IBSA moves US Supreme Court on Indefiniteness Claim affirmed by Fed. Cir.

Federal Court affirms the ruling of the District Court, rejecting the claims being indefinite. The case relates to the US

Update: 2021-03-11 10:45 GMT

IBSA moves US Supreme Court on Indefiniteness Claim affirmed by Fed. Cir. 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...

IBSA moves US Supreme Court on Indefiniteness Claim affirmed by Fed. Cir.

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.

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