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Patentability Considerations

Written By: Andrew Campbell Lee, Ph.D.

Practitioners must consider both the prior art [1] and the language [2] used in claims when preparing a patent application.  Patentable subject matter includes “any new and useful process, machine, manufacture, composition of matter, or any new and useful improvement thereof.” [3] While this language appears to have clear meaning in the engineering field for mechanical and electrical inventions, algorithmic inventions must be claimed with the Alice Corp. Pty. Ltd. v. CLS Bank Intern. decision in mind. [4]

Several court decisions impact the determination of what is patentable.  In Alice, the Supreme Court opined that abstract ideas, which are not themselves patent eligible, would not become patent eligible by “recit[ing] . . . generic computer components configured to implement the same idea.” [5] While several test constructs have been used to determine patent subject matter eligibility, [6] the two-part framework from Mayo was applied in Alice. [7]  The Mayo test includes (1) determining whether the claims are directed to ineligible subject matter (e.g., laws of nature, natural phenomena, and abstract ideas), and (2) if so, a subsequent determination must be made as to “what else is there in the claims before us.” [8]

For example, an inventor’s disclosure for a technique to keep law school students awake during lecture may include a method comprising: identifying a facial expression indicative of weariness; determining a metric based at least in part on the identified facial expression; and determining a change in lighting if the metric exceeds a predetermined threshold. [9] This process, as written, could be a thought exercise (e.g., looking at a crowd of people).  This claim would likely run into Alice issues, falling under either prong of the Mayo test.

The United States Patent and Trademark Office (“USPTO”) has provided some guidance in drafting claims with respect to subject matter eligibility. [10]  With the USPTO’s guidelines in mind, a claim may be crafted such as, for example: A method for automatically adjusting lights based on audience, the method comprising: generating image data, using imaging equipment, indicative of an image; determining, using control circuitry, a facial expression metric associated with the image and based on a plurality of reference templates; and generating, using the control circuitry, a control signal based on the facial expression metric for causing an actuator to articulate a lighting fixture. This claim avoids categorization as an abstract idea, the first prong of the Mayo test, because there is tangible input and output requiring more than a generic computer.  Further, if that same inventor describes training a neural network model to more accurately identify the weary students based on a dataset, the USPTO provides useful claim examples, including discussions, to help address these issues. [11]

 

[1] See 35 U.S.C.A. §§ 102-103 (West 2015) (regarding novelty and obviousness rejections based on prior art).

[2] See 35 U.S.C.A. § 112(b) (the claims must “particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention”).

[3] 35 U.S.C.A. § 101 (West 1952) (“whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title”).

[4] Alice Corp. Pty. Ltd. v. CLS Bank Intern., 573 U.S. 208, 226-27 (2014).

[5] Id. (reasoning that “the system claims are no different from the method claims in substance”).

[6] See State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (1998) (the machine or transformation test); see Bilski v. Kappos, 561 U.S. 593, 605 (2010) (which deemed the machine or transformation test of State Street a tool but not the “sole criterion”); see generally Daniel J. Burns, Patent Practice After Alice, 2016 WL 1595103, at 2 (March 2016) (providing an overview of patent practice following Alice).

[7] Alice, 573 U.S. at 217-18; see Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 77-80 (2012).

[8] Mayo, 566 U.S. at 77-78; see also Alice, 573 U.S. at 217-18.

[9] This claim is merely illustrative and has not undergone the 35 U.S.C. §§ 102-103 patentability analysis.

[10] See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (hereinafter “2019 PEG”); see also October 2019 Update: Subject Matter Eligibility (October 17, 2019), https://www.uspto.gov/sites/ default/files/documents/peg_oct_2019_update.pdf (addressing comments submitted regarding the 2019 PEG).

[11] Subject Matter Eligibility Examples: Abstract Ideas (January 7, 2019), https://www.uspto.gov/sites/default/files/documents/101_examples_37to42_20190107.pdf [https://perma.cc/T9TF-LXXJ] (see particularly Example 39 for training a neural network).

 

 

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Are designs used as a source identifier or purely functional?

Written By: Tabina Haider

In our ever-changing society, the fashion industry has found ways to not only keep up with change, but also facilitate it. High-profile designers, such as Gucci, Christian Louboutin, Yves Saint Laurent, and many others have created unique designs with source identifiers. A source identifier is a way for consumers to know which brand is responsible for the product. [1] Some examples of source identifiers are Gucci’s two “G’s,” Yves Saint Laurent’s “YSL” design, and Christian Louboutin’s signature red bottom shoe soles. However, there has been much controversy as to whether these designs serve exclusively as source identifiers or whether they are an aesthetic function.

