Paul GRIGLOCK, Executor of the Estate of, Sophie Griglock, Deceased, Petitioner-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.
No. 2011-5134.
United States Court of Appeals, Federal Circuit.
Aug. 10, 2012.
1371
Moreover, the court did not clearly err by finding that a skilled artisan would not arrive at a 0.1% w/v olopatadine eye drop by substituting olopatadine for the active compound used in the ophthalmic formulation disclosed in Lever. As the district court explained, a person of ordinary skill in the art would have known that one could not simply substitute one active ingredient for another without adjusting the concentration. Id. at 900. The court thus correctly found that Lever does not teach an ophthalmic formulation with an olopatadine concentration of 0.1% w/v.
Objective evidence further supports the district court‘s holding that claims 4 and 8 would not have been obvious. The district court‘s fact findings regarding the objective considerations are not clearly erroneous. The court found that Patanol® was “an outstanding commercial success,” achieving nearly 70% market share within two years of its launch, accounting for nearly $2 billion in sales within ten years, and garnering wide-spread praise within the industry. Id. at 904. The 0.1% w/v olopatadine concentration recited in claims 4 and 8 is the same as is used in Patanol®. As a result, with respect to claims 4 and 8, Alcon‘s objective evidence demonstrates that “the commercial success was caused by the merits of the invention as distinct from the prior art.” In re Kao, 639 F.3d 1057, 1069 (Fed.Cir.2011). Because Alcon failed to prove by clear and convincing evidence that a 0.1% w/v olopatadine formulation would have been obvious over the prior art, we conclude the district court correctly held that claims 4 and 8 would not have been obvious.
CONCLUSION
In view of the foregoing, we reverse the district court‘s holding that claims 1-3 and 5-7 of the ‘805 patent would not have been obvious. We affirm its holding that claims 4 and 8 would not have been obvious.
REVERSED-IN-PART, AFFIRMED-IN-PART
COSTS
No costs.
Amy J. Fashano, Conway, Homer & Chin-Caplan, P.C., of Boston, MA, argued for petitioner appellant. On the brief was Ronald C. Homer.
Voris E. Johnson, Jr., Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, of Washington, DC, argued for respondent-appellee. With him on the brief were Tony West, Assistant Attorney General, Mark W. Rogers, Acting Director, Vincent J. Matanoski, Acting Deputy Director, and Catharine E. Reeves, Assistant Director.
Before RADER, Chief Judge, LOURIE, and WALLACH, Circuit Judges.
Sophie Griglock‘s estate appeals a decision for compensation under the Vaccine Act,
BACKGROUND
The Vaccine Act established a program to increase the safety and availability of vaccines, and through the Vaccine Injury Compensation Program claimants may get compensation for vaccine-related injuries or death. See
(a) General rule
Compensation awarded under the Program to a petitioner under
section 300aa-11 of this title for a vaccine-related injury or death associated with theadministration of a vaccine after October 1, 1988, shall include the following: [(1)](B) Subject to
section 300aa-16(a)(2) of this title , actual unreimbursable expenses incurred before the date of the judgment awarding such expenses which-(i) resulted from the vaccine-related injury for which the petitioner seeks compensation...
(2) In the event of a vaccine-related death, an award of $250,000 for the estate of the deceased.
....
(4) For actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.
[(a)](2) ... if a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury, and
(3)... if a death occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such death after the expiration of 24 months from the date of the death and no such petition may be filed more than 48 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of the injury from which the death resulted.
Ms. Griglock, a seventy-year-old retired woman, received an influenza vaccination on October 6, 2005. See Griglock v. Sec‘y of Health & Human Servs., No. 09-275V, 2011 WL 839738, at *1 (Fed.Cl. Feb. 11, 2011) (“Special Master‘s Decision“). She went to her doctor on November 23, 2005, complaining of weakness, and was admitted to the hospital that day. Her treating neurologist determined that she suffered from Guillain-Barré Syndrome (“GBS“). After treatment she improved initially, but shortly thereafter she developed respiratory failure and was placed on a ventilator. Ms. Griglock passed away on May 11, 2007; her death certificate lists “ventilator-dependent respiratory failure due to GBS” as the immediate cause of death.
