Intellectual Property

The Legal Persona of Electronic Entities – Are Electronic Entities Independent Entities?

November 13, 2015
Data, Intellectual Property, Internet

Natalie Gao, MJLST Staffer

The advent of the electronic age brought about digital changes and easier accessibility to more information but with this electronic age came certain electronic problems. One such problem is whether or not electronic entities like, (1) usernames online, (2) software agents, (3) avatars, (4) robots, and (5) artificial intelligence, are independent entities under law. A username for a website like eBay or for a forum, for all intents and purposes may well be just a pseudonym for the person behind the computer. But at what point does the electronic entity become an independent entity, and at what point does the electronic entity start have the rights and responsibilities of a legally independent entity?

In 2007, Plaintiff Marc Bragg brought suit against Defendants Linden Research Inc. (Linden), owner of the massive multiplayer online role playing game (MMORPG) Second Life, and its Chief Executive Officer. Second Life is a game with a telling title and it essentially allows its players to have a second life. It has a market for goods, extensive communications functions, and even a red-light district, and real universities have been given digital campuses in the game, where they have held lectures. Players of Second Life purchase items and land in-game with real money.

Plaintiff Bragg’s digital land was frozen in-game by moderators due to “suspicious” activity(s) and Plaintiff brought suit claiming he had property rights to the digital land. Bragg v. Linden Research, Inc., like its descendants including Evans v. Linden Research, Inc. (2011), have been settled out of court and therefore do not offer the legal precedents it could potentially have had regarding its unique fact pattern(s). And Second Life is also a very unique game because pre-2007, Linden had been promoting Second Life by announcing they recognize virtual property rights and that whatever users owned in-game would be belong to the user instead of to Linden. But can the users really own digital land? Would it be the users themselves owning the ditigal land or the avatars they make on the website, the ones living this “second life”, be the true owners? And at what point can avatars or any electronic entity even have rights and responsibilities?

An independent entity is not the same as a legal independent entity because an latter, beyond just existing independently, has rights and responsibilities pursuant to law. MMORPGs may use avatars to allow users to play games and avatars may be one step more independent than a username, but is that avatar an independent entity that can, for example, legally conduct commercial transactions? Or rather, is the avatar conducting a “transaction” in a leisure context? In Bragg v. Linden Research, Inc., the court touches on the issue of transactions but it rules only on civil procedure and contract law. And what about avatars existing now in some games that can play itself? Is “automatic” enough to make something an “independent entity”?

The concept of an independent electronic entity is discussed in length in Bridging the Accountability Gap: Rights for New Entities in the Information Society. Authors Koops, Hildebrandt, and Jaquet-Chiffelle compares the legal personhood of electronic artificial entities with animals, ships, trust funds, and organizations, arguing that giving legal personhood to basically all (or just “all”) currently existing electronic entities bring up problems such as needing representation with agency, lacking the “intent” required for certain crimes and/or areas of law, and likely needing to base some of their legal appeals in area of human/civil rights. The entities may be “actants” (in that they are capable of acting) but they are not always autonomous. A robot will need mens rea to assess responsibility, and none of the five listed entities do not have consciousness (which animals do have), let alone self-consciousness. The authors argue that none of the artificial entities fit the prima facies definition of a legal person and instead they moved to evaluate the entities on a continuum from automatic (acting) to autonomic (acting on its own), as well as the entity’s ability to contract and bear legal responsibility. And they come up with three possible solutions, one “Short Term”, one “Middle Term”, and one “Long Term”. The Short Term method, which seems to be the most legally feasible under today’s law, purposes creating a corporation (a legally independent entity) to create the electronic entity. This concept is reminiscent of theorist Gunther Teubner’s idea of a using a hybrid entity, one that combines an electronic agent(s) with a company with limited liability, instead of an individual entity to give something rights and responsibilities.

Inevitably, even though under the actual claims brought to the court, Bragg v. Linden Research, Inc. mostly seems more like an open-source licensing issue than an issue of electronic independent entity, Koops, Hildebrandt, and Jaquet-Chiffelle still tries to answer some questions that may be very salient one day. Programs can be probabilistic algorithms but no matter how unpredictable the program may be, their unpredictability is fixed in the algorithm. An artificial intelligence (AI), a program that grows and learns and create unpredictability on its own, may be a thing of science fiction and The Avengers, may one day be reality. And an AI does not have to be the AI of IRobot; it does not have to have a personality. At what point will we have to treat electronic entities as legally autonomic and hold it responsible for the things it has done? Will the future genius-programmer, who creates an AI to watch over the trusts in his/her care, be held accountable when that AI starts illegally funneling money out to the AmeriCorp bank account the AI was created to watch over, into the personal saving accounts of lamer non-MJLST law journals in the University of Minnesota? Koops, Hildebrandt, and Jaquet-Chiffelle argues yes, but it largely depends on the AI itself and the area of law.

