Intellectual Property

Open-Source Biotechnology: Failed to Take Root or Waiting in the Wings?

by Joe McCartin, UMN Law Student, MJLST Staff

Biotechnology encompasses a wide range of cutting-edge fields, from the genetic modification of agricultural crops and energy producing bacteria, to immunology and medical device manufacturing. Rapid innovation in these areas has led to today’s most challenging ethical issues. One such concern is the fear that profits, rather than providing incentives for innovation, will slow down innovation by restricting the dissemination of new technologies, processes, and insights. In Volume 6, Issue 1 of the Minnesota Journal of Law, Science, & Technology, Robin Feldman outlined the problems an open-source biotechnology movement, one similar to the open-source computer programming world, faces in patent law, and ways that movement could navigate those complexities and potentially enhance the common good.

Feldman discussed the work of molecular biologist, Richard Jefferson, founder of Cambia and BioForge, who sought to democratize the field of plant genetics. The failure of those efforts was detailed by Sam Finegold in “The Hard Path to Open Source Bioinnovation.” Jefferson claimed that the financial incentives available to researchers were no match for an industry that had become dominated by a small handful of industrial chemical companies.

So, is there a future for open-source biotechnology? While it would seem that the pharmaceutical industry would present similar challenges to the open-source biotech movement, Connie Wong posits that open-source may be exactly what the pharmaceutical industry needs in the face of shrinking R&D budgets. She argues that small, lean players can fully utilize their competitive advantage and still protect their work by using open-source arrangements that create a fair-playing field that allows them to operate nimbly. Perhaps the Affordable Care Act may transform the pharmaceutical industry in a way that creates room for open-source innovations?

But perhaps open-source biotechnology’s real promise can be found in the work of Matthew Todd, who sought to bring the power of open-source to a neglected disease, flatworm infections. The World Health Organization documented the amazingly quick success Todd had finding more cost-effective methods of producing praziquantel, the preferred method of treating flatworm. While recognizing that the task far exceeded his abilities by himself, by tapping into not only researchers, but pharmaceutical and chemical companies, he found not one but two new methods of producing the drug! This appears to be the perfect example of the promise of open-source biotechnology. The profit motive focused attention on other diseases, restricting innovation until an open-source community sprung up. While open-source may not be the future of biotechnology innovation, it may end up playing a large role in a transformed pharmaceutical industry.


Myriad Genetics: A Look at Recent Developments in Patent Law and the Human Genome

by Roma Patel, UMN Law and Public Health Student, MJLST Staff

Years ago, the Supreme Court ruled that inventors are not entitled to federal patent protection for discoveries of laws of nature. The Court said, “natural phenomena are the basic tools with which every would-be inventor starts, so locking up the right to use them in a monopoly held by a specific patent owner will frustrate others who might want to look for new ways to interpret [those] phenomena.”

On June 13, a unanimous decision by the Supreme Court ruled that, “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but complementary DNA is patent eligible because it is not naturally occurring.” The ruling, authored by Justice Thomas, was issued in Association for Molecular Pathology v. Myriad Genetics, a landmark case bringing an end to the practice of patenting isolated parts of the human genome as they originally exist.

The defendants, Myriad Genetics, discovered and then patented the location, sequence and mutations of BRCA1 and BRCA2. Both genes are highly associated with a risk of breast and ovarian cancers. If Myriad’s patent claims were found valid, Myriad would have gained the exclusive right to isolate an individual’s BRCA genes–a necessary step in conducting diagnostic testing for the cancers.

The Plaintiffs, represented by the American Civil Liberties Union and the Public Patent Foundation, consist of a coalition of patients and researchers from University of Pennsylvania, New York University, Columbia, Yale and Emory. Plaintiffs claimed that Myriad’s patent monopoly was invalid under 35 U.S.C. § 101 and that patents on isolated natural genetic sequences would restrict medical research, limiting progress. From a patient’s perspective, such exclusive patent rights would make getting a second opinion regarding genetic predisposition almost impossible. Additionally, exclusivity would keep the cost of testing BRCA 1 and 2 higher through the absence of competitive pricing.