Her estate filed a petition for compensation on April 30, 2009. The Secretary of Health and Human Services (“Government“) responded that there was insufficient evidence to find that the influenza vaccine Ms. Griglock received on October 6, 2005 caused her GBS and subsequent GBS-related death. However, the Government stated it would not contest the issue further and recommended an award of up to $250,000 as a death benefit under
The Special Master determined that the vaccination caused Ms. Griglock‘s GBS and GBS-related death. Furthermore, the Special Master determined that the estate had standing to petition for injury compensation, but that entitlement was limited to death benefits because injury benefits were barred by the applicable statute of limitation under
The estate petitioned for review seeking compensation not only for death benefits under
DISCUSSION
“We review an appeal from the Court of Federal Claims in a Vaccine Act case de novo, applying the same standard of review as the Court of Federal Claims applied to its review of the special master‘s decision.” Broekelschen v. Sec‘y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed.Cir.2010). We give no deference to the Claims Court‘s or Special Master‘s determinations of law, but uphold the Special Master‘s findings of fact unless they are arbitrary or capricious. Id. Accordingly, we review questions of statutory interpretation de novo, and give deference to the Special Master‘s findings of facts. Id. “Thus, although we are reviewing as a matter of law the decision of the Court of Federal Claims under a nondeferential standard, we are in effect reviewing the decision of the Special Master under the deferential arbitrary and capricious standard on factual issues....” Lampe v. Sec‘y of Health & Human Servs., 219 F.3d 1357, 1369 (Fed.Cir.2000).
As an initial matter, the Government argues that the estate lacks standing to file a petition for compensation related to Ms. Griglock‘s injury. Specifically, the Government contends that the plain language of the statute states that only the vaccine-injured person has standing to file a petition for compensation for injury and their estate only has standing to file a petition for compensation for their vaccine-related death. However,
The estate argues that when a petition is properly filed in accordance with
The effect of [the estate‘s] argument is to render the Vaccine Act‘s limitation on the claims for injuries irrelevant where a claimant dies from his or her vaccine-related injury. Claimants who die would always be allowed a claim for injuries as well, so long as they met the new limitation on claims for death benefits. This result renders meaningless the Vaccine Act‘s statute of limitations for claims that petitioner‘s injuries were vaccine-related.
This court previously stated that when petitions are properly filed a “petitioner may receive the compensation for medical expenses, lost wages, and pain and suffering ... in addition to the $250,000 death benefit.” Zatuchni, 516 F.3d at 1315; see id. at 1321. But in Zatuchni, unlike here, petitioner had filed for injury compensation within the thirty-six-month time frame provided in
Indeed, looking at the plain meaning of the Vaccine Act, each section has a distinct purpose:
The estate also contends that a reading of
The timeline of relevant events is uncontested. Ms. Griglock‘s onset of GBS was evident at her doctor‘s visit on November 23, 2005, and she passed away on May 11, 2007. Therefore, the estate satisfied the requirements for a timely petition for death benefits under
The estate‘s overarching policy arguments are not availing. The estate avers that “the Program must be at least as generous as the outside civil system it seeks to replace.”* The estate notes that this court has previously stated “Congress found that the traditional tort system was not working for victims because it resulted in lengthy delays, high transaction costs, and sometimes no recovery.” Capizzano v. Sec‘y of Health & Human Servs., 440 F.3d 1317, 1327 n. 7 (Fed.Cir.2006). However, the Vaccine Act itself shows that there are limitations to the generosity of the program. The Vaccine Program is more generous to petitioners than civil tort actions in some ways, e.g., presumption of causation, less-adversarial proceedings, and relaxed rules of evidence. See
CONCLUSION
For the above mentioned reasons, we affirm.
AFFIRMED.
No costs.