of President Obama's greatest legislative legacies, with wide-ranging and long-lasting effects on medicine and health.

Tuesday, December 6, 2016

Design Patents Totalled

The United States ("U.S.") Patent Act has long included a special damages provision that applies only to design patents.  Under the relevant part of 35 U.S.C. §289 (tellingly-entitled "Additional remedy for infringement of design patent"),
Whoever during the term of a patent for a design, without license of the owner, (1) applies the patented design, or any colorable imitation thereof, to any article of manufacture for the purpose of sale, or (2) sells or exposes for sale any article of manufacture to which such design or colorable imitation has been applied shall be liable to the owner to the extent of his total profit...[emphasis added]

The U.S. Supreme Court disagreed in its decision published on December 6, 2017.  Writing for the unanimous Supreme Court, Justice Sotomayor parsed the meaning of "article of manufacture" to encompass either an entire device or a mere fraction of it, explaining
the term “article of manufacture” is broad enough to encompass both a product sold to a consumer as well as a component of that product.  A component of a product, no less than the product itself, is a thing made by hand or machine.  That a component may be integrated into a larger product, in other words, does not put it outside the category of articles of manufacture.
Applying this logic, she reasoned that "total profit" should be assessed from only that portion of an article of manufacture claimed in an infringed design patent.  Since most modern electronic devices are composed of dozens or hundreds of distinct parts, many of which could be individually-claimed in distinct design patents, the practical implication of this decision will most likely be a substantial decrease in the "total profit" Samsung will owe Apple for design patent infringement.

A broader implication may be a reevaluation of the value of design patents, whose numbers have been climbing rapidly (applications increased by almost 800% from 1963 to 2015).  Now that "total profits" has a totally-new denominator, applying for, acquiring, and maintaining design patents may have become markedly less desirable. 


Monday, November 28, 2016

Deeper Art

BlouinArtinfo ran an article about avante-gard art pioneers Fathomers on November 8, 2016.  Led by peerless Executive Director Stacy Switzer, Fathomers is establishing itself as a locus in quo for perpetrating great art in Los Angeles and beyond.  The article also discusses Problems and Provocations, which chronicles Fathomers' influential 1995-2015 prehistory as Grand Arts through the works of visionary artists, such as Tavares Strahan, Mel Chin, and Michael Jones McKean, and to which I contributed a modest aukwardly-focused pensée entitled "Immortality".

For full disclosure, let me note that I am delighted to serve on the Fathomers board of directors.  In this capacity, I hope for ever more problematic and provocative art to shine through the prism of this wonderful, talented, and challenging organization.

Sunday, November 27, 2016

WIPO Hype O' SIPO

The World Intellectual Property Organization ("WIPO") released its World Intellectual Property Indicators 2016 report on November 23, 2016.  Among various intellectual property data, statistics, and trends, the WIPO report announced that the Chinese State Intellectual Property Office ("SIPO") had become the first national patent office to receive more than one million patent applications in a single year.  In 2015 alone, CIPO logged 1,101,864 distinct applications for patent protection, though these applications included not only applications for "invention patents" (akin to United States ("U.S." utility patents), but also "utility models" ("petit patents") and design patents (similar to U.S. design patents).  In addition, 2015 saw just over one million patent applications filed Chinese citizens.  A breezy overview of the report is available in this WIPO video:



Although it remains unclear whether patents are an accurate metric of innovation, China is on the verge of establishing itself as a patent superpower.

Sunday, October 9, 2016

DNA In The Copyright Office

In an article entitled, "Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses a Matter of First Impression", Chris Holman (who led the effort and was the prime mover of the article), Claes Gustafsson (whose impressive biotechnology company, DNA2.0, designed the DNA sequence submitted to the Copyright Office for registration), and I describe how the United States Copyright Office handled an attempt to register copyright in a synthetic DNA sequence.  Here is the abstract:
In spite of the compelling logic that would support extending copyright to engineered DNA sequences, copyright protection for genetic code has not been legally recognized in the US, or as far as we know anywhere. The Copyright Act is silent on the point, the courts do not appear to have ever addressed the question, and the Copyright Office has taken the position that an engineered genetic sequence is not copyrightable subject matter. In an attempt to advance the conversation, we submitted an engineered DNA sequence to the Copyright Office for registration, and then appealed the Office’s decision refusing to register engineered genetic sequences. This article reports the outcome of our experiment, and provides as supplementary material the actual letter we submitted to the Copyright Office appealing its initial decision not to register genetic sequences (the “Appeal”), along with the Copyright Office’s letter denying our appeal (the “Denial), which provides a detailed explanation of the Office’s position regarding the copyrightability of engineered DNA. The bulk of the article is devoted to refuting the legal and policy justifications set forth by the Office in its Denial.
Thank you very much to Chris and Claes for including me in this fascinating effort to probe the limits of copyrightable subject matter.  This legal adventure will continue.

