More Patentees Follow Wyeth's Lead in Seeking Additional PTA

    By Donald Zuhn --

As we reported yesterday, Director Jon Dudas of the U.S. Patent and Trademark Office filed a Notice of Appeal in the District Court for the District of Columbia on November 28th, appealing the Court's decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit (see "USPTO to Appeal Wyeth v. Dudas").  As we noted earlier this fall in our summary of the Wyeth case, the decision could significantly impact the manner in which the Patent Office makes Patent Term Adjustment (PTA) determinations (see "Wyeth v. Dudas (D.D.C. 2008)").

The Wyeth decision, however, has already had a significant impact in that a number of suits have been filed against Director Dudas asserting improper PTA determinations.  In November, we reported on the first two patentees to follow in Wyeth's footsteps by filing complaints against Director Jon Dudas for similar PTA "miscalculations" (see "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA").  In particular, on September 5th, San Francisco-based Napo Pharmaceuticals, Inc. filed a complaint in the District Court for the District of Columbia, asserting that the correct PTA for U.S. Patent No. 7,341,744 (issued March 11, 2008) should be 1007 days rather than the 453-day period calculated by the Patent Office.  On November 7th, Ironwood Pharmaceuticals, Inc. of Cambridge, MA filed a complaint asserting that the correct PTA for U.S. Patent No. 7,371,727 (issued May 13, 2008) should be 702 days rather than the 411-day period determined by the Office.

Recently, four more patentees filed complaints against USPTO Director Jon Dudas contending that the Patent Office's PTA determinations were incorrect.  On the same day that Director Dudas filed his Notice of Appeal, Solvay Pharmaceuticals GmbH of Hannover, Germany, filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,729 (issued June 3, 2008) should be 633 days rather than the 534-day period calculated by the Patent Office (see complaint).  And on Monday, three more patentees followed suit.  These patentees include:

• Biogen Idec Inc. of Cambridge, MA, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,560 (which issued June 3, 2008) should be 2,058 days rather than the 1,409-day period determined by the Office (see complaint);

• Purac Biochem B.V. of the Netherlands, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,410,556 (which issued August 12, 2008) should be 949 days rather than the 386-day period determined by the Office (see complaint); and

• Molecular Insight Pharmaceuticals, Inc. of Cambridge, MA, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,399 (which issued June 3, 2008) should be 1303 days rather than the 634-day period determined by the Office (see complaint).

Because 35 U.S.C. § 154(b)(4)(A) specifies that "[a]n applicant dissatisfied with a [PTA] determination made by the Director . . . shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent," three of the four patentees above had little choice but to file complaints seeking additional PTA (while Purac had until February 8, 2009 to file its complaint, the other three patentees had until Sunday, November 30th to file their complaints).  And now that the Patent Office has decided to fight Judge Robertson's decision in Wyeth, patentees facing similar situations will be forced to file complaints to obtain additional PTA.  Patent Docs will continue to monitor newly filed actions in the District Court for the District of Columbia in order to identify other patentees seeking corrected PTA determinations.

For additional information regarding this and other related topics, please see:

• "USPTO to Appeal Wyeth v. Dudas," December 2, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008

Comments

[breadcrumbs]

I realilze this site is specifically interested in biotech and pharma, but I wonder just how big the potential list of PTA adjustment cases may be. Can anyone estimate the possible effective total dollar value? Would that dollar value trip any other federal guidelines that the Office must work with?

I know that this past week I have reviewed four cases all showing the USPTO calculations to be off. Three will be pursued and the fourth is merely a matter of days in a non-bio area and not worth the effort to correct.

[Incredibly Curious]

I seem to recall from the earlier discussion of this case that there was a statute of limitations of some sort, i.e., the case had to have issued within ... 3 months of filing suit? Or something?

Am I wrong? What is the statute of limitations?

[Donald Zuhn]

Breadcrumbs:

You raise some interesting questions. When I first wrote about the Wyeth case, I did a search of the USPTO database to determine the number of issued patents that might be impacted by the decision (i.e., patents issuing within 30 days from applications that were filed after AIPA was passed and that were prosecuted for more than three years). This search generated a list of 15,266 patents. However, one would have to examine the Image File Wrappers for a sample of these patents to estimate the percent of patents that would actually be affected by Wyeth. As for estimating the cost from "lost" PTA, it might be a good idea to look at Orange Book listed patents. Nevertheless, you suggest some interesting research projects.

Don

[Donald Zuhn]

Incredibly Curious:

There are three deadlines that would come into play. At the time of payment of the issue fee, an applicant must file a request for reconsideration of a PTA determination the applicant knows to be incorrect. Within two-months of issuance, a patentee must file another request for reconsideration for PTA determinations that are still incorrect or which have become incorrect since the notice of allowance was issued (e.g., as a result of publication delay). And finally, for PTA determinations that have not been corrected (or in response to a denial of the above requests), a patentee must file a suit against the USPTO Director in the District Court for the District of Columbia within 180 days of issuance.

The Office could argue that the failure to file either of the first two requests would constitute a waiver of any PTA owed under Wyeth (when, and if, the Office loses its appeal in Wyeth). I believe this would be a good argument vis-a-vis Chevron, since a court would likely determine that the deadlines specified in 37 C.F.R. for filing the two requests are merely procedural rules.

Don

[Donald Zuhn]

Breadcrumbs:

One correction to my comment above: I meant to write 60 days and not 30 days.

Don