The “Patent Dance” for Now: Rehearing Denied in Amgen v. Sandoz

November 9, 2015
Biotechnology, Food and Drug Law, Health Law, Patents

Jeff Simon, MJLST Staffer

On July 21, 2015, the Federal Circuit’s decision in Amgen v. Sandoz established that a biosimilar applicant does not have to follow the patent dispute resolution procedures set forth by the Biologics Price Competition and Innovation Act. The BPCIA’s “patent dance,” located at 42 U.S.C. § 262(l)(2)(a), sets forth procedures requiring biosimilar applicants to disclose the biosimilar application and information describing the methods and procedures of its production to the sponsor of the reference biologic drug. The Federal Circuit’s fractured decision denied the compulsory nature of the “patent dance,” while still holding that biosimilar applicants are required to provide the biologic drug sponsor 180 days advanced notice of the first commercial marketing of its biosimilar product in accordance § 262(l)(2)(a).

Considering that the decision of the court was split by favoring the biosimilar applicants regarding the issue of the “patent dance” while favoring the biologic sponsor when it came to market disclosure, the decision was far from a satisfying result for either party as neither party came out as the clear victor. As such, both Amgen and Sandoz filed petitions for an en banc rehearing on August 20, 2015. Amgen’s petition for review once again contended that the language of § 262(I)(2)(a) as stated by congress, specifically the use of the word “shall,” indicates that the “patent dance’s” procedures are mandatory. Sandoz contended among other things that the 180-day provision necessarily increases the exclusivity period from 12 years to 12 and a half years and further that the court incorrectly asserted that notice was mandatory and enforceable. Both parties submitted amicus curiae briefs in agreement that, as a matter of first impression, it was appropriate for an en banc rehearing.

However, despite a fractured panel deciding a matter of first impression, Federal Circuit denied a rehearing in decision on October 16, 2015. The decision came as surprise to many of those associated with the biologic drug industry, especially considering the novelty and discord upon the issues. Considering the fact that both parties sought a rehearing, the court may have decided that the issue was undeserving of the court’s continued interest and resources. Both parties may file petitions for certiorari.

In regards to the future implications of the decision, it’s important to note that many of the high revenue pioneer biologic drugs are set to have their US patents expire within the next few years. This expected “patent cliff’ is certain to drive momentum within the biosimilar market. This wave of biosimilar applications is sure to have large implications upon the BPCIA, and particularly whether the “patent dance” is optional. All considered, the issues presented in Amgen may be approaching a level of importance that draws the attention of SCOTUS. It’s possible that a grant of certiorari may be in order to settle the debate on the BPCIA’s “patent dance” and market disclosure requirements, particularly considering the economic ramification of the anticipated biologics’ patent cliff.

Apple Loses Multi-Million Dollar Lawsuit

October 20, 2015
Intellectual Property, Patents

Riley Conlin, MJLST Staffer

Earlier this month, the Wisconsin Alumni Research Foundation (WARF) won a large patent lawsuit against Apple Inc. The suit relates to WARF’s 1998 patent of a technology that improves microchip efficiency. WARF initiated the suit in January 2014 contending that Apple’s A7, A8 and A8X processors violate the patent. The processors are found in the iPhone 5s, 6, 6 Plus, and many variations of the iPad.

Apple denied that their microchips infringed WARF’s patent and contended that the patent was invalid. The U.S. Patent and Trademark Office declined to review the patent’s validity. The jury, sitting in the U.S. District Court for the Western District of Wisconsin, concluded that Apple’s processing chips improperly used technology owned by WARF. U.S. District Court Judge William Conley has scheduled to trial in three phases. First, the jury determined whether or not Apple was liable. Second, the jury will determine the appropriate damages. Finally, the jury will consider whether Apple willfully violated the patent, which could lead to additional damages. Based on Conley’s recent ruling, Apple already faces damages reaching potentially $862.4 million.

WARF has initiated lawsuits around this patent before. In 2008, the foundation used that patent to sue Intel Corp. However, that case never made it to trial, because it was settled shortly prior to it beginning.

In September 2015, WARF filed a subsequent lawsuit against Apple. The foundation contends that Apple’s A9 and A9X chips also infringe upon their patent. The A9 and A9X chips can be found in Apple’s more recent technology including the: iPhone 6S and 6S Plus, and the iPad Pro.

