Category: Biotech & Cleantech

Brain Spray and the Law

Womble Carlyle

Now that we can capture and use the signals emitted by human brains, we should consider whether brain signals are public property. If your face and voice become available to the public through use, is the same true for your thoughts, when they can be read by others?

Several recent news items have illustrated the progress humans have made in understanding the brain’s workings and harnessing an active brain for practical purposes. For example, this week, Duke University researcher Miguel Nicolelis used microchips and the internet to connect the brains of two mice on different continents, so that the thoughts of one can influence the actions of the other. Much of Dr Nicolelis’s work involves creating an exoskeleton that a paralysed person could operate with brain signals.

Similarly, University of Pittsburgh researcher Andrew Schwartz has been working since 2006 to find ways for a person to control a robotic arm with only brain signals. In February 2013, surgeons implanted four microchips in a paralysed patient’s brain that translate her brain’s signals into movement in robotic equipment. 60 Minutes and ABC News showed a video of the Pittsburgh patient feeding herself ice cream through brain signals to a robotic arm.

Such scientific work involving directed brain signals seems like science fiction, but the technology is available right now, and will only improve over time, and soon will be available commercially. Right now, the most rudimentary brain-driven technology can be purchased. High-end toy emporium Hammecher Schlemmer sells a “Telekinetic Obstacle Course” that use focused brain waves to manoeuvre a ball through an obstacle course. The game comes with a headband to read your brain signals and then wirelessly transmit those signals to the game’s air fan, which increases or decreases speed depending on your signal, blowing a foam ball around an obstacle course.

For example, Australian scientist and entrepreneur Tan Le, the founder of Emotiv Lifescience, has created a headset that serves as an interface for reading the wearer’s brainwaves, making it possible to control virtual and physical objects with directed thoughts. Eventually the headset will be conditioned for diagnostic use, but current products using the brain-interface headset for videogames, allowing users to drive virtual race cars with their concentrated thoughts.

Modern science has identified two types of “brain spray”, or signals that can be harnessed from outside of a person’s skull. The first is the directed thoughts described in the examples above, where certain voluntary brain signals, created by the subject concentrating on a goal or action, are read and translated by either a device worn by the subject or by microchips placed in the subject’s head. Research into this field, including US government funded research by DARPA, may lead to practical solutions allowing wounded veterans or other people with disabilities to grasp, drive, walk and talk again.

This type of brain spray will lead to legal concerns. For example, if a wounded soldier is offered a limb that responds to his thoughts, the company providing the limb will want to capture information from the electronics that capture brain signals, both for understanding and improving the equipment and for monitoring its use. Could a disabled person say “no” to the company who was offering a newly functional life, or would he be forced to sign away his brain spray for benefit of science and a company providing the equipment.

We all know that our signals from laptops and smartphones are captured by any number of companies – telephone signal providers, hardware manufacturers, app developers, banks and payment businesses – when we undertake actions or transactions over the internet. There is no reason that the same rules would not apply to our directed thoughts when our computing devices are controlled by focused brain signals. Google is already testing computing in the form of eyeglasses that could easily be equipped to read such brain spray and turn it into both action and data. Our thoughts would be available to our service providers.

The other brain spray that can be captured and turned to practical use is translation of brain activation signals currently read by functional magnetic resonance imagining machines (fMRI). These signals are more intrusive than the focused brain signals described above, because the fMRI provides pictures of what part of a human brain is activated by situations or stimuli. The fMRI pictures can easily be interpreted as triggers for various emotions. Because certain emotions trigger activity in specific parts of the brain, fMRI brain spray comes close to showing what the subject is feeling about the situation he is in.

Scientists currently read and interpret the emotional and logical meanings of fMRI signals from the human brain. In a 2008 article for Atlantic Monthly, Jeffrey Goldberg submitted himself to brain readings where scientists used MRI scanning to observe which areas of Goldberg’s brain reacted to certain images. The scientist showed Goldberg pictures of personal, political and cultural figures, recording his brain’s involuntary reactions with the MRI machine and noting when his brain activated in areas indicating affection and affinity for certain pictures (Goldberg’s wife and Bruce Springsteen) and revulsion at other pictures (Osama bin Laden).

This technology is attractive to corporations wanting to know how to stimulate your urge to buy their products and to see how you react to their advertising. However, do you want companies to know this much about you? Current law holds that if you have no reasonable expectation of privacy, then you cannot stop anyone from harvesting information from you. For example, when you are out on the public roads or when you walk up to an Automated Teller Machine at the bank, you are subjecting your appearance, your facial expressions and even your body itself, to scrutiny, photography, recordation and information capture by other people (or the bank) who share your public space.

If your appearance, your voice, and even your DNA is available to everyone in public (many US courts allow police to collect a suspect’s DNA in public places without a warrant), then why would this rule not extend to your brain spray when you enter the public area at a time that mobile fMRI technology or other brain signal capture technology is commercially available? Exposing your brain signals in public may be no different from exposing your face or your voice at the same time. Why would you have a reasonable expectation of privacy in your brain spray when you know it can be read by anyone with the right equipment? Many will argue that once your body is in a public space, then it can be read by the government or business in any way that they are able.

If there were limits to the use of this technology to read your exposed brain signals, situational rules would have to be developed. For example, when fMRI technology is cost-effective and practical to use from a distance, should you automatically submit to brain scanning just by walking into a certain store, casino, bank or government building? Will companies provide notice before scanning you? Will the scan data be linked to your credit card purchases to identify you, linked to the uniform identifier in your smartphone, or linked to RFID tags in the products you buy?

This technology also has national security applications for interpreting malice in sensitive situations. The government may be able to read a suspect’s brain activity to identify intent to act before the crime takes place, scanning banks and airports for signs of potentially criminal intent. But our criminal law is based on punishment for actions, not thoughts or intentions. Everyone has intemperate thoughts of anger, frustration and fantasies of outrageous exploits, but people manage to keep those ideas in their heads and not act on them. How much do you want the government to know about your unfiltered thoughts, once those thoughts can be read from outside your head?

Once the technology is widely available, anyone could use its invasive and interpretive powers. Employers may examine their workers for hostile thoughts toward management or sympathetic thoughts toward labour organisers. Colleges can probe their applicants’ level of enthusiasm for learning. The military could test for signs of homosexuality in recruits without asking or telling. Lawyers and investigators in divorce cases would have a new avenue to examine unfaithful behaviour. How quickly would enthusiastic opposition dig up the thought crimes of political candidates?

Our laws are inadequate for addressing these issues or protecting the privacy of our brain spray. Current privacy law in the United States would not prohibit harvesting brain spray and would not even require an individual’s permission to do so. The current American privacy laws relating to reading your biometric measurements and physical condition only apply to body signs taken for health care purposes.

