The patent claim should always be directed towards the actual advances being made in the invention for which the patent is sought for. The drafting of the patent must be done in a way, which points out the subject matter. 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, a second paragraph requires that a patent application specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

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Definiteness Claim: Seeking Clarity

The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes an infringement of the patent. A secondary purpose is to provide a clear measure of what the inventor or a joint inventor regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, the first paragraph concerning the claimed invention.

It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art with the boundaries of the protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite. Such a rejection requires that the applicant responds by explaining why the language is definite or by amending the claim, thus making the record clear regarding the claim boundaries before issuance. As an indefiniteness rejection requires the applicant to respond by explaining why the language is definite or by amending the claim, such rejections must identify the language that causes the claim to be indefinite and thoroughly explain the reasoning for the rejection.

IBSA moves Supreme Court

In the recent case of IBSA Institut Biochimique, v. Teva Pharmaceuticals, Federal Court affirms the ruling of the District Court, rejecting the claims being indefinite. The case relates to the US Patent No. 7,723,390 of IBSA that claimed its priority back to an Italian patent application (MI2001A1401). 

IBSA’s patent was related to a “soft gel capsule formulation containing the active ingredient levothyroxine sodium.” The lower court held that the claims were indefinite since the context of the claim being drafted, brings an ambiguous meaning of the term “half liquid” being used while explaining that the gel capsule contains “a liquid or half-liquid.” The term was not defined in the specification despite being present there. Moreover, there was a lack of any scientific source which can specify the meaning of the same.

While giving its contention, IBSA argued, providing the literal interpretation of the term “semi-liquid” as having a thick consistency between solid and liquid. While giving some supportive arguments, IBSA pointed to the Italian Application. Since the application is in Italian, the term being used there was “semiliquido” which was translated to “semi-liquid.” The term was used in the same places in the Italian Application where it uses the term “half liquid”, which also suggests that the term “half-liquid” be synonymous with “semi-liquid.”

While observing the same, the District Court gave no weight to the Italian Application and the same was upheld by the Federal Circuit stating the lack of meaning and thereby indefiniteness. After losing, IBSA has appealed to the U.S. Supreme Court raising some pertinent issues:

• Patents are unique: the rights they confer are strictly territorial, yet there exists an agreed-upon framework among the vast majority of countries for efficiently securing patent rights. This mutual arrangement permits both U.S. and foreign inventors to seek patent protection first in their home country and then, if they choose, to seek similar rights abroad. In both cases, the inventor can claim “priority” to their domestic application, a critical step for warding off the potentially preclusive effects of “prior art” that can bar patenting.
• This efficient system would suffer, if not disappear, without international agreements like the Agreement on Trade-Related Aspects of Intellectual Property Rights (the “TRIPS Agreement”), which establishes a baseline for intellectual property protections among its 140 signatory countries. Amongst other protections, the TRIPS Agreement demands that foreign inventors, and foreign priority applications, be treated like their domestic counterparts. This “national treatment” is a critical protection for U.S. inventors abroad, and for the many foreign inventors who seek to pursue their patent rights in the United States. But the courts below rejected these treaty obligations by choosing to give no weight to a foreign patent application, resulting in a finding of indefiniteness.
• Question: Whether, pursuant to the United States’ obligations under the TRIPS Agreement, codified at 19 U.S.C. § 3511, a court construing the claims of a U.S. patent may give no weight to a foreign priority patent application, despite its submission to the U.S. Patent & Trademark Office during prosecution of the patent-in-question, because it is written in a foreign language and exhibits minor differences from the U.S. patent resulting from a translator’s judgment.

It will be interesting to see how Supreme Court will delve into these pertinent issues.

Author: Saransh Chaturvedi (an advocate) currently pursuing LLM from Rajiv Gandhi School of Intellectual Property Law (IIT Kharagpur).  In case of any queries please contact/write back Global Patent Filing us at support@globalpatentfiling.com.