Anonymity for Anti-Discrimination: Airbnb’s Effort to Dismantle Worldwide Prejudice

Lishayne King

Innovations and advances today occur at much faster and more rapid rates than experienced in past decades. With the innovation of the Internet and the ease with which entities can create websites and brand names, access to information, products, and resources can be achieved with the click of a mouse. Protecting your words, products, and resources, however, can prove difficult without knowledge of the specific safeguards and defenses that you are entitled to under the law. One of the paramount mechanisms that individuals and entities can utilize in seeking to protect their trademarked information is The Lanham Act.

The Lanham Act is the chief source of protection for trademarked information under federal law. Two specific sections of The Lanham Act in particular, are essential in the enforcement of the act. Section 32, codified at 15 U.S.C. § 1114, protects against violations of a registered mark. Section 43(a), codified at U.S.C. § 1125(a), protects consumers and businesses from dishonest business practices. These sections together are designed to prevent the confusion that may arise when one entity utilizes another entity’s trademark while engaged in business.

Nicholas Fedorka

A recent case was decided in the United States Court of Appeals for the District of Columbia Circuit that is creating ripples throughout the realm of administrative and utility law.  It was a direct response to the Federal Communications Commission (“FCC”) adoption of the “2015 Open Internet Order.”  This order reclassified broadband internet from an “information service” to a “telecommunication service” under the Telecommunications Act of 1996.  U.S. Telecomm. Ass’n  v. Fed. Commc’n  Serv., 825 F.3d 674, 678 (D.C. Cir. 2016).  This is a major step in broadband regulation because telecommunication services are subject to common carrier regulation under the Telecommunication Act.  Id.  The 2015 Open Internet Order consisted of three components: 1) Commission reclassified both fixed and mobile broadband as telecommunications services, 2) the commission forbears to include certain parts of the Telecommunications Act that it saw unnecessary, and 3) the commission promulgated five open internet rules that applied to both fixed and mobile broadband services.  Id. at 687.

Three separate groups of petitioners, including U.S. Telecommunications Association, argued against the FCC’s reclassification.  The DC Court of Appeals turned to the Chevron 2-part test of statutory interpretation to see if the FCC’s 2015 Open Internet Order is constitutional under the Telecommunications Act.   Id. at 699.  First, the court asked whether Congress has directly spoken to the precise question at issue and if it is clear then that is the end of that matter.  U.S. Telecom Association, 825 F.3d at 699.  If the Telecommunications Act of 1996 is silent or ambiguous, then the question is whether the agency’s answer is based on a permissible construction of the statute.  Id.  The court held that the statute was ambiguous but the agency’s answer is based on a permissible construction of the statute.  Id. at 700.  Furthermore, the court upheld the FCC’s decision to regulate on a “case-by-case basis” under the act.  Id. at 709.

It will be interesting to see how the FCC regulates broadband services on such a basis.  The idea of regulation by a federal agency within a particular field on a “case-by-case” basis falls within the constitutional law theory of conflict preemption.  If a state determines to regulate broadband internet outside the scope of the FCC’s 2015 Open Internet Order, it appears that the FCC will attempt to strike it down.  But there are still many questions that have yet to be answered.  Have individual State’s already started to regulate broadband internet providers?  Are they in line with the FCC’s Open Internet Order?  How much power do individual states have to regulate broadband providers?  What are the types of State regulation schemes that conflict with the FCC’s Open Internet order?  These questions seem to be unanswered in this unsettled area of the law.  

Justin Farooq

Over the last twenty years, an increasing number of claims have been brought against Internet websites that publish third party content, slowly changing the prevailing notion that such content is never subject to liability.[1] This upsurge in lawsuits comes at no surprise — greater accessibility to such online material, coupled with the proliferation of increasingly powerful, interactive online publishers, has increased exposure to an assortment of legal matters and raised the stakes in online publishing.[2]

Many of the lawsuits brought against online publishers claim violation of §230 of the Communications Decency Act of 1996 (CDA), which provides formidable immunity to online publishers.[3] When originally passed, §230 was intended to shield website owners from liability for illegal content on their websites by third parties in order to promote development of the early Internet, vigorous information sharing, and free speech.[4] The legislative rational behind the immunity provision was that while websites share some attributes to print works such as magazines, which are held liable for third-party content, they are more akin to telecom companies that operate as passive outlets of third-party communication, which are not liable.[5]  However, due to the evolving complexity of the Internet, this distinction between an active or passive conduit of third party information has become much harder to clearly define.

