Intellectual Property

Tribal Sovereign Immunity May Shield Pharmaceutical Patent Owner From PTAB Inter Partes Review

Brenden Hoffman, MJLST Staffer

 

The Eleventh Amendment to the United States Constitution provides for State Sovereign Immunity, stating: “The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.”   Earlier this year, the Patent Trial and Appeals Board dismissed three Inter Partes Review proceedings against the University of Florida, based on their claim of State Sovereign Immunity. See Covidien LP v. University of Florida Research Foundation Inc., Case Nos. IPR 2016-01274; -01275, and -01276 (PTAB January 25, 2017).

Early last month, the pharmaceutical company Allergan announced that it had transferred its patent rights for the blockbuster drug Restasis to the Saint Regis Mohawk Tribe. Restasis is Allergan’s second most profitable drug (Botox is the first), netting $336.4 million in the second quarter of 2017.  Under this agreement, this tribe was paid $13.75 Million initially and will receive $15 Million in annual royalties for every year that the patents remain valid. Bob Bailey, Allergan’s Executive VP and Chief Legal Officer, indicated that they were approached by the St. Regis tribe and believe that tribal sovereign immunity should shield the patents from pending IPRs, stating “The Saint Regis Mohawk Tribe and its counsel approached Allergan with a sophisticated opportunity to strengthen the defense of our RESTASIS® intellectual property in the upcoming inter partes review proceedings before the Patent Trial and Appeal Board… Allergan evaluated this approach closely, with expert counsel in patent and sovereign immunity law. This included a thorough review of recent case law such as Covidien LP v. University of Florida Research Foundation Inc. and Neochord, Inc. v. University of Maryland, in which the PTAB dismissed IPR proceedings against the universities based upon their claims of sovereign immunity.”

IPRs are highly controversial.  The United States Supreme Court recently granted cert. in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC  to determine “whether inter partes review, an adversarial process used by the Patent and Trademark Office (PTO) to analyze the validity of existing patents, violates the Constitution by extinguishing private property rights through a non-Article III forum without a jury.” Until this issue is resolved, IPRs will continue to be by companies such as Allergan seeking to protect their patent rights.  Over the past few years, hedge fund manager Kyle Bass made headlines as a “reverse troll,” by filing IPRs against pharmaceutical companies while simultaneously shorting their stocks. Bailey has stated that “the IPR process has been a thorn in our side…We get a call from reverse trolls on a regular basis. Now we have an alternative.” This move has been well regarded by many critical of IPRs, including an October 9, 2017 post on ipwatchdog.com titled “Native Americans Set to Save the Patent System.”  In addition, the St. Regis Mohawk tribe has indicated that these types of arrangements can help the tribe generate much-needed capital for housing, education, healthcare and welfare, without requiring the tribe to give up any land or money.

However, this arrangement between Allergan and the St. Regis Mohawk tribe has attracted strong criticism from others.  Mylan Pharmaceuticals, a party in the IPR proceedings challenging multiple Allergan patents on Restasis, has called this transfer a “sham” and made comparisons to racketeering cases with lending fraud.  “Allergan Pulls a Fast One” on the Science Translational Medicine Blog states, “‘The validity of your patents is subject to review, unless you pay off some Indian tribe’ does not seem like a good way to run an intellectual property system,” this is a “slimy legal trick,” and “this deal smells.” He suggests that “legal loopholes” like this sully the whole pharmaceutical industry look bad and that this will force Congress to take action.  

In fact, U.S. Senator Claire McCaskill, the top-ranking Democrat on the Homeland Security and Governmental Affairs Committee, has already written a letter to the Pharmaceutical Research and Manufacturers of America urging  them to review “whether the recent actions Allergan has taken are consistent with the mission of your organization.”  She believes that “This is one of the most brazen and absurd loopholes I’ve ever seen, and it should be illegal…PhRMA can and should play a role in telling its members that this action isn’t appropriate, and I hope they do that.”  On October 5, 2017, McCaskill introduced a bill to the Senate “To abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents.”


Mechanical Curation: Spotify, Archillect, Algorithms, and AI

Jon Watkins, MJLST Staffer

 

A great deal of attention has been paid recently to artificial intelligence. This CGPGrey YouTube video is typical of much modern thought on artificial intelligence. The technology is incredibly exciting- until it threatens your job. This train of thought has led many, including the video above, to search for kinds of jobs which are unavoidably “human,” and thereby safe.

