In simple words, patent infringement is the violation of patent rights of a patentee in the country or jurisdiction where the patent has been granted. This violation happens when any third party, makes, uses, sells, offer for sale, a product or process claimed in the patent, granted to the patentee without his/her authorization or license. When a patent is granted, the patentee gets the right to prevent third party (ies) from making, using, selling, offering for sale or importing the patented product in the country where there is patent protection.
To avoid patent infringement, it is highly recommended for the business owners to examine existing patents before launching their new products to ensure that no patent rights are violated in the territory where their product is going to be launched. This investigation to assess patent infringement risk is called as Freedom to Operate (FTO) analysis or clearance search.
How is FTO performed?
Purpose of FTO search is to assess the likelihood of patent infringement upon launch of new product in a specific market. The best time to perform FTO search is at the time of designing the new product because it is easier to make changes in the product specifications and the infringement risk can be minimised or nullified easily at early stage of product development. FTO is a very specialised investigation and analysis of patent documents, done by a skilled attorney, who possesses a good working knowledge of technology as well as law. The final opinion on infringement shall always be rendered by an advocate according to the laws of the jurisdiction. Generally, following steps are taken up to perform FTO analysis:
- Identification of components of the product to be launched and listing out nomenclature of the components, as generally used in the industry.
- Performing a patent search with all possible synonyms of the product component names along with other search techniques to pull all relevant patents with a timeline of 20-22 years. Patent search here may be global or country-specific depending upon the countries in which the product is going to be launched or sold. The business owner must be very focused and specific with respect to patent search strategies to ensure that the right data is extracted.
- For FTO search, generally only “in-force” or live patents are analysed. Therefore, considering very old and expired patents may not be of much use for FTO search. However, expired patents may be extremely helpful to find out technologies or products for which patents have expired. Even though expired patents may not impose any infringement risk but they can certainly provide valuable information otherwise.
- After the relevant patent documents are extracted, it is important to segregate them as “expired”, “abandoned” or “in-force” patents. Further, there may be a need to separate out the patent applications and the granted patents. If there are any risky patent applications, it is highly recommended to monitor them periodically to find out the kind of objections that the examiner raises during prosecution and to know if patent application gets granted as a patent or not.
- Further, during performing FTO search, if there are any “lapsed patents”, there may be chance of restoring such lapsed patent. Therefore, the legal status of lapsed patent shall be checked periodically and the risk it imposes shall be completely ruled out only after the timeline to restore has lapsed and its legal status reflects as “Expired”.
- Patents so extracted during the search shall be analysed in detail by comparing claims of the patents with product features. Generally, patent practitioners prepare claim maps where the portions of the claims with match or overlap with product components are highlighted. Based on the extent of overlap between patent claims and the product components, the patent documents may further be considered as low, moderate or high-risk patents.
How to handle high-risk patents?
In case the FTO analysis reveals high risk patents, using such patents may be detrimental for the business. Following points may be taken into consideration before using such patents:
- Check expiry date of the patent. If the patent is going to expire soon, it is worth to wait for the patent to expire before using it.
- Carefully read and analyse patent claims and try to understand what is claimed. Often the language used in the claims is very complex and expert advice must be sought.
- Perform invalidation search to understand how strong the patent is. This search is performed to identify the grounds on the basis of which a patent may be invalidated. Generally patent search is performed to reveal closest prior art and novelty/inventive step is assessed.
- Based on the outcome of invalidation search, opposition to the grant of patent, if patent is not yet granted; or post-grant opposition or even revocation may be filed. The opposition petition shall have all possible statutory grounds of opposition, which help the Controller of Patents to give decision on invalidating or revoking the patent.
- In case there is no other way out, obtaining license to use the patent may be obtained from the patentee. This option may not be feasible in most of the cases as granting license is at sole discretion of the patentee.
Above listed are few ways to handle a situation where there is a high risk of patent infringement. If none of the step’s work, it is advisable not to use the patent because if patentee takes a legal action, it may be detrimental for the reputation and good will of the business. In Merck vs. Glenmark case, the Delhi High Court passed an injunction against Glenmark for manufacturing the generic drug Sitagliptin and using patented product of Merck as there was prima facie infringement of patent rights of Merck. Delhi High court passed injunction order against Glenmark from manufacturing and selling of Zita and Zitamet. Thereby, patent rights of Merck were protected and enforced.
Patent infringement risk assessment and mitigation shall be integral part of steps to be followed before new product launch. FTO search can be extremely helpful to understand extent of infringement risk and to take right measure to minimise it.
Author: Bindu Sharma, CEO, Origiin IP Solutions LLP
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