Lawyer Monthly Magazine -December 2019 Edition

way of carrying out a claimed method under the proposed amendment to § 112F. Conflicting views on the draft proposal has meant that the initial momentum for reform has been lost for the time being. This will frustrate those in the biotech industry who are keen to see a return the ability to obtain patent protection for their products and processes, which they hope will boost research, and drive investment back into the United States. LM that overruling the patent- eligible-subject-matter case law would herald a return of “nuisance” patents directed to business methods and software, which often contain functionally defined terms. However, rather than reassuring stakeholders in the software industry, the proposal seems to have succeeded mainly in frightening the biotechnology sector. Several witnesses from both sides of the debate raised concerns about the burden that drafters and inventors will face from having to enumerate every reason for not entering the US market. On the other hand, there are those within the biotechnology sector who side with the software industry is favouring the status quo. Genetic testing companies have reaped the benefits of a restrictive patent eligibility criteria, which has resulted in the invalidation of patents to isolated gene products, and so removed the barriers to developing genetic testing kits. Since 2013, aided by this provision, the cost of genetic testing kits has decreased significantly leading to a boom in popularity and numerous spit- kit companies have crowded the genetic testing market. This new Bill, if enacted, will likely prove problematic for US companies such as 23andMe, who offer customers the ability to test their DNA to uncover their ancestry or genetic vulnerabilities. Consequently, this might open the door for a widespread change in the industry. The proposed Bill stuttered when a sticking point emerged during consultations with stakeholders. A last-minute amendment to 35 U.S.C. § 112F, which governs how patentees may claim their invention in functional terms (as opposed to reciting specific physical structures), has been criticized by members of the biotech industry for watering down patent protections. The draft Bill provided that, if any patent claim element is “expressed as a specified function without the recital of structure, material, or acts in support thereof”, then that claim element will be limited to the “corresponding structure, material, or acts described in the specification” and their equivalents. This was offered to assuage concern 42 WWW.LAWYER-MONTHLY.COM | DEC 2019 Special Feature Written by Rosie McDowell, EIP “Since 2013, aided by this provision, the cost of genetic testing kits has decreased significantly leading to a boom in popularity and numerous spit-kit companies have crowded the genetic testing market.” ABOUT ROSIE MCDOWELL Rosie McDowell is an associate attorney at EIP, specialising in life sciences. She has experience in prosecuting patent applications in awide range of technologies including DNA sequencing, biofuels, antibodies, microbiology, pharmaceutics, assay technologies, immunology and oil recovery.