 

However, any feeling of safety that lends may be illusory. AI programs like Emily Howell, which composes sheet music, and Botnik, which writes jokes and articles, are widespread at this point. What these programs produce is increasingly indistinguishable from human-created content- not to mention increasingly innovative. Take, as another example, Harold Cohen’s comment on his AARON drawing program: “[AARON] generates objects that hold their own more than adequately, in human terms, in any gathering of similar, but human-produced, objects. . . It constitutes an existence proof of the power of machines to do some of the things we had assumed required thought. . . and creativity, and self-awareness.”

 

Thinking about what these machines create brings up more questions than answers. At what point is a program independent from its creator? Is any given “AI” actually creating works by itself, or is the author of the AI creating works through a proxy? The answer to these questions are enormously important, and any satisfying answer must have both legal and technical components.

 

To make the scope of these questions more manageable, let’s limit ourselves to one specific subset of creative work- a subset which is absolutely filled with “AI” at the moment- curation. Curation is the process of sorting through masses of art, music, or writing for the content that might be worth something to you. Curators have likely been around as long as humans have been collecting things, but up until recently they’ve been human. In the digital era, most people likely carry a dozen curators in their pocket. From Spotify and Pandora’s predictions of the music you might like, to Archillect’s AI mood board, to Facebook’s “People You May Know”, content curation is huge.

 

First, the legal issues. Curated collections are eligible for copyright protection, as long as they exhibit some “minimal degree of creativity.” Feist v. Rural Telephone Co., 499 U.S. 340, 345 (1991). However, as a recent monkey debacle clarified, only human authors are protected by copyright. This is implied by § 102 of the Copyright Act, which states in part that copyright protection subsists “in original works of authorship.” Works of authorship are created by authors, and authors are human. Therefore, at least legally, the author of the AI may be creating works through a proxy. However, as in the monkey case above, some courts may find there is no copyright-eligible author at all. If neither a monkey, nor a human who provides the monkey with creative tools is an author, is a human who provides a computer with creative tools an author? Goldstein v. California, a 1973 Supreme Court case, has been interpreted as standing for the proposition that computer-generated work must include “significant input from an author or user” to be copyright eligible. Does that decision need to be updated for a different era of computers?

 

The answer to this question is where a technical discussion may be helpful, because the answer may involve a simple spectrum of independence.

 

On one end of the spectrum is algorithmic curation which is deeply connected to decisions made by the algorithm’s programmer. If a programmer at Spotify writes a program which recommends I listen to certain songs, because those songs are written by artists I have a history of listening to, the end result (the recommendation) is only separated by two or three steps from the programmer. The programmer creates a rigid set of rules, which the computer implements. This seems to be no less a human work of authorship than a book written on a typewriter. Just as a programmer is separated from the end result by the program, a writer may be separated from the end result by various machinery within the typewriter. The wishes of both the programmer and the writer are carried out fairly directly, and the end results are undoubtedly human works of authorship.

 

More complex AI, however, is often more independent. Take for example Archillect, whose creator stated in an interview “It’s not reflecting my taste anymore . . .I’d say 60 percent of the things [she posts] are not things that I would like and share.” The process involved in Archillect, as described in the same interview, is much more complex than the simple Spotify program outlined above- “Deploying a network of bots that crawl Tumblr, Flickr, 500px, and other image-heavy sites, Archillect hunts for keywords and metadata that she likes, and posts the most promising results. . .  her whole method of curation is based on the relative popularity of her different posts.”

 

While its author undoubtedly influenced Archillect through various programming decisions (which sites to set up bots for, frequency of posts, broad themes), much of what Archillect does is what we would characterize as judgement calls if a human were doing the work. Deeply artistic questions like “does this fit into the theme I’m shooting for?” or “is this the type of content that will be well-received by my target audience?” are being asked and answered solely by Archillect, and are answered- as seen above- differently from how Archillect’s creator would answer them.

Even closer to the “independent” end of the spectrum, however, even more complex attempts at machine curation exist. This set of programs includes some of Google’s experiments, which attempt to make a better curator by employing cutting-edge machine learning technology. This attempt comes from the same company which recently used machine learning to create an AI which taught itself to walk with very little programmer interaction. If the same approaches to AI are shared between the experiments, Google’s attempts at creating a curation AI might result in software more independent (and possibly more worthy of the title of author) than any software yet.


The Future of Zero-Calorie Soft Drink Trademarks After the TTAB’s Coke Zero™ Ruling and Dr. Pepper Snapple’s Pending Federal Circuit Appeal

Joseph Novak, MJLST Staffer

For the past 13 years, Coca-Cola has been trying to trademark nothing. Well not actually nothing. Zero. As in zero calories. During this time, the Trademark Trial and Appeal Board (TTAB) has denied trademarking Zero for soft drinks, as the term was either generic (Referring to the genus of the good, i.e. Coke Zero as a zero calorie sports drink) or merely descriptive (Describing what the good is, i.e. “Zero” describing “Coke” as a zero-calorie version of the drink); neither of which is distinctive enough upon the Abercrombie spectrum to warrant trademark protection.

