For a long time, people have believed that the structure of claims can and often play a decisive role in patent litigation. This frankness is the basis for the Federal Circuit to confirm the district court’s decision against the generic drug manufacturer in the latest judgment of the District Pharmacopoeia in the Par Pharmaceutical, Inc. v. Hospira, Inc. case. Infringement of Par’s patented formula, clear error standards also had an impact on the results.
These problems were caused in the ANDA litigation, in which the plaintiff claimed Hospira’s US Patent Nos. 9,119,876 and 9,925,657 regarding Par’s Adrenalin® (adrenaline) and its administration method (injection). Hospira advocated non-infringement and invalidity as defenses (the district court filed a defense against Hospira and therefore did not appeal). The Par patent is aimed at a formulation that overcomes the deficiencies of the prior art adrenaline formulations. Due to three different degradation pathways (oxidation, racemization and sulfonation), its shelf life is mainly short. Claim 1 of the ’876 patent is representative:
A composition comprising: about 0.5 to 1.5 mg/mL of epinephrine and/or its salt, about 6 to 8 mg/mL of a tonicity regulator, about 2.8 to 3.8 mg/mL of a pH raising agent, and an antioxidant of about 0.1 to 1.1 mg/mL, pH lowering agent 0.001 to 0.010 mL/mL and about 0.01 to 0.4 mg/mL mL of transition metal complexing agent, wherein the antioxidant includes sodium bisulfite and/or sodium metabisulfite.
(Use boldface in the opinion to indicate restrictions related to Hospira’s appeal). After defining these restrictions, the opinion proposed an interpretation of the term “covenant” used by the district court for each restriction. The parties clearly agreed that the term should have its ordinary meaning, which is “about”; for the Federal Circuit Court of Appeals, Hospira did not provide an explanation to the contrary.
Both parties provided expert testimony on the above three restrictions. Parr’s experts testified that the court used 9 mg/mL sodium chloride to determine the infringement in the range of 6-8 mg/mL (Hospira concentration, although concentrations as low as 8.55 mg/mL are also used) because it It is sufficient to meet the intended purpose, which is to “maintain the integrity of living cells after injecting adrenaline into the blood.” Hospira’s experts only raised objections to his colleagues on whether his skilled technicians believed that 9 mg/mL fell within the “approximately” 6-8 mg/mL range.
Regarding the limitations of transition metal complexes, the district court proved that citric acid is a known chelating agent based on evidence. Hospira stated in its ANDA that the content of elemental impurities (metals) is within international standards (especially ICH Q3D) Guidelines). Par’s experts proved that the corresponding relationship between the standard product and the metal chelating agent concentration stated in the claims is within the required range. Hospira’s experts once again did not compete with Par’s experts in general, but it did prove that the upper limit of the ICH Q3D standard was an inappropriate standard for the district court. Instead, he believes that the appropriate amount should be extracted from Hospira’s test batch, which he believes will require much lower levels of citric acid as a chelating agent.
The two parties are competing to use the pH lowering agent Hospira’s ANDA to specify the concentration of citric acid as a buffer (and its sodium citrate). In the field, citric acid itself is considered to increase pH (and there is no doubt that citric acid itself is A pH lowering agent). According to Par’s experts, subtracting the amount of citric acid in the Hospira formula is enough to make the citric acid fall within the range of the pH lowering agent claimed by Par. “Even those same citric acid molecules will become part of the buffer system (combined Citric acid and sodium citrate are used together as a pH raising agent.” (Although there are obvious contradictions, remember that infringement is a matter of fact. The Federal Circuit will review the district court’s factual decision in a trial. In order to arrive at an obvious error.) Hospira’s experts disagree with Par’s experts and proved (reasonably) that the citric acid molecules in the formulation should not be regarded as both pH-lowering and pH-increasing. However, the district court ruled that Par won the case and Hospira’s proposal would infringe Par’s patent rights. This appeal followed.