While patient’s rights advocates and research and educational institutions applaud the decision, many are critical. Attorney and chemistry professor Bernhard Saxe stated that the Court, “trivializes chemistry and elevates biological “information” over chemical structure in patent law, and that usurps the role of Congress and creates a new class of patent-ineligible subject matter by judicial fiat.” In Issue 2 of MJSLT’s 12th volume, Peter Edwards noted that, “It is unwise to blithely remove patent eligibility from fields in which incentives for innovation have a dramatically positive effect on the population as a whole. Patent law was established to incentivize inventions that are useful to the public, while still allowing fair access to innovations. Because the public benefit resulting from incentivizing gene patents far outweighs the potential for public loss, it is in the country’s best interest to structure and interpret patent law to find genes and methods employing them patent eligible.”

Other case outcomes, Mayo v. Prometheus and In re Bilski have determined most diagnostic claims are not patentable. Now that the Court has determined natural isolated genetic sequences are also not patentable, Myriad’s business model, an enterprise predicated on exclusive administration of the BRCAnalysis test to diagnose breast and ovarian cancers, will be difficult to sustain. Biotechnology businesses driven by research and development and investors may face less of an incentive to innovate, which could mean fewer diagnostic tests available on the market. However, multilateral ownership of such natural phenomena could possibly drive more tests to market at lower prices and provide for more accuracy due to alternate testing options. Time will tell us the precise effect this ruling will have on patients, but for now the road beyond the Myriad decision remains unclear.


Countdown Sochi ’14: Will the USOC Avoid Repeat of Ravelry Stitch?

by Comi Sharif, UMN Law Student, MJLST Staff
Next month, the United States Olympic Committee (USOC) will launch its “Road to Sochi Tour” to count down the final 100 days leading up to the 2014 Winter Olympics. As the games draw near, we are likely to see a rapid increase in the amount of Olympic advertisements and related promotions. From cereal box covers to credit card commercials narrated by Morgan Freeman, materials will flood the market for the weeks leading up to the competition, to the point where one cannot help but get caught up in “Olympic Fever“. The Olympics bring the joy of cheering on our fellow countrymen (and countrywomen) regardless of whether we have ever heard of them or their sport, let alone watched on television before the Games. Though American athletes put in countless hours of commitment in preparation to represent our country, all of it would be for naught without the efforts of the USOC.

Formed in 1894, the USOC is driven by its mission to support U.S. Olympic and Paralympic competitive excellence while exhibiting the values of the Olympic Movement. The key element of this responsibility is generating and allocating revenue. Though the USOC is federally sanctioned under the Ted Stevens Olympic and Amateur Sports Act (ASA), the non-profit corporation does not receive federal financial support. For this reason, the USOC relies heavily on sponsorships to fund its programs.

Due to the importance of sponsorships, the USOC has a major incentive to maintain its positive brand along with the reputation of the Olympics as a whole. For this reason, the ASA also grants the USOC exclusive rights to use a number of words and marks in a commercial or athletic context, including the name “United States Olympic Committee,” the International Olympic Committee symbol (consisting of 5 interlocking rings), and the words “Olympic,” and “Olympiad.” Congress has even granted enhanced protections and enforcement powers to the USOC in some circumstances. As part of these rights, the USOC can authorize the use of the protected words and marks by sponsors as well as bring legal action against violators under the Lanham Act. The rationale is that the more control over Olympic intellectual property the USOC holds, the further it can maintain and promote its good name. This, in turn, makes the exclusive right to use Olympic words and marks more valuable to sponsors, which generates more capital that can be used for the U.S. Olympic program.

The scope of the exclusive rights under the ASA has often been a source of controversy, however. Though many alleged infringers discontinue their use upon the receipt of a USOC-issued cease and desist letter, a number of disputes have been brought to court to challenge the scope of the USOC’s protection and enforcement rights under the ASA.