There has been countless litigation involving aesthetic functionality. If a product feature is deemed functional in any way, it cannot serve as a trademark. [2] In contrast to utilitarian functionality, aesthetic functionality discusses how the look of the product feature serves a functional purpose. [3] Courts have struggled with the application of the doctrine, resulting in issued opinions which define, dispute, and contradict it.

Christian Louboutin red bottom shoe soles provide a great example. Is this design a source identifier or is there an aesthetically functional purpose? When YSL tried to make an all-red shoe, including the soles, Louboutin filed for trademark infringement. [4] YSL claimed having a red sole was functional because it served the function of creating a monochromatic shoe. [5] Even though Louboutin has a valid trademark for the red sole, it is not aesthetically functional because it is not necessary for the sole to be red. The court held it was necessary for the shoe sole to be red in order for YSL to achieve their desired monochromatic shoe. [6] Therefore, Louboutin lost its trademark rights for the red sole in monochromatic red shoes. [7]

Another example involves Glossier’s pink bubble wrap-linked zip-lock pouches which are used to market and sell its cosmetics. Every purchased product is packaged in this signature pouch. Glossier applied for a trademark to register the pink bubble wrap-linked zip-lock pouch, and the United States Patent and Trademark Office (“USPTO”) rejected the application due to the functional design of the packaging. [8] Glossier responded by asserting the bubble wrap is not a feature of the trademark, and it only sought rights in the specific pink color used for the packaging. [9] Because consumers associate the pink color of the bubble wrap and zip-lock bag combination with Glossier products, Glossier claims it can successfully obtain a trademark. [10] The USPTO is currently reviewing the Glossier case. [11]

The Ninth Circuit is expected to clarify the doctrine soon given the doctrine’s controversial and varying application on a case by case basis. [12] Clarity of the doctrine will be integral for companies owning rights to their own designs, strengthening the protections trademarks provide to fashion designers.

 

[1] it law wiki, https://itlaw.wikia.org/wiki/Source_identifier [https://perma.cc/X7RL-JQYJ].

[2] Qualitex v. Jacobson Products Co., Inc., 514 U.S. 159, 165 (1995).

[3] Christian Louboutin S.A. v. Yves Saint Laurent America Holdings, Inc., 656 F.3d 206, 219 (2d Cir. 2012).

[4] Id.

[5] Id.

[6] Id.

[7] Id.

[8] Forget a Logo, Glossier Says that Consumers Know Pink Pouches are Indicators of its Brand, THE FASHION LAW (January 28, 2020), https://www.thefashionlaw.com/home/in-new-trademark-filing-glossier-says-that-consumers-know-pink-pouches-are-indicators-of-its-brand [https://perma.cc/WK2X-PZTL].

[9] Id.

[10] Id.

[11] Id.

[12] David Bernstein, Kathryn Saba, & Emily R. Hush, Ninth Circuit Set to Clarify Aesthetic Functionality Doctrine, IP WATCH DOG (January 17, 2020), https://www.ipwatchdog.com/2020/01/17/ninth-circuit-set-clarify-aesthetic-functionality-doctrine/id=117980/ [https://perma.cc/4B4Y-JLN4].

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The Intersect Between Patents and Public Interest

Written By: Sophia Iams

In response to the novel coronavirus (COVID-19) outbreak, infecting over 193,000 individuals and contributing to over 7,800 deaths [1], the Chinese government is aggressively trying to stop the transmission of the disease and treat those infected. The Wuhan Institute of Virology and BrightGene, a Chinese drug manufacturer, raised concerns of potential circumvention or violation of the intellectual property rights of Gilead Sciences’ investigational drug, remdesivir. [2] Recent in-vitro studies demonstrate remdesivir is a potential treatment against COVID-19. [3]

China’s reputation for lax intellectual property protections in the pharmaceutical industry [4] has the current situation playing into those fears. From a patent application filed in 2016, Gilead is still waiting for a decision from the Chinese Patent Office for a patent protecting remdesivir. [5] On January 21, 2020, the Wuhan Institute of Virology applied for a “use patent” in China for remdesivir for its specific use in treating COVID-19. [6] On February 12, 2020, BrightGene issued a press release indicating the company started mass-producing the active ingredient in remdesivir and working on creating complete doses. [7]

These initial actions are concerning for a few reasons. First, if Wuhan Institute of Virology receives the patent, the Chinese government could use that to negotiate an unfair price for licensing rights from Gilead. [8] Wuhan Institute of Virology has also noted that it would attempt to use the Patent Cooperation Treaty (“PCT”) to export the manufactured drug to cooperating nations. [9] The PCT allows patent protection in many countries through a single “international” patent filing with the World Intellectual Property Organization. [10] Alternatively, the Chinese government could act within its rights under World Trade Organization rules to issue a compulsory license that would enable remdesivir’s use without Gilead’s consent. [11] A compulsory license is intended to allow the original patent holder and presumably the manufacturer to receive a licensing fee, raising the question of which organization will ultimately hold the patent in China. [12] In addition, now that the drug is manufactured by BrightGene, Gilead could be excluded completely. [13]

