Archive for December, 2010

EMA Draft Guidelines For Biosimilar Antibodies Released

Wednesday, December 29th, 2010

From Dr. Stefan Danner

On November 18, 2010, the European Medicines Agency (EMA) released draft versions of two guidelines relating to the regulatory approval of monoclonal antibodies: the “Guideline on biological medicinal products containing monoclonal antibodies”1 and the “Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use”.2 Both guidelines are now subject to public consultation until May 31, 2011.

The former regulation for the approval of biosimilar monoclonal antibodies (mAb) was long-awaited by the pharmaceutical industry, as many basic patents for therapeutic mAb will expire within the next couple of years. The present guideline sets forth the non-clinical and clinical requirements for mAb-containing medicinal products claiming to be similar to another one already marketed (i.e., biosimilars) and complements several previous guidelines for biosimilar medicinal products, based on which 13 such products have been approved so far in Europe.

The second guideline on the immunogenicity assessment of mAb that was released by the EMA is applicable to all biological medicinal products containing mAbs, not just biosimilars.


A European view of RCT v. Microsoft – A Pyrrhic victory?

Wednesday, December 29th, 2010

From Paul Cole

The law gets into a mess when a court does the right things for the wrong reasons.

By way of introduction, the present proceedings concern a method for the production of halftone images created at the University of Rochester, and the following image and background information were downloaded from their website:

Printing devices have long used the technique of halftoning to render the appearance of shades of gray using dot patterns. But high-quality halftones required an exasperating amount of time for printout. Drs. Kevin Parker and Theophano Mitsa developed Blue Noise Mask (BNM), a novel approach to providing high-quality halftones many times faster than the best algorithms available in the late 1980s. Dr. Parker, an expert in the field of medical imaging, had noticed that printouts from his team’s diagnostic equipment were slow and plagued by distracting “noise” patterns called image artifacts. The researchers were unable to tell whether a spot on a picture represented an incipient tumor or an artifact added to the image during printing. For a faster, more accurate way to render the pictures, they conceptualized pictures as being composed of a fine mosaic of black and white dots. This fine mosaic pattern was mathematically constructed into a Blue Noise Mask. After a computer calculates the optimum mask for a printing device, the pre-built mask is stored in the printer’s software to produce halftones almost instantly. For color printers, the mask also halves the number of bits needed to produce a high-quality image, permitting major savings in printing speeds and computer memory.

Researchers at the University of Rochester designed the mask with substantial computer power and several years of work. The BNM was introduced to graphics and other industries in 1991. At that time BNM was a leap forward in halftoning technology. BNM was the first method to combine high quality with virtually instantaneous halftoning.


RCT v. Microsoft – Fed. Cir. “Accepts” Bilski Invitation

Monday, December 27th, 2010

On December 8, 2010, the Fed. Cir. (Rader writing) reversed the district court’s holding that claims to a process for rendering a half-tone image of a digital image were patent ineligible as an attempt to claim an abstract idea. Research Corp. Technologies, Inc. v. Microsoft Corp., 2010-1037 (Fed. Cir. Dec. 8, 2010). (A copy is at the end of this post.) The claims given in the opinion involved the use of an “improved blue noise mask.” The panel spent 10 pages of its 25 page opinion explaining the technology and reproducing claims, and I still don’t have a clue how this technology works (it involves use of an algorithm as well!). The main process claims quite clearly would fail the M or T test, but the courts have more to work with now, and the panel got right to work.

Not surprisingly, the panel had a lot to say about the Supreme Court’s Bilski decision, particularly what it left unsaid:

“Indeed, the Supreme Court in Bilski re-focused this court’s inquiry into processes on the question of whether the subject matter of the invention is abstract. The Supreme Court did not presume to provide a rigid formula or definition for abstractness [citation omitted]. Instead, the Supreme Court invited this court to develop ‘other limiting criteria that further the purposes of the Patent Act and are not inconsistent with its text.”


Prometheus V. Mayo – Fed. Cir: “We Got It Right The First Time.”

Friday, December 17th, 2010

Today, following the vacation and remand of its earlier decision by the Supreme Court post-Bilski, the Federal Circuit again reaffirmed its reversal of the District Court (copy at the end of this post) and held:

“The asserted method claims satisfy the preemption test as well as the transformation prong of the machine-or-transformation test [for patentable subject matter]…..In other words, when asked the critical question, ‘What did the applicant invent?’ Grams, 88 F.2d at 839, the answer is a series of transformative steps that optimize efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs.”

The Federal Circuit held that either one of the recited steps of “administering”  a drug that provides 6-TG to a subject or “determining” the levels of the drug’s metabolites in a subject were sufficiently transformative to meet the M or T test:

“The transformation is of the human body and of its components following the administration of a specific class of drugs and the various chemical and physical changes of the drugs’ metabolites that enable their concentrations to be determined.”

This led the Court to find that claim 46 of the ‘623 patent, which only recites a determining step, also meets the M or T test (and does not bode well for the plaintiffs in Myriad). The Court also reaffirmed that the administering and determining steps were not merely data gathering steps, but were central to the claimed method of optimized therapeutic efficacy.  The Court pointedly, in fn. 2, declined to give weight to the “Metabolite Labs. dissent,” (548 U.S.124), in which Justices Breyer, Souter and Stevens would have found claims to an assay for cobalamin deficiency comprising determining the level of a marker in a fluid of a subject, and comparing it to a benchmark normal,  patent-ineligible as involving “natural correlations and data-gathering steps.”

While the Court agreed that the steps involving comparing the determined level to a benchmark level and concluding that that a need existed to increase or decrease the amount of drug administered (the “warning steps”) were mental steps, and not per se patentable, the Court warned against partitioning a claim into patent-eligible and non-patent eligible steps, and using the presence of patent ineligible steps to exclude the entire claim from further evaluation: “Although the wherein clauses describe the mental processes used to determine the need to change the dosage levels of the drugs, each asserted claims as a whole is drawn to patentable subject matter”.

The Court also found that the claims are not simply directed to a natural phenomenon and specifically held that they do not wholly pre-empt the use of natural phenomena, but rather are drawn to a particular application of naturally occurring correlations. The Court specifically noted that the claims are not an attempt to patent an algorithm, as were the claims in Grams.  The Court cited its opinion in Bilski (545 F.3d at 958): “After all, even though a fundamental principle is not  patent eligible, processes incorporating a fundamental principle may be patent –eligible. Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under s. 101.”

While this decision will probably get on the express train to the Supreme Court, let’s go ahead and “fix” Classen in the meantime.