Lexvivo Returns

My dear friend, the marvelous Bill Tomlinson, Professor of Informatics at the Donald Bren School of Information and Computer Sciences at the University of California Irvine, has revived Lexvivo from internet purgatory.  Why the website went down remains a mystery, but its resurrection is due to computer maven Bill's internet mojo.  Thank you very much, Bill!

Friday, September 16, 2016

Governing Biotechnology

As noted last year by Lexvivo ("Recoordinated Framework", July 2, 2015), the United States federal government has been considering how to update its policy on biotechnology regulation.  On September 16, 2016, the White House released a draft revision of the "Coordinated Framework for the Regulation of Biotechnology" (commonly known as the "Coordinated Framework").  (Thank you to the brilliant Brian Mannix for alerting me about the draft's release.)  The original policy, in force since June 26, 1986, can be found here.  The draft new policy, entitled "Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology", can be found here.  The White House described its reformulated biotechnology regulatory policy as follows:
[It] sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens. In the [draft new policy], the Federal agencies demonstrate their sustained commitment to ensure the safety of future products of biotechnology, increase public confidence in the regulatory system, and prevent unnecessary barriers to future innovation and competitiveness.
Biotechnology has evolved rapidly and radically over the past three decades, so a comprehensive review of the policies that oversees its regulation would seem overdue, especially in light of signal innovations like de novo gene synthesis and in toto genome editing.  Let's hope that this proposed recoordination of policy on that most complex of technologies avoids tripping over its own feet.

Saturday, September 10, 2016

Tuesday, September 6, 2016

2016 Freeman Prize

Sampsa Hyysalo, Torben Elgaard Jensen, and Nelly Oudshoorn just let us know that the book they edited, entitled New Production of Users - Changing Innovation Collectives and Involvement Strategies (Routledge), has received the 2016 Freeman Prize, which is awarded "for a publication which is a significant collective contribution to the interaction of science and technology studies with the study of innovation" by the European Association for the Study of Science and Technology ("EASST").  This award honors "Professor Chris Freeman, renowned expert on the social and economic consequences of developments in science and technology".  Eric von Hippel and I were invited to contribute a chapter, which we coauthored and named "Protecting the Right to Innovate:  Our Innovation "Wetlands"".

Thank you very much to Sampsa, Torben, and Nelly for their wonderful leadership in producing this book!  They deserve the lion's share of the congratulations for winning the Freeman Prize.

Thursday, August 25, 2016

Triumphantly Hip

When I was an undergraduate at Queen's University, The Tragically Hip were our favourite band at Alfie's.  They were awesome then;  they are awesome now.  However, a sad chapter in their story began on May 24, 2016, when The Hip announced that lead singer Gord Downie had been diagnosed with incurable glioblastoma.  I, along with a third of Canadians, including Prime Minister Justin Trudeau, attended, watched, or listened to what may have been The Hip's final concert on August 20, 2016.  Although the entire event is not currently available online, here is the final song of their last encore.  Thank you, Gord, for a lifetime of transcendent Canadian musical poetry.

Friday, July 29, 2016

Zoom Into OneZoom

I would like to thank Matt Ridley for directing me to OneZoom, a wonderful interactive phylogeny of life.  On OneZoom, one can begin at any branch or leaf on Charles Darwin's metaphorical Tree of Life, then increase or decrease the desired level of phylogenetic detail by simple mouse-click or finger-tap.

A 2012 PLOS Biology article by J. Rosindell and L.J. Harmon, entitled OneZoom: A Fractal Explorer for the Tree of Life, explains the concept behind this cool and addictive new evolutionary tool.

