Tuesday, July 25, 2017

IP Afta' NAFTA

The Office of the United States Trade Representative ("USTR") published its "Summary of Objectives for the NAFTA Renegotiation" on July 17, 2017.  Among its musings is a section devoted to intellectual property.  Here are the intellectual property "objectives":

Intellectual Property: 
- Promote adequate and effective protection of intellectual property rights, including through
the following:
  • Ensure accelerated and full implementation of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), particularly with respect to meeting enforcement obligations under TRIPS.
  • Ensure provisions governing intellectual property rights reflect a standard of protection similar to that found in U.S. law.
  • Provide strong protection and enforcement for new and emerging technologies and new methods of transmitting and distributing products embodying intellectual property,including in a manner that facilitates legitimate digital trade.
  • Prevent or eliminate discrimination with respect to matters affecting the availability, acquisition, scope, maintenance, use, and enforcement of intellectual property rights.
  • Ensure standards of protection and enforcement that keep pace with technological developments, and in particular ensure that rightholders have the legal and technological means to control the use of their works through the Internet and other global communication media, and to prevent the unauthorized use of their works.
  • Provide strong standards enforcement of intellectual property rights, including by requiring accessible, expeditious, and effective civil, administrative, and criminal enforcement mechanisms.
  • Prevent or eliminate government involvement in the violation of intellectual property rights, including cybertheft and piracy.
- Secure fair, equitable, and nondiscriminatory market access opportunities for United States persons that rely upon intellectual property protection. 
- Respect the Declaration on the TRIPS Agreement and Public Health, adopted by the World Trade Organization at the Fourth Ministerial Conference at Doha, Qatar on November 14, 2001, and to ensure that trade agreements foster innovation and promote access to medicines. 
- Prevent the undermining of market access for U.S. products through the improper use of a country’s system for protecting or recognizing geographical indications, including failing to ensure transparency and procedural fairness and protecting generic terms.


Among the issues that apparently pique the interest of the USTR are several that may be quite challenging to address.  A few are discussed below.

One is to "[e]nsure provisions governing intellectual property rights reflect a standard of protection similar to that found in U.S. law."  If U.S. intellectual property ("IP") law were fixed and static, this might be relatively straight-forward, encroachments on national sovereignty notwithstanding.  However, U.S. IP law has evolved at a brisk pace over the last decade, with the United States Supreme Court (the "Supremes") overturning long-standing lower court precedents in areas such as availability of injunctive relief, exhaustion doctrine, patentable subject matter, and nonobviousness.  This raises the question of whether Canada and Mexico should be expected continually to change their IP laws to reflect the fluid evolution of U.S. IP laws?

Another is to "Provide strong protection and enforcement for new and emerging technologies..."  Do "new and emerging technologies" include software, DNA, or methods of medical diagnosis or treatment?  If so, will the U.S. Congress statutorily reverse the Supremes' recent decisions in Alice Corporation v. CLS Bank International (2104), Association for Molecular Pathology v. Myriad Genetics (2013), and Mayo Collaborative Services v. Prometheus Laboratories (2012), which rendered inventions in these fields largely unpatentable subject matter?

Questions also arise regarding how the Doha Declaration and "ensur[ing] that trade agreements foster innovation and promote access to medicine" might affect biopharmaceutical patents, and how new NAFTA provisions might attempt to "Prevent the undermining of market access for U.S. products" that, presumably, are described by their sellers using geographical indications registered by others.

An especially intriguing objective is to "Provide strong standards enforcement of intellectual property rights, including by requiring accessible, expeditious, and effective...criminal enforcement mechanisms."  Does this mean that "criminal enforcement mechanisms" must be available not only in copyright, trademark, and trade secrecy law, where they already exist, to some extent, in the U.S., but also extended to patent law, where U.S. law currently lacks such remedies?

As discussed earlier on Lexvivo, the AstraZeneca Canada v. Apotex (2017) decision, in which the Supreme Court of Canada/La Cour Suprême du Canada annulled the "promise doctrine", may help to mollify U.S. demands for Canadian IP conformity.  However, the opaque wording of the USTR's "Summary of Objectives for the NAFTA Renegotiation" introduces considerable uncertainty as to what an acceptable agreement on IP issues would be.
  