Akamai Techs. v. Limelight Networks: An Expansion of the Scope of Patent Direct Infringement

October 13, 2015
Intellectual Property, Litigation, Patents

Tianxiang (“Max”) Zhou, MJLST Staffer

This August the Federal Circuit Court delivered an en banc opinion of Akamai Techs. v. Limelight Networks, affirming the jury decision awarding $40 million in damages. The per curium opinion provided that the Court “unanimously set forth the law of divided infringement under 35 U.S.C. § 271(a)” and there was substantial evidence “support[ing] the jury’s finding that Limelight directly infringed U.S. Patent No. 6,108,703.” Accordingly, the Federal Circuit reversed the District Court’s grant of Limelight’s motion for judgment of non-infringement as a matter of law.

The issue in this case is whether Limelight should be liable for direct infringement of the patent by inducing consumers to infringe the patent and should thus be jointly and directly liable under 35 U.S.C. §271(a). The Supreme Court held that induced infringement under §271(b) requires a single direct infringer. According to the Supreme Court, Limelight should not be liable as the it only performed some but not all of the infringement steps.

The Federal Circuit expanded the scope of direct infringement and held Limelight liable. The Federal Circuit held that Direct infringement under §271(a) occurs where “all steps of a claimed method are performed by or attributable to a single entity.” According to the Federal Circuit, when there are two or more actors from a joint enterprise, all can be charged with the acts of the other, “rendering each liable for the steps performed by the other as if each is a single actor.” The Court further cited the definition of joint enterprise in Restatement (Second) of Torts and provided four factors in determining whether there is joint enterprise.

The case is important because it set forth the rule that the actors in a joint enterprise can be liable for the other actors. The case prevented a possible way to dodge the direct infringement liability by inducing the consumers to perform some of actions of infringement.

Are Trademark’s a Medium for Free Speech?: Federal Circuit Considers Whether Section 2(a) of the Lanham Act Violates the First Amendment

October 6, 2015
Constitutional Law, Intellectual Property, Trademark Law

Michael Laird, MJLST Staffer

The Federal Circuit recently heard arguments en banc in a case considering the relationship between intellectual property regimes, specifically trademark law, and freedom of speech under the First Amendment of the U.S. Constitution. The long-term rule comes from the U.S. Court of Customs and Patent Appeals—the predecessor to the Federal Circuit—in the case In re McGinley. 660 F.2d 481 (C.C.P.A. 1981). There, the court held: “with respect to appellant’s First Amendment rights, it is clear that PTO’s refusal to register appellant’s mark [as a trademark] does not affect his right to use it. No conduct is proscribed, and no tangible form of expression is suppressed.” Id. at 484. Under that traditional rule, trademark law was held consistent with the first amendment because an applicant is still permitted to use a mark, whether or not it is trademark eligible. However, that precedent may be at risk.

On Friday, October 3, the Federal Circuit heard arguments for In re Tam on the question of whether § 2(a) of the Lanham Act is consistent with the right of free speech. Section 2(a) bars trademark eligibility for a mark that “consists of or comprises of immoral, deceptive, or scandalous matter; or matter which may disparage or falsely suggest a connection with persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt, or disrepute.” 28 U.S.C. § 1052(a). In Tam, § 2(a) was the basis for denying trademark registration for “The Slants”, the name of an Asian-American band because of its disparagement of those of Asian descent.

The court appeared to latch on to concerns that the logic of McGinley would be applicable in the copyright regime since rejection of a copyright would also not inhibit the applicant’s right to use that material. The court asked: “would [it] be constitutional and not a first amendment violation if Congress enacted a statute that said, ‘we’re going to regulate Copyrights and not allow copyright registration to issue to scandalous, immoral, or disparaging copyrights?’” Recording of Oral Arguments, In re Tam, No. 2014-1203 at 39:13 (Fed. Cir. October 2, 2015). The Government conceded, and Court appeared to agree that Congress could not bar disparaging art from copyright registration, as it does with trademarks. See id. at 39:33.

If a work cannot be denied copyright registration because the government concludes the work is disparaging, then some distinction between a copyright and trademark must exist for the government to reject a trademark on that basis. The Government was mostly unsuccessful in providing a means to distinguish the two regimes. The court, however, discussed a few possibilities.

First, the nature of speech in copyrighted material differs from the marks which are eligible for trademark protection. Copyrightable material may involve fundamental political speech and other private speech, which is protected under a heightened scrutiny by the first amendment. Id. at 41:30. Conversely, trademarks, as a means to associate the producer of goods and a brand or logo, constitutes commercial speech.

Second, as one judge stated: “the distinction that could be made is that in copyright, if the government has these limitations it’s so coercive that it essentially…prevents you from [certain] speech. Whereas the trademark realm, although it takes away some benefits of federal registration…it’s not so coercive that the restriction is a burden on free speech.” Id. at 44:30. This argument relates to McGinley, since independent of whether a trademark is granted or denied, the mark owner has the right to use his or her mark in public. In the copyright realm however, the logic of McGinley fails because the denial of a copyright might actually chill speech because of the risk that it will be misappropriated by someone else.