As of late-January, Gilead is working with various global health authorities, including Chinese health agencies, to perform experimental human clinical trials using remdesivir. [14] Two phase 3 trials have been initiated in Wuhan with the goals of enrolling 760 patients and obtaining preliminary results in April 2020. [15] The U.S. and international intellectual property community will closely monitor the Chinese government despite the previously improved cooperation between the U.S. and China. [16]

 

[1] World Health Organization (WHO), Novel Coronavirus (COVID-19) Situation, world health organization, https://experience.arcgis.com/experience/685d0ace521648f8a5beeeee1b9125cd [https://perma.cc/N5M7-AHGG] (last viewed Mar. 18, 2020).

[2] Angus Liu, Chinese firm copies Gilead’s remdesivir, the most promising drug against the new coronavirus, FiercePharma (Feb. 12, 2020, 10:28 AM), https://www.fiercepharma.com/pharma-asia/chinese-firm-copies-gilead-s-remdesivir-most-promising-drug-against-new-coronavirus [https://perma.cc/962V-7QMD].

[3] Manli Wang, Ruiyuan Cao, Leiki Zhang, Xinglou Yang, Jia Liu, Mingyue Xu, Zhengli Shi, Zhihong Hu, Wu Zhong & Gengfu Xizo, Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Nature (Feb. 4, 2020) https://www.nature.com/articles/s41422-020-0282-0 [https://perma.cc/5J8K-Z8UB].

[4] Max Nisen, China’s Drug Patent Grab Makes Coronavirus Scary for Pharma, Wash. Post (Feb. 6, 2020, 12:10 AM), https://www.washingtonpost.com/business/chinas-drug-patent-grab-makes-coronavirus-scary-for-pharma/2020/02/05/40dbfbf6-4844-11ea-91ab-ce439aa5c7c1_story.html [https://perma.cc/2QXJ-TCRW].

[5] Associated Press, China scientists want to patent Gilead drug to treat coronavirus patients, MarketWatch (Feb. 6, 2020, 1:44 AM), https://www.marketwatch.com/story/china-scientists-want-to-patent-gilead-drug-to-treat-coronavirus-patients-2020-02-06 [https://perma.cc/3DEJ-5RHQ].

[6] Nisen, supra note 4.

[7] Liu, supra note 2.

[8] Associated Press, supra note 5.

[9] Mary Erica D. Manuel, ‘Owning’ the Cure: Patent rights in the midst of an outbreak, BusinessWorld Online (Feb. 11, 2020, 10:53 PM), https://www.bworldonline.com/owning-the-cure-patent-rights-in-the-midst-of-an-outbreak/ [https://perma.cc/5LZ4-9AY3].

[10] World Intellectual Property Organization (WIPO), Protecting your Inventions Abroad: Frequently Asked Questions About the Patent Cooperation Treaty (PCT), World Intellectual Property Organization, https://www.wipo.int/pct/en/faqs/faqs.html [https://perma.cc/988E-QSZ8].

[11] World Trade Organization, Compulsory licensing of pharmaceuticals and TRIPS, World Trade Organization (Mar. 2018), https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm [https://perma.cc/D2EW-8ULH].

[12] Nisen, supra note 4.

[13] Id.

[14] Press Release, Gilead Sciences, Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV) (Jan. 31, 2020), https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-the-company-ongoing-response-to-the-2019-new-coronavirus [https://perma.cc/V62K-N856].

[15] Liu, supra note 2.

[16] Id.

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23andMe: Who Can See Your Genes?

Written By: Kira Gill

I. Introduction

Beginning in the 1990s, the Information Age expanded upon the available molecular tools used for genetic research.  Accompanying this expansion of tools was a revolution and rise of systems biology. The development of genetic engineering allowed manipulation, creation, and reparation of genetic material and cellular behavior. [1] On October 1, 1990, a group of researchers started the Human Genome Project, an effort to sequence and map all of the human genome. [2] This project was completed in April 2003, taking almost 13 years which led to a complete genetic blueprint for building a human being. [3] Who knew that just three years later, 23andMe would come about, allowing for at-home genetic testing?

