Wednesday, August 26, 2009

Ortho gets mixed decision in appeal of D NJ case

ORTHO-MCNEIL PHARMACEUTICAL v. TEVA is a patent law appeal from a D NJ order granting summary
judgment of invalidity based on anticipation and obviousness, related to the drug Ultracet.

In view of the dissent, one needs to carefully observe what happened in the case. As to the
decision of D NJ, what CHANGED is the judgment of obviousness of claims 43-48, 51, 54, 67, 69, 72, and 74.
Patentee wins on this point. The CAFC found claim 6 NOT to be invalid for anticipation,
but still invalid for obviousness. Patentee loses on this point.

Of the "news" aspect of the case, Bloomberg wrote:

Teva’s Barr unit and Caraco Pharmaceutical Laboratories Ltd. [owned by Sun Pharmaceutical] have been selling copies of the medicine [Ultracet] for more than three years. New Brunswick, New Jersey-based J&J, the world’s largest health-products company, was trying to get the generic medicines pulled from the market.

Ultracet combines acetaminophen, the main ingredient in Johnson & Johnson’s Tylenol, with tramadol hydrochloride, a compound used in the painkiller Ultram. The patent, which expires in August 2011, covers the ratio between the two components.

Of the legal aspect of the case-->

The majority and dissent disagreed on the outcome as to claims 43-48, 51, 54, 67, 69, 72, and 74.
Does (A + B +C +D) render (A + B) obvious?

The majority said "no" and wrote:

Each of claims 43-48, 51, 54, 67, 69, 72, and 74 recites a pharmaceutical
composition with active ingredients consisting of tramadol and acetaminophen in a ratio
of about 1:5 to about 1:19. A single tablet containing only tramadol and acetaminophen
in a fixed dose ratio within the claimed range is not disclosed in the cited prior art. Flick
discloses a four-compound combination comprising tramadol, acetaminophen, and two
other active ingredients. Flick does not suggest that the pentobarbital sodium and
ethoxy benzamide are merely optional for the combination to work as desired.
parties dispute whether Flick suggests that the composition in example 23 exhibits a
synergistic effect.

The majority credited expert testimony:

Ortho submitted uncontroverted expert testimony that one of ordinary skill in the
art would not find it obvious to try to remove two of the four active ingredients disclosed
in Flick example 23 to arrive at the claimed composition.

In dissent, Judge Mayer said "yes."

Example 23 of the Flick patent discloses a combination of
phenacetin and acetaminophen in a ratio that falls squarely within that claimed in the
RE221 patent. The only alleged difference between the tablet disclosed in the asserted
claims of the RE221 patent and the tablet disclosed in example 23 is that the latter also
contains two additional ingredients, pentobarbital sodium and ethoxy benzamide.
that ethoxy benzamide was a known carcinogen and pentobarbital sodium was known
to have antagonistic interactions with analgesics, it would have been obvious to remove
these two drugs from Flick’s formulation.

In his dissent, Judge Mayer invoked KSR:

“If a person of ordinary skill can implement a
predictable variation [of the prior art], § 103 likely bars its patentability.” KSR Int'l Co. v.
Teleflex Inc., 550 U.S. 398, 417 (2007). Here, the removal of pentobarbital sodium and
ethoxy benzamide was a predictable and simple variation on the Flick formulation. See
id. at 421 (“A person of ordinary skill is . . . a person of ordinary creativity, not an
automaton.”); Bayer Schering Pharma AG v. Barr Labs., Inc., No. 2008-1282, 2009 U.S.
App. LEXIS 17372 (Fed. Cir. Aug. 5, 2009) (affirming an obviousness determination
where the patentee was confronted with a limited number of options for modifying a
prior art pharmaceutical composition).

The bottom line is that the patentee won, as to eliminating the summary judgment. Trial remains.
We therefore vacate the district court’s summary judgment invalidating RE’221 claims 43-48,
51, 54, 67, 69, 72, and 74 based on obviousness and remand the case for a trial on the merits.

Of claim 6-->

With respect to the obviousness of claim 6 [as distinct from anticipation], the majority wrote:
With respect to obviousness, there is no dispute that the only difference between
claim 6 and example 23 of Flick is the weight ratio—the additional compounds in the
example are irrelevant because of the transitional phrase “comprising” in the claim.
Example 23 discloses a 1:10 ratio of tramadol to acetaminophen: 25 mg to 250 mg.
Because the difference between 1:7.1 and 1:10 is so slight, Flick creates a prima facie
case of obviousness with regard to claim 6.

As to claim 6, an issue in the case was whether (A + B + C + D) rendered (A + B) anticipated.
The majority found there was a disputed issue of material fact and found summary
judgment as to claim 6 was inappropriate [Whether Flick discloses all of the
limitations of claim 6 is a material question of fact over which Ortho has raised a
genuine dispute. We therefore vacate the district court’s summary judgment that claim
6 is invalid for anticipation. ]

The punchline: the majority found claim 6 to be obvious. [For these reasons, we agree with the district court that Ortho has failed to raise a genuine dispute of material fact regarding the obviousness of claim 6.

Part of the determination on claim 6 turns on a failed showing of unexpected results:

Ortho-McNeil can rebut the prima facie case if it can show that the prior art
teaches away from the claimed range, or the claimed range produces new and
unexpected results over the prior art range. See Iron Grip Barbell Co. v. USA Sports,
Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). Before the United States Patent and
Trademark Office, the district court, and now us, Ortho-McNeil principally relies on
unexpected results in the form of synergy between tramadol and acetaminophen. As
described in RE’221, the observed analgesic effect of tramadol-acetaminophen
combinations exceeds what one would predict from merely adding the effects observed
upon administering each drug individually. See, e.g., RE’221 fig. 1. Ortho-McNeil’s
problem, however, is that its own evidence indicates no perceptible difference in
synergy between a weight ratio of 1:7.1 and 1:10—and indeed over a much broader
range of ratios. Id. Ortho-McNeil does not dispute this. Thus, Ortho-McNeil has failed
to create a material dispute of fact regarding whether “the claimed range achieves
unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 1578
(Fed. Cir. 1990) (emphasis added); cf. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
1311-12 (Fed. Cir. 2006) (“Evidence of commercial success, or other secondary
considerations, is only significant if there is a nexus between the claimed invention and
the commercial success.”).

** An expert went down the tubes:

Dr. Stanski did not opine on that option, and therefore did not create a
material issue of fact regarding whether the prior art teaches away from the claimed
invention. We have considered Ortho’s other arguments and find them to be without

As noted, Ortho did better on OTHER claims:

Ortho’s proffered reading of Flick and the German references, as well as expert
testimony regarding the understanding of one skilled in the art, raises material questions
of fact as to whether a skilled artisan would have found the claimed combination of
tramadol and acetaminophen to be obvious. We therefore vacate the district court’s
summary judgment invalidating RE’221 claims 43-48, 51, 54, 67, 69, 72, and 74 based
on obviousness and remand the case for a trial on the merits.


Post a Comment

<< Home