Wednesday, April 29, 2020

Balm Of Gilead

Today PBS Newshour ran the following detailed story about the latest results concerning a remdesivir clinical trial, with the most relevant portion of the video from 7:32 to 14:44. Although there is tremendous research and development needed to confront the SARS-CoV-2 pandemic, these clinical results are welcome.

Monday, April 27, 2020

The Night The Copyrights Went Out In Georgia

In a decision released April 27, 2020, the United States Supreme Court ("Supremes") decided against the State of Georgia, which had asserted its copyright in "statutory text and accompanying annotations".  Public.Resource.Org ("PRO") "is a nonprofit organization that aims to facilitate public access to governmental records and legal materials."  When it posted on the web a digital version of the "Official Code of Georgia Annotated" ("OCGA") without permission from a Georgia agency named the Code Revision Commission ("Commission"), the Commission sued PRO for allegedly infringing its copyright in the OCGA.


the annotations in Georgia’s Official Code are ineligible for copyright protection, though for reasons distinct from those relied on by the Court of Appeals.  A careful examination of our government edicts precedents reveals a straightforward rule based on the identity of the author. Under the government edicts doctrine, judges—and, we now confirm, legislators—may not be considered the “authors” of the works they produce in the course of their official duties as judges and legislators.  That rule applies regardless of whether a given material carries the force of law.  And it applies to the annotations here because they are authored by an arm of the legislature in the course of its official duties.
After Georgia v. Public.Resource.Org, Inc., anyone considering copying government works of authorship will certainly have Georgia on their mind.

Saturday, April 25, 2020

Inhabiting Technology

This weekend, I began reading W. Brian Arthur's book, The Nature of Technology:  What It Is and How It Evolves.  This has been on my reading list for ages.  Here is a quotation from page 10 that caught my attention:
Most of us do not stop to ponder technology.  It is something we find useful but that fades to the background of our world.  Yet - and this is another source of wonder for me - this thing that fades to the background of our world also creates that world.  It creates the realm our lives inhabit.
So far, I cannot put this book down.

Wednesday, April 22, 2020

Monday, April 20, 2020

No Failure To Thryv

The United States Supreme Court ("Supremes") published its opinion in the patent case Thryv v. Click-to-Call Technologies on April 20, 2020.  In her introduction to the opinion, Justice Ruth Bader Ginsburg provides a clear and succinct overview of the facts, the issues, and the Supremes' decision:
Inter partes review ["IPR"] is an administrative process in which a patent challenger may ask the U. S. Patent and Trademark Office (PTO) to reconsider the validity of earlier granted patent claims. This case concerns a statutorily prescribed limitation of the issues a party may raise on appeal from an inter partes review proceeding. 
When presented with a request for inter partes review, the agency must decide whether to institute review. 35 U. S. C. §314. Among other conditions set by statute, if the request comes more than a year after suit against the requesting party for patent infringement, “[a]n inter partes review may not be instituted.” §315(b). “The determination by the [PTO] Director whether to institute an inter partes review under this section shall be final and nonappealable.” §314(d). 
In this case, the agency instituted inter partes review in response to a petition from Thryv, Inc., resulting in the cancellation of several patent claims. Patent owner Click-to-Call Technologies, LP, appealed, contending that Thryv’s petition was untimely under §315(b). 
The question before us: Does §314(d)’s bar on judicial review of the agency’s decision to institute inter partes review preclude Click-to-Call’s appeal? Our answer is yes.  The agency’s application of §315(b)’s time limit, we hold, is closely related to its decision whether to institute inter partes review and is therefore rendered nonappealable by §314(d).  [Footnote omitted.] 
In light of this decision, it appears parties would be better served appealing to the Director of the PTO to institute IPRs than appealing institution decisions by the Director.

Sunday, April 19, 2020

Diagnostic DNA Dispute

Natera, a California biotechnology company involved in molecular oncology diagnostics, filed a patent infringement suit against ArcherDx on January 27, 2020, alleging infringement of claims of United States Patent No. 10,538,814 (the "'814 patent").  GenomeWeb reported on April 15, 2020, that Natera had amended its complaint to include alleged infringement of claims of U.S. Patent Nos. 10,557,172, 10,597,708, and 10,590,482.

