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Patent-Lawyer-Article The GLOBAL REACH, LOCAL KNOWLEDGE www.patentlawyermagazine.com Annual 2021 COPYRIGHT CTC LEGAL MEDIA The effect of design space on patent grant and recognition for designs Dr. Yongqiang Qi, Partner and Patent Attorney at Corner Stone, examines the latest judicial interpretation and what it means for design. Protect Patent validity against terms crises Page 56 Page 13 AI patenting Page 18 FFrontront ccover_TPL51_v2aover_TPL51_v2a Alternative.inddAlternative.indd 1 118/12/20208/12/2020 110:060:06 CRIPSR-Cas9 A Nobel Prize, a Global Pandemic, and a Patent Dispute walk into a bar… stop me if you’ve heard this one before Richard Gaugeler, Patent Attorney at Cedar White Bradley, explains how a Noble Prize, the Pandemic and a Patent Dispute are all inextricably linked to the CRISPR-Cas9 Technology. ust as the three individuals who walk into a The functioning of the CRISPR-Cas9 technology bar seemingly appear independent from is as follows: First, the faulty sequence in the Jone another, they nevertheless always turn DNA is identified by a scientist. In this case the out to be inextricably linked through some faulty sequence refers to a defective gene common thread. And our Nobel Prize, Pandemic, which codes for Sickle-Cell anaemia. Second, and Dispute are no different. The thread? Of course, CRISPR uses guideRNA to identify, and bind to I must be talking about CRISPR-Cas9 Technology. the sequence. The guideRNA binds to and The revolutionary gene editing tool that can be used unravels the faulty sequence in the DNA molecule. to make precise incisions in genetic material to Third, Cas9 cuts the faulty sequence to either edit or even delete unwanted genetic code. deactivate the gene or replace the faulty sequence COPYRIGHT CTC LEGAL MEDIA The story of CRISPR-Cas9 Technology began with a new correct one. In editing the sequence, in 2002, when Emmanuelle Charpentier began Richard Gaugeler the gene is repaired and the resulting disease, her research into pathogenic bacteria. A later sickle-cell anaemia, is removed from the genome meeting between herself and fellow scientist altogether. Jennifer Doudna in 2011 at a café in Puerto Rico, The CRISPR-Cas9 Technology has near endless led to a discovery previously only imagined in possibilities for use and, has been deemed a movies and sci-fi novels. It is from this date that platform technology providing the springboard their discovery changes all our lives forever. for further advancements in gene editing. Gene editing techniques tend to raise questions CRISPR-Cas9 around the ethical use of technology. CRISPR-Cas9 allows us, for the first time, to One such ethical debate began in November accurately alter the genetic sequence of human 2018 when He Jiankui used CRISPR to produce cells. The alteration may be the deletion of a CRISPR- the world’s first “designer-baby” which was edited certain portion of DNA, effectively neutralizing a “ to remove a gene which produces a HIV receptor particular gene, or editing a portion of DNA, with Cas9 allows effectively making the baby immune to HIV. the effect of changing the gene altogether. us, for the While the debate surrounding the ethics of a CRISPR (Clustered Regularly Interspaced gene editing tool continues, so too will its use. Short Palindromic Repeats) refers to naturally first time, to Good or bad, so revolutionary was this invention, occurring nucleotide sequences found in the accurately that its inventors were awarded one of the genome of certain bacteria. These nucleotide highest accolades in the world. sequences play a role in the bacteria’s anti-viral alter the defence mechanisms. The sequences are genetic The Nobel Prize in Chemistry 2020 separated by spacer sequences which correspond On 7 October 2020, Emmanuelle Charpentier to sequences found in various viral genomes. sequence and Jennifer Doudna were awarded the Nobel Cas9 is a DNA cutting protein and makes up of human Prize in Chemistry for their invention “a method the other half of the technology and, when coupled for genome editing” (CRISPR-Cas9 Technology). with guideRNA, is guided to the DNA sequence cells. The Nobel Prize in Chemistry has been awarded to be cut. RNA is similar to DNA but comprises a 112 times to 186 Nobel Laureates, starting in 1901. single ribbon of molecules, unlike DNA’s double Until 2020 only five women, including Marie helix ribbon. Curie who won the Nobel Prize in both chemistry 30 THE PATENT LAWYER ” CTC Legal Media CCedaredar WWhitehite Bradley_TPL51_v4.inddBradley_TPL51_v4.indd 3030 115/12/20205/12/2020 115:145:14 CRIPSR-Cas9 and physics, had won or shared the win of the their respective institutions, namely; the Nobel Prize for Chemistry. University of California, the University of Vienna The origin of the CRISPR-Cas9 technology and the University of Umeå (collectively referred dates back to 2002 when Emmanuelle Charpentier “Jiankui used to as “UC”) looked to secure their rights in the began her research into pathogenic bacteria, CRISPR to