ARIAD Pharma Inc v. Test

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: ARIAD Pharmaceuticals, Inc. (Delaware)
  • Defendant: Joseph Matal, in his official capacity as Acting Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office
  • Plaintiff’s Counsel: Wilmer Cutler Pickering Hale and Dorr LLP
• Case Identification: 1:17-cv-00733, E.D. Va., 06/26/2017
• Venue Allegations: Venue is based on 35 U.S.C. § 154(b)(4)(A), which provides for exclusive remedy by civil action against the Director of the PTO in the U.S. District Court for the Eastern District of Virginia for applicants dissatisfied with a patent term adjustment determination.
• Core Dispute: Plaintiff seeks judicial review of the U.S. Patent and Trademark Office's calculation of patent term adjustment, alleging the agency improperly calculated prosecution delays and wrongfully denied an additional 33 days of patent term for its patent.
• Technical Context: The patent-in-suit relates to chemical compounds that function as kinase inhibitors, a significant class of drugs used for treating cancers and other diseases.
• Key Procedural History: This action follows a prior lawsuit between the same parties regarding the same patent's term adjustment. In the earlier case, the Court remanded the matter to the PTO on March 31, 2014, for recalculation in light of the Federal Circuit's decision in Novartis AG v. Lee. After the PTO's subsequent decisions on remand and reconsideration resulted in a continued finding of zero days of adjustment, ARIAD filed the present action seeking review of that determination.

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,114,874 - "Substituted Acetylenic Imidazo[1,2-B]pyridazine Compounds as Kinase Inhibitors"

The Invention Explained

• Problem Addressed: The patent background describes the central role of protein kinases in regulating cellular processes and notes that abnormal kinase activity is linked to a range of disorders, including cancer. It identifies an "ever-existing need for new inhibitors selective for various protein kinases" ('874 Patent, col. 1:7-24).
• The Patented Solution: The invention provides a new class of chemical compounds, based on an acetylenic imidazo[1,2-b]pyridazine core structure, that are designed to function as protein kinase inhibitors ('874 Patent, Abstract). These compounds are intended for use in treating diseases mediated by kinases, such as solid tumors and leukemias, including cases that are resistant to other therapies ('874 Patent, col. 2:33-47).
• Technical Importance: The development of novel kinase inhibitors is a critical area of oncology research, offering targeted therapies that can be more effective and have different side-effect profiles than traditional chemotherapy, particularly for cancers driven by specific genetic mutations ('874 Patent, col. 1:16-24).

Key Claims at a Glance

• No claims are asserted for infringement, as this is a dispute with the PTO over the calculation of the patent's term, not a case against a third-party infringer. The patent term adjustment applies to the patent as a whole.
• For context, the independent claims (e.g., claims 1, 6, 10) are composition of matter claims directed to compounds of specific chemical formulas, defining a genus of kinase-inhibiting molecules ('874 Patent, col. 2:48-65; col. 5:6-38).

III. The Accused Instrumentality

Product Identification

The challenged "instrumentality" is not a commercial product but rather the U.S. Patent and Trademark Office's final determination of the Patent Term Adjustment (PTA) for the ’874 Patent, which ARIAD alleges is incorrect (Compl. ¶¶1, 4).

Functionality and Market Context

• The dispute centers on the calculation of "B delay," a type of PTA that compensates a patentee for PTO delays that extend patent prosecution beyond three years from the application filing date (Compl. ¶12). The statute provides that "time consumed by continued examination" requested by the applicant is excluded from the B delay calculation (Compl. ¶12).
• The complaint alleges that the PTO improperly included a 118-day period of its own erroneous delay within the "time consumed by continued examination," thereby unlawfully reducing the calculated patent term (Compl. ¶¶43, 46). The length of a patent's term is of significant commercial importance, particularly for pharmaceutical products, as each day of market exclusivity can represent substantial revenue.