The vast majority of courts interpreting §230 have done so broadly, holding the immunity provision as an almost absolute bar on lawsuits against website owners for publishing questionable third-party content.[6]  Recently, however, this seemingly carte blanche immunity for online publishers has been under closer scrutiny.  In the intricate Internet landscape we live in today, websites are becoming not only the publisher of information, but also have significant power and control over the material that third parties post.

Within the past ten years, several judges have dissented with this broad interpretation of section 230, claiming this granting of broad immunity to online publishers has lead to websites carrying defamatory, illegal, or otherwise harmful postings without any recourse for victims.[7] We are no longer in the days of the early Internet where we need the CDA in order to promote vigorous sharing of information and protection of free speech.[8] Nor can we say that websites of this nature were part of the purpose of the CDA, which was to promote sharing of vital, helpful communications over the Internet for the greater good of society.[9] The potential for abuse simply outweighs the benefits imposed by a broad interpretation of the CDA’s immunity provision.[10]

The latest of such lawsuits involves a putative class action filed July 7, 2016 in California federal court.[11] The case involves a minor user of Snapchat Inc.’s photo messaging app.[12] Plaintff alleges that media published within the “Discover” section of Snapchat’s app reveals to minors sexually inappropriate and offensive material in violation of the CDA.[13]  The “Discover” section allows other media outlets, such as Buzzfeed and Cosmopolitan, to publish on the Snapchat app main page, and thus Snapchat has not only a large amount of control over which third-party media outlets can post, but also a great deal of influence over the type of content they ultimately post.[14]

Snapchat has approximately 150 million users and twenty three percent are between the ages of thirteen and seventeen.[15]  Snapchat does ask for the users birthday during registration since access is restricted to people older than thirteen.[16]   Nonetheless, there is no distinction in the videos available to minors and adults, and no language in the terms of service that notifies minor users of explicit content.[17] Snapchat’s own online community guidelines prohibit users from publicly displaying sexually explicit content.[18] The content Snapchat offers on Discover consistently breaches its own rules.

An intriguing layer about the lawsuit is that the plaintiff’s claim is founded on the infrequently cited CDA Section 230(d), a subsection that still remains to be litigated.[19] Basically, section 230(d) says that online interactive services such as Snapchat, when entering into an agreement with users, must alert such users of the availability of parental control safeguards.[20]  If victorious, this may necessitate changes to the terms of service of almost all interactive online publishers.  As the Internet further develops and online communication increases, more courts seem less eager to hand out immunity without close scrutiny.  It looks probable that as more content goes digital, the tendency to construe the scope of immunity a bit more tightly will remain.  It will be interesting to see how Snapchat will respond.

 

[1] Samuel J. Morley, How Broad Is Web Publisher Immunity Under §230 of the Communications Decency Act of 1996?, Fla. B. J., Feb. 2010, at 8.

[2] Id.

[3] 47 U.S.C.A. § 230 (West 1998).

[4] Id.

[5] Morley, supra note 1.

[6] See Zeran v. Am. Online, Inc., 129 F.3d 327, 331 (4th Cir. 1997).

[7] See Fair Hous. Council of San Fernando Valley v. Roommates.Com, LLC, 521 F.3d 1157, 1177 (9th Cir. 2008) (Dissent).

[8] Id.

[9] Id. at 1178.

[10] Id.

[11] Class Action Alleges Snapchat Exposes Minors To Adult Content, Lexis Legal News (July 8, 2016, 1:58 PM), http://www.lexislegalnews.com/articles/9659/class-action-alleges-snapchat-exposes-minors-to-adult-content.

[12] Id.

[13] Lexis Legal News, supra note 10.

[14] Id.

[15] Shayna Posses, Snapchat Exposes Minors To Explicit Content, Suit Says, Law 360 (July 7, 2016, 8:43 PM), http://www.law360.com/articles/815156/snapchat-exposes-minors-to-explicit-content-suit-says.  

[16] Id.

