Tuesday, January 20, 2015

Relevant to Supreme Court decision in Teva v. Sandoz: measures of molecular weight

Relevant to part III of the Supreme Court decision in Teva v. Sandoz, note the
following text from an earlier post on IPBiz:

A commenter on PatentlyO cites to a PatentDocs post from July 29, 2013 for the text

The Appellants challenged the lower court’s determination that “molecular weight” could be defined, because one of skill in the art would not understand which measurement (Mp, Mw, Mn, or something else) should be used. The specification of the patents-in-suit was silent as to which measurement was appropriate, other than to describe the use of SEC (which can be used to obtain all three values). Statements made in the prosecution history compounded the problem. In response to an indefiniteness rejection in one of the patents, the patentees said that “[o]ne of ordinary skill in the art, upon reviewing the specification, would understand that ‘average molecular weight’ refers to the molecular weight at the peak of the molecular weight distribution curve,” or Mp. However, in response to an identical rejection in an earlier related application, the patentees said that “”[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight,” or Mw.

Teva argued that one skilled in the art would have understood that average molecular weight could only be Mp. Teva asserted that use of SEC without more suggests Mp because determining Mn and Mw required additional calculations. The Court appeared skeptical of this argument, because SEC can be used to calculate all three values. Teva also downplayed the prosecution history by explaining that a skilled artisan would recognize that the statement in the earlier application was false — because “kilodalton units” does not imply weight average. Teva appears to have alleged that the second statement rectified the earlier misstatement. However, there is no indication that the patentees in the later application retracted the earlier statement. Therefore, the Court was left with two contradictory statements that could not be rectified. As such, the claims in Group I were held to be indefinite.

From an IPBiz post, July 27, 2013:

As to the group I claims, Teva had a problem because of arguments made in file histories. For one application, Teva argued molecular weight was Mp (peak average) but for another Mw (weight average). As the CAFC observed, Teva's two definitions cannot be reconciled. There was also an inconsistency within a figure as between the graph itself and the legend for the figure.
[The CAFC stated the peak average molecular weight Mp is the molecular weight of the most abundant molecule in the sample, so that it is not an "average" molecular weight." The CAFC also noted that Mn is the total mass of all molecules divided by the number of molecules, but did not give a definition for Mw. For completeness, Mw is the sum of the (square of molecular weight X number with that molecular weight) divided by sum of (molecular weight X number with that molecular weight).)

link:  http://ipbiz.blogspot.com/2014/10/more-teva-v-sandoz-what-factual-issue.html

A Wall Street Journal post included the text:

 “We continue to believe that [Teva’s] patent is invalid…and we will address that issue with the Federal Circuit Court of Appeals,” said Mylan Chief Executive Heather Bresch in a statement. A spokeswoman for Novartis declined to comment.


**PatentlyO noted


Cybor No Longer Subject to Challenge: The Federal Circuit’s decision in Cybor has long been subject to renewed efforts for en-banc review. This happened most recently in Lighting Ballast Control LLC v. Philips Electronics N.A. Corp. (Fed. Cir. 2014) (En banc).  Although the Supreme Court here modified Cybor and Lighting Ballast, it also foreclosed future challenges to increase the level of deference. Rather, the Court is clear in Teva that – apart from factual conclusions regarding extrinsic evidence – that no deference should be given on appeal.

Masking the Problem of Claim Ambiguity: My problem with the decision is that giving deference on appellate review only masks the major problem that claim scope is not well understood until decided by a court. Claim scope should be clearly understood at the time of issuance rather than years later following an expensive litigation effort.


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