The abstract of the '814 patent describes the inventive subject matter as follows:
The invention provides methods for simultaneously amplifying multiple nucleic acid regions of interest in one reaction volume as well as methods for selecting a library of primers for use in such amplification methods. The invention also provides library of primers with desirable characteristics, such as minimal formation of amplified primer dimers or other non-target amplicons.
Claim 1 of the '814 patent reads as follows:
A method for amplifying and sequencing DNA, comprising: 
ligating adaptors to cell-free DNA isolated from a biological sample, wherein the adaptors each comprises a universal priming site; 
performing a first PCR to simultaneously amplify at least 10 target loci using a universal primer and at least 10 target-specific primers in a single reaction volume; 
performing a second, nested PCR to simultaneously amplify the at least 10 target loci using the universal primer and at least 10 inner target-specific primers in a single reaction volume, wherein at least one of the primers comprises a sequencing tag; 
performing high-throughput sequencing to sequence the amplified DNA comprising the target loci.
It would not a bridge too far to predict that ArcherDx will robustly attempt to raise invalidity defenses against this and other patents claims, invoking both patentable subject matter (that is, 35 U.S.C. §101) and obviousness (that is, 35 U.S.C. §103).

Thursday, April 16, 2020

Diamond On Collapse

Today I want to highlight a book by an author whose pandemic prescience deserves acknowledgement:  Professor Jared Diamond.  His 2005 work of history, Collapse:  How Societies Choose to Fail or Succeed, holds particular relevance to the SARS-CoV-2 disaster even though its specific focus is on environmental catastrophe.

Wednesday, April 15, 2020

Chen On Disaster Law And Policy

The SARS-CoV-2 pandemic has raised into high relief myriad consequential legal and policy conundra.  Fortunately, the brilliant Professor James Ming Chen and his talented co-authors, Daniel A. Farber, Robert R.M. Verchick, and Lisa Grow Sun, wrote a textbook - now in its third edition - precisely on this topic, entitled Disaster Law and Policy.  It is mandatory reading for anyone interested in rights, responsibilities, resilience, and recovery from the global Covid-19 disaster.

Monday, April 13, 2020

The Qualitex Of Commerce Is Not Strained

Few would describe decisions by the United States Court of Appeals for the Federal Circuit ("CAFC") as colorful.  Nevertheless, the CAFC published an important opinion about color on April 9, 2020.  In In re:  Forney Industries, Inc. (CAFC 2020), the CAFC unanimously vacated and remanded a decision by the Trademark Trial and Appeal Board ("TTAB") that had held that
(1) a multi-color mark can never be inherently distinctive, and (2) product packaging marks that employ color cannot be inherently distinctive in the absence of a well-defined peripheral shape or border, we vacate and remand for further proceedings.
In its application for registration of a trademark proposed to cover "packaging for various welding and machining goods based on use in commerce under Section 1(a) of the Lanham Act, 15 U.S.C.
§ 1051(a)", Forney Industries described its packaging as follows:
[t]he mark consists of a solid black stripe at the top. Below the solid black stripe is the color yellow which fades into the color red. These colors are located on the packaging and or labels.
In contrast to the TTAB, the CAFC held that "color marks can be inherently distinctive when used on product packaging, depending upon the character of the color design".

With sincerest apologies to Portia, this case shows that the Qualitex of commerce is not strained.

Saturday, April 11, 2020

Disunitary Patent

The European Unitary Patent was intended to create a valuable patent right, available at a reasonable cost, and enforceable across a wide swathe of the European Union market.  The German Federal Constitutional Court dealt the Unitary Patent a severe blow on February 13, 2020.  An English-language press release summarizing this decision notes:
The Act of Approval to the Agreement on a Unified Patent Court (“the Act of Approval”) to confer sovereign powers on the Unified Patent Court is void. In its outcome, it amends the Constitution in substantive terms, though it has not been approved by the Bundestag with the required two-thirds majority.
The SARS-CoV-2 pandemic distracted me from realizing that this decision had already been delivered.  The United Kingdom's decision not to participate and the German Constitutional Court's rejection of Germany's accession have delivered a severe one-two punch to the Unitary Patent.