[17] Id.

[18] Id.

[19] Jeffery Neuburger, Liability under CDA Section 230? Recent Lawsuit Tries to Flip the Script against Social Media Service, Proskauer (Sep. 8, 2016), http://newmedialaw.proskauer.com/2016/09/08/liability-under-cda-section-230-recent-lawsuit-tries-to-flip-the-script-against-social-media-service/#more-1387.

[20] Id.

 

Brittany Charles

On September 8, 2016, Alphabet, a Google parent, announced a partnership with Chipotle to launch a burrito delivery system at Virginia Tech utilizing—autonomous drones[1]. The FAA has approved the program, but before students begin lining up by the dozens to get their Tex-Mex fix, there are some limitations[2]. First, drones are not allowed to fly over students, therefore, the university has designated a select kiosk where individuals order and wait for their burritos[3]. Secondly, because the drones aren’t allowed to fly over students, only select individuals will be initially capable of ordering burritos via drone[4]. The reality of burrito-bearing drones at the hands of our fingertips is one that is only available to a select few and will come with a variety of issues that may make the technology more infuriating than enticing.

So what’s the issue that no one seems to be talking about? Well, we know that drones aren’t allowed to fly over students—but the privacy of students will inevitably be affected by this technology. The FAA currently prohibits individuals flying for hobby or recreation from flying below 400 ft., near groups of people, or over stadiums or sports events[5]. However, the rules in regards to drones for commercial usage are becoming more lenient to increase innovation[6]. The result? An increasingly complex environment where the government, corporations and universities will have to address the benefits of burritos over student’s privacy. So while we can take a moment to bask in the glory of drone armies bringing Chipotle to hungry boys and girls across our college campuses, we must do so with reservation. With power comes responsibility and who is responsible for student’s privacy?

[1] Matt McFarland, Google drones will deliver Chipotle burritos at Virginia Tech, CNN (Sept. 8, 2016), http://money.cnn.com/2016/09/08/technology/google-drone-chipotle-burrito/.

[2] Kate Cox, Google Will Actually Deliver Burritos By Drone To Some Lucky College Kids, CONSUMERIST (Sept. 8 2016), https://consumerist.com/2016/09/08/google-will-actually-deliver-burritos-by-drone-to-some-lucky-college-kids/.

[3] Matt McFarland, Google drones will deliver Chipotle burritos at Virginia Tech, CNN (Sept. 8, 2016), http://money.cnn.com/2016/09/08/technology/google-drone-chipotle-burrito/.

[4] Kate Cox, Google Will Actually Deliver Burritos By Drone To Some Lucky College Kids, CONSUMERIST (Sept. 8 2016), https://consumerist.com/2016/09/08/google-will-actually-deliver-burritos-by-drone-to-some-lucky-college-kids/.

[5] Where to Fly, FAA (June 14, 2016 1:23:02 PM EDT), https://www.faa.gov/uas/where_to_fly/.

[6] Nyshka Chandran, FAA’s new drone laws go into effect Monday, allowing US companies to innovate, CNBC (Aug. 29, 2016), http://www.cnbc.com/2016/08/29/faas-new-drone-laws-go-into-effect-monday-allowing-us-companies-to-innovate.html.

By: Audrey Ogurchak

On January 15^th, the United States Supreme Court granted certiorari for the case Cuozzo Speed Technologies v. Lee.[1] This case will require the Supreme Court to address two important questions regarding the inter partes review (IPR) proceedings; (1) is it appropriate for the United States Patent and Trademark Office (USPTO) to use a different claim construction standard than used by the federal district court; and (2) are institution decisions insulated from judicial review.[2]