Not surprisingly, other large soft drink companies have opposed allowing Coke to register “Zero”, as no other company would be able to use “Zero” on their own mark subsequent to Coke obtaining such a trademark. This past May, the TTAB issued a ruling in favor of Coke (over the opposition of Dr. Pepper Snapple Group) allowing Coke to register numerous trademarks containing “Zero” for their soft drinks. The TTAB held that “Zero” had “acquired distinctiveness through a showing of secondary meaning”, which is a fancy way of saying that Coke had proven that the millions of dollars they had spent on marketing “Zero” meant that consumers of soft drinks were now likely to associate the term “Zero” with the Coca-Cola brand.

The TTAB ruling also contemplates Coke’s trademark infringement claim against Dr. Pepper’s “Diet Rite Pure Zero” mark for likelihood of confusion. For a mark to infringe upon another, the potentially infringing mark must cause confusion to the consuming public as to source, i.e. a showing that consumers of soft drinks would confuse the source of “Diet Rite Pure Zero” with “Coke Zero” given the distinctiveness of the “Coke Zero” mark. The TTAB essentially punts the infringement issue, dismissing Coke’s infringement claim for a failure to prove priority (because Coke could not show that they had acquired distinctiveness through before Dr. Pepper’s use of the term “Zero”, there was no infringement cause of action).

Dr. Pepper Snapple has appealed the issue of distinctiveness to the Federal Circuit, asking the court to find “Zero” as generic for zero-calorie soft drinks. That appeal is still pending. Assuming the TTAB’s finding of acquired distinctiveness for “Coke Zero” holds, the question becomes whether future uses of “[Soft Drink X] Zero” will be barred by the Patent and Trademark Office (PTO) for likelihood of confusion with “Coke Zero”? Or does this TTAB ruling only prevent future use of “Zero” on its own as a mark for soft drinks?

As outlined in this previous MJLST article, both the PTO (in deciding whether or not to register a trademark) and the Federal Circuit (who hears appeals from TTAB decisions) use the Dupont factors to determine whether there is a confusing similarity between a pending mark and an existing mark. These 13 factors, analyzed together as a whole, include:

  1. The similarity or dissimilarity of the marks in their entireties as to appearance, sound, connotation, and commercial impression.
  2. The similarity or dissimilarity and nature of the goods described in an application or registration or in connection with which a prior mark is in use.
  3. The similarity or dissimilarity of established, likely-to-continue trade channels.
  4. The conditions under which and buyers to whom sales are made, i.e. “impulse” vs. careful, sophisticated purchasing.
  5. The fame of the prior mark.
  6. The number and nature of similar marks in use on similar goods.
  7. The nature and extent of any actual confusion.
  8. The length of time during and the conditions under which there has been concurrent use without evidence of actual confusion.
  9. The variety of goods on which a mark is or is not used.
  10. The market interface between the applicant and the owner of a prior mark.
  11. The extent to which applicant has a right to exclude others from use of its mark on its goods.
  12. The extent of potential confusion.
  13. Any other established fact probative of the effect of use.

Like many likelihood of confusion cases, the analysis would likely come down to (1) similarity between the marks in terms of sight, sound, and meaning, and (2) whether or not either side could show actual confusion or a lack of such. For example, Coke would argue that any subsequent use of “Zero” in connection with a soft drink would be likely to confuse consumers that (according to the TTAB ruling) have come to associate “Zero” and soft drinks with Coca-Cola products. On the other hand, any subsequent user of “Zero” for soft drinks would likely have to rely upon a dissimilarity in appearance of the mark (as “Zero” would be the same in terms of sound and meaning), or show a lack of actual confusion between the two marks. Otherwise, the potential subsequent user could attempt to argue that “Coke Zero” is the mark in its entirety, and that “[Soft Drink X] Zero” is inherently dissimilar in its nature and thus, unlikely to cause consumer confusion.

In any regard, evidence of actual consumer confusion often comes down to which side has better survey design and results, which often correlates with which side has more resources to conduct such a survey. Thus, if the Federal Circuit upholds the TTAB decision to allow the “Zero” trademark, you better believe that Coca-Cola will put in a hero-like effort to protect their long sought-after victory over “Zero.”


