Strategies Employed For the Extension of Patent Term-Market Exclusivity For Pharmaceutical Products – Patents

In the pharmaceutical industry, a lot of research, time, manpower and money goes into R&D for the development of novel drugs and bringing them into market. If the innovations are not protected with a proper fence of integrated technologies then generic companies would exploit the invention without giving much benefit to the innovator company. Hence, it is mandatory for the innovator company to apply for patent protection at least in those geographical areas where the innovator company wishes to market their product, retain monopoly and refrain their competitors entering into the market till the patent term for the innovation expires. This article discusses various strategies employed by the innovator companies in US to extend the life of the patent and gaining market exclusivity for the pharmaceutical product.It is estimated that around 7 to 12 years of extensive research is involved to bring the innovation into a shape, which can be marketed. Apart from product development there are hassles regarding approval of the pharmaceutical product by respective drug authorities. Considering the patent term or the protection offered by the patent to be 20 years from the filing date of the patent, effectively a period of 8 to 10 years would be available with the innovator company to get benefits of their developed product. Innovator companies execute various strategies to extend the life of the patent as well as the product.On grant of patent for the invented drug and regular payment of maintenance fees gives the patent holder monopoly over the drug and rights to exclude other from manufacturing, using and selling the patented invention for a stipulated time. On expiration of the patent, generic competitors would exploit the market, which would lead to reduction of market share and revenue loss for the innovator company. Hence, additional patents are filed in order to fence the invented drug or product. These additional patents for the extension of invention / product protection could comprise of method of preparation, new formulation, method of preparation of formulation, drug derivatives and its metabolites, polymorphs, stereo-selective enantiomers etc. Additional patents filed could also cover improvements to the invention or new uses, which are not mentioned in the initial granted patent.We will discuss in brief various strategies employed by the innovator companies in US to extend the life of the patent and reap maximum fruits for an extended period of time.The Hatch-Waxman Act provides a system wherein the New Drug Applicant (NDA) holder could apply to have extension of its patent. The extension was meant to compensate the applicant for a portion of any time lost after the issuance of a patent during which the testing and approval phases of the FDA’s regulatory review process commenced.Following are the paths by which patent term can be extended:1) Patent term adjustments – delay during patent prosecutionThe patent term adjustment is provided in case of United States Patent and Trademark Office (USPTO) fails to act to patent application from patent filing or fail to reply to applicant’s appeal in a stipulated time.
The purpose of the patent term adjustment provision was to guarantee that patent applicants would still have a patent term of at least seventeen years from grant under the twenty-year patent term system.2) Patent extensions – delays due to regulatory approvalUSPTO can restore the term of a patent that is lost due to delays during regulatory approval by Federal Food and Drug Administration (FDA). Patents relating to drug products, medical devices, food additives, and color additives are eligible for patent extension. The maximum of patent term that may be restored is five years.3) Interim term extensionsIf the term of the patent expires before the certificate of extension is given to the application, then the Director extends the term of the patent up to one year under Interim term extension. This extension is only possible if the director feels that the patent should be considered for extension.Apart from patent term extensions, market exclusivities can be gained separately. Exclusivity gives FDA approved drugs market exclusivity which does not allow the generic competitors to enter into the market till the exclusivity is valid.Following are the market exclusivities offered by FDA:1) New Chemical Entity (NCE) exclusivityNCE exclusivity is awarded for 5 years to NDA applicant who receives the first approval for a drug product. No salt or ester of the novel chemical entity should have ever received FDA approval. During this 5-year period, the FDA is stopped from accepting an Abbreviated New Drug Application (ANDA) for review. The only exception is that if a patent is also listed on the NDA product subject to NCE exclusivity, the FDA may accept an ANDA after 4 of the 5-year period has expired, if the ANDA contains a Paragraph IV certification challenging the patent. NCE exclusivity can be considered as a total exclusivity as generic competitors cannot submit or approve their product while the exclusivity is valid.2) New Use / New Clinical Studies exclusivityThis kind of exclusivity is granted for a period of three years to NDA holder who applies for new use of approved drug. New clinical studies are to be carried out to get approval from FDA for use of the approved drug for its use for new indication. Exclusivity can be granted for new dosage form (Sustained release dosage form, Controlled release dosage form), a new use or indication, a new salt or ester of a drug product, change in concentration, novel drug delivery etc. The 3-year exclusivity may block FDA approval of a generic version until after the exclusivity expires. It is also possible that the FDA approves generic version if approval does not infringe on the protected change.3) Orphan Drug exclusivitySeven-year orphan drug exclusivity is granted to promote research and marketing for the development of drugs to treat rare diseases. US FDA had defined Orphan drug / rare diseases as those diseases affecting 200,000 or fewer patients in the US. This exclusivity period can block the FDA from approving competing generics of a drug product for the orphan use. Applicant may request orphan drug designation for a previously unapproved drug or for an already marketed drug. One or more applicants may receive orphan drug status for the same drug for the same orphan disease.4) Pediatric exclusivityPediatric exclusivity gives an incremental 6 months exclusivity to an existing marketing exclusivity that has been earlier granted or to a patent protection. This type of exclusivity is granted to clinical studies of drugs for pediatric population. This type of exclusivity ensures an incentive for an NDA applicant for the clinical studies carried out specifically for pediatric patients. Products with no patent life or exclusivity remaining cannot qualify for pediatric exclusivity.Hence, it is seen that various methods are adopted by the innovator companies to extend the term of their patent to extend their monopoly in the filed of pharmaceuticals.