Inter partes review is a trial proceeding conducted by the Patent Trial and Appeals Board (PTAB) to review the patentability of one or more claims in a patent on the basis of prior art consisting of patents or printed publications.[3] The challenge may only be raised about issues regarding 35 USC §102, the novelty requirement, and 35 USC §103, the non-obviousness requirement.[4] The IPR proceeding was introduced by the America Invents Act, along with post-grant review proceedings, to replace inter partes reexamination .[5] Many patent holders aren’t too fond of the new proceedings, as, since its institution, the PTAB has allowed 80% of the claims challenged in petitions to go to trial, cancelling 95.2% of all claims for which trial was instituted.[6] Federal Circuit Chief Judge Randall Radar coined the term PTAB “death squads,” claiming that the “death squads [kill] property rights.”[7] Commentators believe that part of the reason for the high rates of claim cancellation has to do with the “broadest reasonable interpretation” (BRI) standard applied by the PTAB for claim construction, or claim interpretation.[8] A finding of invalidity is generally more likely when a patent claim is interpreted under the BRI standard from the PTAB than under the narrower Phillips standard applied by the federal district court, giving claims their “ordinary and customary meaning” from the perspective of one of ordinary skill in the art at the time of the invention.[9]

In the case before the Supreme Court this year, Cuozzo Speed Technologies (“Cuozzo”) owns US Patent No. 6,778,074 (‘074 patent) relating to a speed limit indicator and method for displaying the relative speed limit.[10] In 2012, Garmin International, Inc. and Garmin USA, Inc. (“Garmin”) petitioned the USPTO, requesting an IPR with respect to three claims of the ‘074 patent, contending that the claims were obvious under 35 USC §103(a).[11] The PTAB issued a final decision finding the claims to be obvious and denying Cuozzo’s motion to amend the ‘074 patent by substituting granted claims for the now cancelled claims.[12] On appeal, Cuozzo raised the issues that the IPR was improperly instituted by the USPTO because certain prior art was not raised by the petitioner and that the PTAB applied the incorrect standard, the BRI Standard, when evaluating the scope of the claim.[13] The majority explained that regardless of whether the USPTO should have instituted an IPR, the decision couldn’t be reviewed or challenged, even after a completed IPR proceeding.[14] The majority also explained that the BRI standard is appropriate and that Congress intended the BRI standard to be the rule when the America Invents Act was implemented.[15]

This decision is important as it may decide the fate of challenged patents before the PTAB and the possibly future of the PTAB itself. As the institution of the IPR proceedings is intended to circumvent the costly and time consuming patent litigation process of the federal circuit, it seems as though commentators and patent holders are firm in their belief that the Phillips standard should be the prevailing claim construction standard of the PTAB. Further, as the Supreme Court is in the habit of overruling the Federal Circuit in regards to patent cases, it is likely that the Supreme Court will find that the BRI standard is not appropriate.

[1] Gene Quinn, Supreme Court accepts Cuozzo Speed Technologies IPR appeal, IPWatchdog (Jan. 15, 2016), http://www.ipwatchdog.com/2016/01/15/supreme-court-accepts-cuozzo-speed-technologies-ipr-appeal/id=65076/.

 

[2] Quinn, supra note 1.

 

[3] Inter Partes Review, United States Patent and Trademark Office, http://www.uspto.gov/patents-application-process/appealing-patent-decisions/trials/inter-partes-review (last visited Feb. 2, 2015).

 

[4] United States Patent and Trademark Office, supra note 3.

 

[5] Inter Partes Review, Fish Richardson Post Grant, http://fishpostgrant.com/inter-partes-review (last visited Feb. 2, 2015).

 

[6] Rob Sterne & Gene Quinn, PTAB Death Squads: Are All Commercially Viable Patents Invalid?, IPWatchdog (Mar. 24, 2014), http://www.ipwatchdog.com/2014/03/24/ptab-death-squads-are-all-commercially-viable-patents-invalid/id=48642/.

[7] Sterne & Quinn, supra note 6.

 

[8] Clint Conner et al., Federal Circuit Confirms The Use of Broadest Reasonable Interpretation in Inter Partes Review, Dorsey (Jul. 15, 2015) https://www.dorsey.com/newsresources/publications/client-alerts/2015/07/federal-circuit-confirms-the-use-of-broadest-rea__.

 

[9] Conner, supra note 8.

 

[10] In re Cuozzo Speed Technologies, LLC, 792 F.3d 1268, 1271 (Fed. Cir. 2015).

 

[11] Cuozzo, 792 F.3d at 1272.

 

[12] Id.

[13] Cuozzo, 792 F.3d at 1272 – 73.

 

[14] Id. at 1273.

 

[15] Id. at 1279-80.