IV. Analysis of Patent Term Adjustment Dispute

The core of the legal dispute is the interpretation of the statutory phrase "time consumed by continued examination" under 35 U.S.C. § 154(b)(1)(B)(i) and its application to a specific 118-day period during the prosecution of the ’874 Patent.

The complaint alleges the PTO erroneously declared the application abandoned after ARIAD had properly filed a Request for Continued Examination (RCE) (Compl. ¶25). This error was later acknowledged and rescinded by the PTO (Compl. ¶27). The disputed 118 days run from the date the PTO received the RCE (February 12, 2010) to the date the PTO rescinded the abandonment and forwarded the case for examination to resume (June 10, 2010) (Compl. ¶46). The complaint includes a timeline diagram illustrating this disputed period and its effect on the overall PTA calculation (Compl. p. 14). This diagram shows the 118 days the PTO treated the application as abandoned, which ARIAD argues should not be excluded from the "B delay" calculation (Compl. p. 14).

ARIAD contends that because the application was improperly considered abandoned due to PTO error, no "continued examination" could have occurred or been "consumed" during this 118-day period (Compl. ¶43, ¶47). ARIAD argues this period represents a delay "plainly attributable to the PTO" for which it should be compensated (Compl. ¶47). By subtracting these 118 days from the PTO’s calculation of time consumed by continued examination, ARIAD arrives at a total PTA of 33 days (Compl. ¶50).

The complaint states that the PTO's position is that the entire period from the RCE filing to the notice of allowance counts as "time consumed by continued examination," regardless of its own administrative error (Compl. ¶42). This leads to the PTO's final calculation of 0 days of PTA (Compl. ¶44).

V. Key Statutory Terms for Interpretation

• The Term: "time consumed by continued examination" (from 35 U.S.C. § 154(b)(1)(B)(i)).
• Context and Importance: The definition of this statutory term is critical to the dispute. Whether the 118-day period of erroneous abandonment is included in or excluded from this carve-out directly determines the amount of "B delay" and, consequently, the final patent term adjustment. Practitioners may focus on this term because its interpretation clarifies the allocation of responsibility for delays that occur after an RCE is filed but are caused by the PTO's own administrative missteps.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (PTO's potential view): The complaint alleges the PTO's position relies on a formalistic interpretation where any time after an RCE filing is automatically excluded (Compl. ¶¶41-42). The PTO allegedly argued that because the abandonment was ultimately withdrawn, "there is no period of abandonment in this application," sidestepping the question of whether examination was actually occurring (Compl. ¶55). This suggests a view that the filing of an RCE, not the PTO's active examination, triggers the exclusion.
  • Evidence for a Narrower Interpretation (ARIAD's view): The complaint argues the plain meaning of the word "consumed" implies active PTO engagement in the examination process (Compl. ¶47). It supports this by citing the Federal Circuit's reasoning in Novartis, which found that time after a notice of allowance is not "consumed by continued examination" because examination has presumptively ended (Compl. ¶47). ARIAD argues that, similarly, time cannot be "consumed" by examination when the PTO's own admitted error—erroneous abandonment—has halted the process and prevented examination from even commencing (Compl. ¶¶47, 54).

VI. Other Allegations

No probative visual evidence provided in complaint.

VII. Analyst’s Conclusion: Key Questions for the Case

The resolution of this case will likely depend on the court's answers to the following key questions:

• A core issue will be one of statutory interpretation: Does the phrase "time consumed by continued examination" in the patent term adjustment statute require the PTO to be actively and properly prosecuting an application, or does it refer to a formal status that begins with an RCE filing and ends with allowance, regardless of intervening administrative errors by the PTO?
• A key legal and equitable question will be one of causation and responsibility: Can a delay that is admittedly "plainly attributable to the PTO"—its erroneous holding of abandonment—be counted against the applicant for the purpose of reducing a patent term adjustment award that is statutorily designed to compensate for such PTO-caused delays?