The Future of Zero-Calorie Soft Drink Trademarks After the TTAB’s Coke Zero™ Ruling and Dr. Pepper Snapple’s Pending Federal Circuit Appeal

Joseph Novak, MJLST Staffer

For the past 13 years, Coca-Cola has been trying to trademark nothing. Well not actually nothing. Zero. As in zero calories. During this time, the Trademark Trial and Appeal Board (TTAB) has denied trademarking Zero for soft drinks, as the term was either generic (Referring to the genus of the good, i.e. Coke Zero as a zero calorie sports drink) or merely descriptive (Describing what the good is, i.e. “Zero” describing “Coke” as a zero-calorie version of the drink); neither of which is distinctive enough upon the Abercrombie spectrum to warrant trademark protection.

Not surprisingly, other large soft drink companies have opposed allowing Coke to register “Zero”, as no other company would be able to use “Zero” on their own mark subsequent to Coke obtaining such a trademark. This past May, the TTAB issued a ruling in favor of Coke (over the opposition of Dr. Pepper Snapple Group) allowing Coke to register numerous trademarks containing “Zero” for their soft drinks. The TTAB held that “Zero” had “acquired distinctiveness through a showing of secondary meaning”, which is a fancy way of saying that Coke had proven that the millions of dollars they had spent on marketing “Zero” meant that consumers of soft drinks were now likely to associate the term “Zero” with the Coca-Cola brand.

The TTAB ruling also contemplates Coke’s trademark infringement claim against Dr. Pepper’s “Diet Rite Pure Zero” mark for likelihood of confusion. For a mark to infringe upon another, the potentially infringing mark must cause confusion to the consuming public as to source, i.e. a showing that consumers of soft drinks would confuse the source of “Diet Rite Pure Zero” with “Coke Zero” given the distinctiveness of the “Coke Zero” mark. The TTAB essentially punts the infringement issue, dismissing Coke’s infringement claim for a failure to prove priority (because Coke could not show that they had acquired distinctiveness through before Dr. Pepper’s use of the term “Zero”, there was no infringement cause of action).

Dr. Pepper Snapple has appealed the issue of distinctiveness to the Federal Circuit, asking the court to find “Zero” as generic for zero-calorie soft drinks. That appeal is still pending. Assuming the TTAB’s finding of acquired distinctiveness for “Coke Zero” holds, the question becomes whether future uses of “[Soft Drink X] Zero” will be barred by the Patent and Trademark Office (PTO) for likelihood of confusion with “Coke Zero”? Or does this TTAB ruling only prevent future use of “Zero” on its own as a mark for soft drinks?

As outlined in this previous MJLST article, both the PTO (in deciding whether or not to register a trademark) and the Federal Circuit (who hears appeals from TTAB decisions) use the Dupont factors to determine whether there is a confusing similarity between a pending mark and an existing mark. These 13 factors, analyzed together as a whole, include:

  1. The similarity or dissimilarity of the marks in their entireties as to appearance, sound, connotation, and commercial impression.
  2. The similarity or dissimilarity and nature of the goods described in an application or registration or in connection with which a prior mark is in use.
  3. The similarity or dissimilarity of established, likely-to-continue trade channels.
  4. The conditions under which and buyers to whom sales are made, i.e. “impulse” vs. careful, sophisticated purchasing.
  5. The fame of the prior mark.
  6. The number and nature of similar marks in use on similar goods.
  7. The nature and extent of any actual confusion.
  8. The length of time during and the conditions under which there has been concurrent use without evidence of actual confusion.
  9. The variety of goods on which a mark is or is not used.
  10. The market interface between the applicant and the owner of a prior mark.
  11. The extent to which applicant has a right to exclude others from use of its mark on its goods.
  12. The extent of potential confusion.
  13. Any other established fact probative of the effect of use.

Like many likelihood of confusion cases, the analysis would likely come down to (1) similarity between the marks in terms of sight, sound, and meaning, and (2) whether or not either side could show actual confusion or a lack of such. For example, Coke would argue that any subsequent use of “Zero” in connection with a soft drink would be likely to confuse consumers that (according to the TTAB ruling) have come to associate “Zero” and soft drinks with Coca-Cola products. On the other hand, any subsequent user of “Zero” for soft drinks would likely have to rely upon a dissimilarity in appearance of the mark (as “Zero” would be the same in terms of sound and meaning), or show a lack of actual confusion between the two marks. Otherwise, the potential subsequent user could attempt to argue that “Coke Zero” is the mark in its entirety, and that “[Soft Drink X] Zero” is inherently dissimilar in its nature and thus, unlikely to cause consumer confusion.