 

By: Christopher W. Folk

In the eleventh hour of the twelfth month in the year 2015, the Cybersecurity Information Sharing Act (“CISA”) (Pub. Law No. 114-113)[1], was pushed through Congress as part of an omnibus spending bill that was subsequently signed by President Obama.[2] This bill has been hailed by its sponsors as long overdue and an important step in enhancing our nation’s cybersecurity; while privacy advocates have decried this as the government’s further encroachment on privacy rights.[3] CISA 2015 is an expansive and wide-reaching law and consequently, our focus will be limited to the information sharing portion of this law.

In order to understand CISA 2015 it is important to contemplate what the act covers. The sponsors of this legislation, as well as the White House, have indicated that this act is focused on information sharing between private and federal entities, purportedly to enhance the United States’ cybersecurity posture; whereas privacy advocates claim this is merely an expansion of the cyber-surveillance state.[4] CISA 2015 defines cybersecurity threat as “…an action, not protected by the First Amendment …, on or through an information system that may result in an unauthorized effort to adversely impact the security, availability, confidentiality, or integrity of an information system or information that is stored on, processed by, or transiting an information system.”[5] This seems to pretty much cover everything and anything and of particular interest is the fact that the key language “…that may result in an unauthorized effort…” seems to imply that merely taking an action that has the potential to impact an information system is a cybersecurity threat and that no actual harm must occur. The crux of this is about information sharing, thus, if a private entity shares information with a federal entity the bar is set exceedingly low with respect to establishing that there is a possibility that something could be a threat. This shifts the burden of due diligence and consequently information sharing can occur without the entity really examining the issue and the context to see if harm is “likely” to occur. There is a vast expanse between something that is possible and something that is likely. Under these auspices, an entity could share almost anything that had even an infinitesimal chance of causing harm.

The CISA act addresses areas such as authorization for monitoring and identifying cybersecurity threats, the sharing of cybersecurity threats between federal and non-federal entities, as well as protections from liability related to sharing cybersecurity threats. CISA 2015 provides entities with the authorization to monitor information systems, implement defensive cybersecurity measures, and share cyber threat indicators or defensive measures so long as these actions are done under the guise of cybersecurity purposes.[6] With respect to liability limitations and information sharing protections, none of the information shared for cybersecurity purposes will be made generally available to the public and is exempt from among other things, FOIL laws, preventing the disclosure of any of the shared information.[7] While this may have the effect of helping to encourage information sharing it could also have a chilling effect on oversight as an entity can simply claim that information being sought under disclosure mandates is excluded since it relates to “cybersecurity threat information sharing”. Furthermore, section 106 of CISA 2015 directly addresses liability and states that no cause of action can be initiated or continued in any court against any private entity related to (1) monitoring of an information system or, (2) the sharing or receipt of any cyber threat indicator or defensive measure, so long as these actions are done in accordance with CISA 2015 (which of course relates back to the definition applied to cybersecurity threat).[8] As a result of this language, both the Federal Trade Commission (“FTC”) and the Federal Communications Commission (“FCC”) have effectively been de-fanged by this legislation. Now, neither the FTC nor the FCC can pursue private entities who monitor their information systems so long as the entity establishes that they are acting pursuant to cybersecurity purposes.

In some respects CISA 2015 serves to leverage President Obama’s Executive Order 13691 which was designed to promote the creation of information sharing and analysis organizations (ISAOs) in order to encourage the sharing of cybersecurity threat information between the private sector and the government.[9] While this could be viewed as a positive step one can also counter that this encourages the widespread and continued intrusion into our everyday cyber lives. For CISA 2015 does not just encourage information sharing it also severely limits the liability of any entity that shares information. Whether or not that information ultimately ends up containing personally identifiable information (“PII”) or is ultimately not connected to any viable cybersecurity threat. CISA 2015 does require that non-federal entities review information for PII prior to sharing but the threshold is once again exceedingly low. The act allows the entity to either review the information and remove PII that they “know” identifies a specific individual; or in the alternative an entity may develop a technological solution to remove information unrelated to a cybersecurity threat that the entity “knows” at the time of sharing to be personal information.[10] Here knowingly as defined in the model penal code means essentially that the entity must be “practically certain” that their conduct (e.g. the sharing of information) would both (1) not be connected to a cybersecurity threat, and (2) contain information that would identity a specific individual.[11] In addition to the encouragement of sharing, under section 105, cybersecurity threat information is shared with all of the federal entities subject only to such controls as must be unanimously agreed to by the federal entities.[12] Consequently, any information processing is weighed in favor of expediency and against the unintended release of PII, in spite of the potential collateral damage associated with the sharing of PII. Within this same section, CISA lists a range of authorized activities which allow Federal, State, and Local law enforcement to use cyber threat information for investigations covering a wide range of offenses. Essentially allowing the government access to and use of information that would otherwise be protected under the fourth amendment provisions against unreasonable search and seizures as well as the probable cause requirements.[13]

