Archive for June, 2012

“Obamacare” Survives – Including Path to Generic Biologicals

Thursday, June 28th, 2012

Biotech patent attorneys rejoice – no matter if you represent generic companies or NDA holders,  the 5-4 decision of the Supreme Court upholding the “individual mandate” – not under the commerce clause, but as an appropriate use of Congress’ power to tax – means that all the CLE charges you incurred to attend seminars on the future of generic biologics was not wasted. (A copy of the decision and dissents is available at the end of this post.) If the “Patient Protection and Affordable Care Act” had been voided in its entirety, the path to generic biologics that was included in the Act in some detail would have vanished (Title IV, subtitle A).  I summarized the features of the Act in my post of March 26, 2010 and posted an alert on March 29, 2012.

I am not versed enough in regulatory law to opine on how, or if, the FDA would have continued to promulgate regulations and hold hearings on this touchy subject, but given that bureaucracies seldom opt for more work without direction from Congress, my guess is that the current process would have simply gone into limbo. I welcome your opinions on the way forward, but amidst the furious debate about whether the Act would waste or save the taxpayers’ dollars, it cannot be denied that generic versions of older biologicals would save patients a lot of money.

Lilly Files Amicus Brief in Myriad Remand – With Friends Like This…

Tuesday, June 26th, 2012

Following its reversal of the Fed. Cir.’s decision in Mayo v. Prometheus (“Mayo”), the Supreme Court GVR’d in response to AMP’s (read: ACLU’s) appeal of Myriad’s claims to isolated DNA sequences and to a method of screening potential anti-cancer drugs using cells transformed with BRCA DNA (“claim 20”). I have reviewed a number of the amicus briefs that were filed prior to the June 15th deadline (oral hearing at the Fed. Cir. is set for July 20th) and they prompted me to reflect on the magnitude of what has been lost and the potential for future judicial limits on patentable subject matter.

First, a quick look back at what was lost in Mayo. Certainly, going forward no one is going to draft claims like the main claims to giving an AZA-type drug, measuring the level of the 6-MP metabolite and drawing a conclusion about whether to adjust the dose. However, because the Prometheus claims were method-of-medical treatment claims in disguise, it seems to me that claims to dosing regimens of all types, for any purpose, are no longer patentable subject matter. Such claims are often used by NDA holders to obtain add-on patents, that are listed in the Orange Book as methods of using the approved drug. The Fed. Cir. has invalidated such claims as inherently anticipated or as obvious in view of the primary use of the drug, e.g., an effective dose treats cancer, but the court’s job just got a lot easier.


From The EPO: Oral Proceedings/Interviews Before Examining Division Can Be Held Via Videoconferencing

Thursday, June 14th, 2012

This is a guest post from Lynnea Fedyk, legal process assistant at Schwegman, Lundberg & Woessner, P.A.

Attached are two documents of particular interest regarding Oral Proceedings by video conference and submission of email during video conference.

Should you like to view the complete listing of contents in the Official Journal – May 2012, please go to

Should you like to view the complete EPO newsletter, please go to

 Oral Proceedings by Video Conference

Interviews and Oral Proceedings – Submission of email

Will Universities Benefit from their Micro Entity Applicants?

Monday, June 11th, 2012

In an introductory post on the USPTO’s proposed rules: “Changes to Implement Micro Entity Status for Paying Patent Fees,” 77 Fed. Reg. 31806 (May 30 2010), my partner, Gary Speier, spent some time on new 35 USC 123(a), which defines a micro entity as an applicant (an “individual”) who qualifies as a small entity under 37 CFR 1.27; has not been named as an inventor on more than four previously filed applications, not counting foreign filings or provisionals, did not, in the year previous to the year in which the fee is paid, have a gross income greater than three times the median household income of the preceding year, and has not assigned and is not under an obligation to assign to a higher income entity.

Micro entities will receive a 75% reduction in fees related to filing, searching, examining, issuing and appealing patent applications and maintaining patents. Remember, micro entities are individual inventor-applicants but, in a situation in which they are university employees, and assign to their universities, it is the universities who will be paying the patent fees, and that will benefit from the micro entity status of their employees. Or will they?