US Supreme Court turned away Biogen's appeal of a lower court's decision to invalidate the patent in a ruling that helped clear the way for Mylan's generic version of Tecfidera. (Reuters News Oct 3, 2022).
If you’re into research or patenting, then regardless of the industry sector you belong to, patent invalidations, circumventing patents and dealing with patent infringements are some common challenges you face/overcome. In this post, I shall touch upon how to invalidate a patent.
Patents are an integral part of new product development. If your product is novel, you like to patent it to gain market exclusivity and protect your invention from copying. While, as a developer, you must ensure that product development happens by circumventing all enforced patents (and in compliance to regulations).
But if you believe that a patent is invalid, then patent law provides several grounds to invalidate it. These grounds can be either Prior art or Statutory. It can also be a case where the examiner missed a key excerpt. In some cases, analyzing references can prove to be useful in invalidating the patent.
How to Find Patent Invalidation?
Prior art
Prior art is one of the factors that can lead to patent invalidation. Generally, it is more significant in technical fields that are hard to predict. The closer the prior art is to the invention, the more likely it will be deemed a valid prior art. However, there are a few other factors that must be considered to decide if the prior art is valid.
One of the most important factors in determining whether prior art is relevant is the date of publication. Most patent offices perform their search several months after a patent is filed, but web pages can change or be removed after that time. Thus, it is important to make sure you have selected the most appropriate prior art.
Tip: There is no such thing as a ‘world patent’ or ‘world patent law’. Patents are territorial rights and each country awards patent right based on the patent law of that land.
Prior art can be described in a patent, a published patent application, or a printed publication. According to AIA 35 U.S.C. 102(a), a patent or a published patent application must have disclosed the claimed invention in a prior art document.
An individual or an entity can proceed to invalidate patents, although the high cost of patent invalidation might be a deterrent for individuals. A patent can be invalidated by identifying relevant prior art. Prior art can be either a publication or a patent that has been issued within a year prior to the patent application filing date. However, if the prior art is published before the application filing date, the date of publication must be earlier than the patent application filing date.
Prior art can be any document that was published or in public domain prior to the invention. Even if the document is not widely circulated, it still counts. Furthermore, the publication must be accurate. If the document was published in a journal, but did not have a catalog, it would not be considered as prior art.
An enabling document must provide sufficient details to enable a skilled person to practice the invention. A science-fiction novel, for example, may describe the invention, but not provide sufficient information to allow the average person to practice it. A television series featuring a transporter might describe the invention but never explain how it worked.
Invalidation is not an easy process. Fortunately, there are several ways to challenge a patent. You can file a post-grant opposition or appeal or perform a patent invalidity search. While it may sound simple, the process is difficult and complex. If you are seeking to invalidate a patent, it is important to learn as much as you can about the prior art. It will save you time and money.
Finding relevant prior art that can invalidate a granted patent requires an exhaustive search. A limiting search strategy or relying solely on 102(b) references can miss valuable prior art. Using the techniques described in this blog, you can ensure the most comprehensive search results.
Statutory grounds to invalidate a patent
If you are facing a patent infringement case, you should be familiar with the various ways to invalidate a patent. In the first instance, you can file a declaratory judgment suit to declare the patent invalid. If you are unsuccessful in proving the validity of a patent, the next step would be to file an appeal with the Patent and Trademark Office.
In order to invalidate a patent, you must prove that the same or similar invention was in use before the date of application. Furthermore, you must prove that your invention is useful and is not obvious to another individual. Otherwise, you must prove that you are the first one to come up with this invention.
Another way to invalidate a patent is to present prior art that has been publicly available. This prior art can include a prior publication or a patent that has been in use for at least one year before the date of your application. Depending on your situation, you can use either a publication or a patent if it is more relevant.
Note that, information presented at conferences or meetings can be considered as prior art. Therefore, presenters must always seek legal clearance before going ahead with talks or poster at exhibitions, seminars etc.
While there is no absolute way to invalidate a patent, there are some exceptions to the rule. In some cases, an individual can show that a central concept of a patent was anticipated. In other cases, a patent may be valid if the central concept was already well known or was a combination of known ingredients.
If you are unable to prove that you have a good idea, you should not submit an application for infringement. Patent law is based on disclosure and notice, so if you fail to provide these, you will not have a valid patent. It is also important to note that a patent is only valid if it is described in a clear and unambiguous manner.