Author Marcella David discusses one case in particular in Trademark Unraveled: The U.S. Olympic Committee Versus Knitters of the World (Minnesota Journal of Law, Science & Technology, Vol. 14.2), involving alleged infringement by Ravelry.com in its use of the word “Ravelympics.” Rather than sending a conventional cease and desist letter, the USOC informed Ravelry.com that their use was not only infringing on the USOC’s trademarks, but that their use tends to “denigrate the true nature of the Olympic Games.” Instead of convincing Ravelry.com to switch the name of its event, the letter sparked outrage throughout the online community. Ironically, in an attempt to protect its reputation, the USOC managed to do the exact opposite shortly before the Olympics were set to begin. In her article, David assesses the USOC’s claims of infringement against Ravelry.com while noting areas in need of improvement in the current legal framework of trademark infringement enforcement.

As intellectual property infringement becomes increasingly difficult to prevent and enforce against in the age of the Internet, owners need to be creative and proactive to limit unauthorized use. In regards to the USOC, this means not going too far in enforcing rights, however. So until there is more clarity as to the extent of the USOC’s protection under the ASA, we may be in store for a repeat of the Ravelry fiasco in the coming months. Let the countdown begin!


Will AIA Post-Grant Procedures Reduce Litigation?

by Nihal Parkar, UMN Law Student, MJLST StaffNihal-Parkar-Thumbnail-White-Back.jpgThe America Invents Act (AIA) was signed into law in 2011 and fully went into effect on March 16, 2013. The AIA resulted from efforts to strengthen the US patent system and bring it in conformity with global patenting standards. One of the aims of the AIA was to reduce post-grant litigation related to patent validity. It is common for alleged infringers to challenge the validity of patents that are asserted against them in court. However, such litigation can be expensive and protracted.

Pre-AIA patent law did provide for some processes for challenging patent validity, but they were limited. The AIA tries to expand on pre-existing post-grant patent challenges by providing for patent challenge procedures that mirror litigation (discovery, witness examination, and so on) at an alternative forum for resolving validity disputes: the Patent Trial and Appeal Board at the US Patent and Trademark Office.

It is interesting to contrast pre-AIA scholarly analysis of patent challenge procedures and suggested reforms with post-AIA studies. The Minnesota Journal of Law, Science & Technology provides two contrasting articles on point. An earlier, pre-AIA article by Matthew Sag and Kurt Rohde, Patent Reform and Differential Impact (8 Minn. J.L. Sci. & Tech. 1, 2006) proposed a multistage post-grant review process. They addressed the lack of discovery and other issues in pre-AIA post-grant processes, and concluded that discovery would be unnecessary as long as the scope of reviewable issues was kept narrow. A recent MJLST note by Kayla Fossen, The Post-Grant Problem: America Invents Falling Short (14 Minn. J.L. Sci. & Tech. 573, 2013), reviews the changes introduced by the AIA, and points out that post-grant processes cannot really undo the damage created by ineffective pre-grant procedures. Therefore, the AIA is unlikely to significantly impact post-grant litigation.


Supreme Court to the Rescue: The First Sale Doctrine Survives

by Benjamin Hamborg, UMN Law Student, MJLST Articles Editor

Thumbnail-Benjamin-Hamborg.jpgAs predicted inJohn Wiley & Sons, Inc. v. Kirtsaeng: The Uncertain Future of the First-Sale Doctrine, the Supreme Court last month held, by a 6-3 margin, that the first sale doctrine does apply to works lawfully made outside of the United States. The first sale doctrine, which allows the lawful owner of a copyrighted work to dispose of that copy as he or she sees fit, was in danger of disappearing as applied to works manufactured overseas after the Second Circuit decided in August of 2011 that the doctrine only applied to works made in America.

