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Complex or Not Written Description Is Evaluated Against Claims

by Connor M. Larson | Jan 23, 2025 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents must be evaluated based on the claims themselves, not on their construction. In re Entresto, Case No. 23-2218 (Fed. Cir. Jan. 10, 2025) (Lourie, Prost, Reyna, JJ.)

Novartis owns an approved new drug application (NDA) for a combination therapy of valsartan and sacubitril that Novartis markets under the brand name Entresto®. The term “combination therapy” is used to describe pharmaceuticals where two or more active pharmaceutical ingredients are combined in a single method of treatment. Entresto® is protected by several patents, including the patent at issue. Several generic pharmaceutical manufacturers, including MSN, filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Entresto® prior to the expiration of Novartis’ patent. Novartis sued for infringement.

A unique property of Entresto® is the specific form taken by the active pharmaceutical ingredients, valsartan and sacubitril. The valsartan and sacubitril in Entresto® are present in what is known as a “complex,” meaning the two drugs are bonded together by weak, noncovalent bonds. At issue before the district court was the construction of the claim term “wherein said [valsartan and sacubitril] are administered in combination.” The inquiry focused on whether “in combination” required the valsartan and sacubitril to be chemically separated molecules (not in the form of a complex). The district court adopted Novartis’ proposal to give the term its plain and ordinary meaning because the intrinsic record was silent as to whether the molecules must be separate and not complexed. The complexed form of valsartan and sacubitril was not developed until four years after the priority date of the patent.

After the district court declined to adopt MSN’s “complexed” claim construction, MSN stipulated to infringement. The case proceeded to a bench trial on the issue of validity. The district court found the patent not invalid for obviousness, lack of enablement, and indefiniteness. However, the district court ruled that because the patent did not disclose the complexed form of valsartan and sacubitril, it was invalid for lack of written description. Novartis appealed.

Novartis argued that a complex of valsartan and sacubitril was an after-arising invention that need not have been enabled or described. The Federal Circuit agreed, finding that because the patent did not claim the complexed form of valsartan and sacubitril, those complexes need not have been described. The Court cited its “long-recognized” rule that “the invention is, for purposes of the written description inquiry, whatever is now claimed.” All that was required to meet the written description requirement was a disclosure sufficient to show that the inventors possessed a pharmaceutical composition comprising valsartan and sacubitril administered in combination. The Federal Circuit found that by considering what the claims were “construed to cover,” the district court improperly conflated the distinct issues of patentability and infringement. The Federal Circuit reversed the district court’s finding of invalidity for lack [...]

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Paris Court of Appeals Rejects Pharmaceutical Supplementary Protection Certificate Applications

by Katya Ascher and Edouard Becker | Jun 17, 2021 | EU Update, Life Sciences

One of the conditions for obtaining an SPC is that “the product is protected by a basic patent in force”. The Court of Justice of the European Union (CJEU) clariﬁed to what extent a product must be identiﬁed by the claims to meet this condition in Teva, Eli Lilly, and Royalty Pharma.

In Eli Lilly, the CJEU notes that an active ingredient which is not identiﬁed in the claims of a basic patent by means of a structural or functional deﬁnition cannot be considered to be “protected by a basic patent.”

The active ingredient does not, however, have to be identiﬁed in the claims by a structural formula. A functional deﬁnition of the active ingredient may suffice if it is possible to reach the conclusion on the basis of the claims (interpreted in light of the description of the invention) that they relate “implicitly but necessarily and speciﬁcally, to the active ingredient in question.

Click here to read the full article in our latest International News.

The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

by Paul Devinsky | Feb 25, 2021 | Patents

The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., Case no.18-1876 (Fed. Cir. Feb. 9, 2021) PER CURIAM. The case concerns communications regarding generic approvals and “skinny labels,” which permit companies to sell pharmaceutical products that omit certain patented uses.

On Oct. 2, 2020, a panel of the Federal Circuit (PROST, C.J ., NEWMAN and MOORE, JJ.) issued an opinion finding that Teva induced infringement of a patent covering GlaxoSmithKline’s (GSK’s) drug Coreg® (carvedilol). In a per curiam Order, the Court has now vacated that opinion and set a new round of oral arguments that was held on February 23.

Teva had requested an en banc rehearing the case, which was denied in the Order vacating the Oct. 2, 2020 opinion while ordering panel rehearing limited to the following issue:

Whether there is substantial evidence to support the jury’s verdict of induced infringement during the time period from January 8, 2008 through April 30, 2011.