The term of a patent is clearly defined in the statute. This date is critical for the purpose of any patent invalidation contest. Patents expire under two conditions, first-after it completes its full term and second- if the yearly patent fee for the length of the term is not paid (by the patent holder) in time as stipulated by the patent law.
The term of a patent expires 20 years after its application date. Thus, a patent cannot be invalidated if it has not been used for twenty years.
Once a patent has been granted it may not be revoked or invalidated by a competent authority (patent office, court, appeal body etc) either totally or in part on the ground of non- compliance with formal requirements, however, it may be revoked or invalidated on a matter of substance.
Searching the file wrapper
When conducting a search for patent invalidation, it is important to review all information in the file wrapper. This file contains all documentation and communications related to the application. It can provide valuable competitive intelligence, including the examiner's search strategy and notes from the examiner's interviews. In addition, file wrapper documents can be useful for scientists and technical experts who want to understand the uniqueness of a technology.
The file wrapper is the history of the patent application process. It may be years old and detail every step of the process, including the correspondence between the examiner and the applicant. It can also reveal aspects of the technology that legal counsel could use to refute. Patent drafters also rely on the file wrapper as a guide.
File wrapper information also contains citations, which are documents that are cited against a targeted patent. This information can help the analyst determine which references are used against a patent and which claims are missing. Another important part of the file wrapper is the date restriction. This helps the analyst identify prior arts and prior right cases that are relevant to the targeted patent.
Patents can be valuable sources of information about technology, product, and market. File wrappers contain valuable legal and technical information, and the process of patent application analysis is essential for obtaining these documents. Most innovators believe that the patent issued to them will give them exclusive rights over their products or services. This is not necessarily the case, however. It is possible to invalidate a patent based on its file wrapper.
If you're planning to file for a patent invalidation case, it is important to understand the process and the results. The patent invalidation process is complex and requires a thorough approach. However, it is also essential to be aware of the limitations of the process. For example, some cases can be difficult to find, and this is where a team of experts can prove useful. If the search doesn't turn up any patents, it may be time to abandon the lawsuit.
As the technology landscape continues to evolve, the global competition amongst organizations has become fierce. In order to remain competitive, organizations must invest in continuous technological innovation. This requires large sums of capital, which only large companies can afford. Smaller organizations are left out unless they can afford these enormous costs. An invalidity search can give them the advantage over competitors that don't have the financial resources to make such expensive investments.
An invalidity search is similar to a general prior art search, but it has a much more specific goal. The goal is to determine whether any prior art references exist that invalidate the patent. This research is also helpful in determining the strength of the granted claims.
Continuous Improvement of patenting process
Broadly there are two parts of any patenting process- (i) Internal and (ii) External.
The internal process as the name suggests is internal to the organization, while the external process involves patent office, legal experts, courts etc.
The internal process by and large determines the quality of your patent. For example- how was the product developed? Was a thorough review of enforced patents and prior art around the topic done before embarking product development? How was the patent drafted? What are the claims? etc.
If you ensure that all internal processes underlying prior art review, product development and patent drafting are relevant, then you can be reasonably assured that invalidating your patent will be way-too-difficult.
Furthermore, infringing such a patent will also be way-too-difficult.
The aim of any patent holder is to retain monopoly of the patent to its full term and to stop/ prevent its copying. Both can be achieved by installing a culture of continuous improvement.
Kaizen, ISO, Lean Six Sigma are few common process improvement techniques, though I would recommend Kaizen because of its adaptability and profitability.
What do I mean by adaptability? See, patenting already involves patent laws. In certain sectors such as pharma, aviation, electronics, food, healthcare etc. product development is regulated. Therefore, choosing a continuous improvement method which can gel into any situation, laws, business sector, size, type of problem at-hand etc., is a big boon for success.
Kaizen has maximum adaptability quotient amongst all continuous improvement methods. Moreover, Kaizen implementation requires minimal expenses, hence it is very affordable to small businesses or even startups. Also, Kaizen implementation gives maximum ROI.
Disclaimer: The content on this blog is for educational purpose and not legal advice. Never self-handle patent suits. Always consult a registered patent attorney for any advice on patent matters.
