Archive for the ‘Post-Grant Issues’ Category

Federal Circuit Clarifies Prosecution Laches

Wednesday, November 10th, 2010

The facts of Cancer Research Tech. v. Barr Labs., Inc., App. No. 2010-1204 (Fed. Cir. November 9, 2010) (PDF at end of post) are almost more interesting than the holding, which is : “We…now hold that to establish [the prejudice necessary for a finding of prosecution laches] an accused infringer must show evidence of intervening rights. Since the accused infringer, Barr, was seeking approval of an ANDA on a drug patented by Cancer Research Tech., and brought to market by Schering (not surprisingly) well before Barr filed its ANDA, Barr was not going to be able to meet this burden.

However, the back-story is of some interest to patent prosecutors in the life sciences/pharma area, if only for the light it sheds on PTO prosecution policy. The original application for the patent-in-suit, that covers the anti-cancer drug Temodar, was filed in 1982. In November 1983, in the first substantive office action, the Examiner rejected the claims to a method for treating leukemia as facially lacking utility because leukemia was clearly untreatable, and went on to say that utility could be established by FDA approved tests. The Examiner cited Ex parte Timris, which, ironically was one of the first Board decisions to hold that methods of medical treatment are patentable subject matter. Of course, we take this for granted, as the Fed. Cir. did recently in Prometheus v. Mayo, but Timris was a 1959 decision, not an 1859 decision(!). Still, Examiners threw up every imaginable legal and policy roadblock to support lack of utility and nonenablement rejections of claims to compounds and their uses disclosed to be useful to treat cancer, and then AIDS, at least well into the 90’s. (Just a few years ago, an Examiner asserted that the PTO was the “gatekeeper for the FDA” but that’s another story.)

In vitro inhibition of cancer cells was routinely disregarded. Ex parte Balzarini,(1991), the Board agreed with the Examiner that in vitro efficacy of anti-HIV drugs did not correlate to an expectation of success of human treatment, providing unwarranted difficulties to applicants seeking to slow the epidemic. It was not until In re Brana in 1995 that the Fed. Cir. held that animal models of human disease could suffice to establish utility/enablement in the case of an anti-cancer drug. This holding did not help those of us prosecuting claims to potential anti-HIV drugs, since there was no readily available animal model for the disease but, to its credit, the PTO informally ignored Balzarini almost before it was decided, at least in the HIV area. Interestingly, the Cancer Research Tech. decision mentions that Cancer Research eventually cited In re Buting, a 1969 CCPA decision that held, as did Brana, 27 years later, that positive test results in accepted animal models could establish utility of a compound in humans.


Do You Have Anything To Prove? Frye Fries A Half-Baked Standard

Thursday, March 11th, 2010

The recent precedential decision, Ex parte Frye, Appeal No. 2009-006013 (Bd. App. 2010) reversed the Examiner’s rejection of a claim to a shoe. More importantly, the Board emphasized that the Board on appeal “reviews the particular finding(s) contested by an appellant anew in light of all the evidence and argument on that issue.” This seems self-evident, but the de facto standard of review for some time has been that “The burden on….Appellant is to prove reversible error in the Examiner’s rejections.” Ex parte Setbacken.

This is a heavy burden, considering that the Examiner is presumed to have made a final rejection that is supported by a preponderance of the evidence. In re Oetiker, 977 F.2d. 1443, 1445 (Fed. Cir. 1992).

However, the Frye Board also made it clear that its review for error will only be based on the issues presented by appellant, and only those issues: “Specifically the Board reviews the particular finding(s) contested by an appellant anew in light of all the evidence and argument on that issue…the Board will generally not reach the merits of any issues not contested by appellant.” So if you want the benefit of de novo review of an issue, you had better raise it and argue it, or the golden eggs from your client’s legal goose will be cooked on appeal.

