Originally posted by playez
Perhaps GSK & Genentech had some rather solid IP . Tocopherol phosphate with claims of permeation , solubility etc has been around well before West's ,Ogru's & Gianello's interest . Does POH TP variance show an improvement validating the IP or did Mylan attack the IP claiming prior art ?
And what comparison studies or what could Corrs offer to support the IP ?
Playez
I guess if we can decipher and apply the below in context to your questions we may be better placed to find an answer
https://www.shelstonip.com/news/und...-novelty-freedom-operate-prior-art-searching/
Understanding the differences between patentability (novelty) and freedom to operate prior art searching
Published on 09 Apr, 2018
During the course of the patenting process to protect a new invention, one may require a patentability search (also known as a novelty search) in order to determine whether the new invention is new (novel) and arguably inventive in view of the prior art. This situation can be contrasted with the commercial exploitation of a product (or the working of a method) and the question of whether or not third-party rights may be infringed by that commercial activity, and therefore whether there is freedom to operate in the marketplace.
Patentability and freedom to operate searches are therefore designed with different objectives, and produce a list of different relevant prior art, although it is likely there will be some commonality between the search results. This article is aimed at describing these prior art searches in more detail, and when they may be appropriate.
Patentability (novelty) searching
As alluded to above, a patentability search is aimed at searching the prior art to determine whether claims defining the new invention are novel and arguably inventive in view of the prior art. For example, if the new invention includes features A + B + C + D, that combination will be novel over prior art that discloses features A + B + C, and if the additional feature “D” is not an obvious or routine modification of the prior art, the new invention will be inventive, too.
The prior art is defined as: 1.) information in a document that is publicly available, and 2.) information made publicly available through doing an ‘act’. Note there is no time limit on the prior art, and therefore a document published 5 years ago is just as relevant as one that was published 50 years ago. There is also no restriction on the type of publication, and therefore the publication can be a patent or any non-patent literature, such as a journal publication, or even a poster presentation at a conference. Further, there is no restriction on where that prior art was published or the publication language, and therefore a document published in English is just as relevant as one published in, say, German. An ‘act’ can be any act that discloses the invention, for example an oral disclosure such as a seminar given in public, or potentially demonstrating the invention in public. The prior art also includes an additional third category of documents, being patent specifications filed before your own patent is filed, and which publish afterwards.
Considering this prior art base, it’s obvious that the potential scope of a patentability search can be immense, and it is impossible to search all the relevant literature. Further, all patent databases have limitations, and choice of keywords and ‘classes’ which are searched will also affect the results. Additionally, patent applications are published 18 months after filing, creating an unsearchable ‘dead zone’ which, unfortunately, is part of the risk associated with filing a patent application. Given all these considerations, patent searching is therefore a risk mitigation exercise.
Apart from determining whether the new invention is novel and potentially inventive in view of the prior art, a patentability search can assist in determining how broadly one can claim that new invention, which can give some insights into the commercial value of the patent. A patentability search can also reveal useful commercial information, such as the major competitors in a field, or possible licensees of the invention (discussed further below).
Patentability searching can also be used to determine whether an accepted or granted patent is valid. To explain, during the course of examining a patent for allowability a patent examiner will search the prior art as part of that examination process. However, because prior art searching is an inexact science, it sometimes happens that relevant prior art is overlooked in the examiner’s search and review process or is found in the search but incorrectly dismissed by the examiner as not relevant, resulting in claims being accepted by the patent office which are not new or inventive in view of that (overlooked) prior art, or are overly broad. In these circumstances, the granted patent is invalid, or is only partially valid. This kind of patentability searching is most often conducted by a competitor who wishes to attack an overly-broad patent affecting its current or future commercial activities.
A common misconception amongst patent applicants is that once a patent is granted to their new invention they will be immune from infringing third party patent rights when a product embodying the new invention is commercialised. However, patent rights (being negative rights) do not grant freedom to access the market. In other words, a patent is no guarantee for non-infringement of third party rights, which is the reason to conduct a freedom to operate search and analysis.
Freedom to operate searching
A freedom to operate search (also known as right-to-use, or infringement, or clearance search) is aimed at answering the question of whether or not a third-party’s rights may be infringed by some intended (or actual) commercial activity. Infringement occurs if each and every feature of a claim is copied – conversely, if the product (or method being worked) omits one or more element of each independent claim, infringement is avoided. For example, if the new product includes features A + B + C + D, that combination will infringe an earlier claim that only recites features A + B + C. A patent infringement analysis consists of two steps – the first step is to construe the claims by determining the meaning and scope of each patent claim limitation, and the second step is to compare the properly construed claims to the allegedly infringing product (or the method steps of a method being worked).
