United States: Impact Of Incomplete Notice Of Prior Art

The International Trade Commission (ITC) continues to be a popular venue for enforcing intellectual property rights through Section 337 investigations due, in part, to the fast pace at which the investigations are completed, with most lasting about 16 months. This fast pace has its pit falls, however. If a respondent at the ITC fails to gather and disclose the prior art it needs in a timely manner, the respondent may be precluded from relying on any prior art not identified in its notice unless the respondent can show good cause. In fact, the Administrative Law Judge (ALJ) in Certain Reduced Folate Nutraceutical Products and L-Methylfolate Raw Ingredients Used Therein (Certain Reduced Folate Nutraceutical Products), Inv. No. 337-TA-857, recently denied the respondents' motion to supplement their notice of prior art for failing to establish good cause for supplementation.

In Section 337 proceedings, discovery is typically concluded in four to six months; in contrast, discovery in a district court case may last one to two years. Many ALJs at the ITC set an early deadline for a respondent to provide a notice of prior art on which it intends to rely, usually within two to three months after the investigation is instituted. This time frame is similar to that of district courts having local patent rules which require disclosure of prior art through a defendant's invalidity contentions. In district courts without local patent rules, 35 U.S.C. § 282(c) requires only that a notice of prior art be filed "at least thirty days before the trial."

In Certain Reduced Folate Nutraceutical Products, Respondents Macoven Pharmaceuticals, LLC and Viva Pharmaceuticals, Inc. (collectively, Respondents) filed a motion seeking leave to submit a supplemental Notice of Prior Art adding U.S. Patent No. 6,008,221 (the'221 Patent) approximately one month after the Notice of Prior Art deadline in the procedural schedule. Respondents argued that good cause to supplement their Notice of Prior Art existed because (1) Complainants South Alabama Medical Science Foundation, Merck and Cie, and Pamlab LLC (collectively, Complainants) failed to identify the '221 Patent in their response to Respondents' interrogatory seeking the identity of all prior art to the asserted patent; (2) the '221 Patent was buried among thousands of documents that Complainants produced in discovery; and (3) Complainants failed to identify the '221 Patent in the asserted patent's reexamination proceeding at the USPTO until after Respondents identified the reference. Respondents further asserted that it is in the public interest to fully assess the validity of a patent and that Complainants would not be prejudiced by the addition as there was sufficient time before the exchange of expert reports and the hearing.

Complainants opposed the motion and argued that Respondents failed to show good cause warranting the supplementation. Complainants claimed that Respondents' argument that Complainants failed to disclose the '221 Patent in the asserted patent's reexamination proceeding was a red herring. Finally, Complainants asserted that any supplementation would be prejudicial to Complainants and the procedural schedule would be compromised.

ALJ Essex denied Respondents' motion for leave to supplement their notice of prior art and found no good cause because Respondents failed to show why they could not have found the '221 Patent earlier by simply conducting a prior art search at the USPTO. The ALJ's Order is available online. ALJ Essex determined that the '221 Patent is not an obscure piece of prior art and that both the '221 Patent and the asserted patent share the same prior art classes. Thus, ALJ Essex reasoned that any rational prior art searcher should have searched the asserted patent's prior art classes and would have come across the '221 Patent. Notably, however, ALJ Essex specifically stated that he may have reached a different conclusion if there was some difficulty in locating the '221 Patent, for example if the '221 Patent were a foreign patent, an article, a prior use, or in a foreign language. Accordingly, in the absence of any special reason why a reasonable prior art search would not have uncovered the '221 Patent, ALJ Essex found that there was no good cause for supplementation and denied Respondents' motion.

Practice Tips:

• ITC respondents face the challenge of collecting and reviewing all available public prior art that they can find by the time of their prior art notice, which will likely be due just two to three months into the investigation. A respondent that is unprepared, or fails to start developing its invalidity case immediately upon notice of the investigation, risks potentially devastating preclusion of relevant prior art.
• Parties should be prepared to spend the time and money on exhaustive prior art searches early in the investigation because ALJs may take a narrow view of the "good cause" needed to amend this notice after the deadline set in the procedural schedule.
• Respondents should also be careful to refine their prior art notice to only include references that will be used in the investigation as ALJs have stricken notices of prior art for being too voluminous and thus failing to provide sufficient notice to the other parties.

Below please find other examples of notice of prior art decisions issued in Section 337 proceedings:

• Inv. No. 337-TA-794, Certain Elec. Devices, Including Wireless Commc'n Devices, Portable Music and Data Processing Devices, and Tablet Computers, Order No. 40 – Complainants filed a motion to strike Respondent's notice of prior art which included over 7,000 entries on 380 pages. The Commission Investigative Staff opposed the motion to strike, but recommended that Respondent should be required to file an amended Notice of Prior Art that contained only the references that Respondent planned to rely on at the hearing. The ALJ granted the motion to strike, reasoning the voluminous notice of prior art provided "no notice at all" for Complainants. The ALJ allowed Respondent to re-file its notice of prior art because Complainants improperly withheld their priority date disclosures, but the ALJ noted that Respondent could only include references that appeared in its original notice.
  
  The ALJ's Order is available online.
• Inv. No. 337-TA-790, Certain Coenzyme Q10 Prods. and Methods of Making Same, Order No. 21 – Respondents filed a motion to supplement their notice of prior art to include a newly discovered reference. Respondents argued that good cause existed because the prior art reference, although publicly available, was published in a relatively obscure journal. The ALJ denied the motion to supplement the prior art notice, relying on a prior warning to all counsel at the preliminary conference that "the fact that your expert couldn't find the references is not adequate for good cause."
  
  The ALJ's Order is available online.

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