If a hospital records your blood type or your DNA to test for disease, those records are private and you have the right to keep them from being used for other purposes. However, a reading of your body, including your DNA and your brain spray, is not protected from transmission or sale between companies if the reading was taken for security, marketing or intelligence purposes. The recorded thoughts showing your excitement at the perfect little black dress or those used to power your prosthetic arm may be transferred to anyone. The law leaves you vulnerable.

Brain spray is the ultimate prize in the larger security and privacy debate concerning what personal facts may be captured by commercial or governmental interests. Why bother asking you what you think about a politician or a product when a company can read it directly from your brain? Without legal change, finding out who really loves “mom”, apple pie and America could soon be as simple as a head examination.

Originally published March 22, 2013 in the International edition of Intellectual Property Magazine Online

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A Short-Lived Victory for Generic Drug Manufacturers?

Sheppard Mullin 2012

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where federal law prohibits an action required by state law. The Supreme Court had previously held in Pliva v. Mensing, 564 U.S. ____ (2011) that failure to warn claims against generic drug manufacturers are pre-empted by the Federal Food Drug and Cosmetic Act since generic drug makers must copy innovator drug labeling precisely in order to obtain approval of their products by the U.S. Food and Drug Administration (“FDA”). The Court in Mutual rejected the argument of lower courts that the generic manufacturer could comply with both federal and state law by choosing not to make and distribute the product at all.

The case in question involved the drug sulindac, a non-steroidal anti-inflammatory drug product marketed by the innovator as Clinoril®. The plaintiff in the case had been prescribed sulindac for treatment of shoulder pain. She subsequently developed a case of toxic epidermal necrolysis following taking an FDA approved generic product equivalent to Clinoril®, which resulted in significant and permanent disability (including blindness) and disfigurement. Subsequent to the event, the FDA required a more specific warning as to this possible side effect on sulindac products. A jury found the generic manufacturer liable under a theory that there was a design defect with the product, and the First Circuit affirmed, holding that the generic manufacturer could have complied with both federal and state law by not manufacturing and distributing the product. This was the method by which the lower courts overcame prior precedent that a state law may be impliedly pre-empted when it is not possible to comply with both federal and state law.

The Supreme Court in Mutual noted that the generic manufacturer could not comply with the state law, since federal law requires that the active ingredient, the amount of the active ingredient, the dosage form, and the labeling had to be identical to the innovator product. In this case, it was not possible to redesign the product, and the only way, under New Hampshire law, to remedy the design defect would have been to strengthen the product’s warnings. That too could not be done, as FDA rules require the labeling of the generic to be identical to that of the innovator. The Court ruled that in such a case the state law is without effect, and relevant New Hampshire warning-based design defect cause of action was pre-empted with respect to FDA-approved generic drugs sold in interstate commerce.

The scope of the Mutual decision may be limited to those states where design-defect claims allow for a risk-utility approach such as that the New Hampshire requires. The New Hampshire standard requires, among other things in determining whether there is a valid cause of action for a design defect, a determination as to whether there is a possible warning to avoid unreasonable risk of harm from the design defect and the efficacy of such warning. So not every design-defect claim may be pre-empted, depending on each state’s laws are interpreted. But given the Court’s reasoning, even state laws that do not take into effect the presence of and efficacy of a warning, may be pre-empted, as the generic must copy the formula of the innovator in all respects, except for the inactive ingredients in the product. (It should be noted that generics of some dosage forms – ophthalmic products and injectable products – must, in most cases, contain the same inactive ingredients as in the innovator product in the same amounts).

Furthermore, the FDA may amend its rules to permit ANDA holders to make changes in labeling. See “FDA Rule Could Open Generic Drug Makers to Suits,” The New York Times, Business, July 4, 2013, at B2. As stated in the posting on the OMB website (RIN 0910-A694):

Abstract: This proposed rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change. The proposed rule would describe the process by which information regarding a “changes being effected” (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA’s review of the labeling change. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder’s CBE labeling supplement. These proposed revisions to FDA’s regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements.

The expected date for a Notice of Proposed Rulemaking is September 2013. It could, of course, take FDA quite some time to propose a rule, and put it into effect, given the requirements of the Administrative Procedure Act. And Congressional action is also a possibility.

For the present, however, generic drug manufacturers appear to be shielded from liability under the doctrine of pre-emption from most, if not all, failure to warn and design defect claims under state law. Whether that victory is short-lived or not remains to be seen.

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No Implied Duty to Develop Particular Strata in Pennsylvania (e.g. Marcellus Shale)

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On June 21, 2013, the Superior Court of Pennsylvania (the “Court”) held that a lessee does not owe a duty to a lessor to develop each and every “economically exploitable strata” under an oil as gas lease in Pennsylvania.

In early 2012, Terry L. Caldwell and Carol A. Caldwell, husband and wife (“Plaintiffs”) sued Kriebel Resources Co., Range Resources—Appalachia, LLC and others (“Defendants”) regarding an oil and gas lease executed between the Plaintiffs and Defendants on January 19, 2001 (the “Lease”). The Lease provided for a primary term of twenty four (24) months and so long thereafter as oil or gas was being produced. The Defendants drilled a number of shallow wells on the property that Defendants alleged held the entire property under the terms of the Lease. Plaintiffs brought suit against the Defendants in early 2012 alleging that, among other things, Defendants breached the implied duty to develop the property by not drilling deeper wells to exploit the valuable Marcellus Shale and, based on such potential unexploited value, the current production did not amount to production in paying quantities. The trial court sustained certain preliminary objections raised by the Defendants that resulted in a dismissal of Plaintiffs’ claims. In Terry L. Caldwell et al. v. Kriebel Resources Co. et al. (1305 WDA 2012), the Court affirmed the trial court’s dismissal of the case.

Regarding the duty to develop, Plaintiffs argued that without direct Pennsylvania case law on topic the Court should follow a Louisiana case, Goodrich v. Exxon Co., 608 So.2d 1019 (La. App. 1992), which held that Exxon’s duty to develop as a reasonably prudent operator included the obligation to develop valuable oil-producing sands underlying the leased premises. Based on this rationale, Plaintiffs alleged there is an implied duty to “develop all strata, not simply to extract shallow gas . . .” The Court rejected the application of the Goodrich rationale and held that the specific terms of the Lease were to control. Therefore, because the Lease provides for the continued validity of the Lease upon production of gas and allows for the guarantee of delay rentals if no gas is produced, the Court found that it was “not compelled to follow Louisiana law.” The production from various shallow wells was found to be sufficient to hold the entirety of the leased estate.

The Court also rejected Plaintiffs’ claim that the concept of “paying quantities” should be based on all potential gas strata underlying the Lease and should impose some obligation relating to good faith. The Court quickly dismissed this claim and made clear that “paying quantities” in Pennsylvania merely requires the well to “consistently pay[] a profit, however small.” It is of no legal effect that the extent of the profit produced from these shallow wells is “not to the extent appellants desire.” Due to the continued production in paying quantities and the Court’s failure to impose a duty on Defendants to develop all potentially economic strata, the Court chose not to terminate Defendants’ Lease.