Saturday, July 1, 2017

Canaday!

Bonne Fête du Canada à la terre de nos aïeux!

Happy Canada Day to our home and native land!

Friday, June 30, 2017

Empty Promise

The Supreme Court of Canada/La Cour Suprême du Canada ("La Cour Suprême") rarely decides patent cases.  However, when it does, it really decides them.  On June 30, 2017, La Cour Suprême handed down a decision in AstraZeneca Canada v. Apotex.  At issue was the "promise of the patent" doctrine, which the Canadian Federal Court of Appeal, and the Federal Court of Canada below, have long upheld and elaborated.  To satisfy the utility requirement, the disclosure of a patent must, for each claim, either demonstrate or soundly predict utility.  But the utility analysis does not end there;  in addition, the disclosure must also fulfill any specific promise of utility by demonstrating or soundly predicting it.

In the Hinterland Who's Who of patent doctrines, the promise of the patent is something of a Canadian endemic.  In fact, its existence in Canadian patent law has been an irritant in trade relations with the United States, and might have been addressed during any renegotiation of the North American Free Trade Agreement ("NAFTA").  La Cour Suprême has now declared it extinct.  In his Federal Court decision, Judge Rennie declared the promise of the patent "the yardstick against which utility is measured".  By constrast, La Cour Suprême held that Section 2 of the Patent Act/Loi sur les brevets did not contain any such requirement. In relevant part, Section 2 defines "invention" as
any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter...
This doctrine, however, is unsound. It is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Patent Act. 
[37] The Promise Doctrine is excessively onerous in two ways: (1) it determines the standard of utility that is required of a patent by reference to the promises expressed in the patent; and (2) where there are multiple expressed promises of utility, it requires that all be fulfilled for a patent to be valid.
ultimately, every invention pertains to a single subject-matter, and any single use of that subject-matter that is demonstrated or soundly predicted by the filing date is sufficient to make an invention useful for the purposes of [Section 2].

This judicial decision has implications well beyond the immediate parties in the case.  By relaxing the criteria for meeting the utility requirement, more inventions should be patentable.  Applicants for biopharmaceutical patents, in which demonstrating details of efficacy tends to be more challenging than in other arts, may particularly benefit from the demise of promise doctrine.

The effects of the AstraZeneca Canada v. Apotex may be especially inflammatory to the parties involved in the Eli Lilly and Company v. Canada trade dispute, which largely focused on whether or not promise of the patent doctrine was good Canadian law.  Now that the doctrine has gone up in smoke, it make spark a new fire under Eli Lilly and other patent applicants previously burned by what they view as broken promises. 

Thursday, June 29, 2017

Trademark's New Wave

In Matal v. Tam, an instant landmark decision in trademark jurisprudence, the United States Supreme Court ("the Supremes") held, on June 19, 2017, that the Free Speech Clause of the First Amendment of the U.S. Constitution forbids the U.S. Patent and Trademark Office ("USPTO") from denying registration of a mark simply because it may be racially-derogatory.  The Lanham Act includes specific authorization for such a denial in 15 U.S.C. §1052(a), which ostensibly empowers the USPTO to prohibit registration of any otherwise-registerable mark that

Consists of or comprises immoral, deceptive, or scandalous matter; or...which may disparage or falsely suggest a connection with persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt, or disrepute...
As the Supremes explain in their decision,
This case concerns a dance-rock band’s application for federal trademark registration of the band’s name, “The Slants.” “Slants” is a derogatory term for persons of Asiandescent, and members of the band are Asian-Americans. But the band members believe that by taking that slur as the name of their group, they will help to “reclaim” the term and drain its denigrating force. 
The Patent and Trademark Office (PTO) denied the application based on a provision of federal law prohibiting the registration of trademarks that may “disparage . . . or bring . . . into contemp[t] or disrepute” any “persons, living or dead.” 15 U. S. C. §1052(a).
As Simon Tam, the member of The Slants who filed the trademark application, explained to Time magazine, his band's name is meant to convey a triple entendre:
It actually sounds like a fun, 80s, New Wave-kind of band. And it’s a play on words. We can share our personal experiences about what it’s like being people of color—our own slant on life, if you will. It’s also a musical reference. There are slant guitar chords that we use in our music.
The government cannot refuse to register disparaging marks because it disapproves of the expressive messages conveyed by the marks. It cannot refuse to register marks because it concludes that such marks will be disparaging to others.
Applying strict scrutiny, the CAFC failed to find a compelling governmental interest for abridging the band's speech by denying it a trademark registration.  The Supremes broadly agreed with the CAFC, though several groups of justices filed concurrences to clarify the extent of, and particular reasons for, their decisions.