With OneZoom, one may explore any part of the tree of life, from an individual organism to a entire clade.  I recommend choosing your favourite lifeform as a starting point, then seeing where evolution leads you.  To adapt Ira and George Gershwin's cryptichthyic 1937 song Slap that Bass,
Click that bass
Click away your trouble
Learn to zoom zoom zoom
Click that bass
But beware:  once you dive into OneZoom, you may find it difficult to stop exploring biodiversity.

Thursday, July 28, 2016

Cry Wolf, Not Wolves

An analysis of the entire genomes of wolves and coyotes (Canis latrans) has come to an unexpected conclusion:  there is a single species of North American wolf.  Previously, some biologists, including at the United States Fish and Wildlife Service ("FWS"), which is responsible for implementing the Endangered Species Act ("ESA"), proposed the existence of three species:  the Gray Wolf (Canis lupus), Red Wolf (Canis rufus), and Eastern (or Great Lakes region) Wolf (Canis lycaon).  In their article, Whole-genome sequence analysis shows that two endemic species of North American wolf are admixtures of the coyote and gray wolf, published on July 27, 2016, in Science Advances, Bridgett M. von Holdt and her colleagues instead conclude that:
Consistent with the above results, Great Lakes region wolves and red wolves are admixed populations composed of various proportions of gray wolf and coyote ancestry. The red wolf may have captured genomic elements that were unique to gray wolves and coyotes of the American South. In contrast, the Great Lakes region wolves largely sample lineages of gray wolves and coyotes that have descendants in the extant population, which may include a distinct gray wolf ecotype. We find little evidence of distinct genomic elements in either red or Great Lakes region wolves that would support separate evolutionary legacies.  (References omitted.)
This study has important implications for how the FWS protects various admixed populations of wild canids under the ESA.  Coywolves and woyotes warrant protection despite their admixed genomes, in part because, as keystone predators, they help regulate vital trophic cascades in the ecosystems they inhabit.  However, their newly-uncertain taxonomic status may undermine strong legal protections they would otherwise receive as "species".  Two lessons to draw from these genomic revelations are that (1) the ESA and its interpretation need to continue grappling with rapid progress in genetics and (2) the biologically-wobbly concept of "species" gets riper for replacement with each passing day.

Friday, July 22, 2016

Pigou Breakthrough

Prime Minister of Canada, Justin Trudeau, has announced that his Liberal government will adopt a nationwide price on carbon emissions.  Employing Pigouvian taxes (or subsidies) to internalize putative externalities, as University of Cambridge economist Arthur Cecil Pigou described in The Economics of Welfare, has long been suggested as a cost-effective means to reduce the generation and release of greenhouse gases. Although market-based methods combating climate change have traditionally been anathema to many environmental organizations, the often icy opposition to Pigouvian taxation, or, alternatively, cap-and-trade approaches, seems rapidly to be melting.  Although University of Chicago economist, and Pigou critic, Ronald Harry Coase would likely not approve, Canada has announced it will adopt a Pigouvian approach to curb its carbon emissions, either by individual provinces and territories, or, failing that, through a national policy.  No announcements have yet been made about the taxation of political hot air.

Wednesday, July 13, 2016

Well May She Rule

Brand new Prime Minister Theresa May delivered a remarkable speech upon assuming office on June 13, 2016.  Notable among the topics she addressed were unity and inequality, about which she said the following:
[W]e believe in a union not just between the nations of the United Kingdom but between all of our citizens - every one of us - whoever we are and wherever we’re from.
That means fighting against the burning injustice that if you’re born poor you will die on average nine years earlier than others. 
If you’re black you are treated more harshly by the criminal justice system than if you’re white. 
If you’re a white working-class boy you’re less likely than anybody else in Britain to go to university. 
If you’re at a state school you’re less likely to reach the top professions than if you’re educated privately. 
If you’re a woman you will earn less than a man. 
If you suffer from mental health problems, there’s not enough help to hand. 
If you’re young you will find it harder than ever before to own your own home. If you’re from an ordinary working-class family, life is much harder than many people in Westminster realise.
Although it is much more difficult to effect real social change than simply to utter stirring words, May established a reputation as Home Secretary for setting and accomplishing measurable goals.  May she succeed!

Tuesday, July 12, 2016

First Law Of Robotics

On July 8, 2016, a terrible shooting massacre of police and civilians took place in Dallas, Texas.  My condolences go to all the victims of this tragedy.  There is little I can add that others, including United States President Obama, have not already expressed more eloquently.

