Intellectual Property

Legal Approaches to Synthetic Biology

October 20, 2013
Biotechnology, Intellectual Property

by Nihal Parkar, UMN Law Student, MJLST Note and Comment Editor

Synthetic biology is to biology what androids are to humans. Synthetic biology allows moving beyond the evolutionary constraints of life as we know it. Instead of being restricted to using or repurposing cellular genetic machinery, we can now shape our own genetic tools from the ground up. Instead of merely discovering genes, we can now fabricate genes and synthesize a genome, by restructuring the architecture of life itself.

Research institutions and corporations who have been at the forefront of synthetic biology have taken different approaches to protecting IP. Some institutions have taken up the mantle of promoting open source synthetic biology, having being inspired by the parallel open source software movement. On the other hand, corporations have largely played close to their chest, and have adopted the traditional practices of protecting their innovation through patents, copyrights, and trademarks. A recent MJLST article by Professor Andrew Torrance (Synthesizing Law for Synthetic Biology, Issue 11.2 of the Minnesota Journal of Law, Science & Technology) examines the challenges posed by intellectual property rights to the openness of the brave new world of synthetic biology.

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

October 14, 2013
Intellectual Property, Patents

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

October 14, 2013
Intellectual Property, Patents

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?

October 4, 2013
Intellectual Property

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?

May 8, 2013
Intellectual Property, Patents

by Nihal Parkar, UMN Law Student, MJLST StaffThe 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

April 9, 2013
Intellectual Property

by Benjamin Hamborg, UMN Law Student, MJLST Articles Editor

As 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).

And the Patent Goes to…… the First to File

February 19, 2013
Patents

by Emily Puchalski, UMN Law Student, MJLST Notes & Comments Editor

In just about one month the most monumental provision of the America Invents Act (AIA) will take effect. As of March 16, 2013 patents will be awarded to the first to file rather than the first to invent. This first to file system will bring the United States in accord with many other countries of the world. However, it is important note that the first to invent rule will still apply to patent applications filed before March 16th 2013.

Many patent lawyers and their clients have already began thinking about what the first to file system will mean for the American patent system. For example, a group of patent attorneys have already outlined some strategies that could be employed by inventors and predictions for how the new system will operate. Patent lawyers are not the only ones thinking about what the new systems will look like. Universities, for example, which can derive significant revenues from the patented inventions of its faculty, have implemented strategies for dealing with the new system. The University of North Dakota, for example, has stressed that the changes in the law as of March 16th govern towards immediate disclosure of any invention to the school’s intellectual property office to make sure that it can obtain patent rights on the invention, if desired, by filing an application as soon as possible with the Patent and Trademark Office.

Despite the prominence of the first to file provision of the AIA, it is important to remember that the AIA has many other important provisions aimed at changing the American patent law system. The AIA has also significantly changed the review available after a patent has been granted. The AIA both strengthens existing review procedures and creates new ones as well. In her article published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology, “The Post-Grant Problem: America Invents Falling Short,” author Kayla Fossen provides an in-depth description of the post-grant review process under the America Invents Act. Fossen also takes a look at whether the new post-grant proceedings can effectuate change on the American patent system where patents are frequently invalidated in infringement litigation. Interestingly, Fossen proposes a pre-grant review process that could be used in addition to the post-grant proceedings under the America Invents Act to ensure that patents issued are strong enough to survive validity challenges in any infringement litigation. Even though March 16, 2013 will mark a big change in US patent law, it is important to evaluate the big changes that the America Invents Act has already made, one of them being post-grant review. Luckily, Fossen’s article does just that.

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

December 4, 2012
Intellectual Property, Internet, Social Media

by Ian Birrell

Since 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

December 3, 2012
Intellectual Property, Litigation, Patents

by Thomas Manewitz, UMN Law Student, MJLST Managing Editor

In 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

December 3, 2012
Intellectual Property, Litigation, Patents

by Thomas Manewitz, UMN Law Student, MJLST Managing Editor

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