Nevertheless, the Supremes did all agree to the following droll indictment of government speech:
It is...far-fetched to suggest that the content of a registered mark is government speech, especially given the fact that if trademarks become government speech when they are registered, the Federal Government is babbling prodigiously and incoherently.
One of the underappreciated advantages afforded by the Separation of Powers in U.S. government is the delicious opportunity for each branch of government to lampoon the others.  To borrow the title of one of The Slants' songs, whenever one of the three branches of government gets uppity, either of the other branches can say, "I Wanna Break You Down."  A governance feature as cool as that should be trademarked. 

Thursday, June 15, 2017

Selling Patented Goods Is Exhausting

Lexmark International, Inc. "designs, manufactures, and sells toner cartridges to customers in the United States and abroad."  Impression Products refurbished and resold them, so Lexmark sued Impression Products for patent infringement.  The United States Supreme Court decided Impression Products v. Lexmark International on May 30, 2017, that a patentee who sells its patented products has "exhausted" its patent rights in that product.  Moreover, echoing its decision in an earlier copyright exhaustion case, Kirtsaeng v. John Wiley & Sons (U.S. 2016), the Court held that "[a]n authorized sale outside the United States, just as one within the United States, exhausts all rights under the Patent Act."  Now that the Court has decided cases in both the copyright and patent realms, the issue of exhaustion would seem to be, well, exhausted.

However, all is not lost for patent owners.  The Court suggested that patent owners might still be able to control post-sale uses of patented goods via contract.  It would not be surprising if the Court revisited this particular issue in the near future, now that contract law, not patent law, seems to govern post-sale goods.  As emphasis shifts from patents to contracts, there should be a plentiful number of contract disputes taking the place of patent enforcement actions, and some of these cases will surely raise issues of import to the Court.

Tuesday, June 13, 2017

Dancing The Right Away

The history of dance is littered with tragically unhip steps like the funky chicken, the macarena, or the Gagnam Style invisible horse-ride.  On June 12, 2017, in its Sandoz v. Amgen decision interpreting the Biologics Price Competition and Innovation Act ("BPCIA"), the United States Supreme Court made another set of moves, commonly known as the "patent dance", equally unnecessary.  According to research biologic drug company Amgen, the BPCIA entitled Amgen to an injunction ordering generic biosimilar drug company Sandoz to turn over to Amgen the marketing application it had filed with the FDA.  The Court framed the question as follows:
Is an Applicant [generic biosimilar company] required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor [reference biologic drug company] with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant "shall provide," and, where an Applicant fails to provide that required information, is the Sponsor's sole recourse to commence a declaratory-judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii)?
The Court's answer was unanimous:
If a subsection (k) applicant fails to provide the application and information required under paragraph (2)(A), the reference product sponsor, but not the subsection (k) applicant, may bring an action under section 2201 of Title 28, for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.
Under this rule, a reference biologic drug company whose FDA-licensed biologic drug entered the market first may seek declaratory judgment for infringement of its patent(s) by any would-be competitor generic biosimilar company failing to provide "its biologics license application and related manufacturing information", but may not seek federal injunctive relief to obtain that application and related information.  Nevertheless, opting out of the patent dance does narrow the options available to a generic biologics company, largely letting the research biologic company decide when and how to initiate litigation.

The Court also addressed two other important issues.  It left undecided questions about whether Amgen might be able to obtain injunctive relief under California state unfair competition law, though such availability might be federally preëmpted.  However, contrary to Amgen's assertion that a generic biosimilar company must provide notice to a relevant research biologics company only after its product has been licensed by the FDA, the Court instead decided that "[a biosimilar drug] applicant may provide notice either before or after receiving FDA approval", suggesting that biosimilar drugs could reach market earlier than six months after licensure.

