Catalysis


assessed to ascertain if return on investment is achievable. For all the above points, the customer needs to assess the commercial landscape and what their shareholders expect as key milestones in the company’s lifespan and their product development. However, even where the chances of securing a strong patent appear to be good, in all of this there is still a healthy debate needed for every biocatalytic process as to whether to keep it as a trade secret or embark on a patent filing. What we see at Almac is different customers have different concerns and/or objectives. Some companies may have little concern about how an intermediate is synthesized since their value is captured and secured in the drug substance of matter’s patent and they would like suppliers to compete to make intermediates for their drugs at the lowest possible cost.


Other companies though,


may have different priorities and pressures, for example emanating from venture capital investment and related stakeholders. Process technology for making their drugs and/or intermediates may be much


With biocatalysis in its embryonic years, cloning, expression and sequencing technology was driving a revolution in the health care sector, and biocatalysis - as an offshoot of this - was a major beneficiary.


more important to these companies. Often companies that are keen to protect the developed enzyme processes as much as possible, (especially where such processes are wrapped up in critical pathways) do so for company development and the need to increase shareholder value. Companies must ascertain what


creates the most value, eg is speed of process development and product delivery or commercial protection key at this point?; Is this intermediate


Professor Tom Moody graduated from The Queen’s University of Belfast with a 1st Class BSc (Hons) in chemistry in June 1998 before returning to gain a PhD in Physical Organic chemistry in December 2001. He has also completed a Masters in Business graduating with distinction in July 2007 specializing in business strategy. His work has earned him numerous accolades and he is co-author and author of more than 90 publications and patents. He is currently VP Technology Development and Commercialisation for Arran and Almac in Ireland and works in the area of Chemistry & Biocatalysis and its application towards the synthesis of chiral molecules, metabolites and labelled compounds. He is responsible for managing a multi-disciplinary team of both chemists and biologists to obtain commercially useful biocatalysts and their intended applications, developing biocatalytic processes from mg to tonne scale manufacture including development of fermentation processes to yield the desired biocatalyst. He has been a scientific leader and problem solver in >50 commercial projects in the past three years and acts as a consultant in the area of biocatalyst development for pharmaceutical and biotech companies. He is also an honorary Professor at Queen’s University of Belfast in the area of


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important to a family of valuable compounds or are there multiple technologies available to make the product?; Is there assurance that the enzyme (or technology) will be available at scale if needed?; or is there freedom to operate, etc. For processes enabled by extensive and costly enzyme and process engineering programmes, filing a patent protecting the novel design is most common, particularly in contested market spaces, so as to prevent others from doing the same. A simple publication in a scientific journal would also have the effect of securing permanent access to the technology while avoiding hefty fees. However, this also enables access by others, and is therefore chosen when this is not deemed problematic. Examples have arisen, for example, from Big Pharma research into future generics space, or from API maker’s inventions towards improved supply with key raw materials and building blocks.


A number of factors therefore need to be weighed up in the argument for or against secrecy. Can a good case for inventiveness really be made? Is a competitor likely to find a similar process and obtain a


About the Authors


biocatalysis. He may be contacted at tom.moody@almacgroup.com. Dr Stefan Mix was born in Berlin, Germany, where he completed his secondary education. After graduatiing with a Diploma in chemistry, he received his doctorate in 2004 from the Technical University of Berlin after working in the group of Professor Siegfried Blechert on stereoselective synthetic methodology and olefin metathesis. He is the author of several publications, and has been working with Almac Group since 2005. He has gained broad industrial experience including in applications of biocatalysis, crystallization development, process development for chiral building blocks and APIs, and technology transfer to manufacturing network partners. Hemay be contacted at stefan.mix@almacgroup.com Dr Steve Tayloris an experienced practitioner of biocatalysis


having spent many years allied to the pharmaceutical industry developing enzyme catalyzed processes for small biotech companies through to global chemical companies. He has worked with Almac Sciences for more than 15 years since the inception of the biocatalysis group. In addition to working with Almac, he has interests in projects to biotransform and repurpose natural products for use in cosmetic, food and drug industries through his work for Celbius Ltd.


Summer 2020


www.chemicalsknowledgehub.com


patent themselves? Does it make sense to reveal the sequence of a catalyst and how it was improved? Is the life-time cost of the patent justified? These are just some of the questions that need to be considered.


In conclusion


The proven ability of biocatalytic technology to produce hard cost savings for pre-existing processes or to provide economical access to NCEs in the pharmaceutical sector ensures increased investment year on year in this area. With the use of this cutting-edge technology comes much opportunity for intellectual property generation and this needs careful evaluation in the context of how this is exploited. Almac’s approach is to listen carefully to customer needs and to follow the best path forward that takes account of the numerous risk factors at play. Some cases merit patent application whilst others favour a trade secrecy approach, or the opposite – publication in a journal.


Further information E: tom.moody@almacgroup. com


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