Background

GSK’s patent covers a method of using carvedilol, the active ingredient in Coreg®, for the treatment of congestive heart failure. In 2007, the FDA approved Teva’s application to market generic carvedilol tablets. To obtain that approval prior to the expiration of the patent (or prevailing on noninfringement, invalidity, or unenforceability of the patent in litigation), Teva had “carved out” certain patent-protected left ventricular dysfunction uses and only included claims to treat hypertension, i.e., claims not covered by the GSK patent. That original patent expired in 2007, but it was reissued in 2008.

Teva had deliberately omitted congestive heart failure in its label until the FDA made it add that indication in 2011. In accordance with the Order, the February 23 oral argument focued on alleged infringement in the period before the label change, i.e., the period 2008 and 2011. The outcome is expected to turn on associated activities and statements made by Teva that went beyond the approval of the generic drug with skinny labeling, where Teva did not explicitly claim that their product was for the patent-protected uses.

Federal Circuit Restores Induced Infringement Verdict Against Teva

by April E. Weisbruch | Oct 15, 2020 | Patents

Addressing the issue of whether a generic pharmaceutical company can be found to induce infringement even when all patented uses have been “carved out” of the label (resulting in a so-called “skinny label”), the US Court of Appeals for the Federal Circuit held that circumstantial evidence of inducement was sufficient. The Court relied on evidence that defendant stated its drug was a “complete replacement” for plaintiff’s drug covered by the asserted patent. GlaxoSmithKline LLC et al. v. Teva Pharmaceuticals USA Inc., Case Nos. 18-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Newman, J.) (Prost, C.J., dissenting). The Court reinstated a jury verdict against Teva Pharmaceuticals, ordering it to pay GlaxoSmithKline (GSK) $235 million.

GSK brought suit against Teva in 2014 in response to Teva’s attempt to market a generic form of carvedilol, developed and marketed by GSK under the brand name Coreg®. Coreg® was US Food and Drug Administration (FDA) approved for three separate indications: hypertension, congestive heart failure (CHF), and left ventricular dysfunction following a myocardial infarction (post-MI LVD). After March 2007, however, no GSK Orange-Book-listed patent covered the hypertension or post-MI LVD indications. A reissue patent that issued in January 2008 remained in force for CHF.

In 2002, Teva filed an abbreviated new drug application (ANDA) with the FDA. Before Teva’s carvedilol product was finally approved in September 2007, Teva amended its ANDA and proposed label to “carve out” the CHF indication according to 21 USC § 355(j)(2)(A)(viii)—often referred to as a “section viii carve-out.” Thus, Teva’s carvedilol “skinny label” was only indicated for hypertension and post-MI LVD, neither of which was, at that time, covered by any GSK patent.

After a trial, the jury found that Teva had willfully induced infringement of GSK’s patent and awarded GSK $235 million in damages. The district court then granted Teva’s motion for judgment as a matter of law, concluding that the inducement verdict was not supported by substantial evidence. GSK, the district court reasoned, had failed to prove by a preponderance of the evidence that Teva’s alleged inducement (as opposed to other factors) had actually caused even at least one physician to prescribe generic carvedilol for CHF. GSK appealed.

On appeal, the Federal Circuit overturned the grant of judgment as a matter of law, reasoning that the “intent element” of inducement may be proven through circumstantial evidence. The Court noted that the jury had received evidence of, e.g., “Teva’s promotional materials [referring] to Teva’s carvedilol tablets as AB rated equivalents of the Coreg® tablets,” press releases identifying Teva’s product as “Generic Coreg® Tablets,” Teva’s Monthly Prescribing References, and testimony from GSK’s cardiologist witness that physicians are “completely reliant” on information provided by the generic companies. The majority concluded that this was “ample record evidence . . . to support the jury verdict of inducement.”

Chief Circuit Judge Prost authored a lengthy dissent warning of the broad implications of the majority’s ruling, including contravening the congressional design and intent of the generic approval system, and potentially stifling innovation by giving rise to [...]

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Antitrust Liability Risk When Listing Patents in Orange Book

by Noah Feldman Greene | Mar 5, 2020 | Antitrust, Patents

The US Court of Appeals for the First Circuit held that pharmaceutical companies that wrongly list patents in FDA’s Orange Book must prove they acted in good faith to avoid antitrust liability. In re Lantus Direct Purchaser Antitrust Litigation, Case No. 18-2086 (1st Cir. Feb. 13, 2020) (Kayatta, J).

In applying for FDA approval to market new drugs, drug manufacturers must list all patents that “claim” the drug or the method of using the drug in FDA’s “Orange Book.” Listing a patent in the “Orange Book” allows the drug manufacture to trigger an automatic 30-month stay of FDA approval of any application for a competing drug product.

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Inherent Claim Limitation Necessarily Present in the Prior Art Invalidates Patent

by Mandy H. Kim | Jan 29, 2020 | Life Sciences, Patents

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J).

The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act.

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