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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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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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CRISPR Patent Dispute Unlikely To End With A Winner

Written By: Aaron Shaw

The genetic engineering tool, CRISPR-Cas9, represents the center of an ongoing patent dispute between the University of California, Berkeley, and the Broad Institute of MIT and Harvard.  CRISPR is a protein-based mechanism rendered from bacteria that can be manipulated to precisely splice and replace portions of a plant or animal’s genetic material. [1] Alternative genetic engineering technology are more expensive, taking more time to produce.  As a result, CRISPR is a powerful tool that can be put in the hands of many researchers.

High precision genetic engineering will inevitably raise ethical and legal questions about who can receive treatment and for what purpose. Will we limit ourselves to curing genetic diseases or will we allow ourselves to add favorable traits to humans?  However, the technology remains in its infancy. [2] The current battle involves the USPTO and EPO as to who owns the patents to CRISPR.

Jennifer Doudna, of the University of California Berkeley, and Emanuelle Charpentier, of the University of Vienna, were the first to discover the potential of CRISPR in prokaryotes (bacteria), and they were the first to apply for a patent. [3] [4] They have encountered fierce opposition from the Broad Institute of MIT and Harvard, who predicate their rights to CRISPR by being the first to examine its use in mammalian cells. [5] [6] The Broad Institute obtained a patent from the USPTO in 2017, for CRISPR’s use in eukaryotes (plant and animal cells). [7] Some would consider this a hard knock to UC Berkeley, since it was the first to publish the genetic engineering potential of the CRISPR mechanism.  The obvious next step was to apply the mechanism to eukaryotes. [8]

One month after the Broad Institute received its patent, UC Berkeley was granted a patent for the use of CRISPR in eukaryotes by the EPO. [9] The apparent split decision reveals the complexity of determining the owner of a technology that is groundbreaking, highly lucrative, and used on an international basis.  The Europeans stressed that the initial discovery of CRISPR defined the right to use it in a broad field of application. [10] The American approach appears to have narrowed the process, determining that the initial demonstration of CRISPR in a specific setting, such as in animal cells, created the right for its use in animals.

In 2017, one of our law students wrote about the precedent on this blog. [11] At the time, the most recent news was that UC Berkeley and the University of Vienna had defended their right to the broad use of CRISPR in Europe. [12] One reason this appeared to be a never-ending battle involved the rate of CRISPR innovation.  Such technologies instigate extended legal battles because scientists cannot discern the parameters.  Multiple parties held patents for narrowly defined applications of the CRISPR system. [13] However, the dispute between Berkeley and the Broad Institute still linger as a contentious debate.  The EPO’s decision did not seem to resolve the difference between the strategy of using CRISPR in animal cells while defining such use in animal cells.

In 2018, the US Court of Appeals doubled down, confirming there was “‘no interference in fact’” between the two parties’ patents. [14] In July 2019, UC Berkeley claimed the Broad Institute deceived the PTO by withholding information. [15] The Broad Institute believes this is a low blow. [16] Afterall, UC Berkeley has just filed its eleventh patent (and they are expecting six more) involving CRISPR-Cas9; this time the patents involve precise methods and substances for targeting DNA­—a vital step for the CRISPR system to modify DNA. [17] Without knowing whether the Broad Institute deceived the PTO, it appears Berkeley has conceded by filing narrow patents in the U.S.  It is now clear Berkeley has to compete with all the other discoveries being made, [18][19][20][21] despite not giving up on the dispute. Neither the PTO, nor the EPO, is likely to change patent application requirements any time soon.  This feud is likely headed toward a dead end, but neither party can be blamed for their pursuit, given the capital at risk.

This problem underscores the international challenge biotech companies confront.  Laboratories and pharmaceutical companies conduct expensive and timely research, [22] subsequently compelled to litigate when parties obtain similar patents in other jurisdictions.  This only serves to delay innovation when dealing with such a powerful research tool, and in the case of CRISPR, the issue may go further than the patent offices. The Federal and Drug Administration (FDA) is primarily concerned with somatic cell therapy in humans, but CRISPR-related patent applications are constantly pushing the boundaries of gene editing beyond somatic cell therapy. New technologies advance our understanding of how to apply the law.  The FDA and European Medicines Agency must be responsive to new CRISPR products that charter unregulated waters in order to encourage potential innovation.