invention by filing multiple U.S patent applications. specifically Streptococcus Pyogenes. The seemingly The applications are directed to the CRISPR- innocuous bacteria responsible for Strep throat produce the Cas9 technology and its use in gene editing. and the more severe necrotizing fasciitis also world’s first No sooner had UC filed their patent applications known as flesh-eating bacteria. that the Broad Institute, which represents a Emmanuelle’s work focused on understanding “designer- collaboration between MIT and Harvard, filed what made this bacterium so aggressive and baby”. their patent applications to the same technology. resistant to antibiotics. UC’s applications, although filed first, claim In 2006 at the University of California, Jennifer the CRISPR-Cas9 technology for gene editing in Doudna was studying RNA. Jennifer’s experience cells, i.e. without any specificity to bacterial led her to focus specifically on RNA interference. (prokaryotic) or mammalian (eukaryotic) cells. During her studies into RNA Jennifer heard of The Broad Institute however, claim their invention research into repeated sequences found in the ” to the gene editing capabilities of CRISPR-Cas9 bacteria, appearing to match genetic sequences in mammalian (eukaryotic) cells. According to found in the DNA of different viruses. Broad, this invention is a more specific and The idea was that once the bacteria had more challenging use of the technology. The successfully fended off a viral attack, a portion Broad Institute also decided to fast-track their of the viral DNA is coded into the bacteria’s applications and receive granted patents before owns DNA sequence. The coding provided a the earlier filed applications of UC. memory on how to identify and destroy similar UC argued that their technology creates the viruses should further infections take place in platform for gene editing in any cell, while the the future. Broad Institute argue that eukaryotic cells are The repeated sequences are dubbed Clustered far more complex than prokaryotic cells and Regularly Interspaced Short Palindromic Repeats, that editing genes in eukaryotic cells as claimed or CRISPR for short. in their patent applications is far more complex. As the research continued, an association between Additionally, that their ability to successfully edit COPYRIGHT CTC LEGAL MEDIA CRISPR and proteins called Cas was discovered. 1 M. Jinek, K. Chylinski, eukaryotic cells where others had previously The Cas-genes are similar to other genes which I. Fonfara, M. Hauer, failed, entitles them to the patent and the code for proteins whose job it is to unravel and J.A. Doudna, and accompanying rights. cut DNA strands in an organism’s genome. E. Charpentier, A Most of, if not all of, the patents in dispute In 2009 Emmanuelle, while working at Umeå Programmable Dual- have been filed pre-March 16, 2013 where the RNA-Guided DNA University in Sweden, studied small, gene patent system switched from a First-to-Invent Endonuclease in Adapted regulating RNA molecules. During her research Bacterial Immunity, system to a First-to-File system. Emmanuelle discovers that the small RNAs 337(6096) Science 816-21 A First-to-File system relates to the actual found in S. Pyogenes are very similar to the (Aug. 17, 2012). filing date on when an application is presented CRISPR sequence in the bacterium’s genome. Continued research shows that is the CRISPR system in S. Pyogenes requires just one protein Résumé to cleave DNA, that protein is Cas9. Richard Gaugeler, Patent Attorney In 2011, Emmanuelle and Jennifer combine Richard joined CWB as a Patent Attorney in 2016. In this role, Richard their intellect to understand Cas9’s function in works with inventors, entrepreneurs, and start-ups in creating IP to S. Pyogenes. provide registrable IP rights throughout the MENA region and beyond. After continued testing and experimentation He also assists R&D teams at large oil & gas organizations in the they discover that Cas9 can cut DNA into two evaluation and development of new inventions and potential new parts. patents. Richard works closely with UAE inventors through his work on Prior to publishing their findings in 2012, in the the Takamul Program and innovation programs. As part of these Jinek et al. paper1, they combine the tracrRNA programs, he provides patent and commercialization support to local and CRISPR-RNA to form ‘guide-RNA’, to cut inventors, entrepreneurs, academic institutions, private sector, and DNA at a location of their choosing. government bodies. Richard routinely advises clients on patent and design preparation, registration, prosecution, and maintenance. He A patent dispute prepares and prosecutes patents in various jurisdictions, including the With great patent, comes great litigation, and European Patent Office, The United States Patent and Trademark CRISPR-Cas9 Technology is no exception with Office, and the World Intellectual Property Office. Richard performs disputes taking place in both the US and Europe.
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