Hailed by many as a victory for American consumers, See Gary Shapiro, Supreme Court Gives American Consumers Victory Over Copyright Owners in Kirtsaeng vs. John Wiley & Sons, FORBES (March 20, 2013, 9:16 AM), the decision also represents an important victory for American manufacturing. A decision to the contrary by the Supreme Court would have given companies in the United States, particularly publishing companies, an incentive to move manufacturing plants oversees in order to gain unlimited control over the resale of their products. In fact, any company would have been able to gain such control simply by affixing a copyrightable image or other work to an uncopyrightable product, such as a watch. Of course, as pointed out in Kirtsaeng v. John Wiley & Sons: No Good Deed Goes Unpunished, it remains to be seen whether this decision has a negative impact on the rest of the world, as publishers now have a disincentive to sell textbooks at a discounted rate in impoverished countries. See Roy Zwahlen, Kirtsaeng v. John Wiley & Sons: No Good Deed Goes Unpunished, PATENTLY BIOTECH (March 26, 2013).


Six Strikes and You’re Out: Can a New RIAA Policy Solve Old Online File Sharing Problems?

by Ian Birrell

Thumbnail-Ian-Birrell.jpgSince at least 1999 when Napster was originally launched, internet piracy, or downloading copyrighted materials (especially songs, videos, and games,) has been a contentious activity. The Recording Industry Association of America (RIAA) has historically taken a very public and aggressive stance by finding individuals associated with IP addresses matching those where this “file sharing” is coming from. After finding such a target, the RIAA would send a letter demanding a settlement for thousands of dollars or threatening litigation, risky and expensive to the target, despite a potentially very small monetary value of downloaded material. The RIAA suits, which have continued for a number of years, include a number of well publicized absurd claims.

This journal has written on the RIAA policies before. In 2008, we published a student note by Daniel Reynolds named The RIAA Litigation War on File Sharing and Alternatives more Compatible with Public Morality. Reynolds argued then that the policies were ineffective and unconscionable and urged change.

Change is coming. Later this year, after a number of years in development, a number of major carriers are planning to institute a “six-strikes” plan. This is a voluntary agreement between ISPs and certain content providers (the government is not involved,) and is made to target peer-to-peer downloading. The plan has a notice phase, an acknowledgement phase, and a mitigation phase. Under the plan, a private carrier – say, Time Warner – will first notify a user that there has been an allegation of illegal copyright activity, then force a user who may be infringing (and who may or may not own the account) to acknowledge having received such notices, before the user finally suffers consequences. These consequences can include throttling of internet speed or having popular websites blocked.

Proponents point to a few positives under this proposal, including the user’s right to appeal to an independent arbitrator (for a $35 fee.) Additionally, though lawsuits are still permitted by copyright holders, the hope is that the system will educate the public about copyright infringement and that, on notice that their behavior is illegal, infringement will at least slow down. Ron Wheeler, a Senior VP at Fox, said that, “This system is not designed to produce lawsuits–it’s designed to produce education.

Unfortunately, a lack of education may not be the underlying problem. Reynolds noted that, even in 2004, awareness of the (il)legality of file sharing was widespread. And increasing awareness may not sharply decrease infringement. Critics further note that, despite the safeguards, penalties are ultimately based on accusations rather than definite findings of infringement. If the system ultimately works, though, it may be worth the headaches for both sides. Consumers will not be able to infringe (as much) but the public will also not suffer suits against twelve-year-olds for sharing music.


Apple & Samsung Litigation Shows Need for Patent Reform

by Thomas Manewitz, UMN Law Student, MJLST Managing Editor

Thumbnail-Thomas-Manewitz.jpgIn the past two years, two of the world’s mobile technology leviathans, Apple and Samsung, have engaged in multibillion dollar patent infringement litigation. Specifically, Apple has been seeking damages and fighting for injunctions on several of Samsung’s mobile products in markets across the globe. On August 24, 2012 in the United States, Apple won a 1.049 billion dollar damages award for Samsung’s “willful patent infringement.” In the same lawsuit, Samsung counter sued and won zero damages. In the wake of this trial, Apple is seeking an injunction for 20 Samsung products.