One surprising aspect of these awful events was the use of a robot to kill the suspected shooter.

In Runaround, his short story published in 1942, Isaac Asimov described "The Three Laws of Robotics".  They are
1.  A robot may not injure a human being or, through inaction, allow a human being to come to harm.
2.  A robot must obey the orders given it by human beings except where such orders would conflict with the First Law.
3.  A robot must protect its own existence as long as such protection does not conflict with the First or Second Laws.
Asimov foresaw some of the ethical implications of employing robots to kill.  Humanity will increasingly live all of them.

Friday, July 8, 2016

TheraNOs

The enfant terrible of unicorns, medical testing firm Theranos, Inc., has had its horn substantially clipped by the Centers for Medicare & Medicaid Services ("CMS").  On July 7, 2016, the CMS announced - on Theranos' own website - that the privately-held company will suffer the following sanctions beginning August 6, 2016:
– Revocation of the [Newark, California] laboratory’s CLIA [Clinical Laboratory Improvement Amendments] certificate which, as dictated by the regulations, includes a prohibition on owners and operators of the lab from owning, operating or directing a lab for at least two years from the date of revocation 
– Limitation of the laboratory’s CLIA certificate for the specialty of hematology 
– A Civil Money Penalty 
– A Directed Portion of a Plan of Correction 
– Suspension of the laboratory’s approval to receive Medicare and Medicaid payments for any services performed for the specialty of hematology 
– Cancellation of the laboratory’s approval to receive Medicare and Medicaid payments for all laboratory services
These penalties represent serious blows to Theranos.

Wednesday, July 6, 2016

Raisin d'État

In response to a petition filed with the Agricultural Marketing Service ("AMS") of the United States Department of Agriculture ("USDA") by Little People of America ("LPA"), "a nonprofit organization that provides support and information to people of short stature and their families", the AMS announced on June 23, 2016, that it plans to amend its federal regulations on raisin nomenclature,
removing five references to the term ‘‘midget’’ in the following sections: 52.1845(b) and (c), 52.1850(a)(2) and (a)(3), and Table I.
As its reasoning, the AMS states,
The revisions will modernize and help clarify the language of the standard by removing dual terminology for the same requirement.
Once the rule is final, on July 23, 2016, the AMS plans to use the descriptor "small" to describe diminutive raisins.

Congratulations to the LPA for achieving this regulatory redress.  

Tuesday, July 5, 2016

XY Zone

In an echo of Matt Ridley's recent observation that female leadership is on the rise around the world, the two leading finalists to become leader of the Conservative and Unionist Party - and, incidentally, next Prime Minister of the United Kingdom - are both impressive women:  Theresa May and Andrea Leadsom.  This is promising news for both the Tories and their country, whose future is beclouded by political and economic uncertainty.

Saturday, June 25, 2016

Brattachment

If the United Kingdom does actually Brexit the European Union, the country could be a superb candidate to Brattach itself to the rival North American Free Trade Agreement.  Commonalities in history, culture, and level of economic development raise intriguing possibilities for a "North Atlantic Free Trade Agreement".

Friday, June 24, 2016

German Headquarter

On June 23, 2016, a small majority of voters in the United Kingdom ("U.K.") expressed their preference to quit membership of the European Union.  Much has been, and will be, written elsewhere about various consequences of this decision for the U.K..  I would like to highlight an important implication for the post-Brexit European Union ("E.U.").

Using 2014 GDP figures, the U.K. economy makes up 17.6% of the total GDP of the E.U., while Germany accounts for a larger, yet comparable, 20.7%.  Removing the U.K. from the E.U., the economy of Germany would contribute more than 25% of total E.U. GDP, and be almost 40% larger than the next largest national economy, that of France.  Time will tell what effects such a large imbalance of economic power will have on the governance and stability of the E.U..  With the U.K. gone, it will be much more difficult to view the E.U. as club of equals.

Thursday, June 23, 2016

Zip Zep Infringement

A jury in a Central District of California district court found on June 23, 2016, that the band Led Zeppelin, in its classic song "Stairway To Heaven", did not infringe the band Spirit's copyright on its song "Taurus".  The decision came despite similarities between the two songs, and acceptance by the jury that members of Led Zeppelin had had access to Spirit and its song.