Perhaps the most important result of the Sandoz v. Amgen decision is clarification about the patent dance.  Just as the whip and nae-nae is decidedly optional, so too, the Supremes have decided, is the patent dance.

Thursday, April 27, 2017

AUTM In Spring

The Milken Institute released its latest annual report on academic inventing, licensing, and entrepreneurship on April 20, 2017.  The report, entitled Concept toCommercialization - The Best Universitiesfor Technology Transfer, includes a league table of top technology transferors.  The top ten are as follows:
1.  University of Utah
2.  Columbia University
3.  University of Florida
4.  Brigham Young University
5.  Stanford University
6.  University of Pennsylvania
7.  University of Washington
8.  Massachusetts Institute of Technology
9.  California Institute of Technology
10. Carnegie Mellon University
Notice a remarkable performance by Utah, which hosts two of the top four universities on the list.

Monday, April 24, 2017

Syngenta Pays The China Price In Court

I had the pleasure of being interviewed earlier today on Bloomberg Radio regarding Syngenta's many litigations for introducing its genetically-modified Viptera corn into domestic and international agricultural commodity markets.  Here is a link to the interview.  Thank you very much, David Sucherman (producer), June Grasso (cohost), Michael Best (cohost), and Margaret Cronin Fisk (legal reporter) for a fun chat about a fascinating scientific, economic, and legal issue.

Wednesday, March 29, 2017

All Patents Great And Small

Professor Jevin D. West and I published a new article, entitled "All Patents Great and Small - A Big Data Network Approach to Valuation", on March 27, 2017, in the Virginia Journal of Law and Technology.  The article is freely available for download here.  Here is a summary of our article:

Measuring patent value is an important goal of scholars in both patent law and patent economics.  However, doing so objectively, accurately, and consistently has proved exceedingly difficult.  At least part of the reason for this difficulty is that patents themselves are complex documents that are difficult even for patent experts to interpret.  In addition, issued patents are the result of an often long and complicated negotiation between applicant and patent office (in the United States, the United States Patent & Trademark Office), resulting in an opaque “prosecution history” upon which the scope of claimed patent rights depends.  In this article, we approach the concept of patent value by using the relative positions of issued United States patents embedded within a comprehensive patent citation network to measure the importance of those patents within the network.  Thus, we tend to refer to the “importance” of patents instead of “value,” but there is good reason to believe that these two concepts share a very similar meaning.  Our study examines both patent litigation and patent importance, and suggests that litigated patents tend to be more important than non-litigated patents, and the higher the federal court level in which patent litigation takes place the more important the patents there litigated tend to be.  These findings are consistent with the findings of influential studies on patent value carried out by Allison et al. in 2004 and 2009, in which litigated patents were generally found to be more valuable than non-litigated patents and those litigated most often were found to be especially valuable.  Our findings also reveal marked differences in the mean and median importances of patents litigated in different federal district courts.  Finally, we find several geographic clusters of federal district courts characterized by the litigation of disproportionately important patents.  These clusters do not cleanly correspond to traditional assumptions about where, geographically, important technologies, and the owners of patents that claim them, tend to be located.  Somewhat unexpectedly, the largest federal district court cluster for highly important patent litigation spans the southern-central United States.  Future studies will attempt to address a number of additional questions that arise out of our findings in this article.
We thank the dedicated and talented staff of the Virginia Journal of Law and Technology, our research assistants who performed miracles compile and analyze mountains of data, and our many colleagues and family members who provided incisive and valuable comments and suggestions about how to improve our article.  We hope "All Patents Great and Small" will be the first in a series of articles in which we describe our work on big patent data. 