In any regard, evidence of actual consumer confusion often comes down to which side has better survey design and results, which often correlates with which side has more resources to conduct such a survey. Thus, if the Federal Circuit upholds the TTAB decision to allow the “Zero” trademark, you better believe that Coca-Cola will put in a hero-like effort to protect their long sought-after victory over “Zero.”


Your Honor, That Guy “Subconsciously” Copied My Music!

Meibo Chen, MJLST Staffer

Under the Copyright Act, 17 USC § 106, a copyright owner of a copyrighted work has exclusive rights to reproduce, create derivative works, distribute, perform, or display that work.  The Copyright Act specifically carves out provisions that make it applicable to the music industry.  Thus, it is no surprise that the music industry frequently utilized the courts to protect its respective works.  While seemingly superfluous and redundant, such legal actions are justified as copyright infringement and piracy cost the US economy nearly $12.5 billion and more than 71,000 jobs yearly.

Copyright infringement, to the traditional public audience, simply would translate to: “that person downloaded my copyrighted music without my permission,” or “that person copied by song without my permission.”  Here is the kicker that the average consumer or musician most likely would not know.  There is such a thing called “subconscious copying” and “subconscious copyright infringement.” The illustrative case is George Harrison vs Bright Tunes Music Corp.  Long story short, the second musician wrote a song that very similar to that of the first musician’s, give or take a few notes and chords.  Even though the judge did not believe the second musician purposefully plagiarized, the second musician was nonetheless liable for a whopping $587,000.00 for subconscious plagiarism.

Flash forward to 2000, the 9th Circuit decided a similar case in Three Boys Music Corp. v. Michael Bolton, and put Learned Hand’s “subconscious copying” concept on the mantle.  More specifically, the 9th Circuit articulated the concept as requiring (1) a chain of events established between plaintiff’s work and defendant’s access to that work or (2) plaintiff’s work has been widely disseminated.

That boils down to an almost ridiculously broken cause of action for copyright infringement.  It is as if more famous musical works get more deference in an infringement case, just because more people heard it.  It also takes the objective standard and throws it out the window, as this “subconscious copying” forces a judge or jury to dive inside the mind of the alleged infringer.  To make it even more ridiculously broken, the fact-finder has to determine the SUBconscious.


Extending the Earth’s Life to Make It Off-World: Will Intellectual Property Law Allow Climate Change to Go Unchecked?

Daniel Green, MJLST Staffer

The National Aeronautics and Space Administration (NASA) recently discovered seven Earth-like planets. Three of these planets are even located the specific distance from the star, Trappist-1, in order to be considered in the proposed “Goldilocks zone” necessary to sustain life, thereby bringing about the conversation of whether a great migration for humanity is in order such as seen in movies of the last ten years such as Passengers, The Martian, Interstellar, even Wall-E. Even Elon Musk and Stephen Hawking have made statements that the human race needs to leave earth before the next extinction level event occurs. The possibility that these planets may be inhabitable presents some hope for a future to inhabit other planets.

Sadly, these planets are forty light years away (or 235 trillion miles). Although relatively near to Earth in astronomical terms, this fact means that there exists no possibility of reaching such a planet in a reasonable time with present technology despite the fact that NASA is increasing funding and creating institutes for such off worldly possibilities. As such, humankind needs to look inward to extend the life of our own planet in order to survive long enough to even consider such an exodus.

Admittedly, humanity faces many obstacles in its quest to survive long enough to reach other planets. One of the largest and direst is that of climate change. Specifically, the rise in the temperature of the Earth needs to be kept in check to keep it within bounds of the two-degree Celsius goal before 2100 C.E. Fortunately, technologies are well on the way of development to combat this threat. One of the most promising of these new technologies is that of solar climate engineering.

Solar climate engineering, also known as solar radiation management, is, essentially, a way to make the planet more reflective in order to block sunlight and thereby deter the increase in temperature caused by greenhouse gases. Though promising, Reynolds, Contreras, & Sarnoff predict that this new technology may be greatly hindered by intellectual property law in Solar Climate Engineering and Intellectual Property: Toward a Research Commons.

Since solar climate engineering is a relatively new scientific advancement, it can be greatly improved by the sharing of ideas. However, the intellectual property laws run directly contrary to this, begging the question as to why would anyone want to hinder technology so vital to the Earth’s survival. Well the answer lies in numerous reasons including the following three:

  • Patent “thickets” and the development of an “anti-commons”: This problem occurs when too many items in the same technological field are patented. This makes patents and innovations extremely difficult to patent around. As such, it causes scientific advancement to halt since patented technologies cannot be built upon or improved.
  • Relationship to trade secrets: Private entities that have financial interests in funding research may refuse to share advancements in order to protect the edge it gives them in the market.
  • Technological lock in: Broad patents at the beginning of research may force others to rely on technologies within the scope of the patent when working on future research and development. Such actions may ingrain a certain technology into society even though a better alternative may be available but not adopted.