[1] Jennifer Doudna, Genome-editing revolution: My Whirlwind year with CRISPR, Nature (December 22, 2015), https://www.nature.com/news/genome-editing-revolution-my-whirlwind-year-with-crispr-1.19063 [https://perma.cc/QSV3-Y2JD].

[2] Id.

[3] Heidi Ledford, Why the CRISPR patent verdict isn’t the end of the story, Nature (February 17, 2017), https://www.nature.com/news/why-the-crispr-patent-verdict-isn-t-the-end-of-the-story-1.21510 [https://perma.cc/X4D7-37RC].

[4] Jinek, Marti, et. al., A programmable dual RNA-guided DNA endonuclease in adaptive bacterial immunity, 337 Science 816-821 (2012).

[5] Heidi, supra note 3.

[6] Cong, Le, et. al., Multiplex Genome Engineering Using CRISPR/Cas Systems, 339 Science 819-823 (2013).

[7] Heidi, supra note 3.

[8] Programmable DNA Scissors found for bacterial immune system, Science Daily (June 28, 2012), https://www.sciencedaily.com/releases/2012/06/120628193020.htm [https://perma.cc/72MW-DRCH].

[9] Jef Akst, UC Berkeley Receives CRISPR Patent in Europe, The Scientist (March 24, 2017) https://www.the-scientist.com/?articles.view/articleNo/48987/title/UC-Berkeley-Receives-CRISPR-Patent-in-Europe/ [https://perma.cc/B8WR-3D2B].

[10] Id.

[11] Charles Cheng, A Gene-Editing Patent Dispute – What Does it Mean?, USF Blogs: Intellectual Property and Law Journal (March 28, 2017), https://usfblogs.usfca.edu/iptlj/2017/03/28/a-gene-editing-patent-dispute-what-does-it-mean/#more-1002 [https://perma.cc/ZT9L-K5QL].

[12] Jim Daley, Berkeley CRISPR Inventors Get Another Important European Patent, The Scientist (March 12, 2018), https://www.the-scientist.com/?articles.view/articleNo/52042/title/Berkeley-CRISPR-Inventors-Get-Another-Important-European-Patent/ [https://perma.cc/NTP7-UNMS].

[13] Heidi, supra note 3.

[14] Mark Terry, UC-Berkeley Rekindles U.S. Patent Dispute with the Broad Institute over CRISPR, BioSpace (August 1, 2019), https://www.biospace.com/article/crispr-patent-battle-isn-t-quite-over-yet/ [https://perma.cc/3T9P-4CC3].

[15] Id.

[16] Id.

[17] University of California, U. Vienna, Charpentier Get 11th U.S. CRISPR Cas-9 Patent, ClinicalOmics (August 26, 2019), https://www.clinicalomics.com/topics/precision-medicine-topic/university-of-california-u-vienna-charpentier-get-11th-u-s-crispr-cas-9-patent/ [https://perma.cc/N755-F965].

[18] Jon Cohen, Nirja Desai, With its CRISPR revolution, China becomes a world leader in genome editing, Science (August 2, 2019, 8:00 AM), https://www.sciencemag.org/news/2019/08/its-crispr-revolution-china-becomes-world-leader-genome-editing [https://perma.cc/3N7J-4B3C].

[19] Rich Haridy, CRISPR breakthrough allows scientists to edit multiple genes simultaneously, Newatlas (August 15, 2019), https://newatlas.com/crispr-cas12a-gene-editing-multiple-eth-zurich/61068/ [https://perma.cc/WK2C-A5WW].

[20] CRISPR gene editing may halt progression of triple-negative breast cancer, Medical Xpress (August 26, 2019), https://medicalxpress.com/news/2019-08-crispr-gene-halt-triple-negative-breast.html [https://perma.cc/Z8J3-G4RF].

[21] Hanae Armitage, Scientists Zero in on cancer treatments using CRISPR, Stanford Medicine (August 26, 2019), https://scopeblog.stanford.edu/2019/08/26/scientists-zero-in-on-cancer-treatments-using-crispr/ [https://perma.cc/9WV9-QZT3].

[22] Biotechnology Law, HG.org, https://www.hg.org/biotechnology.html [https://perma.cc/7BNM-H34X] (last visited Jan. 26, 2020).

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What will incentivize owners to patent their augmented reality creations?