Methods For Patent Invalidation – Patents

Patent invalidationA patent is a territorial right granted by the government of the territory to an inventor to exclude others from making, using, offering for sale, or selling an invention throughout the territory or importing the invention into the territory for a limited time in exchange The invention must be novel, e.g., not fully disclosed in any single prior art reference. (2) The invention must be non-obvious for public disclosure of the invention.Criteria of patentability:
Foremost criteria for the grant of a patent application for an invention is that the invention should be new, i.e. 1) The invention must be novel, e.g., not disclosed in any of the prior art reference and 2) The invention must be non-obvious, e.g., the invention should not be obvious to any person who is skilled in the art on the date of filing of the invention as patent application. Another criteria for the grant of the patent is industrial use of the invention.If a granted patent is blocking any product ready to be commercialized, then it is the strategy of the company whose product is ready to be commercialized to invalidate the patent. Invalidation of the granted patent is prosecuted in judicial courts. According to certain patent office rules, patent invalidation cases can be initiated by “Any person interested”. “Any person interested” can be defined as a person engaged in, or in promoting research in the same field as to which the invention relates. Patent can be invalidated on various grounds.These grounds / strategies for the invalidation of a patent which are followed by attorneys in the judicial courts are mentioned below:1) Invention claimed in the patent is not novel.
The claimed invention is present in the prior art as any published document. If the claimed invention is lacking novelty with regards to the earlier disclosed knowledge or prior use can invalidate the patent.2) Subject of the claim of the patent is not an invention.
Patent offices of different countries have patent laws, which defines the patentable subject matter. An invention does not falling in the criteria of the patentable subject matter can be invalidated on the grounds that the subject of the claim of the patent is not an invention according to the patent law of that country.3) Patent was wrongfully obtained by a person other than the person entitled.
Applicants of the patent should be the inventors who have worked on the invention. Insufficient disclosure of inventors’ details or disclosure of a person as an inventor who is wrongfully mentioned to be the inventor can form the basis of invalidation of patent. The issue here is that a patent may be invalidated or revoked in many jurisdictions, if the patent applicant or inventor is not the true and first inventor.4) Insufficient disclosure of the invention
It is the duty of the inventors to disclose all material information relating to the invention, including the best mode to accomplish the invention, all material art known to the inventor, and any information that might render the invention unpatentable, such as a public use or published description of the invention occurring more than one year prior to the filing date of the patent application. Any deliberate efforts for insufficient disclosure or description of information related to the invention can form the basis for invalidation of the patent. Another basis of invalidation of patent is false suggestion or representation to any fact or statement made in connection to the grant of the patent.5) Obviousness
Claimed invention is obvious to any person skilled in the art and does not involve any inventive step can be invalidated on the basis of obviousness. If a person skilled in the art (appointed by the court) considers the claimed invention to be evident and easily discoverable as of on the priority date of the claimed invention, then the claim of the patent can be invalidated on the grounds of obviousness.6) The claims included in the patent are not fully substantiated by the description provided.7) Failure to disclose information relating to foreign applications.8) First to file / First to invent
US patent laws follows the patentability criteria to be first to invent whereas other countries patent laws follow the First to file concept. In US, invalidation of the patent can be based on first to invent basis where any inventor who has first invented the invention is given preference.9) Patent holder did not exercise diligence in pursuing the patent application process (Patent grace period)In US and Japan, a grace period of 6 to 12 months is allowed for filing patent application after publication of the patented idea or device. If the inventor publishes the invention, an application can still be validly filed which will be considered novel despite the publication, provided that the filing is made during the grace period following the publication. Filing of patent application after the expiry of the grace period allowed by the respective patent offices can be a ground for the invalidation of the granted patent.