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Financial Innovation for Clean Energy Deployment: Congress Considers Expanding Master Limited Partnerships for Clean Energy

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Technological innovation is driving renewable energy towards a future where it is cost competitive without subsidies and provides a growing share of America’s energy. But for all the technical progress made by the clean energy industry, financial innovation is not keeping pace: access to low-cost capital continues to be fleeting, and the industry has yet to tap institutional and retail investors through the capital markets. This is why a bipartisan group in Congress has proposed extending master limited partnerships (MLPs), a financial mechanism that has long driven investment in traditional energy projects, to the clean energy industry.

Last month Senators Chris Coons (D-DE) and Jerry Moran (R-KS) introduced the Master Limited Parity Act (S. 795); Representatives Ted Poe (R-TX), Mike Thompson (D-CA), and Peter Welch (D-VT) introduced companion legislation (H.R. 1696) in the House of Representatives. The bills would allow MLP treatment for renewable energy projects currently eligible for the Sec. 45 production tax credit (PTC) or 48 investment tax credit (ITC) (solar, wind, geothermal, biomass, hydropower, combined heat and power, fuel cells) as well as biofuels, renewable chemicals, energy efficient buildings, electricity storage, carbon capture and storage, and waste-heat-to-power projects. The bill would not change the eligibility of projects that currently qualify as MLPs such as upstream oil and gas activities related to exploration and processing or midstream oil and gas infrastructure investments.

MLPs have been successfully utilized for traditional fossil-fuel projects because they offer an efficient means to raise inexpensive capital. The current total market capitalization of all energy-related MLPs exceeds $400 billion, on par with the market value of the world’s largest publicly traded companies. Ownership interests for MLPs are traded like corporate stock on a market. In exchange for restrictions on the kinds of income it can generate and a requirement to distribute almost all earnings to shareholders (called unitholders), MLPs are taxed like a partnership, meaning that income from MLPs is taxed only at the unitholder level. The absence of corporate-level taxation means that the MLP has more money to distribute to unitholders, thus making the shares more valuable. The asset classes in which MLPs currently invest lend themselves to stable, dividend-oriented performance for a tax-deferred investment; renewable energy projects with long-term off-take agreements could also offer similar stability to investors. And since MLPs are publicly traded, the universe of potential investors in renewable projects would be opened to retail investors.

The paperwork for MLP investors can be complicated, however. Also, investors are subject to rules which limit their ability to offset active income or other passive investments with the tax benefits of an MLP investment. Despite the inherent restrictions on some aspects of MLPs, the opportunities afforded by the business structure are generating increasing interest and support for the MLP Parity Act.

Proponents of the MLP Parity Act envision the bill as a way to help renewable energy companies access lower cost capital and overcome some of the limitations of the current regime of tax credits. Federal tax incentives for renewable energy consist primarily of two limited tools: tax credits and accelerated depreciation rates. Unless they have sizeable revenue streams, the tax credits are difficult for renewable project developers to directly use. The reality is only large, profitable companies can utilize these credits as a means to offset their income. For a developer who must secure financing though a complicated, expensive financing structure, including tax equity investors can be an expensive means to an end with a cost of capital sometimes approaching 30%. Tax credits are a known commodity, and developers are now familiar with structuring tax equity deals, but the structure is far from ideal. And as renewable energy advocates know all too well, the current suite of tax credits need to be extended every year. MLP treatment, on the other hand, does not expire.

Some supporters have noted that clean energy MLPs would “democratize” the industry because private retail investors today have no means to invest in to any meaningful degree in clean energy projects. Having the American populace take a personal, financial interest in the success of the clean energy industry is not trivial. The initial success of ‘crowd-funded” solar projects also provides some indication that there is an appetite for investment in clean energy projects which provide both economic and environmental benefits.

Sen. Coons has assembled a broad bipartisan coalition, including Senate Finance Energy Subcommittee Chair Debbie Stabenow (D-MI) and Senate Energy and Natural Resources Ranking Member Lisa Murkowski (R-AK). Republican and Democratic cosponsors agree that this legislation would help accomplish the now-familiar “all-of-the-above” approach to energy policy.

However, some renewable energy companies that depend on tax credits and accelerated depreciation are concerned that Republican supporters of the legislation will support the bill as an immediate replacement for the existing (but expiring) suite of renewable energy tax credits. Sen. Coons does not envision MLP parity as a replacement for the current production tax credits and investment tax credits but rather as additional policy tool that can address, to some degree, the persistent shortcomings of current financing arrangements. In this way, MLPs could provide a landing pad for mature renewable projects as the existing regime of credits is phased out over time, perhaps as part of tax reform.

So would the clean energy industry utilize MLP structures if Congress enacts the MLP Parity Act? The immediate impact may be hard to predict, and some in renewable energy finance fear MLP status will be less valuable than the current tax provisions. This is in part because the average retail investor would not be able to use the full share of accompanying PTCs, ITCs, or depreciation unless Congress were also to change what are known as the “at-risk” and “passive activity loss and tax credit” rules. These rules were imposed to crack down on perceived abuse of partnership tax shelters and have tax implications beyond the energy industry. Modifying these rules is highly unlikely and would jeopardize the bipartisan support the bill has attracted so far. But other renewable energy companies believe they can make the structure work for them now, and industries without tax credits — like renewable chemicals, for instance — would not have the same concerns with “at-risk” and “passive activity loss” rules. Furthermore, over the long term, industry seems increasingly confident the structure would be worthwhile. Existing renewable projects that have fully realized their tax benefits and have cleared the recapture period could be rolled up into existing MLPs. Existing MLP infrastructure projects could deploy renewable energy assets to help support the actual infrastructure. Supporters of the legislation see the change as a starting point, and the ingenuity of the market will find ways to work within the rules to deliver the maximum benefit.

The future of the MLP Parity Act will be linked to the larger conversation in Congress regarding tax reform measures. The MLP Parity Act is not expected to pass as a stand-alone bill; if it were to be enacted, it would most likely be included as part of this larger tax-reform package. Congress currently is looking at ways to lower overall tax rates and modify or streamline technology-specific energy provisions. This has many renewable energy advocates on edge: while reform provides an opportunity to enact long-term policies (instead of one-year extensions) that could provide some level of stability, it also represents a chance for opponents of renewable energy to exact tough concessions or eliminate existing incentives. As these discussions continue in earnest this year, the reintroduction of the MLP Parity Act has already begun to generate discussions and mentions in policy white papers at both the House Ways and Means Committee and the Senate Finance Committee. Whether a highly partisan Congress can actually achieve such an ambitious goal as tax reform this year remains uncertain. But because of its bipartisan support, the MLP Parity Act certainly will be one of the many potential reforms Congress will consider seriously.