Written By: Gabriela Vasquez

Initially, virtual reality was confined to a two-dimensional screen. [1] Over the years, virtual reality has surpassed its capacity, moving in a 3-dimensional direction with the ability to interact with humans and other physical objects. This process is known as Augmented Reality (AR). It is technology that adds digital content to our experience of the physical world. [2] AR makes the physical world “clickable” by inserting digital interactive hyperlinks into our physical space. [3]

Today, AR is mostly used to enhance the sense of sight. [4] Engineers are working to digitally augment our fields of vision in various ways, for example, mobile computing, digital imaging, advertisements, and content creation. [5] Due to the extreme commercial activity implicated in the process of distributing AR to the public and the rapid innovation and competition in the market, intellectual property disputes in the world of augmented reality are on the rise.

There have been numerous patent infringement issues arising in the last few years. Notably, Lennon Image Technologies, LLC (“Lennon”) has filed various patent infringement suits against multiple online retailers over the years for its patent titled “Customer Image Capture and Use Thereof in a Retailing System”. [6] Lennon’s patented technology developed a virtual “try-on” system, giving customers the opportunity to virtually assess the selected merchandise without having to physically try-on the apparel. [7] A variety of these suits have resulted in settlements or the online retailer’s removal of the virtual try-on feature from their website after receiving allegations of infringement. [8] This is likely due to the expenses attached to patent infringement litigation and the recognition of how expensive it is for anyone to patent their creations and designs.

In a seller’s market, there is pressure to introduce the next best thing. Augmented reality provides the highly competitive online retailer market with the technology and ability to create unique, interactive shopping experiences for customers. These experiences can include the ability to try-on or test-drive a product without leaving your couch, browse virtually, design custom goods, or receive product specs and features information in context. [9] Providing these features gives online retailers the opportunity to increase their revenue, retain clients, and set their brand apart from similar competitors. [10]

Virtual retailers and the creators of AR technology have a huge incentive to patent creations and designs before they hit the market, as these virtual “experiences” risk losing novelty through disclosure. AR in virtual retail will only continue to expand at faster rates in years to come. It is of utmost importance that virtual retailers are aware of the necessity to protect the AR technology they spend a significant amount of time and money to distribute to the public, hoping to profit through e-commerce. If their competitors have the ability to introduce the same exact AR interactive shopping experience without legal restraints, less economic incentives exist for developers and the virtual retailers that foot the bill.

[1] Brian D. Wassom, IP in an Augmented Reality, ABA (Jan./Feb. 2014) https://www.americanbar.org/groups/intellectual_property_law/publications/landslide/2013-14/january-february/ip_an_augmented_reality/.

[2] Id.

[3] Id.

[4] Id.

[5] Id.

[6] Customer Image Capture and Use Thereof in a Retailing System, U.S. Patent No. 6624843 B2 (filed Dec. 8, 2000 ) (issued Sep. 23, 2003 ).

[7] Id.

[8] Wassom, supra note 1.

[9] Lisa Terry, VR in Retail: The Future of Shopping is Virtual and Augmented, INSIGHTS (Jul. 31, 2018) https://perma.cc/LS7X-AR62.

[10] Id.

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The Rising Issue of Current Patent Infringement Remedies

Written By: Ashley Kim

Today, it is questionable whether current patent infringement remedies are adequately furthering the goal of patent law – that is, “[promoting] the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” [1] An exponential progress in the field of science has produced an overwhelming number of fledgling start up tech companies that have contributed to the development of valuable innovation.

However, recent scholars have expressed a concern over excessive damages for patent infringement to inventors at the expense of infringers. [2] It is well admitted that the progress in science has provided “too great a degree of protection to patents” and as a result, such excessive damages would “reduce the overall incentive for firms to develop commercial products.” [3] Therefore, coming up with an efficient assessment for patent infringement damages has always been an issue. [4]

Traditionally, when a patent is infringed, compensation was thought to “[put] the patent holder in the position it would have been in had its patent rights not been infringed.” [5] Generally, lost profits or actual damages and reasonable royalty damages have been the two pillars of remedies for patent infringement. [6] In fact, due to the difficulty in proving lost profits, courts usually refer to the “reasonable royalty” damages, and specifically to the Georgia-Pacific Factors when actual damages cannot be ascertained. [7]

The most problematic issue of using Georgia-Pacific Factors is that they assess “ex post considerations.” [8] Ex post considerations inflate the value of the patent due to the fear of litigation (especially for small companies). [9] In addition, “lock-in” costs pertaining to “the investments made in the allegedly infringing product and the cost to switch to a non-infringing alternative,” ultimately overestimate the value of the patent. [10]

Rather than focusing on the value of the technology, current damages focus on reasonable royalties based on ex post considerations, such as an infringer’s investment. [11] Therefore, the practice perpetuates excessive damages in favor of patent holders that negatively incentivize firms from actualizing the products. It is imperative for courts to carefully consider the impact of implementing ex post considerations when deciding reasonable royalty and thus should balance incentives of patent holders and would-be infringers to further the goal of the Patent Act.