Tuesday, March 28, 2017

Temporal Patent Hygiene

Section 286 of the United States ("U.S.") Patent Act defines a window of opportunity in which a patent owner may recover for an alleged infringement:
Except as otherwise provided by law, no recovery shall be had for any infringement committed more than six years prior to the filing of the complaint or counterclaim for infringement in the action. 
In the case of claims against the United States Government for use of a patented invention, the period before bringing suit, up to six years, between the date of receipt of a written claim for compensation by the department or agency of the Government having authority to settle such claim, and the date of mailing by the Government of a notice to the claimant that his claim has been denied shall not be counted as part of the period referred to in the preceding paragraph.
In its March 21, 2017, decision, SCA Hygiene Products Aktibolag et al. v. First Quality Baby Products, a patent infringement dispute focusing on U.S. Patent No. 6,375,646 ("Absorbent Pants-Type Diaper"), the U.S. Supreme Court considered whether the ancient common law defense of laches could prevent recovery within a period specifically defined by a Congressional statute of limitations.  Laches is
the legal doctrine that a legal right or claim will not be enforced or allowed if a long delay in asserting the right or claim has prejudiced the adverse party. [Definition from LAW.COM]
The alleged diaper infringer, First Quality Baby Products ("First Quality") argued that SCA Hygiene Products Aktibolag et al. ("SCA Hygiene") waited so long before suing for patent infringement that laches precluded recovery.

[l]aches cannot be interposed as a defense against damages where the infringement occurred within the [six-year] period prescribed by [the statute of limitations in] §286.
Whether or not this is the best rule, it at least provides clarity about when an alleged infringer may or or may not be sued, providing a modicum of temporal hygiene in the often messy corpus of patent law.

Monday, March 27, 2017

Chevron Deference

A mere two days after Spring's official start, on March 22, 2017, six justices of the United States Supreme Court executed a nearly-perfect pyramid stunt in their Star Athletica v. Varsity Brands decision.  The question before the court was
whether the arrangements of lines, chevrons, and colorful shapes appearing on the surface of [Varsity Brands'] cheerleading uniforms are eligible for copyright protection as separable features of the design of those cheerleading uniforms.
The alleged infringer, Star Athletica, argued that such shapes imprinted on cheerleading uniforms are uncopyrightable subject matter because they constitute "useful articles".  The Supremes' majority opinion noted that
[t]he ultimate separability question, then, is whether the feature for which copyright protection is claimed would have been eligible for copyright protection as a pictorial, graphic, or sculptural work had it originally been fixed in some tangible medium other than a useful article before being applied to a useful article.
The Court summarized the test it would apply:
...a feature of the design of a useful article is eligible for copyright if, when identified and imagined apart from the useful article, it would qualify as a pictorial, graphic, or sculptural work either on its own or when fixed in some other tangible medium.
Applying its test to the facts of the case, the Court explained
First, one can identify the decorations as features having pictorial, graphic, or sculptural qualities. Second, if the arrangement of colors, shapes, stripes, and chevrons on the surface of the cheerleading uniforms were separated from the uniform and applied in another medium—for example, on a painter’s canvas—they would qualify as “two-dimensional . . . works of . . . art,” §101. And imaginatively removing the surface decorations from the uniforms and applying them in another medium would not replicate the uniform itself. Indeed, respondents have applied the designs in this case to other media of expression—different types of clothing—without replicating the uniform. [Omitted].
Siding with Varsity Brands, the Court noted that "[t]he decorations are therefore separable from the uniforms and eligible for copyright protection. [Footnote omitted]"

Though Canal Street hawkers of knockoff clothing may now have to consider dismounting from their copyright-infringing business practices, clothing designers not wanting their designs copied will likely lead an enthusiastic cheer.  Only time will tell whether Star Athletica v. Varsity Brands leads to more or less innovative fashion.

Tuesday, January 24, 2017

Brexit Becomes Bruncertainty

The United Kingdom ("U.K.") Supreme Court has ruled that the U.K. government needs the approval of Parliament before it can trigger divorce proceedings from the European Union ("E.U.) by invoking Article 50(2) of the Treaty on European Union.  On June 23, 2016, a majority of voters in the United Kingdom European Union membership referendum voted yes to the question
Should the United Kingdom remain a member of the European Union or leave the European Union?