Third, the court differentiated the purpose of the copyright and trademark regimes: “isn’t a copyright a forum for the expression of the arts…whereas a trademark goes to the very heart of stability in the marketplace?” Id. at 5:23. Like a distinction between the nature of a trademark and copyright, the purpose of the systems diverge. Copyright is inherently protective of speech generally. Yet, most trademarks do not concern traditional speech, but protecting an association between the producer of a good and a brand or other mark.

Whether any argument will persuade the court that trademark law is distinct from copyright in some way that permits a disparagement bar to trademark registration remains to be seen. Notably, the court need not resolve the issue, if it were to determine that § 2(a) should be upheld or rejected based on the whether a trademark constitutes private, public, or commercial speech. Either way, the implications of the court’s ruling could impact another major ongoing disparagement case concerning the Washington Redskins’ trademark which is being appealed in the Fourth Circuit. If you are interested in listening to the argument in full, you can find a copy here.

Inter Partes Review: A Questionable Item in the Generic’s Tool Kit

October 6, 2015
Food and Drug Law, Health Law, Patents

Will Orlady, MJLST Lead Articles Editor

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman). Since then, pioneer pharmaceutical manufacturers and their generic counterparts have resolved patent disputes in federal district court under the Hatch-Waxman patent dispute framework. This framework is admittedly complex. But it forces interested parties to engage with Hatch-Waxman, mandating compliance with congressionally determined policy decisions regarding pharmaceutical exclusivity. Hatch-Waxman’s patent dispute framework was part of the larger bill, crafted to balance the interests of pioneer and generic drug manufacturers. Congress enacted the law to address two (apparently competing) goals: (1) to encourage innovation in pharmaceutical research and development and (2) to help generic drugs reach the market more quickly. The tension between these goals merits further discussion.

Before Hatch-Waxman, concerns grew that drug prices were too high and that access to certain treatments was too limited. Thus, there was both need and substantial demand for cheaper, generic drugs. On the other hand, pioneer drug manufacturers complained of inadequate market exclusivity following FDA’s New Drug Application (NDA) process. Put simply, pioneer companies spent (and continue to spend to this day) approximately $1 Billion brining a new drug to market. On top of the money, pioneer manufactures potentially spend several years of their drugs’ valuable patent terms going through the NDA process. Thus, pioneer companies noted that recouping R&D and regulatory expenses was not feasible given the “short” market exclusivity period.

Hatch-Waxman was a carefully wrought legislative compromise. It granted pioneers a patent term extension based on the length of FDA’s regulatory review, non-patent market exclusivity provisions, a mechanism for increasing the public notice of patents and patent challenges, and an automatic injunction forbidding FDA approval of a generic drug in certain circumstances. The generic manufacturers got, among other things, the Abbreviated New Drug Application (ANDA), making the regulatory process for generic drugs less onerous. To be sure, Hatch-Waxman is not without its critics, and its nuances are immense. But it is important to remember that the act represents a careful Congressional balancing of industry and public interests. Hatch-Waxman’s patent dispute resolution mechanism squarely fits within this compromise.

Enter the America Invents Act (AIA) of 2011. Of note, the AIA revised certain post-grant opposition procedures. Specifically, the law expanded the importance of inter partes review (IPR). IPR is a process by which a third party may have a patent reexamined by the patent office to verify that the office validly issued the patent. Since the AIA’s enactment, IPR has become immensely popular. Why is this? IPR offers a potential alternative to district court litigation. It provides advantageous invalidation standards—e.g. the “broadest reasonable interpretation” during claim construction. Further, IPR allows patent challenges with relatively limited discovery, cutting both the time and cost of district court patent litigation. Finally, IPR petitioners have been enormously successful in invalidating many of the patents challenged to date.

Needless to say, IPR frightens patentees holding rights to valuable patents. Can you see where I’m going here? Are particular Congressional mandates and policy determinations on a collision course?

The post-AIA surge of IPR proceedings has pioneer pharmaceutical manufacturers worried—rightly so. Generic manufacturers are already petitioning the U.S. Patent and Trademark Office (PTO) for IPR of patents protecting various pharmaceutical and biologic products. Given the aforementioned advantages of IPR, this shouldn’t come as a surprise, but that is not to say that it is not remarkable. Generic manufacturers could be leveraging the advantages of IPR to force pioneer drug manufacturers to settle patent disputes out of district court. Or, of more consequence, they could be using IPR to skirt the patent dispute frameworks required by Hatch-Waxman and the BPCIA (for biologics).