The likelihood of an appeal to the 9th Circuit Court of Appeal is high, in part because the result of this case seems discordant with the finding that the song Blurred Lines, by Robin Thicke and Pharrell Williams, had infringed the copyright in Marvin Gaye's song "Got to Give it Up".  In the wake of these two district court decisions, the law of copyright infringement in music appears quite muddy.

The time is ripe for some guidance from a higher court.  As the Zeppelin song counsels,
And it's whispered that soon, If we all call the tune
Then the piper will lead us to reason.
Musicians now hope that the Court of Appeals will pipe up soon.

Friday, May 20, 2016

FDA Finalizes Food Facts

On May 20, 2016, the United States ("U.S.") Food and Drug Administration ("FDA") released the final version of the revised food and drink labels legally-required to accompany most food and drink sold in the U.S..  Here is an example of a new label:
The differences between the old and new food labels are subtle, but not trivial.  Among the changes are requirements that sellers use more realistic serving sizes reflective of how much a typical person would actually eat at one sitting.  For example, the old regime allowed preposterous serving sizes such as three lonely potato chips!  The new label must list much larger amounts.  In addition, a new subcategory of carbohydrates must list the amount of sugars added to a serving of food or drink above and beyond those sugars found in the preprocessed version of that food or drink.

Although food and drink labels are often ignored by consumers, they do provide a valuable source of nutritional information for any who care to read them.  This information can be crucial to people on special diets or with conditions such as diabetes.  The FDA could have opted for a more revolutionary approach to revamping label design, but, instead, the agency appears to have decided on a gradual, evolutionary approach to improvement.  At least the latest changes might reduce the impression that anyone who eats more than three potato chips at one sitting - a nearly-universal trait - is a shameless glutton.

Thursday, May 19, 2016

National Academies On GE Crops

The influential United States National Academies ("NAs") released their latest assessment of the environmental and health risks of genetically-engineered ("GE") crops on May 17, 2016.  Despite widespread, and often inchoate, anxiety among the public, GM crops have rapidly displaced non-GE crops around the world.  So, are they safe?

The NAs' report, entitled Genetically Engineered Crops:  Experiences and Prospects, provides a comprehensive review of existing scientific evidence.  Although they hedge their answers, as befits the complexity of published studies, the NAs conclude that evidence for negative consequences of GE crops is generally lacking.  They suggest that the economic effects lean to the positive side of the cost/benefit ledger:
The available evidence indicates that GE soybean, cotton, and maize have generally had favorable economic outcomes for producers who have adopted these crops, but outcomes have varied depending on pest abundance, farming practices, and agricultural infrastructure. Although GE crops have provided economic benefits to many small-scale farmers in the early years of adoption, enduring and widespread gains will depend on such farmers receiving institutional support, such as access to credit, affordable inputs such as fertilizer, extension services, and access to profitable local and global markets for the crops.

The NAs concluded that neither humans nor animals appear to have been harmed by consuming food derived from GE crops:
The committee carefully searched all available research studies for persuasive evidence of adverse health effects directly attributable to consumption of foods derived from GE crops but found none. Studies with animals and research on the chemical composition of GE foods currently on the market reveal no differences that would implicate a higher risk to human health and safety than from eating their non-GE counterparts. Though long-term epidemiological studies have not directly addressed GE food consumption, available epidemiological data do not show associations between any disease or chronic conditions and the consumption of GE foods.
And, the NAs found little evidence that GE crops harm the environment:
The use of insect-resistant or herbicide-resistant crops did not reduce the overall diversity of plant and insect life on farms, and sometimes insect-resistant crops resulted in increased insect diversity, the report says. While gene flow – the transfer of genes from a GE crop to a wild relative species – has occurred, no examples have demonstrated an adverse environmental effect from this transfer. Overall, the committee found no conclusive evidence of cause-and-effect relationships between GE crops and environmental problems. However, the complex nature of assessing long-term environmental changes often made it difficult to reach definitive conclusions.

