Bits and Bytes No. 102

  • PPAC Nominations are due by May 15 – The new PTO director will presumably pick the nominee and will likely have time to suggest a nominee.
  • IP Scholars Conference 2009: This annual event will be held at Cardozo Law in NYC on August 6th and 7th, 2009. This is usually a large gathering of IP focused academics and academic minded individuals presenting original works-in-progress. Deadline for submissions is April 30, 2009. Individual submissions and questions should be directed to David Morrison at For more information, visit Submissions include topic, abstract, author name, & academic affiliation.
  • ANDA Infringement: Section 271 of the patent act provides a cause of action for patent infringement based on an unauthorized submission of an abbreviated new drug application (ANDA) for a patented drug or method. In a recent decision, the New Jersey district court found that the submission may still be an act of infringement even if the ANDA itself does not provide sufficient information to conclude that the use would be infringing. Instead, “the Court must look to the whole of the product, which means considering its ultimate useable state, as well as the ANDA-contemplated process and compound.”PDL Biopharma, Inc. v. Sun Pharm. Indus. Ltd., 2-07-cv-01788 (NJD March 31, 2009).

5 thoughts on “Bits and Bytes No. 102

  1. 4

    “Surprisingly, while finding these facts were undisputed, the district court still granted a summary judgment of infringement without ever finding there was one state of the drug product that simultaneously met all claim limitations”

    Gosh, I wonder how the district court managed to screw this up? Maybe the Federal Circuit can take a close look at the patentee’s briefs. What are the odds there are some statements in there intended to mislead the court? Sanction time.

  2. 3

    Hi Dennis:

    On the ANDA case, there seems to be a slight discrepancy in the case name that could give some readers trouble in finding the case. Westlaw is reporting the case as EKR Therapeutics, Inc. v. Sun Pharmaceutical Industries, Ltd., No. 07-1788 (KSH), 2009 WL 901761 (D.N.J. Mar. 31, 2009). (PDL Biopharma is a plaintiff in the case). While the court did look to the product at a whole it made two other alarming conclusions that readers may wish to consider.

    The accused drug product at issue in EKR had to be diluted to a certain level before being administered to a patient. The accused infringer argued that in its undiluted state, its drug product failed to meet one claim limitation since it had too high of a concentration of a first constituent, and when it was diluted, while the first constituent then fell to a level within the claimed concentration range, a second constituent then fell below the required concentration level of a second claim limitation even though in its undiluted form the second constituent met the second claim limitation. Surprisingly, while finding these facts were undisputed, the district court still granted a summary judgment of infringement without ever finding there was one state of the drug product that simultaneously met all claim limitations, and without ever addressing why it did not have to make such a finding. See 2009 WL 901761 *17 & *19 (the claims at issue were composition claims and a method of making the composition).

    What was also surprising, and what may have a more profound impact on future ANDA litigation is the district court’s conclusion that since § 271(e)(2) considers the “use” of a drug product it is proper to consider the product in its state just before being administered to a patient even though there was no question that a health care provider, and not the generic manufacturer, performed the dilution to put the product in its final administered state. The patentee was ready to argue that the generic manufacturer induced infringement under § 271(b) since the generic drug maker provided the drug product with instructions for the health care provide to make the diluted form of the final product. The district court held that was not necessary, and proceeded to consider the drug product in its administered state with out regard to who put it in that state. Id. at *12 and *16. Hence, the evidentiary requisites of showing knowledge of the patent and intent to infringe, as required for any inducing claim, were avoided. To the extent that there was an issue of possible joint infringement of the method of making claim, the district court also did not consider that issue. It will be interesting to see how the Federal Circuit will treat this view of § 271(e)(2) where the end user does the final step to put an accused drug product in infringing form.

  3. 2

    This BRIEFING TIP bears repeating:

    Some briefs, for example, briefs filed with the CAFC, are limited to a maximum number of pages. This tip may fit about one extra page of pleadings, for example — TO MAKE 16 PAGES WORTH FIT INTO 15 PAGES — and still meet the CAFC requirements. The requirement is 14 point type double spaced.

    Word Perfect worked better in most regards for briefs than does MS Word today. But the world switched to MS I guess because of the success of MS Windows.

    Word Perfect spaced lines of 28 point Times Roman 28 points apart.
    However, MS Word spaces 28 point Times Roman 31.5 points apart, which puts 3.5 points of wasted space between lines.
    But you can set MS Word to exactly 28 points and save space for a longer, hopefully more persuasive, argument.

    Here’s how: Using MS Word to conform exactly to the double line spacing requirement for 14 pt type do this:

    1) Hit Control “a” to highlight the whole job.

    2) Right click with cursor on the highlighted text.

    3) Left click “Paragraph”

    4) Set “Line spacing” to “Exactly” and “At:” to “28 pt” (which is exactly double line space for 14 pt type).

    5) Then Click OK (and hopefully you can fit 16 pages into 15 pages).

    As Mr. Monk would say, You’ll thank me in the morning.

  4. 1

    Hey DC-

    I thought a Bit/Byte on IP firms’ layoffs and struggles (vel non) during the downturn might ellicit interesting commentary. abovethelaw has layoff news on quite a few IP firms.

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