Samsung provides the market with a popular Apple alternative that does not come close to dominating the market share. In the context of the litigation, both Samsung and Apple were forced to release their U.S. sales numbers. Samsung, who is at risk of having its products blocked from the U.S. markets, sold 21 million smart phones and 1.4 million tablets, while Apple sold 86 million smart phones and 34 million tablets. New and different products are now at risk from being removed from consumer markets because of our patent litigation structure. I will not argue that this case alone will temper innovation; however, it does beg the question as to whether or not high profile patent litigation, and the patent system as it currently stands, optimizes the production societal good and innovation. Perhaps the United States patent system should be reorganized based on different principle. For a discussion of the reorganization of the patent system see the United States patent system see Liza Vertinsky’s article in the Minnesota Journal of Law, Science & Tehcnology, “An Organizational Approach to the Design of Patent Law.”


Apple & Samsung Litigation Shows Need for Patent Reform

by Thomas Manewitz, UMN Law Student, MJLST Managing Editor

Thumbnail-Thomas-Manewitz.jpgIn the past two years, two of the world’s mobile technology leviathans, Apple and Samsung, have engaged in multibillion dollar patent infringement litigation. Specifically, Apple has been seeking damages and fighting for injunctions on several of Samsung’s mobile products in markets across the globe. On August 24, 2012 in the United States, Apple won a 1.049 billion dollar damages award for Samsung’s “willful patent infringement.” In the same lawsuit, Samsung counter sued and won zero damages. In the wake of this trial, Apple is seeking an injunction for 20 Samsung products.

Samsung provides the market with a popular Apple alternative that does not come close to dominating the market share. In the context of the litigation, both Samsung and Apple were forced to release their U.S. sales numbers. Samsung, who is at risk of having its products blocked from the U.S. markets, sold 21 million smart phones and 1.4 million tablets, while Apple sold 86 million smart phones and 34 million tablets. New and different products are now at risk from being removed from consumer markets because of our patent litigation structure. I will not argue that this case alone will temper innovation; however, it does beg the question as to whether or not high profile patent litigation, and the patent system as it currently stands, optimizes the production societal good and innovation. Perhaps the United States patent system should be reorganized based on different principle. For a discussion of the reorganization of the patent system see the United States patent system see Liza Vertinsky’s article in the Minnesota Journal of Law, Science & Tehcnology, “An Organizational Approach to the Design of Patent Law.”


Ask Not What Your Country Can Do For Your Patent . . .

by Caroline Marsili, UMN Law Student, MJLST Staff

Thumbnail-Caroline-Marsili.jpgThe candidates aren’t talking about patents (with the exception of a brief quip about IP piracy in last Tuesday’s debate). But if it’s “all about the economy,” they should be talking patent policy.

In the presidential and vice-presidential debates of recent weeks, the candidates have exchanged vitriol and “gotchas,” and have established a contrast in both policy and character for voters. Notably absent from the debates has been discussion of innovation, and more specifically, the role of IP policy in innovation. IP policy would seem an attractive platform for discussing job creation, as IP industries account for a vast portion of the Nation’s jobs and GDP (“IP-intensive industries” accounted for 27.7 of all jobs in the economy in 2010). It’s possible that the candidates find common ground on this issue. Alternatively, the topic is, for the time-being, moot in the wake of the America Invents Act, the full effects of which are yet to be seen.

Since its passage just over a year ago, some critics have expressed doubt that the Act will create jobs and promote innovation as promised. Others argue not that the Act is failing, but that it represents a misplaced effort to reform patent policy.

The solution? “Don’t just reform patents, get rid of them.” A recent working paper by Boldrin & Levine makes the bold case that our patent system is ultimately more trouble than it’s worth. The authors admit that abolishing patents “may seem ‘pie-in-the-sky'” and acknowledge the glut of transitional issues that would need addressing; just the same, they conclude that the key to reforming our patent system is to get rid of it. Their central beef with the system is the want of empirical evidence that it does what it purports to do: promote innovation and productivity. Meanwhile, there are other incentives for innovation and many negative externalities of the patent system.

