patents

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.


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.


Shapewear Patent War: Case of the Bad Patent?

by Jennifer Nomura, UMN Law Student, MJLST Staff

Thumbnail-Jennifer-Nomura.jpgWhen most people think of patents they think of the latest computer technology or advances in medical science; but what about women’s shapewear? For those unaware of what shapewear is, it’s basically the modern version of a corset; it keeps everything pulled in, but (hopefully) more comfortable than a corset. Heather Thomson, founder of Yummie Tummie, has a patent on some of her styles of tank-top shapewear. Corset_Patent_Image.jpgWhen she found out that Spanx, a competing company, was making a very similar looking piece of shapewear, Thomson wasn’t happy. Thomson sent a cease-and-desist letter to Sara Blakely, founder of Spanx and then took to social media to complain. Websites like Forbes and the Huffington Post picked up the story. So far, the situation sounds fairly typical of other patent infringement cases, so why all the press coverage? Did I mention that Heather Thomson is a TV star of Bravo’s Real Housewives of New York? Needless to say, Thomson is not afraid of a little drama. Thomson has declared war against Blakely and Spanx. But Sara Blakely is not the underdog in this situation. Blakely founded Spanx in 2000 and is now a self-made billionaire. Blakely has now filed a declaratory judgment action in court alleging that Spanx is not infringing any of Yummie Tummie’s patents.

Spanx has been in the shapewear business 8 years longer than Yummie Tummie and has its own patents, so this might be the case of the “bad patent”. In an article entitled Patent Reform and Differential Impact, published in Issue 8.1 of the Minnesota Journal of Law, Science & Technology, authors Matthew Sag and Kurt Rohde define a “bad patent” as one “that should not have been issued.” But Sag and Rohde want to go further. HeatherThomasPatent-cmp.jpg They argue that the term “bad patent” should also include “a patent that was validly issued but is now the subject of hyper-assertion.” The main concern with bad patents is that they “are capable of generating significant revenues and thus have a distorting effect on the allocation of resources in the economy.” This can happen where once a patentee sends a cease-and-desist letter, even if the patent qualifies as a “bad patent,” the alleged infringer will immediately license with the patentee. Or it could be that the parties could take their dispute to court, like Spanx and Yummie Tummie. Now there will be an expenditure of money on both sides trying to settle this issue in court. There is also a drain on public resources as the conflict has to make its way through the court system. Sag and Rohde make several proposed reforms in order to remedy the problem of bad patents. One of their proposed reforms to the litigation process is by fee-shifting. Fee-shifting would require the patentee to pay the costs of litigation if the patent was invalidated based on easily-discoverable prior art. This proposed reform could push potential patent applicants to perform a more comprehensive search through current patents before submitting their application to the PTO. Fee-shifting could prevent bad patents from being issued in the first place, or at least making patentees think twice before they try to enforce their patent against an alleged infringer.

While the public’s interest in the dispute between Yummie Tummie and Spanx has more to do with the reputations of both founders, this situation could revive a push for reform to the patent litigation system. Perhaps there will be a revival of the interest to limit or eliminate “bad patents.”


And the Patent Goes To…… The First to File

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

Thumbnail-Emily-Puchalski.jpgIn 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.


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 Written Description Requirement Strikes Back

by Nihal Parkar, UMN Law Student, MJLST Staff

Nihal-Parkar-Thumbnail-White-Back.jpgThe written description requirement for patents often resembles the proverbial neglected middle child–it is left to its own devices and entrusted with its own care. The typical patent practitioner carefully chisels away at the claims with a thesaurus, and then proceeds to encase the exquisite sculpture with a glob of written description. Yes, the detailed description of the drawings and alternative embodiments may follow the core structure of the claims, but let’s face it–the average specification is hardly as painfully beautiful as the average claim.

A recent paper by Aaron Rabinowitz in Volume 12 of the Minnesota Journal of Law, Science & Technology, Ending the Invalidity Shell Game: Stabilizing the Application of the Written Description Requirement in Patent Litigation, analyzes this paradox in the context of how courts apply the written description requirement to routinely invalidate patents issued by the USPTO–those very issued patents that have gone through the tortious path of examination at the PTO and have been vetted by examiners and reshaped in course of the ping-pong game of office actions and their replies.

A high level of invalidation by the courts seems problematic. After all, shouldn’t patent owners be entitled to rely on the PTO’s evaluation of their patent, and be freely able to assert the patent against alleged infringers in court, without fearing that the court will find the written description to be as addled with holes as the typical chunk of Swiss cheese? Well, the courts can’t quite be blamed, given that the PTO works in mysterious ways. Reviewing the file wrapper often does not explain how each claim fulfilled the written description requirement in combination with the rest of the specification. A law firm helpfully points out, “Make Sure Your Patents Do Not Prove Their Own Invalidity!” To add to the complexity of the situation, the “written description requirement is separate from enablement.”

Patent owners would be wise to worry about the potential pitfalls of the written description getting shredded between Scylla and Charybdis. As Rabinowitz points out, “over 2000-2009, parties that attacked a patent on written description grounds succeeded more than forty percent of the time.”

Fortunately, Rabinowitz does not merely cry wolf, but supplies some solutions to keep the wolf at bay. To strengthen a patent’s validity, patent applicants can choose “to affirmatively identify the written description support for their claims in the application”. And then eagerly wait for “the PTO to either approve or question the applicant’s statement of support.” Of course, with patent examiners already being somewhat overburdened, the PTO may not be enthusiastic about yet another step in prosecution.

Rabinowitz’ article raises an interesting question that is often overlooked, and provides a practical, workable solution that is likely to be of benefit to patent owners, patent challengers, the PTO, and the courts.