[1] U.S. Const. art. I, § 8, cl. 8.

[2] Hon. Arthur J. Gajarsa, William F. Lee & A. Douglas Melamed, Patent Damages Symposium: Breaking the Georgia-Pacific Habit: A Practical Proposal to Bring Simplicity and Structure to Reasonable Royalty Damages Determinations, 26 Tex. Intell. Prop. L.J. 52, 53 (2018).

[3] Id.

[4] William F. Lee & A. Douglas Melamed, Breaking the Vicious Cycle of Patent Damages, 101 Cornell L. Rev. 385, 391 (2016).

[5] Id. at 394.

[6] Id. at 395.

[7] Id.

[8] Gajarsa, supra note 2 at 54.

[9] Id.

[10] Id.

[11] Lee, supra note 4 at 465.

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Gene Therapy: Therapy For All, But Patents For None?

Written By: Elyse Gottschalk

If you Google the top 10 life-improving inventions of the 2000s, unsurprisingly, the top of the list is “mobile broadband”, the technology that brought live streaming to “cat video” lovers across the globe. [1] While Apple and Samsung were in a race for the best smart phone, science was partaking in its own endeavor – the task of sequencing the human genome, known as the Human Genome Project. After nearly 13 years, three billion DNA base pairs and every gene in the human genome were identified, qualifying it as the second ranked life-improving invention of the 2000s. [2]

But, the Human Genome Project was not the end. It was the beginning of the “genomic revolution”, with the race for development of gene-based therapies at the forefront. [3]

Gene therapy, the replacement of mutated, dysfunctional genes with functional ones as a cure for lifelong (typically fatal) diseases caught the interest of scientists, recognizing the expansive and potentially lucrative opportunity. However, development and testing of these kinds of treatments involves huge amounts of money, and scientists are beginning seek patents to protect their discoveries. [4]

Gene patents are one of the most controversial categories of patents in the United States and abroad. Patent proponents focus on incentivizing invention and promoting commercialization through the economic efficiency provided by a patent monopoly. [5] They argue that, without the protection of patents, because of the unusually high failure rate of biology-based research, the economic burden would limit development to large biopharma companies that could absorb the loss. In addition, in the absence of patent protection, collaborative efficiencies would be stagnated, with companies relying on trade secrets as a means of protection, slowing the development of treatments. [6]

Those opposing patent protection to genetic material argue that it is not consistent with the intent of 35 U.S.C. § 101, which does not historically extend patent protection to phenomena of nature. [7] Their concerns were addressed in Association for Molecular Pathology v. Myriad Genetics, where the Supreme Court held that a gene sequence in its natural form was not patentable, as distinguished from cDNA, a stripped version of DNA sequence isolated in a lab. [8] This means that a specific version of the DNA once isolated or with a specific mutation is patentable, while the sequence itself is broadly available for use.

While the court refused to address the public policy implications, this was a win for those concerned that gene patenting had negative implications for patient care. In fact, as part of the Appellate courts review, the AMA submitted an amicus curiae brief stated that gene patents interfere with diagnosis and treatment, quality assurance, and patient access to health care because it limited the options available for the treatments, leaving patients at the mercy of those holding the monopoly. [9]

Gene therapy, though in its infancy, is becoming a hot topic for scientists and patent lawyers alike. While the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics has provided some guidance into the patentability of genetic material and treatments, like gene therapy itself, the potential developments remain largely untapped. Patent attorneys, the scientists of patent law, will find themselves tasked with navigating the world of opportunities (and associated challenges) presented by the “genomic revolution”, by walking the line between protecting the inventor and benefiting society. The public policy implications that are the underpinnings of patent law are no exception here.

[1] Will McClennan, Great Life-Improving Inventions of the 2000s, The Richest (Nov. 23, 2013), https://www.therichest.com/business/technology/the-top-10-life-improving-inventions-of-the-2000s/.

[2] Id.