Judge Taranto believed that the Federal Circuit affirmed that Judge Dyke and Judge Stoll also attended the meeting. Hospira’s appeal involved the district court’s decision on each of the three restrictions. The Federal Circuit first confirmed the findings of the District Court in its opinion that the concentration of 9 mg/mL sodium chloride in the Hospira formulation actually fell within the “approximately” 6-8 mg/mL limit claimed by Par. The expert group pointed out that when using the term “approximately”, “avoid using strict numerical boundaries for specified parameters,” Cohesive Techs cited. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), based on Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Quoting Monsanto Tech’s statement, when “about” is modified in the claims, the claimed numerical range can be extended beyond the range to the extent that the skilled person will “reasonably consider” the scope covered by the claim. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). In such cases, if neither party advocates reducing the scope of the claim, the determination is based on the cohesion standard. The elements of this standard include whether the alleged infringing formula is “moderate” from the scope of protection (Conopco, Inc. v. May Dep’t Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , And how critical is the scope of protection for the purpose of limiting (not the present invention) itself. Although acknowledging that the claim constitutes a contribution to the court’s decision on this issue, the Federal Circuit pointed out: “Whether the defendant’s device meets a reasonable “covenant” meaning under certain circumstances is a matter of technical facts,” v. US Int’l Trade Comm’, 75 F.3d 1545, 1554 (Federal Court, 1996). Here, the panel believes that the district court has appropriately adopted the precedent described here, and its decision is based on expert testimony. The District Court held that Par’s experts were more convincing than Hospira’s experts, especially to the extent that it relied on “technical facts, the importance of the purpose of the restriction, and the non-criticality of the restriction.” In contrast, the district court held that Hospira’s experts “did not perform a meaningful analysis of the technical background or function of the claimed tonicity modifier.” Based on these facts, the expert panel found no obvious errors.
Regarding the limitations of transition metal complexing agents, the Federal Circuit rejected Hospira’s argument that the district court should have focused on its proposed general formula rather than the provisions in its ANDA. The Panel finds that the District Court correctly regarded citric acid as the transition metal complexing agent described in the claims, which is consistent with the expert testimony of both parties. Based on the testimony that citric acid actually acts as a chelating agent, this view rejects Hospira’s argument that citric acid is not intended to be used as a chelating agent. According to 35 USC§271(e)(2), the standard for ruling infringement in ANDA litigation is the content described in the ANDA (as the court pointed out, it is a constructive infringement), citing Sunovion Pharm. , Inc. v. Teva Pharm. , USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Hospira’s reliance on its ANDA is the ICH Q3D standard, which supports the district court’s ruling, at least not because this citation was added to the ANDA after the FDA required “alternative information” in this area. ANDA did not remain silent on this issue. The Federal Circuit found that the district court had sufficient evidence to prove that Hospira’s statement fully complied with the restriction.
Finally, regarding the pH-influencing properties of citric acid and its buffers, the Federal Circuit based on Hospira’s claim and did not reserve the right to claim on this issue. In addition, the Federal Circuit learned that the panel held that the (same) specifications of the ’876 and ’657 patents “at least strongly indicate the opposite.” Since the Federal Court did not challenge this (or any other place) claim, the Federal Court held that the District Court did not reach an obvious conclusion that Hospira’s formulation violated the explained claim (among other things, this) It depends on the public content of the court). Specifications) and be confirmed.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Federal Circuit Court 2020) Panel: Opinions of Circuit Judge Dyk, Taranto and Stoll, Circuit Judge Taranto
Disclaimer: Due to the general nature of this update, the information provided here may not be applicable to all situations, and no action should be taken on this information without specific legal advice based on specific circumstances.
©McDonnell Boehnen Hulbert & Berghoff LLP today = new Date(); var yyyy = today.getFullYear(); document.write(yyyy + “”); | Lawyer Ads
The website uses cookies to improve the user experience, track the use of anonymous sites, store authorization tokens and allow sharing on social media networks. By continuing to browse the site, you accept the use of cookies. Click here to learn more about how we use cookies.
Copyright © var today = new Date(); var yyyy = today.getFullYear(); document.write(yyyy + “”); JD Supra, LLC