In Galderma Laboratories v. Tolmar, Inc., the Federal Circuit reversed the district court’s findings that the Orange Book-listed patents for Galderma’s Differin® 0.3% gel product were not invalid as obvious. In so doing, the Federal Circuit took a narrow view of “unexpected results” that Judge Newman warns may “disincentivize” improvement patents in the field of medicine. Continue reading this entry
In Daiichi Sankyo Co. v. Rea (D. D.C. Dec. 3, 2013), the U.S. District Court for the District of Columbia rejected the plaintiff’s arguments that equitable tolling should apply to permit its claim for additional Patent Term Adjustment (PTA) under Wyeth. In so doing, the court followed much of the reasoning in Novartis AG v. Kappos (D. D.C. 2012), which is on appeal at the Federal Circuit. Although the court held that equitable tolling is available in principle, it found that the patentee had not established the required extraordinary circumstances.
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On December 5, 2013, the U.S. House of Representatives passed H.R. 3309, the “Innovation Act” originally introduced by Congressman Goodlatte (R-VA). The bill passed by a vote of 325-91, with four amendments to the bill as introduced. Chairman Leahy has introduced similar legislation in the Senate, but significant differences remain to be resolved. Nevertheless the fact that Congress was able to agree on H.R.3309 suggests that 2014 may bring another round of significant U.S. patent reform. Continue reading this entry
On November 29, 2013, the USPTO published its proposed rules to implement “the Hague Agreement Concerning International Registration of Industrial Designs.” The changes relate to the design patent provisions of Title I of the Patent Law Treaty Implementation Act (PLTIA). Written comments on the proposed changes to design patent practice are due by January 28, 2014. Continue reading this entry
In the non-precedential decision in In re Eaton, the Federal Circuit reversed the USPTO Board decision affirming rejections of anticipation and obviousness. The court found that the Board decision strayed from its own claim construction and was founded on plain factual errors.
The Application At Issue
The application at issue was Eaton’s U.S. 11/145,716, directed to a method of treating psoriasis using a vitamin composition:
1. A method of treating psoriasis by administering to a person a vitamin supplement composition comprising at least about 25 micrograms to about 2,200 micrograms of folic acid, at least about 25 micrograms to about 2,500 micrograms of vitamin B12, and at least about 0.5 milligrams to about 20 milligrams of vitamin B6, wherein said composition is essentially free of anti-oxidants.
The Claim Construction Issue
One of the cited prior art references (“Jungkeit”) disclosed the treatment of psoriasis with a composition comprising:
500 µg of folic acid, 20 mg of vitamin B6, 150 µg of vitamin B12, 200 mg of vitamin C, and 50 mg of vitamin E.
Both vitamin C and vitamin E are antioxidants, and the ’716 application teaches that vitamin C in particular is an anti-oxidant to be avoided. Thus, the main claim construction issue related to the meaning of “essentially free of anti-oxidants.” The ’716 application defines this phrase as follows:
By “essentially free” it is meant that the vitamin composition should not contain an amount of antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement. The presence of lower amounts of antioxidants would not render the vitamin composition of the present invention ineffective or of reduced effectiveness.
According to the court, the Board correctly construed this phrase as meaning that the composition ”should not contain an amount of antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement,” or an amount that would “render the vitamin composition … ineffective or of reduced effectiveness,” such that “lower amounts” of antioxidants may be present, but the effectiveness of the composition must not be reduced.” However, the Board strayed from its construction in finding anticipation and obviousness.
The court explained that, in order to anticipate the claims on appeal:
[T]he prior art compositions must have an amount of antioxidant that does not result in “reduced effectiveness.” …. [S]ubstantial evidence does not support the Board’s finding that Jungkeit’s composition is “essentially free of antioxidants.” The Board and the examiner have not analyzed the prior art for reduced effectiveness.
The court noted that the “Board and examiner assumed, without any rationale, that because Jungkeit states that its composition was effective at treating psoriasis, Jungkeit’s use of 200 mg of vitamin C would meet the applicant’s definition of ‘essentially free of antioxidants.’” As the court explained, “Jungkeit’s disclosed compositions may be effective, but still have an amount of antioxidant that ‘inactivate[s] some of the vitamin B12 and/or folic acid.’” Thus, the court noted, “the fact that Jungkeit’s composition is not ‘ineffective’ does not mean that it reads on the ‘essentially free of antioxidants’ limitation.
The court found that both the examiner and the Board relied on a factual error that undermined the obviousness findings. In particular, while Jungkeit discloses a composition with 200 mg of vitamin C, the examiner and the Board characterized that Jungkeit’s composition as including only 200 μg of vitamin C (1/1000th the actual amount). As the court noted, both the examiner and the Board relied on the assertion that it would have been obvious to “optimize” the amount of antioxidant present, but the court found no “rationale for adjusting the concentrations of antioxidants … to be ‘essentially free of antioxidants.’”
In fact, both Jungkeit and Mantynen disclose compounds where the concentration of antioxidants is greater than the concentrations of either folic acid or the B-vitamins.
The Office has not established on this record that a motivation exists to modify Jungkeit or Mantynen to be essentially free of antioxidants. ….
The court cited Leo Pharmaceutical Products., Ltd. v. Rea, for the proposition that, “[I]n the face of such divergent compositions with express disclaimers of the other’s contents,” the record demonstrates neither a motivation to “adjust” the prior art concentrations nor a motivation to combine them.
Thus, the court reversed the Board’s determinations of anticipation and obviousness.
Broadest Reasonable Interpretation?
I can feel the applicant’s pain in this case. How could both the examiner and the Board reject compositions said to be “essentially free of anti-oxidants” over prior art that teaches compositions where anti-oxidants are essential components present in significant amounts? The answer probably lies in the USPTO’s adoption of the “broadest reasonable interpretation” of the claims. As shown here, the USPTO tends to stretch that liberal claim construction paradigm beyond the bounds of reason.