 Subsequently, the U.K. government has been preparing to inform the E.U. of its intention to "Brexit" under Article 50(2).  The January 24, 2017, Supreme Court decision found the government lacked the prerogative power to effect Brexit without Parliament's formal consent, stating that
121.  Where, as in this case, implementation of a referendum result requires a change in the law of the land, and statute has not provided for that change, the change in the law must be made in the only way in which the UK constitution permits, namely through Parliamentary legislation.
The disarray caused by the Brexit referendum vote has now been compounded by the question of how, of even if, Parliament will actually achieve Brexit.  After all, Parliament could decline to invoke Article 50(2), or, it could decide to vote against Brexit.  Only time will tell.

Meanwhile, Brexit has become Bruncertainty.

Saturday, January 7, 2017

Great Grouper Groups

The Caribbean Sea once teemed with Nassau groupers (Epinephelus striatus), orangey-brown white-striped fish that can reach 25 kgs in size.  For most of the year, these fish are elusive, tending to hide amongst the coral and rocks of reefs to avoid becoming meals for sharks.  However, during full moons in the Northern hemisphere winter, they gather in great numbers in mating aggregations by the ocean bottom to reproduce.  Savvy fishers learned where and when to drop their nets for rich catches, and, over time, Nassau grouper populations plummeted.  Based in large part on remarkable research by brave biologists, who actually dive to the bottom of the ocean, far offshore, in the middle of the night, to observe these mating aggregations and tag their participants, conservation rules now ban the fishing of reproducing Nassau groupers.  As a consequence, populations of these fish have recently risen substantially.  My friend, Dr. Richard Nemeth, who is a Research Professor at the University of the Virgin Islands ("UVI"), has been at the forefront of this research, which was featured in Scientific American on January 5, 2017.  One of the highlights of the Biodiversity Law class I teach in the Virgin Islands will be meeting with Rick next week at UVI to discuss his research and its conservation applications.  In appreciation for the hospitality UVI always shows my students, I will reciprocate by giving a lecture there on the biology, policy, and law of deextinction.

Friday, January 6, 2017

Setting Innovation Free

I was honoured and delighted when the Centre for International Governance Innovation ("CIGI") invited me last year to become a Senior Fellow.  It is a pleasure to work with this talented group of thinkers, including Deputy Director Dr. Bassem Awad, a wonderful scholar who shares my interests in intellectual property and innovation.  As my first project for CIGI, I have written Set Innovation Free, an essay discussing the emerging power of user, open, collaborative, and free innovation (sensu von Hippel).  Here is my essay.  Here is a cool video CIGI produced to accompany my essay:

Thursday, January 5, 2017

Biolawpalooza


Courtesy of Hank Greely:

Law and the Biosciences Conference Announcement:
The Bio Lawlapalooza!

Advances in the biological sciences from such fields as genetics, neuroscience, reproductive biology, and ecology are increasingly challenging society and the laws that attempt to order, regulate, and protect it.  These advances are crystalizing a new area of work: Law and the Biosciences.  We take a very broad view of Law and the Biosciences and see it encompassing the intersections of both fields. It ranges from CRISPR’d babies and head transplants to patent law in the biosciences with intermediate stops at FDA, health plan coverage decisions, torts, property, and more.  It also includes ways in which biology and its models and approaches may help us understand better that living and evolving organism that is “the law.”

The four of us, in conjunction with the open access, Oxford University Press published Journal of Lawand the Biosciences, and the Stanford Center for Law and the Biosciences, will host the first annual Bio Lawlapalooza Conference at Stanford Law School on Thursday afternoon and all day Friday, April 20 and 21.  We hope this will provide a forum for people interested in Law and the Biosciences to gather, talk, and share insights, following the precedent of Patent Con, among other conferences.  Registration is free but participants will be responsible for their own travel and accommodation expenses; much meals will be included.

We welcome scholars who are interested in presenting at the conference as well as those who just want to attend, listen, talk, and schmooze. But we encourage all scholars interested in Law and the Biosciences to apply to present at the Conference.  Titles and abstracts of proposed presentations are due on January 30, 2017; the organizers will make decisions about presentations by February 10.  The peer-reviewed Journal of Law and the Biosciences will welcome submissions coming out of the conference.

Please contact Hank at hgreely@stanford.edu with any questions. We hope to see you all at Stanford in late April 2017!