[3] Simon Trip and Martin Gruber, Economic Impact of the Human Genome Project (2011).

[4] Id.

[5] Laurie L. Hilla, The Race to Patent the Genome: Free Riders, Hold Ups, and The Future of Medical Breakthroughs, 11 Tex. Intell. Prop. L.J. 221, 237-42 (2003).

[6] Id.

[7] Id.

[8] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).

[9] Id.

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Non-Appropriation in Space: A Surprisingly Old Dilemma with Patent Law

A Brief History on the Need for Patent Reform as More Nations and Private Entities Enter Space

Written By: Jessica Ramsey

On January 27, 2017, the Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space, Including the Moon and Other Celestial Bodies (the “Outer Space Treaty”) celebrated its fiftieth anniversary.[1] Arguably the most important body of space law with 89 signatory states[2], it is both shocking and predictable that the Treaty has never been amended.[3]

Why?

History explains. In October 1957, the U.S.S.R. successfully launched the first artificial satellite, Sputnik I, effectively initiating the Space Race.[4] The following July, the United States founded the National Aeronautics and Space Administration (“NASA”).[5] Less than a year later, the United Nations created the Committee on the Peaceful Uses of Outer Space (COPUOS).[6]

In 1967, COPOUS created the Outer Space Treaty, which was signed by over 50 nations amid the Cold War and global fear of nuclear weapons positioned in space.[7]  The Treaty is seventeen Articles of broad, cautionary language, warding against extending the arms race beyond the atmosphere.[8] Yet, because of its breadth, it has proven significantly more difficult to amend than to sign.

But here is where questions regarding patents in space likely began. Article II of the Outer Space Treaty explicitly states that space, including celestial bodies, “is not subject to national appropriation” by any means.[9]

Put bluntly, this is the precise opposite objective of a patent. Patents are territorial rights and almost every country has its own patent laws.[10] There are cooperative international systems like the Patent Cooperation Treaty (WIPO patents),[11] but these still do not remove the territorial nature of patents.[12]

Thus, the dilemma is revealed: patent law only provides protection in the territory of the country the patent is filed within. Even international patent laws require the territory be under control of a party state.[13] If no one country can control any territory in space, how is the appropriate patent law in space determined?

In 2004, this question was considered in “Intellectual Property and Space Activities,” a WIPO issue paper.[14] The document explains reconciling patent and space law is important mostly because space activities are becoming increasingly privatized.[15] These non-governmental entities tend to be “more conscious of their ‘property,’” including intellectual property.[16] This, paired with increasing international cooperation and immense private investments required in space activities, heightened the need for “simple, uniform and reliable” IP laws.[17]

Yet, the Outer Space Treaty and both national and international IP laws remain largely unchanged.[18] The only United States code specifically regarding IP in space was enacted in 1990 and merely overlaid current patent laws onto the territory of outer space.[19] This rather cookie-cutter approach is not in alignment with the Outer Space Treaty’s stance on “no national appropriation” in space.[20]

As of 2019, it has been 61 years since the first artificial satellite launched into space and 51 years since the signing of the Outer Space Treaty.[21] COPUOS membership has risen from 18 to 92 member states.[22] The Cold War has ended, the Internet was created, and the world has reached new heights of globalization.

Yet, the dilemma remains. The faster people enter space; the faster inventions will be produced as problems are experienced and subsequently solved through technology. The more technology created in space, the higher the need for uniform patent laws.

How will territorial patent laws and non-appropriative space law be reconciled?

 

[1] Jonathan Lim, The Future of the Outer Space Treaty – Peace and Security in the 21st Century, Global Politics Review 4, Oct. 2018, http://www.globalpoliticsreview.com/publications/2464-9929_v04_i02_p072.pdf (last visited Feb. 17, 2019).

[2] Id.

[3] 18 U.S.T. 2410.

[4] Steve Garber, Sputnik and The Dawn of the Space Age, NASA, Oct. 10, 2007, https://history.nasa.gov/sputnik/ (last visited Feb. 17, 2019).

[5] Steven J. Dick, The Birth of NASA, NASA, Mar. 28, 2008, https://www.nasa.gov/exploration/whyweexplore/Why_We_29.html (last visited Feb. 17, 2019).

[6] Committee on the Peaceful Uses of Outer Space, United Nations Office for Outer Space Affairs,

http://www.unoosa.org/oosa/en/ourwork/copuos/index.html (last visited Feb. 17, 2019).