Is Regulation of Greenhouse Gases Through the Clean Air Act Becoming “Too Big to Fail”?

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In a much-publicized decision in 2007, the Supreme Court ruled that the United States Environmental Protection Agency (USEPA) is authorized to regulate greenhouse gases (GHGs) through the Clean Air Act. Massachusetts v. EPA, 549 U.S. 497 (2007). A slew of recent cases have rejected plaintiffs’ attempts to assert common law claims for damages based on the consequences of past emissions of GHGs. The courts generally have found that USEPA has occupied the role of regulating GHGs, and challenges to the agency’s actions must be brought through the appropriate administrative channels. As the Supreme Court weighs whether to grant certiorari in the Coal. for Responsible Regulation, Inc., et al. v. EPA, No. 09-1322 (D.C. Cir. June 26, 2012), the case that addresses four USEPA GHG rules, the Supreme Court may have difficulty in changing course from the idea that GHGs should be regulated pursuant to the Clean Air Act.

Comer v. Murphy Oil et al., No. 12-60291 (5th Cir. May 14, 2013).

In the aftermath of Hurricane Katrina, Mississippi Gulf residents sued numerous energy companies, alleging that the defendants’ emissions of GHGs exacerbated the severity of and damage caused by the Class 5 hurricane (hereinafter Comer I). The claims ranged from public and private nuisance, trespass and negligence, to fraudulent misrepresentation and conspiracy. The district court dismissed Comer I with prejudice, finding that the plaintiffs had no standing to bring these claims and the claims were non-justiciable because they involved a political question.

Comer I became mired in technical details and procedures, and ultimately the plaintiffs tried to refile the case to bring an entirely new lawsuit, Comer II. The Fifth Circuit dismissedComer II because the plaintiffs brought the same claims they alleged in Comer I, and the district court had already dismissed those claims on the merits. The court applied the doctrine of res judicata, which bars parties from litigating the same claim a second time, and, consequently, Comer II was barred by the district court’s original dismissal in Comer I. Because Comer I held that plaintiffs have no standing to challenge GHG emissions through common law claims, it supports the idea that GHGs should be regulated through the Clean Air Act, rather than addressed through litigation.

Native Village of Kivalina v. ExxonMobil Corp. et al., No. 09-17490 (9th Cir. Sept. 21, 2012).

Kivalina is a village located on the far northwest shore of Alaska. The village had long been protected by the winter ice that persisted and protected the land mass itself. Due to melting icebergs and rising sea levels, the village land mass is eroding, and remains unprotected by the ice wall for much of the year. The village almost certainly will be either eroded into nothingness or inundated by the Arctic Ocean in the next twenty years. Kivalina sued a large group of energy companies, alleging that the GHGs emitted by them resulted in global warming and their village’s imminent destruction. Under a theory of common law public nuisance, the village sought damages to allow the relocation of the community.

The District Court held that political questions such as those raised by the allegations were not justiciable. Further, the court held the plaintiffs lacked Article III standing because they could not show that the named defendants likely caused the injuries, nor could the injuries be traced to an act of any of the defendants.

The Ninth Circuit agreed but expounded on the role of federal common law in pollution cases. The Court noted that federal common law has developed to fill gaps arising in cases of transboundary pollution and that those cases generally arise as nuisance claims. Despite its acknowledgement that nuisance claims can be used to regulate pollution, the Ninth Circuit explained that where a statute directly addresses the underlying issue, developing a federal common law was not necessary to address the issue. Accordingly, because the Supreme Court found that Congress acted through the Clean Air Act to address GHG pollution inMassachusetts v. EPA, filling the gap with federal common law (or public nuisance claims) was not necessary. Furthermore, the Ninth Circuit found that federal common law does not fill a gap solely based on the type of relief requested. In other words, the plaintiffs inKivalina sought damages rather than emission reduction, the latter being the type of relief afforded by the Clean Air Act. Although the plaintiffs’ requested relief was not available under the Clean Air Act, the Clean Air Act still displaced federal common law and prevented plaintiffs from seeking damages through a common law claim (such as public nuisance).

Consequently, Kivalina, like Comer, supports the idea that USEPA is charged with regulation of GHGs through the Clean Air Act.

Public Trust Doctrine Cases

Along a similar avenue, a number of public trust doctrine cases have been filed on behalf of children since 2011. In these cases, the plaintiffs allege that children’s futures are being affected by the lack of action to regulate GHGs, and they request that the various agencies cited in the lawsuits — primarily USEPA and Department of the Interior — take immediate action to reduce GHGs. These cases use the public trust doctrine as the basis of the complaint by alleging that the atmosphere is a common resource that must be managed for the public good and the agencies have failed to properly manage that resource. These cases have generally been dismissed for failure to state a claim for which relief can be granted.See Alec L. v. Perciasepe, No. 11-cv-2235 (D.D.C. May 22, 2013); Sanders-Reed v. Martinez, No. D-101-cv-2011-01514 (D.N.M. July 14, 2012); Alec L. v. Jackson, No. 1:11-cv-02235 (D.D.C. May 31, 2012); Loorz v. Jackson (D.D.C. April 2, 2012); Filippone v. Iowa Dep’t of Natural Resources, No. 2-1005, 12-04444 (Iowa Ct. App. Mar. 13, 2013); Aronow v. State, No. A12-0585 (Minn. Ct. App. Oct. 1, 2012).

In general, cases arising under the public trust doctrine face two challenges. First, the Supreme Court held in PPL Montana, LLC v. Montana, No. 10-218 (2012), that the public trust doctrine is a matter of state, not federal, common law and so a federal claim is not justiciable in federal court. Second, in AEP v. Connecticut, No. 10-174 (2011), the Supreme Court held that the role of regulating GHGs, and any consequence(s) of GHGs, has been occupied by the Clean Air Act and therefore challenges to the regulation of GHGs should be brought through the Clean Air Act rather than through a common law claim. Again, these cases are important for the future of GHG regulation because they affirm the agency’s role as the regulator of GHGs through the Clean Air Act.

Montana Envt’l Info. Center v. U.S. Bureau of Land Mgmt., No. cv-11-15-GF-SEH (D. Mont. June 14, 2013).

In another case affirming the role of the Clean Air Act in regulating GHGs, environmental groups claimed that the Bureau of Land Management (BLM) failed to adequately consider climate change, global warming, and the emission of GHGs in violation of the National Environmental Policy Act (NEPA) before approving oil and gas leases on federal land in Montana in 2008 and 2010. The environmental groups argued that BLM’s failure to follow NEPA procedures would result in emissions of methane gas from the oil and gas leases at issue. The release of methane gas would cause global warming and climate change, which would present a threat of harm to their aesthetic and recreational interests in lands near the lease sites by melting glaciers, warming streams, and promoting the destruction of forests through the proliferation of plagues of beetles.