Effectively, the public outcry following the Snowden revelations about widespread cyber-surveillance were overcome as this expansive bill pushed through the House and the Senate and was dutifully signed by President Obama. As though the encouragement and promotion of information sharing did not have enough potential for misuse, this Act goes a step further by declaring that all of this information is exempt from the standard disclosure laws and that entities involved in cybersecurity threat analysis, monitoring, defense, and sharing are exempt from lawsuits. To further ensure that no hurdles exist, the definition of cybersecurity threat adopted in this legislation is overly broad and covers everything unless a first amendment exception can be successfully asserted – which is no small task. In short, the Cybersecurity Information Sharing Act of 2015 seems to stack the deck in favor of entities and against individuals’ privacy rights.

[1] Cybersecurity Information Sharing Act of 2015, Pub. L. 114-113, 129 Stat. 694, 694-744 (2015).

[2] Christopher Harvie & Cynthia J. Larose, Happy New Year – Cybersecurity Information Sharing Act, National Law Review (Jan. 6, 2016), http://www.natlawreview.com/article/happy-new-year-cybersecurity-information-sharing-act.

[3] Jack Detsch, Is the Cybersecurity Act really government spying in disguise?, The Christian Science Monitor (Dec. 23, 2015), http://www.csmonitor.com/World/Passcode/2015/1223/Is-the-Cybersecurity-Act-really-government-spying-in-disguise.

[4] Robyn Greene, Cybersecurity Information Sharing Act of 2015 is Cyber-Surveillance, Not Cybersecurity, Open Technology Institute (Apr. 9, 2015), https://www.newamerica.org/oti/cybersecurity-information-sharing-act-of-2015-is-cyber-surveillance-not-cybersecurity/.

[5] Cybersecurity Information Sharing Act of 2015, supra note 1, at 696.

[6] Id., at 699-700.

[7] Id., at 702.

[8] Cybersecurity Information Sharing Act of 2015, supra note 1, at 709-10.

[9] The White House, Office of the Press Secretary, FACT SHEET: Executive Order Promoting Private Sector Cybersecurity Information Sharing, (Feb 12, 2015), https://m.whitehouse.gov/the-press-office/2015/02/12/fact-sheet-executive-order-promoting-private-sector-cybersecurity-inform.

[10] Cybersecurity Information Sharing Act of 2015, supra note 1, at 701.

[11] Model Penal Code §2.02(2)(b) (Am. Law Inst., 2016).

[12] Cybersecurity Information Sharing Act of 2015, supra note 1, at 695, 703 (Federal Entity includes: Dept. of Commerce, Dept. of Defense, Dept. of Energy, Dept. of Homeland Security, Dept. of Justice, Dept. of the Treasury, and the Office of the Director of National Intelligence).

[13] Greene, supra note 4.

By: William Salage

Public Citizen, a pharmaceutical watchdog group, issued a report warning that Section 2151, also known as the Orphan Procut Extension Now Act [OPEN], a provisions in the 21^st Century Cures Act [CCA] could significantly increase the price of drugs, decrease innovation, and water down the Food and Drug Administration’s [FDA] approval standards.[1] The CCA passed through the House of Representatives in July 2015 with a stated purpose of encouraging biomedical innovation, particularly for those with rare diseases.[2]

However, legislation passed in 1983 called the Orphan Drug Act [ODA], provided powerful incentives to drug developers, such as market exclusivity, tax credits, research grants, waivers of FDA fees, and Priority Review Vouchers, create treatments for “orphan”, rare, diseases.[3] Orphan drugs are therefore drugs which are designated by the FDA to treat a disease which affects less than 200,000 individuals in the United States.[4] The ODA and its current incentives have turned a niche field of pharmaceutical development into a powerhouse, with orphan drugs being estimated to control 19% of the total share of drug prescriptions by 2020.[5]

Section 2151 encourages drug manufacturers to repurpose existing drugs to treat an orphan disease by “providing each manufacturer that wins approval for a new orphan indication on an existing FDA-approved drug with an additional six months of monopoly protections for all indications on that drug.”[6] In other words, Section 2151 encourages drug developers to find orphan indications for successful drugs by allowing a six month extension in patent protection which could equate to billions in profit.