There is no need to despair yet though since several steps can be taken to combat barriers to the advancement of solar climate engineering and promote communal technological advancement such as:

  • State interventions: Government can step in so as to ensure that intellectual property law does not hinder needed advancements for the good of humanity. They can do this in numerous action such as legislative and administrative actions, march-in rights, compulsory licensing, and asserting a control over funding.
  • Patent pools and pledges: Patent pools allow others to use one’s patents in development with the creation of an agreement to split the proceeds. Similarly, patent pledges, similarly, limit the enforcement of a patent holder by a promise in the form of a legally binding commitment. Though patent pools have more limitations legally, both of these incentivize the concept of sharing technology and furthering advancement.
  • Data commons: Government procurement and research funding can promote systematic data sharing in order to develop a broadly accessibly repository as a commons. Such methods ideally promote rapid scientific advancement by broadening the use and accessibility of each advancement through the discouragement of patents.

Providing that intellectual property laws do not stand in the way, humanity may very well have taken its first steps in extending its time to develop further technologies to, someday, live under the alien rays of Trappist-1.


Halo Electronics v. Pulse Electronics: More Discretion of District Courts in Granting Enhanced Damages

Tianxiang (Max) Zhou, MJLST Staffer

The recent US Supreme Court case, Halo Electronics v. Pulse Electronics, grants district courts more discretion in determining “enhanced damages.” The previous clear standard of the enhanced damages became murkier after this case and left much room for lower courts to decide what constitutes enhanced damages.

Section 284 of the Patent Act provides that, in a case of infringement, courts “may increase the damages up to three times the amount found or assessed.” Enhanced damages are appropriate only when the patentee proves, by clear and convincing evidence, that the infringer “willfully” infringed the patent. Prior to Halo, courts adopted a bifurcated approach to enhanced damages established in In re Seagate: First, the patentee must show the infringer’s recklessness by clear and convincing evidence, that “the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent.” If the objective standard of recklessness is satisfied, then patentee must demonstrate that the risk was either known or so obvious that it should have been known to the accused infringer.

In Halo, the jury in the district court found a high probability that the infringement was willful. However, the district court refused to grant an enhanced damages based on the two-part test, and found as a matter of law, that the patentee did not prove objective recklessness of the infringer. The Federal Circuit Court affirmed the decision.

However, the Supreme Court reversed the Appeal Court’s decision, and rejected the two-part test set forth in In re Seagate. Specifically, the Supreme Court, citing Octane Fitness LLC v. ICON Heath & Fitness, Inc, found that the test is “unduly rigid, and it impermissibly encumbers the statutory grant of discretion to district courts.” Though rejecting the two-part test, the Supreme Court did not give a clear guideline for lower courts to follow. Halo provides that, “[a]s with any exercise of discretion, courts should continue to take into account the particular circumstances of each case in deciding whether to award damages, and in what amount.” According to the Supreme Court, district courts are “‘to be guided by [the] sound legal principles’ developed over nearly two centuries of application and interpretation of the Patent Act.” Besides, the Supreme Court found that the prior two-part test, which requires a finding of objective recklessness, excludes discretionary punishment of “wanton and malicious pirate” who intentionally infringes another’s patent, and a district may grant enhanced damages even in the absence of a finding such objective recklessness.

Overall,  Halo broadened district courts’ discretion in evaluating facts of patent infringement and granting enhanced damages. While the Halo decision will definitely increase the unpredictability of patent infringement lawsuits, it is still unclear whether the broad discretion of district courts will open the gate of flood of enhanced damages. Besides, before we think about the standard of enhanced damages, it is also worthy to consider the policy implications of enhanced damages, and to ask whether and when enhanced damages are appropriate. Anyway, it would be exciting to see a clearer standard of enhanced damages in future cases, or amendments of laws and regulations.


Solar Climate Engineering and Intellectual Property

Jesse L. Reynolds 

Postdoctoral researcher, and Research funding coordinator, sustainability and climate
Department of European and International Public Law, Tilburg Law School

Climate change has been the focus of much legal and policy activity in the last year: the Paris Agreement, the Urgenda ruling in the Netherlands, aggressive climate targets in China’s latest five year plan, the release of the final US Clean Power Plan, and the legal challenge to it. Not surprisingly, these each concern controlling greenhouse gas emissions, the approach that has long dominated efforts to reduce climate change risks.