Indeed, if pioneer pharmaceutical manufacturers hold patents allowing for market exclusivity, the patents should be validly issued. It is, however, simultaneously important to remember that Congress has treated drug and biologic patents differently since, at the very least, 1984. Pharmaceutical patents are remarkable in at least three key ways. First, patents on commercially successful drugs are extraordinarily valuable. Congress (at least ostensibly) allows this because of the enormous regulatory barriers to entry. In other words, it’s a trade. FDA imposes supra-burdensome regulatory costs to ensure new drugs are safe and effective. Consequently, Congress allows pioneer drug manufacturers to unilaterally exploit the market to recoup losses, and make money. Second, pharmaceutical patents read on particles of matter that are harnessed to treat disease and save lives. This creates a unique demand. And third, pharmaceutical patents read on products which require sensational development costs, including the time and money required for regulatory approval.

Does this mean pharmaceutical patents should be treated differently, or made exempt from IPR? The answer is not so simple. But legislators, scholars, and practitioners should consider whether IPR is having unintended consequences within the pharmaceutical industry. Just as a quick example: Did Congress truly intend for the AIA’s IPR to be a way around Hatch-Waxman or the BPCIA? And even if it did, does it make sense to put enormously valuable patents at the mercy of an overburdened administrative agency? As I said, the answers don’t come readily. It’s a policy debate that needs to happen. Until it does, I think it unwise to abandon previously established Congressional compromises—i.e. Hatch-Waxman—for a hasty change to our patent system.

The Mystery of the Preliminary Injunction’s Tiny Role in Patent Litigations in China and Some Newest Developments

September 30, 2015
Intellectual Property, Patents

Sen “Alex” Wang, MJLST Managing Editor

In an unpublished note completed early February this year, I compared the current standards of granting preliminary injunctions in patent litigations in the Chinese People’s courts and the US federal courts. The preliminary injunction, an equitable remedy that has long been available to patent litigants in the US, was not codified in the Chinese Patent Act until 2000 as part of China’s effort to fulfill its obligations after joining the WTO. Since then, China has been consciously strengthening the protection for intellectual property rights within its jurisdiction and has taken great pride in the progress it has made so far. In particular, the numbers of patent applications as well as litigations in China have skyrocketed in China, and the People’s courts have become more confident in handling high profile patent cases and issuing large damage awards. However, the preliminary injunction, even after its inception in the Chinese Patent Act, has only played a mysteriously tiny role in protecting the patentees’ rights during the years. For example, from 2003 to 2009, the People’s courts in Guangdong province, one of the biggest and most developed provinces in China, ruled respectively on 54, 19, 21, 20, 24, 5, and 11 preliminary injunction applications involving intellectual property rights (not just patents) while granting only 17, 6, 12, 8, 5, 2, and 1 of the applications in each corresponding year. By contrast, the number of intellectual property cases considered by the People’s courts in Guangdong during the same time frame was 1465, 3199, 4257, 3644, 3989, 5312, and 7152, respectively.

As a powerful and drastic remedy, the preliminary injunction exists to provide speedy relief from irreparable injury and is “generally granted under the theory that there is an urgent need for speedy action to protect the plaintiff’s rights.” Apple, Inc. v. Samsung Elecs. Co., 678 F.3d 1314, 1334 (Fed. Cir. 2012) (O’Malley, J., concurring-in-part, dissenting-in-part) (internal citation omitted). In the US, the Federal Circuit utilized, for a long time, a balancing—or so called “sliding scale”—test for issuing preliminary injunctions, where the movant must establish a right thereto in light of four factors: (1) a reasonable likelihood of success on the merits; (2) irreparable harm if an injunction is not granted; (3) the balance of hardships tipping in its favor; and (4) the impact of the injunction on the public interest. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001) (citing Hybritech, Inc. v. Abbott Laboratories, 849 F.2d 1446, 1451 (Fed. Cir. 1988)). None of the factors, taken individually, is dispositive; rather, the court must “weigh and measure each factor against the other factors and against the form and magnitude of the relief requested.” Id. However, following the Supreme Court’s rulings in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006) and Winter v. NRDC, Inc., 555 U.S. 7 (2008), the Federal Circuit has given up its balancing test to comply with the more rigorous requirements set forth by the Supreme Court. Compare Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1365 (Fed. Cir. 2008), with Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1375–76 (Fed. Cir. 2009). Currently, “a showing on one preliminary injunction factor does not warrant injunctive relief in light of a weak showing on other factors.” Wind Tower Trade Coal. v. United States, 741 F.3d 89, 100 (Fed. Cir. 2014).

