In re Glatt Air Techniques – Glatt Sailing for Applicants

Posted on January 5, 2011 by Warren Woessner

In re Glatt Air Techniques, Inc. (January 5, 2011) (link below), the Fed. Cir. in dicta reminded the PTO that evidence of commercial success – unlike a showing of unexpected results –need not be commensurate in scope with the claims it is alleged to support. The panel said that such evidence must be considered if what was sold was within the scope of the claims. Of course, this does not change the fact that such evidence – which is almost always disregarded by the Office – must be shown to be related to the merits of the invention, e.g., to the recited combination of elements, as opposed to non-meritorious factors like effective marketing efforts and the like.

In re Glatt

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EMA Draft Guidelines For Biosimilar Antibodies Released

Posted on December 29, 2010 by Warren Woessner

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.

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

Posted on December 29, 2010 by Warren Woessner

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.

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.

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

Posted on December 27, 2010 by Warren Woessner

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.”

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