Public Citizen argues that “the current orphan drug approval system is hardly in need of a stimulus”.[7] Rather, the current incentive programs have caused the most activity in orphan drug development in history. The average return on investment for orphan drugs is “nearly double that for non-orphan drugs: $14.90 versus $7.90 for every dollar invested in Phase III trials (human trials) respectively”.[8] Moreover, the high prices are one of the major contributing factors making orphan drugs so lucrative. In 2014 the cost to a patient for a typical drug was $5,153, while the average cost for an orphan drug per patient was $98,534.[9]

Public Citizen argues Section 2151 encourages pharmaceutical companies with patented lucrative drugs to obtain a new indication for that drug to treat a new orphan disease and in return receive 6 months’ additional patent protection.[10] However, the effect of this system is

To increase the costs of both orphan and non-orphan drugs.[11] The six-month extension applies to all indications of the drug, therefore preventing significantly cheaper generic drugs from entering the market. Moreover, such indications can be stacked, which could increase the patent protection for years to come, costing patients close to $4 billion.[12]

Furthermore, to meaningfully advance rare disease research, the pharmaceutical company must focus directly on the disease itself.[13] However, even under the current form of the ODA incentive programs, only 33% of the new orphan indications were newly developed molecules.[14] As such, even under the current incentive regime, pharmaceutical companies are not adequately encouraged to engage in new and innovative research. Section 2151 exasperates this problem. Section 2151 further encourages pharmaceutical companies to reinvest money into discovering a new use for old drugs, rather than investing that same money in new research.[15]

Finally, Section 2151, further deteriorates the FDA’s approval standard for orphan drugs.[16] As part of the ODA, the FDA has a low approval standard for orphan drugs, recognizing there is only a small population to conduct clinical trials on and the need to get some form of treatment out to those suffering from a rare disease. However, many drugs with orphan status, because of federal regulation, do not strictly treat just orphan patients or are used off label. As such, orphan drugs are often used in populations larger than 200,000 patients. Therefore, encouraging further mass development of orphan drugs, for the sake of obtaining orphan status, may lead to a decrease in regulatory scrutiny on the part of the FDA to many of the drugs being sold to the general public.[17]

 

 

[1] Sammy Almashat, Sarah Sorscher & Steven Knievel, House Orphan Drug Proposal: A Windfall for Pharma, False Cure for Patients, Public Citizen, at 1 (Dec. 8, 2015), http://www.citizen.org/ documents/2289.pdf.

 

[2] Sammy Almashat, Sarah Sorscher & Steven Knievel, House Orphan Drug Proposal: A Windfall for Pharma, False Cure for Patients, Public Citizen, at 1 (Dec. 8, 2015), http://www.citizen.org/ documents/2289.pdf.

 

[3] Developing Products for Rare Disease & Conditions, US Food and Drug Administration, (Oct. 19, 2015) http://www. fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525.htm.

 

[4] Id.

 

[5] EvaluatePharma, Orphan Drug Report 2014, (Oct. 2014), http://info.evaluategroup.com /rs/evaluate pharmaltd/images/2014OD.pdf.

 

[6] Sammy Almashat, Sarah Sorscher & Steven Knievel, House Orphan Drug Proposal: A Windfall for Pharma, False Cure for Patients, Public Citizen, at 4 (Dec. 8, 2015), http://www.citizen.org/ documents/2289.pdf.

 

[7] Id. at 8.

 

[8] Id.

 

[9] Almashat, supra note 1.

 

[10] Id. at 4.

 

[11] Id. at 13.

 

[12] Id. at 13.

 

[13] Id. at 6.