Across the Pacific Ocean, the Chinese People’s courts, under a civil law system, rely heavily on statutes, regulations, and other promulgated rules. To comply with the requirements of the TRIPS Agreement, both Article 66 of the Chinese Patent Act and Article 100 of the Chinese Civil Procedure Act now recognize the preliminary injunction as a provisional remedy in patent litigations. While the acts passed by the People’s Congress form the statutory bases for issuing preliminary injunctions, in practice, the more detailed procedural as well as substantive requirements for obtaining such provisional remedy are actually found in in several judicial interpretations and judicial policy documents promulgated by the Supreme People’s Court (SPC). The foundational judicial interpretation in this regard is the Several Provisions of the Supreme People’s Court Concerning the Application of Law to Pre-trial Cessation of Patent Infringement (最高人民法院关于对诉前停止侵犯专利权行为适用法律问题的若干规定) [hereinafter Provisions on Pre-trial Cessation of Patent Infringement] (2001), the Article 11 of which requires the People’s courts to consider four factors when ruling on an application for a preliminary injunction, namely (1) whether the alleged current or imminent conduct infringes the patent; (2) whether the applicant will suffer irreparable harm without an injunction; (3) the guarantee provided by the applicant; and (4) whether the public interest will be disserved. Despite the SPC’s wording of the first factor, it has been treated as inquiring into the applicant’s likelihood of success on the merits. As to the second—irreparable harm—prong of the test, there had been a great amount of confusion among the lower courts until Cao Jianming, vice president of the SPC, pointed out in February 2008 that the core of the irreparable harm analysis is whether the damage can be compensated by monetary award and whether there is a reasonable expectation of collecting such award in light of the alleged infringer’s financial condition.

With the first two factors being the most important in the determination, the standard in China looks very similar to the one currently used in the federal courts in patent cases as the Rule 65 of Federal Rules of Civil Procedure also mandates the applicants to provide security. This similarity between the standards makes one even more curious about why preliminary injunctions have only been utilized at such a low rate in patent cases in China. The answer—also the problem of the current Chinese approach—lies in the restrictions buried in two judicial policy documents from the SPC. Although the four-factor test seems to be applicable to all patent cases, the SPC has confined the issuance of preliminary injunctions to cases where the facts are clear and the infringement is easy to determine. Opinions on Issues Concerning Maximizing the Role of Intellectual Property Trials in Boosting the Great Development and Great Prosperity of Socialist Culture and Promoting the Independent and Coordinated Development of Economy (关于充分发挥知识产权审判职能作用推动社会主义文化大发展大繁荣和促进经济自主协调发展若干问题的意见) [hereinafter Opinions on Maximizing the Role of Intellectual Property Trials], art. 16 (2011). In particular, when there is no literal infringement and the court has to conduct complicated technical comparisons, a preliminary injunction is deemed inappropriate. Opinions on Several Issues Concerning Intellectual Property Trials Serving the Overall Objective Under the Current Economic Situation (关于当前经济形势下知识产权审判服务大局若干问题的意见) [hereinafter Opinions Under the Current Economic Situation], art. 14 (2009). In addition, if the alleged infringer has challenged the validity of the patent(s) in question or has initiated a separate declaratory judgment action, the courts are required to be extremely cautious in granting preliminary injunctions. Id.

This “clear” and “easy” yet rigid approach seems to be contrary to the legislative intent of introducing such a provisional remedy in the first place and only makes sense to some extent when considered in a bigger context. On several different occasions and in various promulgated documents, the SPC has expressed some serious concern that preliminary injunctions or the process by which they are granted may be abused to impede competition, while adding to the concern is the present procedural setup of obtaining a preliminary injunction. In the People’s Courts, there is no similar remedy as a TRO but only a general preliminary injunction. It is general in the sense that the application can be filed before, at the same time with, or after the commencement of an infringement action, and once granted, the injunction will usually remain in force until the final adjudication on the merits take effect. Provisions on Pre-trial Cessation of Patent Infringement art. 14. Furthermore, a preliminary injunction issued before the filing of an infringement action will, so long as the applicant initiates the formal infringement suit within 15 days of getting the injunction, enjoin the alleged infringer all the way until the end of the infringement action. Id. Also, a preliminary injunction can be issued without notice to the enjoined party, although the courts have the obligation to notify the enjoined party no later than 5 days after the issuance of the injunction. Id. art. 9. Moreover, the People’s courts only have 48 hours (96 hours at most) to make a decision in writing after receiving eligible applications. Id. Additionally, though the People’s Courts are authorized to summon one or all parties to clarify factual issues, no hearing of any form is required. Id. One final point, the enjoined party has no right to appeal but may apply, within 10 days of receiving the injunction, for review once, though the injunction will not be suspended during the review period and there will still be no guaranteed hearing opportunity. Id. art. 10. Given the powerful nature of the remedy once granted, the tight time frame for making a decision in writing, and the limited hearing requirement, it is understandable that the fear of mistakes and misuses has prompted the SPC to take a cautious position.