The relevant commercial activity can include, where the invention is a product, to make, hire, sell or otherwise dispose of the product, to use or import it, or keep it for the purpose of doing any of those things. Further, offering the product to do those things can be relevant commercial activity. Also, following the steps of a method or process can be relevant commercial activity, including to make, hire, sell, use or import a product resulting from a method or process. Specifically, a freedom to operate search compares a commercial product/method to patents which are in force and granted to third parties. To be in-force, the granted patent must be being actively maintained by payment of the yearly renewal fees, and must not have expired, i.e., less than 20 years old for a standard patent. These considerations (i.e., being in-force, granted, and not expired) are not relevant for a patentability search, and therefore some prior art that is relevant for a patentability search may not be relevant for a freedom to operate search. An additional complexity with a freedom to operate search is that patent applications remain unpublished for 18 months, and so an earlier-filed, unpublished patent application could potentially present an infringement risk.
What is relevant for patentability searching (i.e., the whole of the patent disclosure) is only minimally relevant for freedom to operate searching, which is all about the claims. Accordingly, freedom to operate searching is notoriously more difficult than patentability searching as it is significantly more difficult to search the scope of patent claims. Additionally, different applicants use different claim language, making it easy to miss highly relevant patents in the search. Furthermore, differences in opinion in construing the scope of claims can make it difficult to be definitive as to whether a claim is infringed or not. Accordingly, a freedom to operate analysis can only ever evaluate the risk that a product might be infringing on someone’s intellectual property. To complicate matters, any part or combination of parts of a product can infringe a granted patent, which significantly expands the scope of potential relevance for complex products.
The most common situation in practice is where a client wants to commercialise a new product (or work a new method) and wants to understand whether there is freedom to operate in the marketplace. That client may also be simultaneously seeking patent protection for their invention which is embodied in that product (or in the new method). Because of the different prior art relevant to patentability, and to freedom to operate, it is possible that a new invention may be patentable in view of the prior art but also infringes on a third party’s IP. In this case, a number of options present, namely:
a) a license may be required from that third party to commercialise that new product (or work the new method),
b) the third party’s IP may prove to be invalid in view of the prior art, in which case no license is required,
c) a non-infringing workaround can be developed, or
d) the third-party rights can be acquired.
Another common question from applicants is whether a freedom to operate search undertaken in one country covers other countries. Patent rights are jurisdictional, and therefore a freedom to operate search will need to be conducted in each country in which the product (or method) will be commercialised. For example, it may be possible to commercialise a new device in say, Australia, if there are no Australian patents covering device (or Australian patent applications that are likely to give rise to patents covering the device). However, there may not be the same freedom to operate in say, New Zealand, where patents may have been issued covering, say, the process used to make the device. The equivalent patent may not exist in Singapore and hence there would be no restrictions on the commercialisation of the device in that country.
Whilst occasionally applicants may commission a patentability search and interpret the results themselves, the same is not true for a freedom to operate search, which always requires a patent attorney to interpret the claims of the granted patents considered relevant by the patent searcher, and to provide an opinion on the risk of infringement. This, coupled by the additional complexity of a freedom to operate search compared to a patentability search, means that a freedom to operate search and analysis is usually the more costly of these two kinds of searches.
As third-party IP rights may act as ‘roadblocks’ to commercialisation of a product or service, and as significant resources are usually required to commercialise new products or services, it is important to understand the risks of infringement before going to market.
Are there any other ‘types’ of prior art searching?
Other types of searching include:
a) State-of-the-Art, which is a patent and non-patent literature search designed to identify existing solutions and potential competitors within a given technological field, and is useful before planning R&D;
b) Landscape or Strategic, which is aimed at mapping out the competitive landscape including identifying opportunities in that landscape, highlighting industry trends and technology evolution, assessing the value of a patent portfolio, and identifying potential licensees; and
c) Mining, which is usually carried out in order to find and gather related patent assets owned by a third party.
What options are available to commission a patentability or a freedom to operate search?
Patentability searches are available from IP Australia on a provisional patent application (called an ‘International Type Search’
or a ‘Preliminary Search and Opinion’ (PSO) on a standard complete patent application. An alternative is to file a PCT application, whereby the International Searching Authority (ISA) will automatically issue an International Search Report and Written Opinion (ISR/WO) about two months after the PCT is filed. A further alternative is to commission the patentability search via a patent attorney firm. Freedom to operate searching, however, is not offered by IP Australia, as a registered patent attorney is required to review the search results and provide an opinion on the risks of infringement of third party rights.
Conclusions and summary
A patentability search is carried out to answer the question of whether a new invention is unique over what already exists in the prior art, whereas freedom to operate searching and analysis is aimed at determining the risk of a product (or the working of a method) infringing third party patent rights. Whilst there are some similarities in these questions, the relevant prior art, the legal issues, and the analyses are substantially different, and it is important to understand the different approaches taken to answer each question, and the limitations of the results. The discussion above has focussed on patent rights, however, the same considerations apply for other forms of IP, such as trade marks and designs.
Shelston IP regularly conducts patentability and freedom to operate searching for its clients including interpretation of the search results, and can tailor a patent search to your commercial objectives.
The content of this article is general in nature and must not be relied on in lieu of advice from a qualified professional in respect of your particular circumstances.
Keywords freedom to operate searching, novelty, patentability searching
Authors:
Michael Zammit PhD
Principal
(20min delay)