[7] 18 U.S.T. 2410.

[8] Id.

[9] Id.

[10] Protecting intellectual property rights (IPR) overseas, United States Patent and Trademark Office, Jul. 4, 2009, https://www.uspto.gov/patents-getting-started/international-protection/protecting-intellectual-property-rights-ipr (last visited Feb. 17, 2019).

[11] Inside WIPO: What is WIPO?, World Intellectual Property Organization, https://www.wipo.int/about-wipo/en/ (last visited Feb. 17, 2019)

[12] PCT FAQs: Protecting your Inventions Abroad: Frequently Asked Questions About the Patent Cooperation Treaty (PCT) (status on October 2017), World Intellectual Property Organization, https://www.wipo.int/pct/en/faqs/faqs.html (last visited Feb. 17, 2019).

[13] Id.

[14] Intellectual Property and Space Activities: Issue paper prepared by the International Bureau of WIPO, World Intellectual Property Organization, Apr. 2004, https://www.wipo.int/export/sites/www/patent-law/en/developments/pdf/ip_space.pdf (last visited Feb. 17, 2019).

[15] Id.

[16] Id.

[17] Id.

[18] 18 U.S.T. 2410; World Intellectual Property Organization, supra note 12.

[19] 35 U.S.C § 105 (1990).

[20] 18 U.S.T. 2410.

[21] Garber, supra note 4; 18 U.S.T. 2410.

[22] Committee on the Peaceful Uses of Outer Space: Membership Evolution, United Nations Office for Outer Space Affairs, http://www.unoosa.org/oosa/en/ourwork/copuos/members/evolution.html (last visited Feb. 17, 2019).

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Many Cannabis Entrepreneurs “Caught In The Weeds” When Trying To Protect IP

Written by: Danielle Keller

The legal growth, distribution, and commercial sales of cannabis has created an opportunity for many entrepreneurs. However, experts in the industry note several barriers to obtaining protection along with some possible solutions. While it is not impossible to secure IP rights on cannabis-related inventions, there are a “number of factors to consider and a number of complexities.”[1] Some issues the industry is currently running into include:

  • Regulatory complexities: Many state laws that legalize the production and sale of cannabis products conflict with federal law which lists cannabis as a “Schedule 1” drug under the Controlled Substances Act, making possession of cannabis illegal.[2]
  • Troubles with Trademarking: Federal trademark protection is not achievable with the requirement that the thing sought to be trademarked must have a “lawful use in commerce” Under the Federal Trademark Act.[3]
  • Undeveloped Industry: The cannabis industry has been likened to the “wild west”[4] as the industry grows and businesses are working to establish broad protection of their products and processes in gaining a competitive advantage.
  • Patenting a Plant: As with any patent, the inventor bears the burden of proving that their cannabis plant is not a naturally occurring substance as is– rather, they have altered a natural substance so that the invention is new and novel. This is an added level of complexity as developer in this instance must show that the plant can be asexually reproduced.[5]

While this list is not exhaustive, there are certainly a number of factors to consider and a number of complexities to be aware of. Experts urge entrepreneurs to hire an IP attorney early on to navigate these complexities, and to assist in the development of an IP strategy. Businesses should also act fast to submit applications to the USPTO, “I always recommend applying for federal or state trademark registration at the outset of starting a cannabis business,” Jeffrey D. Welsh (founder of Frontera Law Group, a boutique law firm specializing in the legal cannabis industry). [6]

 

[1] Carly Klein, The Complicated Relationship Between IP Law & CannabisIPWatchdog, Nov. 10, 2018, https://www.ipwatchdog.com/2018/11/10/complicated-relationship-ip-law-cannabis/id=102941/.

[2] Id.

[3] Alison Malsbury, The Anatomy of a Cannabis Trademark TTAB DecisionCanna Law Blog, June 16, 2018, https://www.cannalawblog.com/the-anatomy-of-a-cannabis-trademark-ttab-decision/.

[4] Javier Hasse, Protecting Your IP Is (No Surprise) Even Harder in the Cannabis BusinessGreenEntrepreneur, Jan. 2, 2019, https://www.greenentrepreneur.com/article/324845.

[5] Klein, supra note 1.

[6] Hasse, supra note 4.