 

[14] Id. at 6.

 

[15] Almashat, supra note 1, at 7.

 

[16] Id. at 8.

 

[17] Id. at 10-11.

By: Samantha Dente

The next great frontier in medical advancements is the use of 3D printing. Although the use of 3D printing in medicine is still in its beginning stages, there are already huge implications from its use.

Most recently in September, a cancer patient received a 3D printed titanium sternum and partial rib cage to replace the bones he had lost during cancer treatment.[1] Compared to traditional flat plate implants, which tend to loosen over time and thus require follow up invasive procedures for maintenance or replacement, the success of the surgery marks a breakthrough in the medical community.[2] In addition to the more durable material, another benefit of 3D printed implants is that the implant can be made to resemble the patient’s actual anatomy with the aid of CT scans.[3]

In August, another breakthrough occurred when the FDA approved a 3D printed prescription pill for consumer use to treat epilepsy.[4] The 3D technology allows pills to be made more porous which allows them to dissolve faster and thus act quicker.[5] Before that, in 2013, a two-year-old girl born without a trachea received a 3D printed windpipe built with her own stem cells. [6]

One of the biggest areas of concern is how the use of 3D printing will change research and development (R&D) for medical device manufacturers and pharmaceutical companies.[7] One of the foreseeable functions 3D printing is the ability to print tissues and organs for drug testing, which would in turn eliminate the need for animal testing or synthetic models which are less accurate.[8] Currently, the average R&D cost for a new drug is approximately $4 billion and the failure rate of drugs in clinical trials is 90% due to differing animal and human responses to testing.[9] By lowering the risk of trial failure, this would lead to a reduction of cost and clinical trial failures.

In 2013, the U.S. funded the “Body on a Chip” project, and just this year the first organ chips are coming to market.[10] In an effort to curb the issues with R&D described above, the project encouraged universities to essentially 3D print organs through the following process: prints of sample tissue meant to mimic human organs are placed on a microchip and connected with a blood substitute to keep cells alive. [11] This allows doctors to more accurately test specific treatments and monitor their effectiveness.[12] The military has shown interest in this project in the hopes of one day developing treatments for nuclear and biological incidents and has funded about $39 million into projects at Harvard and MIT.[13]

Although there was concern over FDA roadblocks, it has surprisingly expressed openness to the use 3D printing in R&D.[14]

It has been about thirty years since 3D printing technology was first introduced, and the biotechnology community is finally harnessing its true power and potential.[15] It has been predicted that patients eventually may be able to print their own medicines at home, which would in turn lead to a transition in how medications are prescribed.[16] It may seem like science fiction, but it is a possibility that could become a reality sooner than we think.

 

[1] Kelly Hodgkins, Cancer Patient Undergoes World’s First 3D Printed Sternum Replacement Surgery, Digital Trends (Sep. 11, 2015), http://www.digitaltrends.com/cool-tech/sternum-ribs-3d-print-implant/.

[2] Id.

[3] Id.

[4] Dominic Basulto, Why It Matters That the FDA Just Approved The First 3D Printed Drug, The Washington Post (Aug. 11, 2015), https://www.washingtonpost.com/news/innovations/wp/2015/08/11/why-it-matters-that-the-fda-just-approved-the-first-3d-printed-drug/.

[5] Id.

[6] Zuzanna Fiminska, 3D Printing Set To Revolutionize Pharma, Eye For Pharma (July 15, 2014), http://social.eyeforpharma.com/clinical/3d-printing-set-revolutionize-pharma.

[7] Id.

[8] Id.

[9] Id.

[10] Towards a Body-On-A-Chip, The Economist (Jun 13, 2015), http://www.economist.com/news/science-and-technology/21654013-first-organ-chips-are-coming-market-and-regulators-permitting-will-speed.

[11] Fiminska, supra note 6.

[12] Id.

[13] Towards a Body-On-A-Chip, supra note 10.

[14] Basulto, supra note 4.

[15] Bethany Gross, Evaluation of 3D Printing and Its Potential Impact on Biotechnology and Chemical Sciences, Analytical Chemistry (Jan. 16, 2014), http://pubs.acs.org/doi/pdf/10.1021/ac403397r.

[16] Basulto, supra note 4.