The district court dismissed the lawsuit because the environmental groups lacked standing to bring the claim. The court found that the environmental groups failed to demonstrate that BLM’s alleged failure to follow proper procedure created an increased risk of actual, threatened, or imminent harm to their recreational and aesthetic interests in lands near the lease sites. Although the environmental groups had local recreational and aesthetic interests at heart, the court found that the effects of GHG emissions are diffuse and unpredictable, and the groups presented no scientific evidence or recorded scientific observations to support their assertions that BLM’s leasing decisions would present a threat of climate change impacts on lands near the lease sites. Furthermore, the environmental groups did not show that methane emissions from the lease sites would make a meaningful contribution to global GHG emissions or global warming. The court therefore found that the environmental groups failed to establish injury-in-fact and causation. As a result, the court foreclosed another potential avenue for litigating claims surrounding GHG emissions, and potential plaintiffs now seem to be left only with direct challenges to USEPA’s regulations (or lack thereof).

Conclusion

The Court would mark a dramatic shift if it moved away from these cases. By the time the Supreme Court has the opportunity to review climate change regulation again, the Obama administration may have set a “too big to fail” bar with its climate policies. Regardless of what happens in the future, however, as of today, the Court’s decision in Massachusetts v. EPA appears to have had a pronounced impact, acceding to USEPA the authority to regulate GHGs through the Clean Air Act, and denying common law remedies for impacts tied to climate change.

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Basic Guidelines for Protecting Company Trade Secrets

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Under the Uniform Trade Secrets Act (UTSA), “trade secrets” are generally defined as confidential proprietary information that provides a competitive advantage or economic benefit. Trade secrets are protected under the Economic Espionage Act of 1994 (EEA) at the federal level, and the vast majority of states have enacted statutes modeled after the UTSA (note that some jurisdictions, such as California, Texas and Illinois, have adopted trade secret laws that differ substantially from the UTSA; thus, businesses should research laws in the relevant jurisdiction(s).). Under the UTSA, to be protectable as a trade secret, information must meet three requirements:

i. the information must fall within the statutory definition of “information” eligible for protection;

ii. the information must derive independent economic value from not being generally known or readily ascertainable by others using appropriate means; and

iii. the information must be the subject of reasonable efforts to maintain its secrecy.

Trade secret theft continues to accelerate among U.S. companies, and can have drastic consequences. To combat this threat, Congress and certain state legislatures have recently enacted legislation to broaden trade secret protection. As a result, it is paramount that companies safeguard all proprietary information that may qualify as protectable trade secrets. This blog post explains some key trade secrets concepts, and offers pointers on how to identify and protect trade secrets.

(1) Determine Which Data Constitutes “Information”

The UTSA-type statutes generally define “information” to include:

Financial, business, scientific, technical, economic, and engineering information;

Computer code, plans, compilations, formulas, designs, prototypes, techniques, processes, or procedures; and

Information that has commercial value, such as customer lists or the results of expensive research.

Courts have similarly interpreted “information” to cover virtually any commercially valuable information. Examples of information that has been found to constitute trade secrets includes pricing and marketing techniques, customer and financial information, sources of supplies, manufacturing processes, and product designs.

(2) “Valuable” and “Not Readily Ascertainable” Information

To be protectable, information must also have “economic value” and not be “readily ascertainable” by others. Courts generally determine whether information satisfies this standard by considering the following factors:

Reasonable measures have been put in place to protect the information from disclosure;

The information has actual or potential commercial value to a company;

The information is known by a limited number of people on a need-to-know basis;

The information would be useful to competitors and would require a significant investment to duplicate or acquire the information; and

The information is not generally known to the public.

(3) Take Reasonable Measures to Maintain Secrecy

Businesses should implement technical, administrative, contractual and physical safeguards to keep secret the information sought to be protected. Companies should identify foreseeable threats to the security of confidential information; assess the likelihood of potential harm flowing from such threats; and implement security protocols to address potential threats. Examples of security measures might include restricting access to confidential information on a need-to-know basis, employing computer access restrictions, circulating an employee handbook that outlines company policies governing confidential information, conducting entrance interviews for new hires to determine whether they are subject to restrictive covenants with former employers, conducting exit interviews with departing personnel to ensure that the employee has returned all company materials and agrees to abide by post-employment obligations, encrypting confidential information, limiting access to confidential information through passwords and network firewalls, track all access to network resources and confidential information, restrict the ability to email, print or otherwise transfer confidential information, employ security personnel, limit visitor access, establish surveillance procedures, and limit physical access to areas that may have confidential information.

Conclusion

This blog post is intended to provide some broad guidelines to identifying and protecting company trade secrets. Most if not all companies have confidential information that may be protectable as a trade secret. But certain precautions need to be in place to ensure that the information is protectable. Because each company and situation is different, you should seek advice about your specific circumstances.

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Supreme Court – Being Unanimous Appears to be Part of the Justices’ DNA

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On June 13, 2013, the U.S. Supreme Court unanimously decided in Association for Molecular Pathology v. Myriad Genetics, Inc. that naturally occurring DNA segments are not patent eligible because they are products of nature and merely isolating such segments does not change their status for patent eligibility. However, complementary DNA (cDNA) is patent eligible because it is not naturally occurring.

Isolated DNA sequences – patent ineligible

In the third opinion since 2010 dealing with the scope of patent eligibility,1 the Court found that Myriad’s claims directed towards isolated DNA segments fell “squarely within the law of nature exception.” Slip op. at 13.  Myriad discovered an “important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” Slip op. at 12. The Court rejected the idea that isolation of DNA segments requires severing of chemical bonds, which creates a non-naturally occurring molecule. While Myriad may have expended a significant amount of research effort to discover the location of the genes of interest, effort alone does not render such subject matter patentable.

For landmark Supreme Court decisions regarding patent eligibility, please click here.

cDNA sequences – patent eligible

The Court noted that cDNA differs from isolated DNA segments and does not present the same obstacles for patent eligibility. Notable distinctions, according to the Court, are that cDNA’s creation results in an exons-only molecule, which is not naturally occurring. While acknowledging that the nucleotide sequence of cDNA is dictated by nature, the Court focused on the fact that creation of cDNA “unquestionably creates something new.” Slip op. at 17. cDNA is distinct from the DNA from which it was derived, and thus is not a product of nature. However, the Court noted that, in some instances, such as a very short segment of DNA having no intervening introns, the cDNA may be indistinguishable from the DNA. In such a situation, that cDNA is not patent eligible.