Yet last week, an alternative approach received a major—but little noticed—boost. For the first time, a federal budget bill included an allocation specifically for so-called “solar climate engineering.” This set of radical proposed technologies would address climate change by reducing the amount of incoming solar radiation. These would globally cool the planet, counteracting global warming. For example, humans might be able to mimic the well-known cooling caused by large volcanos via injecting a reflective aerosol into the upper atmosphere. Research thus far – which has been limited to modeling – indicates that solar climate engineering (SCE) would be effective at reducing climate change, rapidly felt, reversible in its direct climatic effects, and remarkably inexpensive. It would also pose risks that are both environmental – such as difficult-to-predict changes to rainfall patterns – and social – such as the potential for international disagreement regarding its implementation.

The potential role of private actors in SCE is unclear. On the one hand, decisions regarding whether and how to intentionally alter the planet’s climate should be made through legitimate state-based processes. On the other hand, the private sector has long been the site of great innovation, which SCE technology development requires. Such private innovation is both stimulated and governed through governmental intellectual property (IP) policies. Notably, SCE is not a typical emerging technology and might warrant novel IP policies. For example, some observers have argued that SCE should be a patent-free endeavor.

In order to clarify the potential role of IP in SCE (focusing on patents, trade secrets, and research data), Jorge Contreras of the University of Utah, Joshua Sarnoff of DePaul University, and I wrote an article that was recently accepted and scheduled for publication by the Minnesota Journal of Law, Science & Technology. The article explains the need for coordinated and open licensing and data sharing policies in the SCE technology space.

SCE research today is occurring primarily at universities and other traditional research institutions, largely through public funding. However, we predict that private actors are likely to play a growing role in developing products and services to serve large scale SCE research and implementation, most likely through public procurement arrangements. The prospect of such future innovation should be not stifled through restrictive IP policies. At the same time, we identify several potential challenges for SCE technology research, development, and deployment that are related to rights in IP and data for such technologies. Some of these challenges have been seen in regard to other emerging technologies, such as the risk that excessive early patenting would lead to a patent thicket with attendant anti-commons effects. Others are more particular to SCE, such as oft-expressed concerns that holders of valuable patents might unduly attempt to influence public policy regarding SCE implementation. Fortunately, a review of existing patents, policies, and practices reveals a current opportunity that may soon be lost. There are presently only a handful of SCE-specific patents; research is being undertaken transparently and at traditional institutions; and SCE researchers are generally sharing their data.

After reviewing various options and proposals, we make tentative suggestions to manage SCE IP and data. First, an open technical framework for SCE data sharing should be established. Second, SCE researchers and their institutions should develop and join an IP pledge community. They would pledge, among other things, to not assert SCE patents to block legitimate SCE research and development activities, to share their data, to publish in peer reviewed scientific journals, and to not retain valuable technical information as trade secrets. Third, an international panel—ideally with representatives from relevant national and regional patent offices—should monitor and assess SCE patenting activity and make policy recommendations. We believe that such policies could head off potential problems regarding SCE IP rights and data sharing, yet could feasibly be implemented within a relatively short time span.

Our article, “Solar Climate Engineering and Intellectual Property: Toward a Research Commons,” is available online as a preliminary version. We welcome comments, especially in the next couple months as we revise it for publication later this year.


Biosimilar Licensing

Jeff Simon, MJLST Staffer

On February 18th, Sandoz filed a petition for certiorari appealing to the supreme court to revisit the Federal Circuit’s holding in Amgen v. Sandoz. Prior to Sandoz’s petition for certiorari, the Federal Circuit denied a rehearing of the case en banc back on October 16th. Sandoz is seeking the Supreme Court to review the Federal Circuit’s holding that it could not market Zarxio, the biosimilar equivalent of Amgen’s patented biologic Neupogen, until 180 days after Zarxio received FDA approval.

Sandoz will most likely take the stance that the Federal Circuit misinterpreted the BPCIA and particularly 42 U.S.C § 262(l)(8)(A). This paragraph states that a subsection (k) biosimilar applicant seeking approval under the BPCIA shall provide notice of marketing to the reference product sponsor (biologic brand manufacturer) not later than 180 days before the date of the first commercial marketing of the licensed biological product. According to Sandoz, the Federal Circuit incorrectly held that notice shall not be given prior to FDA approval of the biosimilar. The Federal Circuit noted that the statute uses the term “licensed” biologic product, implying that the biosimilar must first obtain FDA licensure before notice of commercial marketing can be given. Sandoz argued that the statute does not require the biosimilar applicant to stay notice until 180 days of licensure, and that such an interpretation would grant the reference product sponsor a six-month extension of exclusivity on the biologic product. Accordingly, Sandoz contends that such an interpretation would result in consequences unintended by the drafters of the Biologics Price Competition and Innovation Act, stating that if such was the intention of Congress, the BPCIA would have been drafted to include a fourteen-and-a-half-year exclusivity period. It’s important to note that the Federal Circuit was unanimous regarding its decision on 180-day notice of commercial marketing.

