US Courts of Appeal, Federal Circuit (CAFC). Decided: November 1, 2017
Watson Laboratories, Inc. appeals the District of Delaware¡¯s final judgment holding Watson failed to prove by clear and convincing evidence that claims 9 and 11 of U.S. Patent No. 8,613,950 (¡°the ¡¯950 patent¡±) would have been obvious.
The '950 patent is an invention with a title of "Pharmaceutical Forms With Improved Pharmacokinetic Properties". It issued on December 24, 2013. It had been filed as a national stage application of PCT/EP2006/001393, which is again a PCT application of German patent application No. 102005009240.3. It claims priority to March 1, 2005. Bayer is listed as its asignee.
Bayer markets a commercial embodiment of the ¡¯950 patent, vardenafil ODT(oral disintegrating tablet) under the name Staxyn. And Watson filed an Abbreviated New Drug Application (¡°ANDA¡±) with the FDA seeking approval to market a generic version of Staxyn. Bayer sued Watson asserting infringement of the ¡¯950 patent.
Claims 9 and 11 are the only claims at issue. Both claims depend on claim 8.
Claim 8. A drug formulation in the form of an uncoatedtablet which disintegrates rapidly in the mouth and releases the drug in the mouth without swallowing the tablet comprising vardenafil hydrochloride trihydrate, and at least two sugar alcohols.
Claim 9. The drug formulation according to claim 8, wherein said sugar alcohols are a mixture of sorbitol and mannitol.
Claim 11. The drug formulation of claim 8, wherein at least one sugar alcohol is sorbitol.
The district court held a six-day bench trial to review the validity of the ¡¯950 patent. Watson argued the claimed formulation of vardenafil would have been obvious to a person of ordinary skill in the art based on multiple exemplary references including academic journal articles and published patent materials which show a motivation to create an ODT formulation of vardenafil, and select mannitol and sorbitol as sugar alcohols.
The district court rejected each of Watson¡¯s arguments. It found a person of ordinary skill in the art would not have been motivated to create an ODT formulation of vardenafil and would not have used mannitol and sorbitol as excipients.
CAFC disagreed with the district court and reversed the judgment of the court below. It was held that the district court clearly erred in finding a skilled artisan would not have been motivated to use the claim elements, and that claims 9 and 11 of the ¡¯950 patent would have been obvious.
LG Electronics, Inc. filed a trademark application to register QLED (in standard characters) on the Principal Register for goods including mobile phones, smart phones, laptop computers, Computers, tablet computers, and LED panels. The Trademark Examining Attorney originally refused registration on the ground that QLED is merely descriptive of Applicant¡¯s goods.
Then LG amended the application to seek registration on the Supplemental Register. But the Examining Attorney continued the the smae refusal, and also refused registration on the additional ground that QLED is generic and therefore incapable of distinguishing the identified goods.
When the Examining Attorney made both refusals final, LG filed a request for reconsideration, which the Examining Attorney denied. Applicant then appealed to TTAB (Trademark Trial and Appeal Board).
The sole issue to be decided at the TTAB was whether QLED is generic for the disputed goods and, thus unregistrable on the Supplemental Register for those goods. The TTAB affirmed the refusal.
In order to qualify for registration on the Supplemental Register, a proposed mark must be capable of distinguishing the applicant's goods or services. Generic terms are not qualified for registration. And a termm is generic if it refers to the class or category of goods or services in connection with which it is used.
The Examining Attorney maintained that QLED was an acronym for and substantially synonymous with the generic term ¡°quantum dot light emitting diode,¡± a type of display technology that is a key feature of the disputed goods, and that relevant consumers would readily recognize QLED as such.
LG contended that there was no consensus as to the meaning or understanding of QLED. However, LG did not dispute that the acronym QLED is ¡°substantially synonymous¡± with the generic term ¡°quantum dot light emitting diodes,¡± according to TTAB. After reviewing the contentions of both parties, the TTAB affirmed the refusal to register QLED on the Supplemental Register on the ground that it was generic for the disputed goods.