What the Court did not decide

The Court was careful to note that its decision did not implicate method claims, patents on new applications based on discoveries related to specific genes, or patentability of DNA in which the order of naturally occurring nucleotides has changed. Thus, the eligibility of methods of manipulating DNA, applications of knowledge learned from DNA segments, and manipulations of DNA sequences are questions still on the table.

Standing

An additional interesting aside is the Court’s approach to the declaratory judgment standing issue. The Court, in footnote 3, simply indicates that under all of the circumstances presented, the MedImmune standard had been met. Whether this opens the door to additional declaratory judgment actions in the future is uncertain.

Impact

This decision will likely not have a devastating impact on the patent portfolio of genetic diagnostic companies. These companies typically focus more on patents directed towards multi-gene products, methods, and cDNAs than on claims directed to isolated DNA sequences to protect their genetic tests. Nevertheless, should a company seek to assert a patent with claims directed to isolated DNA sequences, such an assertion will now be subjected to summary judgment motions based on the patent ineligibility of such claims.

In the long term, however, today’s decision will likely have a big impact on businesses engaged in developing chemical and biological therapeutics, with patents directed to isolated naturally occurring compounds. The Court has held that merely separating a segment of DNA from its natural surrounding is “not an act of invention.” How such analysis could be applied in the chemical and pharmaceutical arts remains to be seen. The Court’s opinion likely will be used to attack chemical and pharmaceutical patents directed towards naturally occurring compounds like proteins, antibodies, and other naturally occurring biomolecules. Whether such patents fall within chemical compositions or focus on the chemical changes, which result from isolation that the Court has suggested may be patentable, will likely be determined on a case by case basis.

Lastly, in an era of ever polarizing politics, it is fascinating to see that this decision, like most other recent U.S. Supreme Court decisions involving patents,2 is a 9-0 decision.  All of the current justices unanimously agree on what is the appropriate scope of patent eligibility.

1 Bilski v. Kappos, 130 S. Ct. 3218 (2010) and Mayo Collaborative Services v. Prometheus Lab., Inc., 132 S. Ct. 1289 (2012) are two unanimous U.S. Supreme Court decisions dealing with the patent eligibility of method claims.

2 See Bilski v. Kappos, 130 S. Ct. 3218(2010); Mayo v. Prometheus, 132 S. Ct. 1289(2012); Caraco Pharm. Lab., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012); Kappos v. Hyatt, 132 S. Ct. 1690 (2012); Bowman v. Monsanto Co., No. 11-796 (2013).

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New Cybersecurity Guidance Released by the National Institute of Standards and Technology: What You Need to Know for Your Business

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The National Institute of Standards and Technology (“NIST”)1 has released the fourth revision of its standard-setting computer security guide, Special Publication 800-53 titled Security and Privacy Controls for Federal Information Systems and Organizations2 (“SP 800-53 Revision 4”), and this marks a very important release in the world of data privacy controls and standards. First published in 2005, SP 800-53 is the catalog of security controls used by federal agencies and federal contractors in their cybersecurity and information risk management programs. Developed by NIST, the Department of Defense, the Intelligence Community, the Committee on National Security Systems as part of the Joint Task Force Transformation Initiative Interagency Working Group3over a period of several years with input collected from industry, Revision 4 “is the most comprehensive update to the security controls catalog since the document’s inception in 2005.”4

Taking “a more holistic approach to information security and risk management,5” the new revision of SP 800-53 also includes, for the first time, a catalog of privacy controls (the “Privacy Controls”) and offers guidance in the selection, implementation, assessment, and ongoing monitoring of the privacy controls for federal information systems, programs, and organizations (the “Privacy Appendix”).6 The Privacy Controls are a structured set of standardized administrative, technical, and physical safeguards, based on best practices, for the protection of the privacy of personally identifiable information (“PII”)7 in both paper and electronic form during the entire life cycle8of the PII, in accordance with federal privacy legislation, policies, directives, regulations, guidelines, and best practices.9 The Privacy Controls can also be used by organizations that do not collect and use PII, but otherwise engage in activities that raise privacy risk, to analyze and, if necessary, mitigate such risk.

Description of the Eight Families of Privacy Controls

The Privacy Appendix catalogs eight privacy control families, based on the widely accepted Fair Information Practice Principles (FIPPs)10 embodied in the Privacy Act of 1974, Section 208 of the E-Government Act of 2002, and policies of the Office of Management and Budget (OMB). Each of the following eight privacy control families aligns with one of the eight FIPPs:

  1. Authority and Purpose. This family of controls ensures that an organization (i) identifies the legal authority for its collection of PII or for engaging in other activities that impact privacy, and (ii) describes the purpose of PII collection in its privacy notice(s).
  2. Accountability, Audit, and Risk Management. This family of controls ensures that an organization (i) develops and implements a comprehensive governance and privacy program; (ii) documents and implements a privacy risk management process that assesses privacy risk to individuals resulting from collection of PII and/or other activities that involve such PII; (iii) conducts Privacy Impact Assessments (“PIAs”) for information systems, programs, or other activities that pose a privacy risk; (iv) establishes privacy requirements for contractors and service providers and includes such requirements in the agreements with such third parties; (v) monitors and audits privacy controls and internal privacy policy to ensure effective implementation; (vi) develops, implements, and updates a comprehensive awareness and training program for personnel; (vii) engages in internal and external privacy reporting; (viii) designs information systems to support privacy by automating privacy controls, and (ix) maintains an accurate accounting of disclosures of records in accordance with the applicable requirements and, upon request, provides such accounting of disclosures to the persons named in the record.
  3. Data Quality and Integrity. This family of controls ensures that an organization takes reasonable steps to validate that the PII collected and maintained by the organization is accurate, relevant, timely, and complete.
  4. Data Minimization and Retention. This family of controls addresses (i) the implementation of data minimization requirements to collect, use, and retain only PII that is relevant and necessary for the original, legally authorized purpose of collection, and (ii) the implementation of data retention and disposal requirements.
  5. Individual Participation and Redress. This family of controls addresses implementation of processes (i) to obtain consent from individuals for the collection of their PII, (ii) to provide such individuals with access to the PII, (iii) to correct or amend collected PII, as appropriate, and (iv) to manage complaints from individuals.
  6. Security. This family of controls supplements the security controls in Appendix F and are implemented in coordinating with information security personnel to ensure that the appropriate administrative, technical, and physical safeguards are in place to (i) protect the confidentiality, integrity, and availability of PII, and (ii) to ensure compliance with applicable federal policies and guidance.
  7. Transparency. This family of controls ensures that organizations (i) provide clear and comprehensive notices to the public and to individuals regarding their information practices and activities that impact privacy, and (ii) generally keep the public informed of their privacy practices.
  8. Use Limitation. This family of controls addresses the implementation of mechanisms that ensure that an organization’s scope of use of PII is limited to the scope specified in their privacy notice or as otherwise permitted by law.