Earlier, Amgen declined to seek a petition of certiorari regarding the Federal Circuit’s holding that the Patent Dance provisions of the BPCIA are not mandatory. However, on March 24, 2016, Amgen asked the Supreme Court to review both portions of the Federal Circuit’s opinion, including its holding regarding the Patent Dance provisions of the Act. Amgen’s cross petition came in response the Sandoz’s petition for certiorari. In its opinion, the Federal Circuit held that the information exchange and patent dispute resolution mechanisms of the BPCIA were not mandatory, and that a subsection (k) applicant may avoid these provisions subject to the consequences contemplated by the BPCIA.

Amgen v. Sandoz was the first case regarding these provisions of the BPCIA as Neupogen was the first marketed biologic to come of patent since the passing of the BPCIA. If the Supreme Court is to review the decision of the Federal Circuit, it may elect to delay until the decision of pending cases such as Amgen v. Apotex. Regardless, the possible grant of certiorari has important implications for the biotechnology and pharmaceutical industries, as a looming patent cliff is set for the biologics industry in the next 5 years.


Compulsory Licensing and Health Law

Nolan Hudalla, MJLST Staffer

In her articleA Public Health Imperative: The Need for Meaningful Change in the Trans-Pacific Partnership’s Intellectual Property Chapter, Roma Patel discusses the benefits that TRIPS “flexibilities” provide to the pharmaceutical markets in developing nations. Specific to this discussion, Ms. Patel notes that malaria is a permissible reason for a country to declare a “national emergency” or “circumstance of extreme urgency” under TRIPS. Such a declaration would allow a nation to utilize the TRIPS compulsory licensing provision. This permits “a government to allow the sale and manufacture of patented medicine without the patent holder’s consent.” With the recent development of aviable malaria vaccine, what can we expect the impact of this provision to be? In particular, will countries invoke compulsory licensing on the basis of a malaria “national emergency,” and, if so, what results can we anticipate?

According to history, we can’t expect much. According to Nicol & Owoeye, “[t]o date, there is little to suggest that the Implementation Decision and the Protocol [for the compulsory licensing provisions] can meaningfully contribute to reversing the failure of the industrialized world to supply essential medicines to the countries that need them the most. Nor does there appear to be widespread enthusiasm for using Implementation Decision and Protocol mechanisms to facilitate the provision of low-cost or no-cost pharmaceuticals to those most in need.” This certainly appears to be true for impoverished African nations. For example, the continent has already been devastated by the HIV/AIDS epidemic, yet compulsory licensing has not provided a sufficient solution. In fact, according to a UNAIDS report, “[o]f the 21.2 million people in Africa eligible for antiretroviral therapy in 2013 under the 2013 WHO guidelines, only 7.6 million people were receiving HIV treatment as of December 2012.”

Brian Owens’ article Questions Raised about Whether Compulsory Licenses get Best Pricesdiscusses one of the reasons for the disappointing results of compulsory licensing. He notes that “[t]he use of so-called ‘compulsory licenses’ by developing countries to obtain cheaper drugs for HIV and AIDS by circumventing patents has not been the best strategy for achieving the lowest prices over the past decade . . . .” Expanding on this, Owens states that, “of the 30 cases of compulsory licensing from 2003 to 2012 for which reliable data was available, the median price achieved through international procurement was lower for 19 of them [than compulsory licensing]—in the majority of cases by more than 25% . . . . The effect was strongest in the poorest countries, where in six out of seven cases the procurement price was more than 25% lower than the compulsory license price.” Amir Attaran, the director of the study discussed in Owens’ article, asserts that “countries should not rush into using compulsory licenses until they have exhausted all other options. “Countries can save money using compulsory licenses, but they can save more by negotiating and using international procurement channels . . . If saving money is paramount, then compulsory licenses may not be the optimal strategy.”

Unfortunately, saving money is paramount for many African nations. Thus the greatest “flexibility” given to these nations is not always a practical solution. Perhaps the arrival of the first malaria vaccine will motivate international leaders to learn from prior experience. Hopefully the international community will reconsider compulsory licensing, as Roma Patel did, to determine how it can better provide access to life-saving medications.