The ECP, epi and Business Europe have collaborated to produce a downloadable, fifty page guide to practice before the EPO. While not binding on Examiners, it was issued under the authority of the EPO and is a sort of mini-MPEP, intended for use by both applicants and Examiners. A copy is provided at the end of this post. You can read more about it here.
Posts Tagged ‘biotechnology law’
“Handbook of Quality Procedures Before the EPO”
Monday, March 26th, 2012Indian Patent Office Grants Compulsory License To Bayer Drug
Wednesday, March 21st, 2012
Finding that Bayer had failed the requirement to “work” the invention in India, e.g., manufacture and sell at a reasonable price, the Indian Patent Office granted Natco Pharma, an Indian company, a “compulsory license” to make, use and sell a generic version of the anti-cancer drug Sorifenib. (A copy of this decision can be found here and also at the end of this post.) If your client/company/institution has an Indian patent on a drug, don’t forget to fill out the working forms that your associate should remember to send to you. However, this decision does not answer the question of whether or not an Indian company could seek approval to market a drug not yet approved by your client or its licensee in, say, the US or the EU, if the Indian company went through the NDA process in India. I know this sounds unlikely but, at the least, this decision should remind us all to take “working requirements” seriously, particularly for drugs that are moving through the approval processes outside of India.
Natco_vs_Bayer_Decision_of_Controller_of_Patents_Mumbai_9_Mar_2012
Supreme Court Declines To Review “New And Improved” Written Description Requirement
Wednesday, February 22nd, 2012
On 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.
A “Modest Proposal” For The RCE Crisis
Friday, February 10th, 2012
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.