Some of the Privacy Controls, such as Data Quality and Integrity, Data Minimization and Retention, Individual Participation and Redress, and Transparency also contain control enhancements, and while these enhancements reflect best practices which organizations should strive to achieve, they are not mandatory.11 The Office of Management and Budget (“OMB”), tasked with enforcement of the Privacy Controls, expects all federal agencies and third-party contractors to implement the mandatory Privacy Controls by April 30, 2014.

The privacy families must be analyzed and selected based on the specific operational needs and privacy requirements of each organization and can be implemented at various operational levels (e.g., organization level, mission/business process level, and/or information system level12). The Privacy Controls and the roadmap provided in the Privacy Appendix will be primarily used by Chief Privacy Officers (“CPO”) or Senior Agency Officials for Privacy (“SAOP”) to develop enterprise-wide privacy programs or to improve an existing privacy programs in order to meet an organization’s privacy requirements and demonstrate compliance with such requirements. The Privacy Controls supplement and complement the security control families set forth in Appendix F (Security Control Catalog) and Appendix G (Information Security Programs) and together these controls can be used by an organization’s privacy, information security, and other risk management offices to develop and maintain a robust and effective enterprise-wide program for management of information security and privacy risk.

What You Need to Know

The Privacy Appendix is based upon best practices developed under current law, regulations, policies, and guidance applicable to federal information systems, programs, and organizations, and by implication, to their third-party contractors. If you provide services to the federal government, work on government contracts, or are the recipient of certain grants that may require compliance with federal information system security practices, you should already be sitting up and paying attention. This revision puts privacy up front with security.

Like other NIST publications, this revision will be looked at as an industry standard for best practices, even for commercial entities that are not doing business with the federal government. In fact, over the last few years, we have seen increasing references to compliance with NIST 800-53 as setting a contractual baseline for security. We expect that this will continue, and now will include both the Security Controls and the Privacy Controls. As such, general counsel, business executives and IT professionals should become familiar with and conversant in the Privacy Controls set forth in the new revision to SP 800-53. At a minimum, businesses should undertake a gap analysis of the privacy controls at their organization against these Privacy Controls to determine if they are up to par or if they have to enhance their current privacy programs. And, if NIST 800-53 appears in contract language as the “minimum standard” to which your company’s policies and procedures must comply, the gap analysis will at least inform you of what needs to be done to bring both your privacy and security programs up to speed.

1 The National Institute of Standards and Technology is a non-regulatory agency within the U.S. Department of Commerce, which, among other things, develops information security standards and guidelines, including minimum requirements for federal information systems to assist federal agencies in implementing the Federal Information Security Management Act of 2002.

2 See Security and Privacy Controls for Federal Information Systems and Organizations, NIST Special Publ. (SP) 800-53,
Rev. 4 (April 30, 2013), http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf.

3 The Joint Task Force Transformation Initiative Interagency Working Group is an interagency partnership formed in 2009 to produce a unified security framework for the federal government. It includes representatives from the Civil, Defense, and Intelligence Communities of the federal government.

4 See NIST Press Release for SP 800-53 Revision 4 at http://www.nist.gov/itl/csd/201304_sp80053.cfm. Revision 4 of
SP 800-53 adds a substantial number of security controls to the catalog, including controls that address new technology such as digital and mobile technologies and cloud computing. With the exception of the controls that address evolving technologies, the majority of the cataloged security controls are policy and technology neutral, focusing on the fundamental safeguards and countermeasures required to protect information during processing, while in storage, and during transmission.

5 See NIST Press Release for SP 800-53 Revision 4 at http://www.nist.gov/itl/csd/201304_sp80053.cfm.

6 See Appendix J, Privacy Control Catalog to Security and Privacy Controls for Federal Information Systems and Organizations, NIST Special Publ. (SP) 800-53, Rev. 4 (April 30, 2013),http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf. Appendix J was developed by NIST and the Privacy Committee of the Federal Chief Information Officer (CIO) Council.

7 Personally Identifiable Information is defined broadly in the Glossary to SP 800-53 Revision 4 as “Information which can be used to distinguish or trace the identity of an individual (e.g., name, social security number, biometric records, etc.) alone, or when combined with other personal or identifying information which is linked or likable to a specific individual (e.g., date and place of birth, mother’s maiden name, etc.). See page B-16 of Appendix B, Privacy Control Catalog to Security and Privacy Controls for Federal Information Systems and Organizations, NIST Special Publ. (SP) 800-53, Rev. 4 (April 30, 2013),http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf. However, as stated in footnote 119 in Appendix J, “the privacy controls in this appendix apply regardless of the definition of PII by organizations.”

8 Collection, use, retention, disclosure, and disposal of PII.

9 See page J-4 of Appendix J, Privacy Control Catalog to Security and Privacy Controls for Federal Information Systems and Organizations, NIST Special Publ. (SP) 800-53, Rev. 4 (April 30, 2013),http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf.

10 See NIST description and overview of Fair Information Practice Principles at http://www.nist.gov/nstic/NSTIC-FIPPs.pdf.

11 See pages J-4 of Appendix J, Privacy Control Catalog to Security and Privacy Controls for Federal Information Systems and Organizations, NIST Special Publ. (SP) 800-53, Rev. 4 (April 30, 2013),http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf.

12 See page J-2 of Appendix J, Privacy Control Catalog to Security and Privacy Controls for Federal Information Systems and Organizations, NIST Special Publ. (SP) 800-53, Rev. 4 (April 30, 2013),http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf.

EEOC Files Two Genetic Information Nondiscrimination Act Lawsuits in Two Weeks

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The EEOC recently filed its first-ever lawsuit alleging a violation of the Genetic Information Nondiscrimination Act (GINA) – and subsequently filed its second GINA lawsuit one week later.

The first lawsuit settled, with a fabrics distributor paying $50,000 and agreeing to take other specified actions (i.e. posting an anti-discrimination notice, among other things) after the EEOC alleged a violation of GINA and the Americans with Disabilities Act (ADA). Specifically, with respect to GINA, the EEOC charged that the distributor violated the Act when it asked the woman for her family medical history in a post-offer medical examination, including questions relating to the existence of heart disease, hypertension, cancer, tuberculosis, diabetes, arthritis, and “mental disorders” in her family.

The second lawsuit remains pending and was filed against a nursing and rehabilitation center. The EEOC similarly charged that the center violated GINA when it requested family medical history in a post-offer, pre-employment medical examination. The second lawsuit also alleges violations of the ADA and Title VII of the Civil Rights Act.

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According to the EEOC, GINA “makes it illegal to discriminate against employees or applicants because of genetic information, which includes family medical history; and also restricts employers from requesting, requiring or purchasing such information.”