Although the SPC’s current approach is to some extent understandable, it has comprised the preliminary injunctions’ function as an important provisional remedy for patent holders and has likely caused many patent holders to refrain from even considering this option as evidenced by the extremely low application rate in Guangdong. Fortunately, the SPC has finally noticed this alarming trend. On February 26, 2015, the SPC published for public comment a draft SPC Judicial Interpretation on Several Issues in Application of Law in Determination of Action Preservation in Intellectual Property and Competition Controversies ((最高人民法院关于审查知识产权与竞争纠纷行为保全案件适用法律若干问题的解释) (征求意见稿)). This new judicial interpretation purports to supersede prior judicial interpretations involving preliminary injunctions in patent and trademark cases. According to the draft, the time frame for rendering a preliminary injunction decision is a non-emergency matter may be adjusted to 30 days. It also details other procedural as well as substantive aspects of preliminary injunctions such as the jurisdiction of the court, what constitutes “irreparable harm,” hearing and notice requirement, handling of appeals of cases and handling of oppositions to provisional measures, the effect of changed circumstances, civil liability arising from wrongful application, and other matters. Notably, the draft adopts the exact same four-factor test in the US federal courts. However, it only requires the People’s courts to evaluate the four factors as a whole under the circumstances without identifying any single factor as dispositive. This arguably bears a resemblance to the balancing or sliding scale analysis once used in patent cases in the US federal courts, which opens up the possibility of greater use of preliminary injunctions in the People’s courts in the near future.

It’s Apple Season: Federal Circuit Court Rules for Apple in Patent Dispute, Requiring Samsung to Change Some of Its Technology Features

September 24, 2015
Competition, Intellectual Property, Patents

Emily Harrison, MJLST Editor-in-Chief

This month, the United States Court of Appeals for the Federal Circuit gave Apple its latest victory against its biggest competitor, Samsung. In May 2014, the United States District Court for the Northern District of California denied Apple’s motion for a permanent injunction to bar Samsung from using software or code tending to infringe patented features in Apple’s products. However, on September 17, 2015, the court in Apple Inc. v. Samsung Electronics Co. Ltd., No. 2014-1802, 2015 WL 5449721 (Fed. Cir. Sept. 17, 2015), held that the lower court abused its discretion in failing to grant Apple the permanent injunction, and remanded the case to the lower court for reconsideration of the motion.

The current dispute between the competitors surrounds Apple’s patents covering its slide-to-unlock, autocorrect, and data detection features. The federal circuit notes that Apple has invested billions of dollars in introducing the iPhone. To decrease the risk associated with its large investments, Apple has applied for and received patents for much of the technology it has developed in the iPhone, including the features at issue. Furthermore, Apple filed a motion seeking permanent injunction that would bar Samsung from “making, using, selling, developing, advertising, or importing into the United States software or code capable of implementing the infringing features in its products.” The federal circuit found that Apple established a “causal nexus” between irreparable harm and Samsung’s infringement such that there was “some connection between infringing features and demand for competitor’s products,” Apple suffered irreparable harm, Apple lacked adequate remedy at law, and both the balance of hardships and public interest favored the injunction.

In determining the consequences of this decision, the court emphasizes the narrowness of this injunction: “This is not a case where the public would be deprived of Samsung’s product. Apple does not seek to enjoin the sale of lifesaving drugs, but to prevent Samsung from profiting from the unauthorized use of infringing features in its cellphones and tablets.” The court was also convinced that Samsung could remove the patented features without recalling products or disrupting customer use. Although the injunction is arguably narrow, the court’s decision may have a broad impact on product differentiation requirements with respect to complex technology. The federal circuit’s decision also signals a greater willingness to protect patent rights of inventors in the face of a key market rival.

The BPCIA Patent Dance: A Patent Law Cliffhanger

September 5, 2015
Intellectual Property, Patents

Will Orlady, MJLST Lead Articles Editor

In 2009, Congress enacted the Biologics Price Competition and Innovation Act (“BPCIA”), found at 42 U.S.C. § 262(k) and § 262(l). The BPCIA created an abbreviated pathway to FDA approval for biologic products that the agency found to be sufficiently similar to biologic products already approved for market sale (“biosimilars”). The BPCIA also created mechanisms for resolving patent disputes related to biosimilars. Colloquially known as the “patent dance,” the BPCIA’s patent dispute resolution mechanisms allows participants to go through a series of negotiations and disclosures—all in place to limit the complexity and cost of patent litigation. Parties complying with the “patent dance’s” requirements can enjoy safe harbor from costly patent litigation. The underlying policy of the BPCIA’s “patent dance” is to narrow the scope and reduce the costs associated with patent disputes.