Nevertheless, the NAs do warn that biotechnology is a dynamic and evolving set of techniques, and suggest ongoing regulatory oversight:
Emerging genetic technologies have blurred the distinction between genetic engineering and conventional plant breeding to the point where regulatory systems based on process are technically difficult to defend. The committee recommends that new varieties—whether genetically engineered or conventionally bred—be subjected to safety testing if they have novel intended or unintended characteristics with potential hazards.
  This report will not be the final word on GE crops.  In fact, the popularity among consumers of food they perceive as "non-GE" represents a substantial, continuing challenge to GE crops, with increasing demands by the public and national regulators that GE and non-GE crops be carefully sequestered from one another to avoid cross-contamination.  Time will tell whether or not scientific assessments such as the NAs' will change public opinion.  In the meantime, both supporters and opponents of GE crops have the benefit of this new and authoritative source of evidence and analysis from the NAs.

Monday, May 2, 2016

Closing The (Google) Books On Fair Use

The United States Supreme Court wrote the final chapter on Authors Guild v. Google, Inc.. on April 18, 2016, simply ordering that
[t]he petition for a writ of certiorari is denied. Justice Kagan took no part in the consideration or decision of this petition.
Lexvivo previously covered the Google Books case on October 16, 2015, in Book 'Em Google!.  Perhaps now we can all turn the page on this type of fair use.

However, never fear, intellectual property aficionados, for, on May 2, 2016, the Supremes also issued the following two orders:
CERTIORARI GRANTED 
15-866  STAR ATHLETICA, L.L.C. V. VARSITY BRANDS, INC., ET AL. The petition for a writ of certiorari is granted limited to Question 1 presented by the petition. 
15-927  SCA HYGIENE PRODUCTS V. FIRST QUALITY BABY PRODUCTS The petition for a writ of certiorari is granted.
The former involves a copyright case probing the contours of functionality in copyright.  The latter is a patent case on whether laches is available as a defense to infringement within the statutory six-year window for recovering damages authorized by 35 U.S.C. §286 (Time limitation on damages).

So, there will be much more intellectual property fun to come.

Thursday, February 4, 2016

Aukward Law

The Long Now Foundation posted a story on February 4, 2016, describing a wonderful meeting I had the honour of participating in last summer at the International Centre for Life in Newcastle, U.K..  The meeting was organized and hosted by peerless peer and gifted author (most recently of The Evolution of Everything - How Ideas Emerge), Matt Ridley.  Key inspirations were champions of deextinction Stewart Brand and Ryan Phelan, along with Ben Novak, lead researcher for the Long Now Foundation's Revive & Restore Passenger Pigeon (Ectopistes migratorius) project.  Together with an expert group of genomicists, geneticists, developmental biologists, ecologists, and others, we explored how the Great Auk (Pinguinis impennis) might be brought back from extinction.  I contributed a legal and policy framework for reviving and reintroducing the Great Auk from oblivion.

The Great Auk is extinct.  Long live the Great Auk!

Tuesday, February 2, 2016

Human CRISPR Becomes Clearer

The agency responsible for regulating reproductive biology in the United Kingdom ("U.K."), the Human Fertilisation and Embryology Authority ("HFEA"), has made the U.K. the first democracy to approve the application of CRISPR/Cas9 to human embryos.  (Similar experiments took place in China in 2015, causing a firestorm of controversy.)  Here is its February 1, 2016, announcement:
Our Licence Committee has approved an application from Dr Kathy Niakan of the Francis Crick Institute to renew her laboratory’s research licence to include gene editing of embryos. 
The committee has added a condition to the licence that no research using gene editing may take place until the research has received research ethics approval. 
As with all embryos used in research, it is illegal to transfer them to a woman for treatment.
This is a momentous step in CRISPR/Cas9 research, and one that is sure to create tremendous pressure for similar regulatory approvals among other democracies fearing they might fall behind in this revolutionary biotechnology.  Le déluge vient.

Sunday, January 24, 2016

Gilbergstrom and Sullivan

With his permission, I would like to post the lyrics of my brilliant friend Carl Bergstrom's wonderful new song "Modern Research Parasite".  Built on a rhythmic scaffold provided by Gilbert and Sullivan's "Major-General's Song" from The Pirates of Penzance, enjoy Carl's masterpiece. Here it is:
I am the very model of a modern research parasite,
I build on other research leaving only here-and-there a cite.
I know the Nobel laureates and quote the fights cladistical,
From Felsenstein to Farris using language most statistical. 
I can passage flu in ferrets to endanger all humanity,
And argue open access until Harnad sounds like Hannity.
I know our mythic history, from Galen to Chetverikov,
And advocate the medicines you cannot get generic of. 
I’ve memorized the sequence of each ENCODE base of DNA,
And I can tell at sight Feng Zhang from Doudna and Charpentier.
But still I need your data like anemics need their ferrocite.
I am the very model of a modern research parasite.
For more context, check out Carl's Twitterstream:  @CT_Bergstrom.  I hope Carl gets the band back together so he can post his live rendition on YouTube.