If you’re into research or patenting, then regardless of the industry sector you belong to, patent invalidations, circumventing patents and dealing with patent infringements are some common challenges you face/overcome. In this post, I shall touch upon how to invalidate a patent.
Patents are an integral part of new product development. If your product is novel, you like to patent it to gain market exclusivity and protect your invention from copying. While, as a developer, you must ensure that product development happens by circumventing all enforced patents (and in compliance to regulations).
But if you believe that a patent is invalid, then patent law provides several grounds to invalidate it. These grounds can be either Prior art or Statutory. It can also be a case where the examiner missed a key excerpt. In some cases, analyzing references can prove to be useful in invalidating the patent.
How to Find Patent Invalidation?
Prior art
Prior art is one of the factors that can lead to patent invalidation. Generally, it is more significant in technical fields that are hard to predict. The closer the prior art is to the invention, the more likely it will be deemed a valid prior art. However, there are a few other factors that must be considered to decide if the prior art is valid.
One of the most important factors in determining whether prior art is relevant is the date of publication. Most patent offices perform their search several months after a patent is filed, but web pages can change or be removed after that time. Thus, it is important to make sure you have selected the most appropriate prior art.
Tip: There is no such thing as a ‘world patent’ or ‘world patent law’. Patents are territorial rights and each country awards patent right based on the patent law of that land.
Prior art can be described in a patent, a published patent application, or a printed publication. According to AIA 35 U.S.C. 102(a), a patent or a published patent application must have disclosed the claimed invention in a prior art document.
An individual or an entity can proceed to invalidate patents, although the high cost of patent invalidation might be a deterrent for individuals. A patent can be invalidated by identifying relevant prior art. Prior art can be either a publication or a patent that has been issued within a year prior to the patent application filing date. However, if the prior art is published before the application filing date, the date of publication must be earlier than the patent application filing date.
Prior art can be any document that was published or in public domain prior to the invention. Even if the document is not widely circulated, it still counts. Furthermore, the publication must be accurate. If the document was published in a journal, but did not have a catalog, it would not be considered as prior art.
An enabling document must provide sufficient details to enable a skilled person to practice the invention. A science-fiction novel, for example, may describe the invention, but not provide sufficient information to allow the average person to practice it. A television series featuring a transporter might describe the invention but never explain how it worked.
Invalidation is not an easy process. Fortunately, there are several ways to challenge a patent. You can file a post-grant opposition or appeal or perform a patent invalidity search. While it may sound simple, the process is difficult and complex. If you are seeking to invalidate a patent, it is important to learn as much as you can about the prior art. It will save you time and money.
Finding relevant prior art that can invalidate a granted patent requires an exhaustive search. A limiting search strategy or relying solely on 102(b) references can miss valuable prior art. Using the techniques described in this blog, you can ensure the most comprehensive search results.
Statutory grounds to invalidate a patent
If you are facing a patent infringement case, you should be familiar with the various ways to invalidate a patent. In the first instance, you can file a declaratory judgment suit to declare the patent invalid. If you are unsuccessful in proving the validity of a patent, the next step would be to file an appeal with the Patent and Trademark Office.
In order to invalidate a patent, you must prove that the same or similar invention was in use before the date of application. Furthermore, you must prove that your invention is useful and is not obvious to another individual. Otherwise, you must prove that you are the first one to come up with this invention.
Another way to invalidate a patent is to present prior art that has been publicly available. This prior art can include a prior publication or a patent that has been in use for at least one year before the date of your application. Depending on your situation, you can use either a publication or a patent if it is more relevant.
Note that, information presented at conferences or meetings can be considered as prior art. Therefore, presenters must always seek legal clearance before going ahead with talks or poster at exhibitions, seminars etc.
While there is no absolute way to invalidate a patent, there are some exceptions to the rule. In some cases, an individual can show that a central concept of a patent was anticipated. In other cases, a patent may be valid if the central concept was already well known or was a combination of known ingredients.
If you are unable to prove that you have a good idea, you should not submit an application for infringement. Patent law is based on disclosure and notice, so if you fail to provide these, you will not have a valid patent. It is also important to note that a patent is only valid if it is described in a clear and unambiguous manner.