Congress enacted the BPCIA. Time passed, and its “patent dance” flew under the radar—until this year. In 2014, Sandoz became the first company to file a Biologic License Application pursuant to the BPCIA’s abbreviated procedure. Despite availing itself of the BPCIA’s abbreviated approval procedures, Sandoz snubbed the “patent dance.” In its litigation against competitor Amgen, Sandoz argued that the BPCIA’s “patent dance” was not compulsory. The matter made its way to Judge Richard Seeborg in the Northern District of California. In a detailed opinion, Judge Seeborg outlined both Amgen’s and Sandoz’s positions and ultimately sided with Sandoz, ruling that the “patent dance” is optional (the abbreviated statutory biosimilar FDA approval scheme notwithstanding). The parties appealed the matter to the Federal Circuit. The Court heard the matter on June 3, 2015.

On July 21, 2015, the Federal Circuit handed down its decision in Amgen v. Sandoz, answering whether the BPCIA’s “patent dance” is compulsory for those manufacturers availing themselves of the BPCIA’s abbreviated FDA approval scheme. A fractured panel (led by J. Lourie) held that the “patent dance” is optional. Conceding that the statutory provisions involved are immensely complex, the Court stated that the provisions involved must be read in the context of the entire statute. The relevant provisions in light of the entire statute lead Judge Lourie to the conclusion that Congress intended the “patent dance” to be optional.

“We therefore conclude that, even though under paragraph (l)(2)(A), when read in isolation, a subsection (k) applicant would be required to disclose its aBLA and the manufacturing information to the RPS by the statutory deadline, we ultimately conclude that when a subsection (k) applicant fails the disclosure requirement, 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e) expressly provide the only remedies as those being based on a claim of patent infringement. Because Sandoz took a path expressly contemplated by the BPCIA, it did not violate the BPCIA by not disclosing its aBLA and the manufacturing information by the statutory deadline.”

Judge Newman dissented on this point.

Though the Federal Circuit has answered whether the “patent dance” is compulsory for the time being, the parties have petitioned the court to hear the matter en banc. This is not surprising given the divided tone of the deciding panel’s opinion. Practitioners and scholars alike are now waiting to see whether the Court uses this matter to affirm or re-decide the “patent dance” question. Even if the Federal Circuit denies the en banc petition, a petition for certiorari would not be out of the question. The instant issue may just be juicy enough to grab SCOTUS’s attention.

I’m Not a Doctor, But…: E-Health Records Issues for Attorneys

March 20, 2015
Cyber Security, Healthcare, Intellectual Property, Litigation, Privacy

Ke Huang, MJLST Lead Articles Editor

The Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) generally provides that, by 2015, healthcare providers must comply with the Act’s electronic health record (EHR) benchmarks, or, the government would reduce these providers’ Medicare payments by one percent.

These provisions of the HITECH Act are more than a health policy footnote. Especially for attorneys, the growing use of EHRs raises several legal issues. Indeed, in Volume 10, Issue 1 of the Minnesota Journal of Law, Science & Technology, published six years ago, Kari Bomash analyzes the consequence of EHRs in three legal-related aspects. In Privacy and Public Health in the Information Age, Bomash discusses how a Minnesota Health Records Act amendment relates to: (1) privacy, especially consent of patients, (2) data security (Bomash was almost prescient given the growing security concerns), and (3) data use regulations that affect medical doctors.

Bomash’s discussion is not exhaustive. EHRs also raise legal issues running the gamut of intellectual property, e-discovery, to malpractice. Given that software runs EHRs, IP industry is very much implicated. So much so that some proponents of EHR even support open source. (Another MJLST Article explains the concept of open source.)

E-discovery may be more straightforward. Like other legal parties maintaining electronic stored information, health entities storing EHR must comply with court laws governing discovery.

And malpractice? One doctor suggested in a recent Wall Street Journal op-ed that EHR interferes with a doctor’s quality of care. Since quality of care, or lack thereof, is correlated with malpractice actions, commentators raised the concern that EHR could raise malpractice actions. A 2010 New England Journal of Medicine study addressed this topic but could not provide a conclusive answer.

Even my personal experience with EHRs is one of the reasons that lead me to want to become an attorney. As a child growing up in an immigrant community, I often accompanied adult immigrants, to interpret in contract closings, small-business transactions, and even clinic visits. Helping in those matters sparked my interest in law. In one of the clinic visits, I noticed that an EHR print-out of my female cousin stated that she was male. I explained the error to her.

“I suppose you have to ask them to change it, then,” she said.

I did. I learned from talking to the clinic administrator the EHR software was programmed to recognize female names, and, for names that were ambiguous, as was my cousin’s, the software automatically categorized the patient as male. Even if my cousin’s visit was for an ob-gyn check-up.

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