Supreme Court Declines To Review “New And Improved” Written Description Requirement

New and Improved RequirementsOn Tuesday, the Supreme Court denied Centocor’s (now “Janssen”) petition for cert. and so let stand a ruling that Centocor’s patents on humanized monoclonal antibodies (covering Abbott’s Humira) are invalid for failure to meet the written description requirement (WDR) of s. 112(1). Since cert. was not requested following the en banc decision in Ariad v. Lilly, which essentially reached the same conclusion on drugs — not yet discovered — that might alter the NF-kB pathway, this was the first good chance the Supreme Court had to weigh in on the heightened WDR that has been applied with regularity by panels of the Fed. Cir. to invalidate biotech patents claiming early stage inventions since it was articulated by Judge Lourie in the 1997 U. of Cal. v. Lilly decision. As I have written in a number of posts on subsequent decisions, this new and improved WDR has led biotech patentees down a trail of legal tears as, with few exceptions, their patents have failed the WDR – even if the claims were arguably enabled by the specification—a question that the Fed. Cir. has increasingly refused even to consider once the increasingly easy button of the WDR has been used to invalidate the patent.

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Griffith Hack And Ambercite Map The Alzheimer’s Disease Patent Landscape

Although I received this report: “Clearing The Fog; Patenting Trends For The Treatment Of Alzheimer’s Disease” both directly and from a number of colleagues, I won’t presume that it has been widely read, but it should be. (A copy of the report can be found at the end of this post.) Well-known IP attorney Debbie Beadle and consultant Mike Lloyd, along with George Mokdsi, Doris Spielthenner and Amanda Stark have created a map that reveals the different therapeutic approaches to treating the disease, the relationships between the patents and published patent applications in the area, their relative “importance” and the leading research companies and institutions that are patenting in the various therapeutic arenas. Surprisingly, the report reads like a good detective novel, as the analyzers boiled some 48,000 patents down to the leading 2153 patents that fell into 23 clusters. The clusters could themselves be focused into two major groupings – drugs targeted to beta amyloid and drugs targeted to the Tau and serotonin pathways. (Surprisingly, there was nearly and equal number of patents in each group!)

Preparing this report was not all carried out by computer algorithms; it took a lot of attorney time to get these patents into the right categories, even with the help of what Ambercite calls “Network Patent Analysis” to rank patents. But wouldn’t you like to know what the top ranked patents are in these two – and even more forward-looking – areas? And of course, you would want to know who is doing all this filing. We all know that the biggest, even “strongest” patent portfolio will not necessarily guarantee a winning drug, but the report could guide you toward less well-known therapeutic approaches that are getting up to speed. Will be it a progeny patent of US 4666829, the “granddaddy patent” which first disclosed amyloid polypeptide or will it be “the next new thing” in Alzheimer’s discovery research? Read this report and your guesses –and your stock picks –will get a lot more educated.

Whitepaper_Clearingthefog_February2012

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A “Modest Proposal” For The RCE Crisis

Commentators, including Prof. Hal Wegner, have been sounding the alarm regarding the increasing number of requests for continuing examination that applicants are filing. The PTO projects 325,000 RCE’s by FY 2018. They have gone further in recent posts, in attributing these filings to “outlier examiners” who refuse to continue prosecution after final rejection, even after agreeing that fairly simple amendments would result in allowance.  Some of these examiners are intent on “making law” – in other words, they have the tenure to ignore the MPEP and controlling decisional law. Other examiners are simply “young,” at least in experience. I find that these Examiners fail to allow applications because they don’t understand the concepts of burden or proof and/or what is, or is not, evidence of patentability. Wegner writes, “All the good intentions to improve the patent system will be for naught if the RCE continues to be used by outliers within the Office to swamp the system for personal production goals.” Hal has suggested a system whereby, after final rejection, applicants can petition to have the application transferred to another Group Unit for review by a senior examiner.

Given that these outlier examiners cannot be fired or retired, I think the solution is to bring back the “strong Practice Specialists” and to bring them back in force. From the mid- 90’s until about 2003, Group 1600/1800 had three “strong Practice Specialists” – Richard Schwartz, Brian Stanton and Margaret Parr. I only worked with the first two, but heard many good reports about Margaret as well. Needless to say, they are no longer at the Office. These were bright, experienced (ex-)Examiners who had real power to effectively compel examiners to allow cases.

This is how the system worked. If the issues were extremely focused – meaning that 99% of the time the final rejection was based on alleged anticipation or on a fairly straightforward obviousness rejection – often based on just one or two references – and the Examiner was clearly (of course) wrong – I would call Richard or Brian. They would pull a number of the examiner’s pending cases at once – so as to attempt to prevent retribution if they determined that I was wrong –and review the rejection in question. If they agreed with me, they would walk into the examiner’s office and tell them why he/she should allow the case. If the examiner absolutely refused, the case might go to appeal, but they could block the examiner from filing an Answer. Although Brian and Richard did not always agree with me, I never had to go this far. They could also offer a compromise. Historically, Director John Doll absorbed a lot of criticism for how he ran 1600/1800 in this period but this is one thing he got right.

So, Director Kappos, let’s try it again. Only let’s unleash an “A Team” of thirty or more Practice Specialists with a mandate to break up the types of stalemates that lead to RCEs. I know that there are Prosecution Ombudsmen, but so far as I can tell they have no clout, particularly with senior outlier examiners. Appeal Conferences have been no help, either. Applicants cannot participate and a negative outcome – almost assured since the examiner and his SPE or Group Director are going to make up 2/3 of the panel – will only lead to more RCEs.  Simple raising the cost to applicants to file an RCE or to appeal is not a fix, not when they have no choice. Let’s have some change that matters, to coin a phrase.

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Supplemental Examination Decision Tree – Lots of Dead Branches?

Well, I wish it were that simple, but I keep trying to conjure examples that would lead me to use supplemental examination to “purge inequitable conduct (IC)” that I discover after my patent issues, and which could provide the basis for a successful IC attack on the patent. (Even the Office doesn’t presume that charges of inequitable conduct will go away post-Therasense.)

Issues of hard-core fraud on the patent office (e.g., faked experimental data in declarations and the like) aside, it would seem that I would first need to become aware of deceptive/evil intent involved with submission or failure to submit an item of information (IOI). If there is not some level of deceptive intent (knowingly withholding an IOI or making an incomplete submission), there will be no finding of IC by the court, even if the IOI (e.g., the publication) is “but for” material.

Now the deciding gets more difficult. If the IOI is “but for” material, you are going to have to narrow the claims. So I see no need to do other than file a narrowing reissue application. Remember, there is no longer a requirement to state that the overly broad claims were obtained “without deceptive intent.” Likewise, if the IOI is “but for” material and there is no evidence of deceptive intent, narrowing reissue is certainly the way to go. An example might be a 102(b) reference that was discovered years after the patent issued.

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