As noted in both press releases, one of the six national priorities identified by the EEOC’s Strategic Enforcement Plan is for the agency to address emerging and developing issues in equal employment law, which includes genetic discrimination. As this recent EEOC action signals a focus on GINA issues, employers are encouraged to ensure their policies related to employee medical information and examination comply with the Act.

How Monsanto Applies to Nonagricultural Biotechnology

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The facts behind the Supreme Court’s recent ruling in Monsanto v. Bowman are simple enough. Farmers are able to buy soybeans containing Monsanto’s patented glyphosate resistance technology under a license that permits them to plant and grow one generation of crops. Vernon Bowman skirted this program, however, by purchasing commodity soybeans from a grain elevator knowing that the seeds would nonetheless likely contain the very same Monsanto technology. He then planted the seeds, raised crops, and saved seeds from these crops to plant new crops. The Supreme Court held that Bowman’s actions infringed Monsanto’s patents because unlicensed growth of the seeds was a new making of the patented invention. Consequently, the doctrine of patent exhaustion did not provide any defense as to these new seeds.

This was not a surprising result for the biotechnology industry. The idea that patent rights in seed progeny are not exhausted by the original sale of their “parents” was well established in the United States, and is even codified in the European Biotechnology Directive.

The Court left us with a relatively clear answer regarding the scope of patent exhaustion related to seeds. The use of the purchased, licensed seeds for consumption and/or processing cannot be interfered with by the original seller, as the patent rights on those individual (sold) seeds have been exhausted. The planting and cultivation (i.e., replication) of those seeds, however, can only be done under a license from the patentee. In other words, even though someone sells you a bag of seed, you have no right to plant and grow that seed without a license (although there may be a good argument that the license should be implied in appropriate cases).

So, where does Bowman leave us when it comes to determining the infringement or enforceability of self-replication biotechnology patents outside of the agricultural context? For other patented self-replicating (or easily replicable) technologies, the circumstances may present more complicated questions.

Biotechnology inventions such as cell lines, bacteria, and other living material often must exist in a condition of continuous self-replication simply to be maintained for any use. Vectors, plasmids, etc., replicate within cells, and from generation to generation within host cells, allowing for production of vastly more nucleic acid copies than initially used for transfection. Even small linear nucleic acids such as those used for primers and probes may be “replicated” to generate large quantities relatively easily using PCR or other methods in molecular biology. In each case, (cells, viruses, vectors, probes), something analogous to planting, watering, cultivating, is required. In view of the Bowman decision, the question persists as to whether such replication will be permitted or considered an unlicensed “remanufacture” or new making of the original, patented item.

In this regard, we note that Justice Kagan left open the possibility that the replication might be “a necessary but incidental step in using the item for another purpose.”[1] Certainly, the replication contemplated in this part of the opinion is that which must necessarily occur in connection with some authorized practice of the invention. Maintenance of culture cells, for example, where the cells are necessarily replicating only for the purpose of maintaining the culture during its authorized use or in preparation for such use is one example that seems to fit comfortably within this aspect of the Court’s opinion.  In other words, a license for multigenerational use of a cell line may be implied in these circumstances, even if it is not given expressly.

Other technologies may not present quite so simple an analysis. DNA vectors can be used for a variety of purposes, not all of which require replication. For example, vectors can be used as probes or markers, they can be used to transport sequences of interest for further manipulation, or they can be used as immunizing agents. None of these uses require or specifically contemplate replication. Of course, some vectors are used in contexts where replication is likely or assumed (e.g., transfection of cells or bacteria, generation of transgenic tissues or organisms). The consideration of vectors under Bowman will, therefore, likely depend more heavily on context, including the sales and licensing practices of the patentee.

Some commentators have characterized the Bowman holding as “limited to the facts,” pointing to the Court’s comment that “[o]ur holding today is limited – addressing the situation before us, rather than every one involving a self-replicating technology.”[2] Attempts to limit Bowman to its specific facts should be taken carefully. Indeed, the Court cut through much of the surrounding facts to reach its core holding – that replication is a new making of the patented invention and an infringement in the absences of a license. Accordingly, it does appear that the holding may address the most important “situation” for all self-replicating technologies, even if it does not address all of the context-dependent permutations of the facts involving self-replication technologies.

Consequently, assertions of “self-replicating” material turning otherwise innocent parties into patent infringers are simply not credible. To paraphrase the Court in Bowman, the soybeans Bowman took home from the grain elevator didn’t plant themselves, didn’t spray themselves with glyphosate, and didn’t otherwise cultivate themselves to produce the unauthorized crop. Similarly, in biotechnology, it is likely that unauthorized and infringing activity will quite clearly fit the Monsanto “situation” and be easily recognizable as infringement. For example, maintaining an initial cell culture in the hands of the licensee-purchaser, although it also involves replication, should be easily distinguished from distribution of the culture (or vectors, or phage, etc.) to unauthorized third parties.

Nonetheless, given the potential for unnecessarily complex analysis and possible confusion of courts, patent holders should carefully consider how their license provisions may be used to clarify not only express grant and restriction provisions, but also how the license may shape an understanding of how the invention works and its intended use. The dividing line between authorized and infringing activity will be influenced by context, and parties are well advised to define that context by the licensing contract and not rely on the bare contours of the doctrine of patent exhaustion. The license is the place where the parties involved, the patent holder and the licensee, have a chance to agree on what is authorized and what is not. It is also the place where the patent holder has an opportunity to shape future interpretations of what the practice of the invention encompasses and what it does not. An effort to be as comprehensive as possible in the positive, express grant of the license may be as important as the restrictions that are expressly stated. If, as is quite possible, the restrictions fail to contemplate the full scope of intended unauthorized activities, a grant of authorization that is more specific may allow a court to more accurately determine what is “necessary but incidental” to the authorized practice of the invention and what is not.

The Bowman decision provides the biotech community some much needed clarity regarding self-replicating inventions. Perhaps equally important, the Court displayed a keen sensitivity to the negative implications of an overly broad exhaustion doctrine. While there will undoubtedly be further development of the law as it is applied to different technologies, the fundamental ability to control self-replicating inventions at each generation through the grant or withholding of a license places authority where it belongs – with the patentee. And, by reducing the need for complex work-arounds, the clarified authority and more calibrated level of control provided by theBowman decision should facilitate licensing negotiations to the benefit of both parties.

This article was written by guest bloggers Christopher Jeffers, Ph.D., Carl Massey, Jr., Thomas F. Poché, Ph.D.

[1]Although the Court referenced the copyright statute, 17 U.S.C. § 117(a)(1), in conjunction with this “necessary but incidental” fact pattern, the statute actually considers only computer programs and states there is no infringement if “a new copy or adaptation is created as an essential step in the utilization of the computer programin conjunction with a machine and that it is used in no other manner.” From this, better language in the Bowmanopinion might have been “necessary and essential” or even “necessary and incidental.” 

[2] Bowman Op. at 10.

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