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care sector, and biocatalysis - as an offshoot of this - was a major beneficiary. The amount of searchable enzyme sequence data that was readily available increased rapidly and exponentially, and this inevitably influenced IP strategy. Homology claims became the centre of attention for a period of time in an attempt to capture as many wild-type enzymes as possible, whose sequences were known, for a process of interest. Thus, typical claim language would refer to an enzyme sequence and any derivatives of the enzyme to a certain level of homology in protein sequence. It was realised, however that claiming all enzymes to a level of 80% homology to the discovered enzyme often yielded little protection since enzymes with much lower levels of homology could be just as effective for a given biotransformation. Meanwhile, enzyme engineering and evolution technology became a widely practised technology, thus introducing another level of complexity to the landscape. In the formative years of this technology, the focus of attention turned towards broadly protecting enzymes and engineered mutants in patent claims with less regard for any particular intended use. This had the unintended consequence of revealing much about the underlying technology and approach involved, disclosing how subtle changes in enzyme structure were able to influence catalyst performance. Furthermore, it fired up an argument as to whether a biocatalytic process should be patented at all for fear of teaching others about the underlying technology. This is aside from the ongoing concerns of others’ regard for respecting intellectual property rights. Today a strong biocatalysis patent will most likely combine three elements into its main claims to give the assignee the best chance of securing a competitive advantage:
• First, it will have a reaction focus, defining the core reaction that is of commercial interest together
Summer 2020
Catalysis
Figure 2 – Enzyme selection to product isolation.
with varying amounts of detail on the reaction conditions required for the biocatalytic reaction to occur.
• Second, there will be enzyme/ catalyst definition to describe the origin of the enzyme/ catalyst, which can be either the commercial source or the sequence data elsewhere in the patent. If the sequence is given, there may be an attempt to capture homologues by a traditional claim of percentage sequence identity to the originating sequence.
• Third, and critically, there will be definition of changes that have been made to the engineered or wild-type enzyme sequence that endows the enzyme with properties that enhance its performance to a level where its use allows the reaction of interest to become viable. This immediately raises the bar for others to find something similar and change, for example, an enzyme of lower homology in other ways at the sequence level, since it is now prior art and has been shown to be possible. When these three elements are combined, the patent application has a good chance of satisfying three key requirements:
commercial value, novelty and inventiveness. This last requirement of inventiveness is of course the hardest to satisfy. If an assignee can argue that their target reaction is greatly improved and enabled through deliberate and inventive choice or design of the enzyme, then they have the best chance of securing a granted patent. It should be noted that a mere sequence of an enzyme (standard enzyme catalysis) is no longer patentable, may it be a wild type or even an engineered enzyme within a screening kit. For the process to be both novel and inventive, the application must show or demonstrate reasons why the enzyme is superior or enables the specific A to B transformation which would not have been obvious to anyone skilled in the art. This means that the selected enzyme from a commercial kit needs to be further engineered for the A to B transformation to identify a new sequence that has superior enabling power to allow the transformation to work commercially.
Choose the IP strategy that suits best The options for the customer are as follows: 1. Substance of matter patent –
this is the best for the customer as they control their end product (independent of the technology used to synthesize it). 2. Process patent – protects their A to B transformation, whether using an enzyme or not. This is the easiest patent to file, however it may be harder to get granted in the future due to meeting novelty and inventiveness criteria. The enzyme can simply be stated in the patent as the commercial code just like any other chemical reagent. 3. Process patent with sequence and homology claims. To get this granted, the divulged sequence will need to be designed for the specific A to B transformation and show both novelty and inventiveness. Simply taking a wild type or engineered enzyme sequence from a commercial kit is not enough to be novel and inventive and therefore not patentable in its own right. It is best to go for option 2 above by not showing the sequence to the world. 4. New catalysis for a said enzyme, eg an unexpected reaction not known for being catalyzed by an enzyme in prior art. This is probably the best and tightest patent. When claims are broad, the patent becomes very hard to police. If it is a very specific reaction, good commercial planning needs to be
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