 

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Inconsistency in the Application of Patent Law

Written by: McKenzie Thomsen

Consistency is one of the founding principles of the United States’ system of law. The rule of law requires “law be applied equally, without unjustifiable differentiation.”[1] The Patent and Trademark Office [PTO] and Patent Trial and Appeals Board [PTAB] use guidelines and precedent as standards for granting and reviewing validity of patents. The guidelines however, should be under some scrutiny for their inconsistent application. This inconsistency has heightened in the past few months.

Most recently, on Tuesday October 9, 2018, SSL Services LLC [SSL] asked the Supreme Court to review section 325(d) of the Patent Act, the Multiple Proceedings rule.[2] The Multiple Proceedings Rule states that the PTAB “may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.”[3]

SSL’s patent for a system establishing virtual private networks previously survived nine validity challenges, but lost the tenth challenge brought by Cisco Systems, Inc. [Cisco]. Cisco challenged the patent’s validity using references that were used in previous re-examinations. SSL argued that under the Multiple Proceedings rule, the challenge should be rejected because the prior art references were used in previous validity challenges. However, the court allowed the challenge using these references reasoning that Cisco was not part of the previous examinations and Cisco was challenging claims that were previously unchallenged. Upset with the outcome, SSL petitioned for writ of certiorari stating, “The board’s multifactor standard for applying section 325(d) has resulted in no workable standard at all, thus producing inconsistent outcomes.”[4]

The Multiple Proceedings rule is applied discretionarily and thus easily applied inconsistently as SSL argues happened in its lawsuit. Further, on September 24, 2018, the Federal Circuit found against inventor, Hyatt, and upheld the section of the Manual of Patent Examining Procedure [MPEP] that allows the patent office to reopen prosecution after an appeal and reject claims.[5] Hyatt filed an appeal to the PTAB when the PTO decided to reopen prosecution. It was rejected, and Hyatt filed suit against the PTO asking for the repeal of said section of MPEP, stating “An examiner’s decision not to reopen prosecution is another condition that must be satisfied before an appeal reaches the board. These conditions on the PTAB reaching the merits of an appeal do not conflict with the requirement that the PTAB reviews rejections.”[6]

When a patent is reopened the appeal ends and the case returns to the patent examiner and the prosecution phase. The rate at which prosecutions are reopened varies and is “highly dependent on individual examiners.”[7] The ability to reopen prosecutions indefinitely can wear down an inventor, especially considering that getting a patent costs tens of thousands of dollars and so being drawn back into prosecution can be a worst-case scenario for many inventors and even end the pursuit of getting a patent.

Again, the application of the law of patent’s is inconsistent because it is too discretionary.
These are but two examples of allegations against the PTO and PTAB alleging inconsistent application of patent law. Unless the patent law system can justify the inconsistent application of its law, these cases show that the system is in danger of not being in line with the longstanding public policy of consistency that shields citizens from an unfair system of law.

 

[1] Steyn, Karen, Consistency – A Principle of Public Law?, Judicial Review (May 1, 2015), https://doi.org/10.1080/10854681.1997.11426924.

[2] Bultman, Matthew, Justices Urged to Mull Repeat Patent Challenges Under AIA, Law360 (Oct. 10, 2018), https://www.law360.com/ip/articles/1090719/justices-urged-to-mull-repeat-patent-challenges-under- aia?nl_pk=d73da8e3-976b-4657-afe0- 0dd35cb81961&utm_source=newsletter&utm_medium=email&utm_campaign=ip.

[3] 35 USC § 325(d) (2012).

[4] Bultman, supra note 2.

[5] Bultman, Matthew, Fed. Circ. Preserves Rule Inventors Say Can Be A Burder, Law360 (Oct. 5, 2018),
https://www.law360.com/articles/1089917/fed-circ-preserves-rule-inventors-say-can-be-a-burden?nl_pk=d73da8e3- 976b-4657-afe0-0dd35cb81961&utm_source=newsletter&utm_medium=email&utm_campaign=special.

[6] Id.

[7] Id.

 

A Gene-Editing Patent Dispute – What Does It Mean?

Written By: Charles Cheng

Is this just another ordinary patent dispute? Time will tell. A high profile patent dispute between the University of California, Berkeley and the Broad Institute of MIT and Harvard has just concluded a year-long proceeding called interference proceeding at US Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB).[1] On February 15, 2017, PTAB announced its decision after both parties presented their oral arguments before a three-judge panel in December 2016.[2] The proceeding was to determine which party has actually “invented” a gene-editing technology called CRISPR-cas9.[3] Continue Reading