Other authors have proposed less radical approaches to revamping the patent system. In her recent article in MJLST, “An Organizational Approach to the Design of Patent Law“, Liza Vertinsky also finds that empirical literature fails to decisively connect patents to innovation and economic growth. However, Vertinsky takes a more optimistic approach to the floundering patent system, arguing that policy-makers should seize reform efforts as an opportunity to tailor the patent law to innovation objectives. The America Invents Act, she argues, isn’t a significant change in the direction of patent policy and instead seeks to remedy narrower concerns with administrative backlog, litigation costs and patent quality. In her view, patent policy should be revamped to encourage innovation based on how individuals and organizations–corporations, Congress, the PTO–really function.

Vertinsky’s “organizational approach” entails a new way of thinking about patents in terms of how patent policy, informed by economic theory, should be fashioned to strengthen the organization of innovation rather than focusing on incentivizing acts of invention. For example, patent laws can be tailored to the needs of different innovation processes across different industries. While sweeping changes in patent policy are unlikely at this time (witness the battles encountered in passing and implementing the America Invents Act), Vertinsky’s proposals should inform discussion among policy-makers about what the patent system can and should do. The Obama Administration’s national innovation strategy neglected to give patent policy a more central role in encouraging innovation, but the desire to build an “innovation economy” is certainly there, and a rational and successful patent policy is vital to attaining the kinds of high-level jobs and industry the country needs and the candidates promise.

(Others think patent policy may not matter at all. What do you think?).


The Supreme Court to Decide the Fate of the First-Sale Doctrine in Kirtsaeng

by Benjamin Hamborg, UMN Law Student, MJLST Articles Editor

Thumbnail-Benjamin-Hamborg.jpgLater this month, the U.S. Supreme Court is scheduled to hear oral arguments in Kirtsaeng v. John Wiley & Sons, Inc., a case which should decide once and for all whether the first-sale doctrine applies to works manufactured outside of the United States. As I described last spring in volume 13 of the Minnesota Journal of Law, Science & Technology, the case arises from Supap Kirtsaeng’s attempt to take advantage of the disparity in pricing between textbooks manufactured for sale in the United States and those manufactured and sold internationally. Kirtsaeng’s plan involved purchasing textbooks published by John Wiley & Sons, Inc.’s wholly-owned subsidiary John Wiley & Sons (Asia) Pte Ltd., then reselling the textbooks online to consumers within the United States.

While textbooks published by John Wiley & Sons, (Asia) Pte Ltd. for the international market are nearly identical in terms of content to their U.S. counterparts, the international versions sell for significantly less due to differences in quality and design. When John Wiley & Sons, Inc.–as the registered copyright holder of the United States editions of the works sold by Kirtsaeng–sued for copyright infringement, Kirtsaeng based his defense on the first-sale doctrine, which allows “the owner of a particular copy [of a copyrighted work] . . . lawfully made under this title . . . to sell or otherwise dispose of the possession of that copy” without the permission of the copyright holder.

The question the Supreme Court will face on October 29th is whether the first-sale doctrine applies to works manufactured outside of the United States, a question which the Second–in John Wiley & Sons, Inc. v. Kirtsaeng–and Ninth Circuits have already answered in the negative. The prospect of nationwide denial of the first-sale doctrine to works manufactured outside of the United States has broad implications with regard to the sale of gray-market goods within the United States. Many large United States retailers, particularly online retailers, use gray-market goods to deliver products to customers at a substantial savings. In fact, there exists “an estimated $63 billion annual market ‘for goods that are purchased abroad, then imported and resold without the permission of the manufacturer.'”

Narrowing of the first-sale doctrine may even affect the ability of libraries in the United States to lend foreign manufactured books. As Andrew Albanese recently pointed out, “if a library bought a book in the U.S. from a U.S. publisher, and that book happened to be printed in China . . . . the uncertainty the Second Circuit interpretation [of the first-sale doctrine] would create for libraries could deter many libraries from lending [the] materials in question.” Finally, if the Second Circuit’s holding is affirmed by the Supreme Court, companies that manufacture copyright-protected goods within the United States will have an incentive to move their manufacturing plants abroad so as to gain greater control over the sale of their products.