In this ongoing patent infringement case, Magistrate Judge Burke issued a report and recommendation to deny Teva’s Rule 12(b)(6) motion to dismiss GlaxoSmithKline’s (GSK) induced infringement allegations relating to generic product sales during a select time period (January 2008‒May 2011). The magistrate determined that while Teva carved out the patented indication of use, other instructions in the generic product label plausibly evidence Teva’s intent to induce infringement of the patented methods. GlaxoSmithKline LLc, et al. v. Teva Pharmaceuticals USA, Inc., Case No. 14-cv-0878, slip op. July 20, 2016 (D. Delaware, Magistrate Judge Christopher J. Burke)

In 2014, GSK filed this patent infringement action relating to the active ingredient carvedilol (Coreg®) which was initially identified for the treatment of hypertension. Coreg® then became the first beta blocker the US Food and Drug Administration (FDA) approved for the treatment of congestive heart failure (CHF) after observation that the long term use reduced mortality in CHF patients. Coreg® was initially approved in 1997 for treatment of mild-to-moderate CHF in conjunction with other therapies, and subsequently in 2001 was approved for treatment of mild-to-severe CHF. Although initially contraindicated for heart attack patients, in 2003, GSK obtained an expanded indication for these patients based on positive clinical studies. Thus, the Coreg® label includes three indications relating to use for: hypertension, mild-to-severe CHF and heart dysfunction after heart attack.

Teva filed an abbreviated new drug application (ANDA) in 2002, submitting a Paragraph IV certification of invalidity against the then-Orange Book-listed ‘069 patent method of treatment claims. The ‘069 patent was later reissued and relisted by GSK as the ‘000 patent. In 2007, Teva submitted an amended ANDA including a Section VIII carve out for the indication of use for the treatment of mild-to-severe CHF. Teva obtained FDA approval in 2007 based on the skinny label (lacking the mild-to-severe CHF indication) and the labelling remained the same until 2011.

In this suit, GSK’s complaint initially asserted indirect infringement allegations against generic filers Teva and Glenmark for the method of treatment claims of the ‘000 patent. Teva and Glenmark successfully moved to dismiss these original allegations, as well as allegations indirect infringement allegations in GSK’s first amended complaint because Teva’s label carved out the indication for the treatment of mild-to-severe CHF (pre-2011). Although Teva’s motion was granted, the court granted GSK leave to amend its pleadings, and GSK filed second amended complaint alleging indirect infringement of the ‘011 patent based on Teva’s pre-2011 product sales. Teva filed another motion to dismiss claims relating to pre-2011 carvedilol product sales.

In considering the present motion to dismiss, the magistrate judge applied the Rule 12(b)(6) pleading standards to this case inquiring whether GSK’s second amended complaint plead facts plausibly showing that in spite of its carve out, “Teva specifically intended third parties to infringe the ‘000 patent and knew that the third party’s acts constituted infringement.” Teva contended that GSK failed to state facts showing Teva’s specific intent to induce or knowledge of infringement, although GSK alleged that Teva actively publicized the “AB-rating” for generic carvedilol without highlighting that its product was not approved for all of the same indications as Coreg®.

The magistrate found GSK’s allegations that Teva was promoting its product as AB-rated alone was not sufficient to make out a claim for inducement at least because: (1) the Orange Book explains that an AB-rating means that the product is therapeutically equivalent to the brand product, but only for the conditions or uses specified in the labeling for the generic product, and in view of that explanation; (2) it cannot be assumed that third parties will necessarily mistake the generic product for being fully-substitutable; or that (3) Teva had the intent for third parties to be mistaken. However, the court found “a small piece of intent” in GSK’s allegations that Teva’s press releases evidenced an intent to capture sales for all therapeutic uses of the generic product because Teva’s press releases referenced the total annual sales of Coreg®, which included sales for treatment of CHF. More significantly, the court found GSK’s allegations relating to Teva’s labelling may indicate the plausibility that Teva specifically intended third parties to infringe the ‘011 patent. Specifically, the Coreg® indication of use for heart dysfunction after heart attack (included in Teva’s label) is drafted such that it includes reference to CHF patients, such as: “Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤40% (with or without symptomatic heart failure)” (emphasis added, citing also to language in the clinical studies, “heart failure/fluid retention” adverse event and patient advise sections referencing “heart failure”). The magistrate’s analysis analogized the facts in this case to the Federal Circuit’s decision in AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010). In that case the generic manufacturer’s approved labeling included an indication for a non-patented twice-daily use, but instructions on dose titration could lead to a once-daily dose that was patented. In AstraZeneca, the court found the “pertinent question is whether the proposed label instructs users to perform the patented method [if it does then] the proposed label may provide evidence of [a generic manufacturer’s] affirmative intent to induce infringement.” Here, the court determined that it was plausible that in spite of Teva’s carve out, the broader labeling and instructions may be viewed as an encouraging consumers to infringe the ‘000 patent because there is a relationship between the two patient populations—heart attack patients may also be CFH patients—as the labelling suggests.

Finally, the magistrate found further support of Teva’s inferred intent to induce infringement in the fact that allegedly there are not substantial non-infringing uses for Coreg®. Specifically, Teva was aware that: (1) GSK has marketed the product in the United States only for treatment of CHF and (2) uses for the other approved indications are purportedly minimal.

Therefore, the magistrate found GSK’s pleaded facts sufficient to survive Teva’s Rule 12(b)(6) challenge and recommended that the District Court deny Teva’s motion. On August 25, 2016, Teva filed a memorandum in opposition to the magistrate’s report and recommendation. Trial is scheduled to begin in this case on June 12, 2017.

Practice Note

Patents that issue after an ANDA is filed cannot serve as the basis for an infringement claim under §271(e)(2).