The term of a patent is clearly defined in the statute. This date is critical for the purpose of any patent invalidation contest. Patents expire under two conditions, first-after it completes its full term and second- if the yearly patent fee for the length of the term is not paid (by the patent holder) in time as stipulated by the patent law.
The term of a patent expires 20 years after its application date. Thus, a patent cannot be invalidated if it has not been used for twenty years.
Once a patent has been granted it may not be revoked or invalidated by a competent authority (patent office, court, appeal body etc) either totally or in part on the ground of non- compliance with formal requirements, however, it may be revoked or invalidated on a matter of substance.
Searching the file wrapper
When conducting a search for patent invalidation, it is important to review all information in the file wrapper. This file contains all documentation and communications related to the application. It can provide valuable competitive intelligence, including the examiner's search strategy and notes from the examiner's interviews. In addition, file wrapper documents can be useful for scientists and technical experts who want to understand the uniqueness of a technology.
The file wrapper is the history of the patent application process. It may be years old and detail every step of the process, including the correspondence between the examiner and the applicant. It can also reveal aspects of the technology that legal counsel could use to refute. Patent drafters also rely on the file wrapper as a guide.
File wrapper information also contains citations, which are documents that are cited against a targeted patent. This information can help the analyst determine which references are used against a patent and which claims are missing. Another important part of the file wrapper is the date restriction. This helps the analyst identify prior arts and prior right cases that are relevant to the targeted patent.
Patents can be valuable sources of information about technology, product, and market. File wrappers contain valuable legal and technical information, and the process of patent application analysis is essential for obtaining these documents. Most innovators believe that the patent issued to them will give them exclusive rights over their products or services. This is not necessarily the case, however. It is possible to invalidate a patent based on its file wrapper.
If you're planning to file for a patent invalidation case, it is important to understand the process and the results. The patent invalidation process is complex and requires a thorough approach. However, it is also essential to be aware of the limitations of the process. For example, some cases can be difficult to find, and this is where a team of experts can prove useful. If the search doesn't turn up any patents, it may be time to abandon the lawsuit.
As the technology landscape continues to evolve, the global competition amongst organizations has become fierce. In order to remain competitive, organizations must invest in continuous technological innovation. This requires large sums of capital, which only large companies can afford. Smaller organizations are left out unless they can afford these enormous costs. An invalidity search can give them the advantage over competitors that don't have the financial resources to make such expensive investments.
An invalidity search is similar to a general prior art search, but it has a much more specific goal. The goal is to determine whether any prior art references exist that invalidate the patent. This research is also helpful in determining the strength of the granted claims.
Continuous Improvement of patenting process
Broadly there are two parts of any patenting process- (i) Internal and (ii) External.
The internal process as the name suggests is internal to the organization, while the external process involves patent office, legal experts, courts etc.
The internal process by and large determines the quality of your patent. For example- how was the product developed? Was a thorough review of enforced patents and prior art around the topic done before embarking product development? How was the patent drafted? What are the claims? etc.
If you ensure that all internal processes underlying prior art review, product development and patent drafting are relevant, then you can be reasonably assured that invalidating your patent will be way-too-difficult.
Furthermore, infringing such a patent will also be way-too-difficult.
The aim of any patent holder is to retain monopoly of the patent to its full term and to stop/ prevent its copying. Both can be achieved by installing a culture of continuous improvement.
Kaizen, ISO, Lean Six Sigma are few common process improvement techniques, though I would recommend Kaizen because of its adaptability and profitability.
What do I mean by adaptability? See, patenting already involves patent laws. In certain sectors such as pharma, aviation, electronics, food, healthcare etc. product development is regulated. Therefore, choosing a continuous improvement method which can gel into any situation, laws, business sector, size, type of problem at-hand etc., is a big boon for success.
Kaizen has maximum adaptability quotient amongst all continuous improvement methods. Moreover, Kaizen implementation requires minimal expenses, hence it is very affordable to small businesses or even startups. Also, Kaizen implementation gives maximum ROI.
Disclaimer: The content on this blog is for educational purpose and not legal advice. Never self-handle patent suits. Always consult a registered patent attorney for any advice on patent matters.
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Categories: Patents | Continuous Improvement
Keywords and Tags:
#Patents #Biogenpatentinvalidationcase #Mylanpatentinvalidationcase #Tecfidera #howtoinvalidatepatents
