For some time, I have wanted to do a post on this recent Fed. Cir. decision (Appeal No. 2015-2073 (Fed. Cir. , August 10, 2016),) in which the Fed. Cir. panel of Judges Moore, Linn and O’Malley (writing) reversed a PTAB decision finding most of the claims of U.S. Patent No. 7,917,843 obvious over a single prior art reference, U.S. Patent .No. 5,859,636 (“Pandit”). Claim 1 is more than a page long, and I will not try to describe it in any detail, except to say that it can be exemplified by the use of a computer program to build an address book.
Archive for the ‘Post-Grant Issues’ Category
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.
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.
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.
• 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.
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.