Friday, April 10, 2020

Genealawgy

Professor Teneille Brown of the University of Utah S.J. Quinney College of Law published a thought-provoking article, entitled "Why We Fear Genetic Informants: Using Genetic Genealogy to Catch Serial Killers", in the Fall 2019 issue of The Columbia Science & Technology Law Review.  In the abstract of her article, Professor Brown suggests that,
Rather than banning the use of genetic genealogy to catch serial killers and rapists, I call for improved direct-to-consumer consent processes, and more transparent privacy and security measures. This will better protect genetic privacy in line with consumer expectations, while still permitting the use of LRFS [long-range familial searching] to deliver justice to victims and punish those who commit society's most heinous acts.
Her article is well worth reading.

Monday, April 6, 2020

SciAm On Covid-19

Scientific American has published a nice primer on the SARS-CoV-2 virus and the Covid-19 pandemic. Here it is:
This is a nice antidote to some of the misinformation floating around the world.

Friday, April 3, 2020

Ridley On Reason

The admirable Matt Ridley recently gave a wide-ranging interview on SARS-CoV-2 and his forthcoming book, How Innovation Works And Why It Flourishes In Freedom:
Enjoy the wonderful acoustics from his home closet.

Thursday, April 2, 2020

Curb Your Covidiasm

Here's Larry David's paean to staying home and social distancing:
As public service announcements go, it's prett-ay, prett-ay, prett-ay good.

Wednesday, April 1, 2020

Pandemic Unpatenting

Among other legislative responses to the SARS-CoV-2 pandemic the Canadian Parliament packed into its COVID-19 Emergency Response Act are several amendments to Canadian patent law:
PART 12
 
R.S., c. P-4
 
Patent Act
 
51  The Patent Act is amended by adding the following after section 19.3:
 
Application by Minister
19.4  (1)  The Commissioner shall, on the application of the Minister of Health, authorize the Government of Canada and any person specified in the application to make, construct, use and sell a patented invention to the extent necessary to respond to the public health emergency described in the application.
 
Contents of application
(2)  The application must
(a)  set out the name of the patentee and the number, as recorded in the Patent Office, of the patent issued in respect of the patented invention;
(b)  include a confirmation that the Chief Public Health Officer, appointed under subsection 6(1) of the Public Health Agency of Canada Act, believes that there is a public health emergency that is a matter of national concern;
(c)  include a description of the public health emergency; and
(d)  specify a person, if any, that is to be authorized to make, construct, use and sell the patented invention for the purposes of responding to the public health emergency.
 
Cessation of effect
(3)  The authorization ceases to have effect the earlier of
(a)  the day on which the Minister of Health notifies the Commissioner that the authorization is no longer necessary to respond to the public health emergency set out in the application, and
(b)  one year after the day on which it is granted.
 
Notice
(4)  The Commissioner shall notify the patentee of any authorization that is granted under this section and provide them with the information referred to in subsection (2).
 
Payment of remuneration
(5)  The Government of Canada and any person authorized under subsection (1) shall pay the patentee any amount that the Commissioner considers to be adequate remuneration in the circumstances, taking into account the economic value of the authorization and the extent to which they make, construct, use and sell the patented invention.
 
Authorization not transferable
(6)  An authorization granted under this section is not transferable.
 
For greater certainty
(7)  For greater certainty, the use or sale, in relation to a public health emergency, of a patented invention that is made or constructed in accordance with an authorization granted under this section is not an infringement of the patent.
 
Power of Federal Court
(8)  On the application of the patentee, the Federal Court may make an order requiring the Government of Canada or any person authorized under subsection (1) to cease making, constructing, using or selling the patented invention in a manner that is inconsistent with the authorization granted under this section.
 
Restriction
(9)  The Commissioner shall not make an authorization under subsection (1) after September 30, 2020.

How extensively, and with respect to which particular patented inventions, Canada will invoke this compulsory licensing provision by the end of the SARS-CoV-2 pandemic remains to be seen.