Privilege Primer

Friday, January 8th, 2010

Guest Posting from Ron Shutz

Case: Keefe v. Bernard, 2009 W.L. 346738 (Oct. 30, 2009).
Topic: Corporate Attorney/Client & Work Product Privilege


The attorney representing both the doctor and his corporate employer in a medical malpractice action interviewed an orthopedic surgeon also employed by the corporation. The plaintiff sought discovery of a report the defendants’ attorney prepared summarizing the interview. The trial court ordered it produced despite the defendants’ claim of attorney-client privilege. In an interlocutory appeal, the Iowa Supreme Court addressed the first impression corporate attorney-client issues the case presented. The Court held that communications between an attorney representing a corporation and a corporate employee are only protected by the attorney-client privilege if the discussions cover the employee’s actions as they relate to the potential liability of the corporation. Here, the report revealed that the surgeon was interviewed solely as a witness to the events at issue. The Court held such discussions are not attorney-client privileged. However, the Court found that the report was attorney work-product privileged because it showed the attorney’s mental processes. Though protected material, the defendant was required to turn the report over to the plaintiffs as a sanction for defendant’s failure to notify plaintiffs of the interview as required by Iowa law. In order to protect disclosure of the attorney’s opinion work (which the Court noted “is for all practical purposes, immune from discovery”) the Court ordered the report redacted to disclose only the facts, information and statements attributable to the surgeon.

BuLITS Points

• As a general rule, when an employee discusses with company counsel his or her own actions relating to the potential liability of that company, those communications are protected by the company’s attorney-client privilege.

• Depending on the law of the jurisdiction, if an employee is interviewed by corporate counsel and provides information as a witness to the actions of others, those communications may not be protected by the attorney-client privilege, but could still be protected as attorney work product.

To avoid possible sanctions, counsel should ensure there are no statutory limitations or ethical prohibitions before interviewing or deposing a witness.

And Remember

There are two layers to the attorney work product privilege. An opponent might be able to get at relevant non-privileged information embedded in your work with a demonstration of substantial need or undue hardship. But (unless something far worse has occurred) your mental impressions, conclusions, opinions, or legal theories should never face such a disclosure.


Friday, October 16th, 2009

Judge Randall Rader of the Federal Circuit was the luncheon speaker at the AIPLA Annual Meeting Friday in DC and, as usual, he spoke well. So many of his fellow- (and one female) judges where there that he quipped: “Now that we’re here and we have a quorum, shall we vote on inequitable conduct?” (Nervous laughter from large audience.) He set up his comments by recalling a meeting he had with the judiciary in Brazil, where he encountered a “Patent Skeptisauros” judge who argued that the patent system itself was outdated, nonfunctional and was doing damage to Brazil and other less-developed countries.

Judge Rader said he replied that it was the accuser’s understanding that was non-functional and destructive. He argued that we live in a world where technology is decentralized and that no single entity can “keep pace with the patent system.” Rather, the patent system functions to bring innovators together to cooperate and to coordinate their work. A “patent thicket” should not be thought of as a legal minefield, but rather as an invitation to begin such cooperation and coordination. He recalled a conversation with a Japanese colleague who said, in effect, that the comparative global advantage of the U.S. going forward is innovation and invention and asked, “Why are you trying to limit it?”

While the title of the talk was “Trolls and Other Creatures of the Night,” Judge Rader spent relatively little time on that topic. He dismissed the definition of patent troll as one who holds patents but does not practice them (commercially) as unfairly including universities and other research institutions. He said that the proper definition is “anyone who asserts a patent far beyond its value” and that the power of trolls can be limited if district court judges can develop procedures to properly value IP early in the litigation process, where they must be the “gatekeepers of damages.”

In addition, Judge Rader acknowledged the role of patent litigation in setting the fence lines of IP, and urged us to consider that “Good fences make good neighbors.”

As lunch speeches go, this was no rubber chicken, and I applaud Judge Rader for getting AIPLA’s new business year (and new President, Alan Kasper) off to a good start.