Wednesday, January 20, 2016

Trademark Parking

Private trademarks involving public parks might seem an odd juxtaposition.  However, this phenomenon may not be as rare as one might suppose.  For instance, Donald J. Trump has apparently registered federal trademark rights in "Central Park".  Now a trademark dispute has erupted over the names of several famous hotels located inside Yosemite National Park.  As a consequence, these iconic hotels may soon have new monikers.  For example, the Ahwahnee Hotel may transform into the much more prosaic "Majestic Yosemite Hotel".  What's next?  Perhaps Yosemite itself could be renamed "A Few Hours East of San Francisco National Park"?  Changing such famous names is bound to cause controversy, as NPR discussed on January 19, 2016.

Detaching trademarks from these famous hotels would certainly cause consumer confusion, not to mention consumer disillusionment.  On the other hand, since a new company would be managing the hotels, there could also be consumer confusion as to the source of hotel management if the names were to remain the same.  Negotiations are most likely proceeding between the departing manager of the hotels, Delaware North, and incoming managers, Aramark, because, with the hotels detached from their trademarked names, the value of the trademarks to anyone is likely to decay rapidly.

Tuesday, January 19, 2016

GMOOPS!

The leading scientific journal Nature has reported possible shenanigans in research on the genetically-modified organisms ("GMOs") at the University of Naples.  As the article relates,
Papers that describe harmful effects to animals fed genetically modified (GM) crops are under scrutiny for alleged data manipulation. The leaked findings of an ongoing investigation at the University of Naples in Italy suggest that images in the papers may have been intentionally altered. The leader of the lab that carried out the work there says that there is no substance to this claim.
Peer reviewed biological research finding adverse health effects from GMOs is elusive.  Nature points out that
The papers’ findings run counter to those of numerous safety tests carried out by food and drug agencies around the world, which indicate that there are no dangers associated with eating GM food.
This research, and the allegations of misconduct it has spawned, should provide much food for thought among both opponents and proponents of food biotechnology.  Bon appétit!

Monday, January 18, 2016

Star Wars: A New Hip

I finally saw the Star Wars Episode VII. Here is my review.

The Force Awakens is a fine workmanlike film. If it were the final project of a student, it would earn a B+. This is a good grade, really, though one that leaves ample room for improvement. Frankly, I, like many people, was relieved that it was not bad. Here is my new hope: the series will wipe the sleep out of its eyes, stretch, get out of bed, and go about its day without a yawn.

The two major themes of the Star Wars series appear to be (1) kids rebel against their parents and (2) bad guys are obsessed with death stars. The first of these is certainly universal, and, to be sure, the far more frightening of the two. Just ask any parent. The second must now have reached its physical limit. Having struck out three times, the dark force forces should really rethink how best to impose evil on the entire cosmos. Death stars are not the way. Things are now so bad for the bad that perhaps they should resort to the last of last resorts: management consultants. Surely McKinsey & Company could offer some innovative new approaches to managing evil change. How about more relatable names for Sith, such as Freddy, Diane, George, or Simone, or even new colors for lightsabers, like pink, pinstripe, paisley, or rainbow?  Rock stars, throwing stars, or even star fruit would be far preferable to Star Wars' apparent death stare decisis.

Now, what about casting?  It was fun to see prominent crossovers and veteran actors. One wonders if Kylo Ren will soon be joined by his partner Kylo Stimpy. What a brave decision to cast a Teletubby, Po, as the leading rebel pilot, when Tinky Winky would obviously have been a far safer choice! Including Han, Leia, Luke, and Chewbacca was a poignant reminder of the perils of an inadequate retirement insurance system. Finally, The Force Awakens provided a reminder of how universal British accents are throughout the universe, whether for baddies or goodies, though I question the quixotic decision that allowed actress Daisy Ridley to speak in her plummy native Westminster accent while fellow Brit John Boyega had to exchange the dulcet tones of his British accent for a less mellifluous Yankee drawl.

May the Force fully awaken in the next installment!