II. 23andMe

23andMe is a company founded in Silicon Valley which aims to use genetic testing to boost personalized healthcare and allow individuals to learn more about their heritage. [4] 23andMe charges $99 to customers to take a saliva test at home and receive information about the individual’s ancestry. [5] For $199, customers will not only receive ancestry traits, but also information of one’s health predispositions. [6] After 23andMe receives your sample, it takes just 2-3 weeks for the results to come back, compared to the 13 years it took for the Human Genome Project. [7] From human to human, the genes are about 99.5% the same; however, there are variants in the genome which include different genes passed down from parent to child. [8] 23andMe identifies the variants in the sample and analyzes them to find unique traits within the person. [9] Naturally, a plethora of legal issues have stemmed from this new technology.

III. Privacy Issues

There has been a long list of privacy issues which have occurred due to the highly accessible genetic information offered by 23andMe.  A few cases in particular pose more serious issues including sperm donors who were typically offered the option to remain anonymous. [10] Using 23andMe’s services, offspring of sperm donors have been able to track those who had wished to remain anonymous. [11] One woman violated her contract by trying to find her sperm donor through 23andMe. [12] She was successful, but the sperm bank ordered a cease-and-desist against her and revoked the use of the other gametes she had purchased from the same donor. [13]

Another issue that remains is the use of the DNA collected from at-home tests by police to match DNA samples in current cases. [14] Although these test results are extremely beneficial to the police for solving open cases within their database, for example, the Golden State killer, the use raises concerning issues. [15] A class action lawsuit was also filed against 23andMe in regard to the data being stored in a large database and its use by third parties. [16] Since the technology is so new and the development occurred so rapidly, there is not much legal precedent regarding genetics and privacy.

IV. Genetic Information Nondiscrimination Act of 2008

Currently, there is only one prominent law that regulates genetic privacy, the Genetic Information Nondiscrimination Act of 2008 (GINA). [17] GINA is a federal law which passed due to increasing concerns about the accessibility of genetic information. [18] GINA prohibits health insurance companies from requesting, requiring, or using genetic information to make decisions about an individual’s eligibility for health insurance. [19] Also, GINA prohibits employers from discriminating against their employees based upon their genetic information. [20] In essence, GINA only offers minimal protection as it applies only to health insurance and employment issues.

V. Conclusion

Overall the accessibility and publicity of private genetic information brings up a series of legal issues.  Per its advertisements, 23andMe has taken action by becoming FDA approved. [21] It also addressed privacy concerns by stating the genetic information is not given to other databases without explicit consent from consumers and cannot be taken by law enforcement unless demanded by a subpoena or court order. [22] The legislature has started intervening but has been limited to GINA thus far. As issues with genetic privacy continue, the legislature will have to adapt and balance the public interest of privacy, as well as the benefits that this data produces, such as steps towards personalized healthcare and cures to genetically predisposed diseases.

 

[1] D. Ewen Cameron, Caleb J. Bashor & James J. Collons, A brief history of synthetic biology, 12 Nature Rev.: Microbiology. 381, 381-90 (2014).

[2] The Human Genome Project, NATIONAL HUMAN GENOME RESEARCH INSTITUTE, https://www.genome.gov/human-genome-project [https://perma.cc/XQ5T-P5TQ].

[3] Id.

[4] 23andMe, https://www.23andme.com/howitworks/ [https://perma.cc/ZZ9G-FXKQ].

[5] Id.

[6] Id.

[7] Id.

[8] Id.

[9] Id.  

[10] Meghana Keshavan, ‘There’s no such things an anonymity’: With consumer DNA tests, sperm banks reconsider long-held promises to donors, Stat. (Sept. 11, 2019), https://www.statnews.com/2019/09/11/consumer-dna-tests-sperm-donor-anonymity/ [https://perma.cc/R3DT-YZAF].

[11] Id.

[12] Id.

[13] Id.

[14] Christi J. Guerrini, Jill O. Robinson, Devan Petersen & Amy L. McGuire, Should police have access to genetic genealogy databases? Capturing the Golden State Killer and other criminals using a controversial new forensic technique, 16 PLOS Biology1, 1-9, Oct. 2, 2018.

[15] Id.

[16] CBS News/AP, Class-action lawsuit filed against 23andMe over misleading marketing, CBS NEWS (Dec. 4, 2013, 12:32 PM), https://www.cbsnews.com/news/class-action-lawsuit-23andme/ [https://perma.cc/CZM5-RMRD].

[17] Genetic Discrimination, NATIONAL HUMAN GENOME RESEARCH INSTITUTE, https://www.genome.gov/about-genomics/policy-issues/Genetic-Discrimination [https://perma.cc/U55N-FPPV].

[18] Id.

[19] Id.

[20] Id.

[21] 23andMe, https://www.23andme.com/howitworks/ [https://perma.cc/ZZ9G-FXKQ].

[22] Id.