02-1540,-1541,-1542,-1543,-1544,-1545,-1546,-1547,-1548,-1549,
03-1021,-1022,-1023,-1025,-1027
SCHERING CORPORATION,
Plaintiff-Appellant,
v.
GENEVA PHARMACEUTICALS, INC. and NOVARTIS CORPORATION,
and
TEVA PHARMACEUTICALS USA, INC.,
and
ANDRX CORPORATION, ANDRX PHARMACEUTICALS LLC,
and ANDRX PHARMACEUTICALS, INC.,
and
MYLAN PHARMACEUTICALS, INC.,
and
WYETH, ESI-LEDERLE, WYETH PHARMACEUTICALS, and WYETH
CONSUMER HEALTHCARE (formerly American Home Products
Corporation,
Wyeth-Ayerst Laboratories, and
and
IMPAX LABORATORIES, INC.,
APOTEX, INC. and NOVEX PHARMA,
COPLEY PHARMACEUTICAL, INC.,
and
GENPHARM, INC.,
Defendants-Appellees.
- 2 –
Robert G. Krupka, Kirkland
& Ellis LLP, of
Robert D. Bajefsky, Finnegan,
Henderson, Farabow, Garrett & Dunner, L.L.P., of
Robert S. Silver and William
J. Castillo, Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd., of
Philadelphia, Pennsylvania for defendants-appellees Apotex, Inc. and Novex
Pharma.
Douglass C. Hochstetler,
Schiff, Hardin & Waite, of
Jo-Anne M. Kokoski. Of counsel on the
response was Kevin M. Flowers, Ph.D., Marshall Gerstein & Borun, of
Appealed
from:
Chief
Judge John W. Bissell
02-1540,-1541,-1542,-1543,-1544,-1545,-1546,-1547,-1548,-1549,
03-1021,-1022,-1023,-1025,-1027
SCHERING CORPORATION,
Plaintiff-Appellant,
v.
GENEVA PHARMACEUTICALS, INC. and NOVARTIS CORPORATION,
and
TEVA PHARMACEUTICALS USA, INC.,
and
ANDRX CORPORATION, ANDRX PHARMACEUTICALS LLC,
and ANDRX PHARMACEUTICALS, INC.,
and
MYLAN PHARMACEUTICALS, INC.,
and
WYETH, ESI-LEDERLE, WYETH PHARMACEUTICALS, and WYETH
CONSUMER HEALTHCARE (formerly American Home Products
Corporation,
Wyeth-Ayerst Laboratories, and
and
IMPAX LABORATORIES, INC.,
APOTEX, INC. and NOVEX PHARMA,
COPLEY PHARMACEUTICAL, INC.,
and
GENPHARM, INC.,
Defendants-Appellees.
ON COMBINED
PETITION FOR PANEL REHEARING
AND REHEARING
EN BANC
O R D E R
A
combined petition for panel rehearing and rehearing en banc was filed by the
Appellant, and responses thereto were
invited by the court and filed by the Appellees. This petition for panel rehearing was
referred to the panel that heard the appeal, and thereafter the petition for
rehearing en banc and responses were referred to the circuit judges who are
authorized to request a poll whether to rehear the appeal en banc. A poll was requested, taken, and failed.
Upon
consideration thereof,
IT
IS ORDERED THAT:
(1) The petition for panel rehearing is denied.
(2) The petition for rehearing en banc is denied.
NEWMAN,
Circuit Judge, dissents from the denial of rehearing en banc in a separate
opinion.
LOURIE,
Circuit Judge, dissents from denial of the petition for rehearing en banc in a
separate opinion.
GAJARSA,
Circuit Judge, would rehear the appeals en banc.
SCHALL,
Circuit Judge, did not participate in the vote.
The
mandate of the court will issue on
FOR
THE COURT
________________ _____________________
Date Jan
Horbaly
Clerk
cc: Robert G. Krupka, Esq.
Robert D. Bajefsky, Esq.
Douglass C. Hochstetler, Esq.
Thomas L. Creel, Esq.
E. Anthony Figg, Esq.
Robert S. Silver, Esq.
Edgar H. Haug, Esq.
Julie Ann Petruzzelli, Esq.
Colin A. Underwood, Esq.
02-1540, -1541,
-1542, -1543, -1544, -1545, -1546, -1547,
-1548, -1549,
03-1021, -1022, -1023, -1025, -1027
Plaintiff-Appellant,
v.
GENEVA PHARMACEUTICALS, INC. and
NOVARTIS CORPORATION,
and
TEVA
PHARMACEUTICALS USA, INC.,
and
ANDRX CORPORATION, ANDRX
PHARMACEUTICALS LLC,
and
ANDRX PHARMACEUTICALS, INC.,
and
MYLAN
PHARMACEUTICALS, INC.,
and
WYETH, ESI-LEDERLE, WYETH
PHARMACEUTICALS, and WYETH
CONSUMER HEALTHCARE (formerly
American Home Products Corporation,
Wyeth-Ayerst
Laboratories, and
and
IMPAX
LABORATORIES, INC.,
APOTEX,
INC. and NOVEX PHARMA,
COPLEY
PHARMACEUTICAL, INC.,
and
GENPHARM,
INC.,
Defendants-Appellees.
NEWMAN, Circuit
Judge, dissenting from denial of rehearing en banc.
I write to state my concern for
the panel's departure from the established law of anticipation. The court holds "anticipated" a
novel chemical compound (descarbethoxyloratidine or DCL), a compound not known
to the prior art and that did not previously exist. The Schering inventor discovered it in vivo
as a degradation product of loratidine, isolated it, determined its structure,
and found its biologic properties. The
panel nonetheless holds that this new compound is unpatentable on the ground of
"inherent anticipation."
The law is that a product is
"anticipated" if it is not new.
Conversely, it is not anticipated if it is new. A new product may of course be unpatentable
based on obviousness, but it is not subject to unpatentability for lack of
novelty. No precedent supports the
position that a product whose existence was not previously known and is not in
the prior art is always unpatentable on the ground that it existed
undiscovered. If the law is to be
changed in this direction it must be done en banc.
DISCUSSION
The panel appears to have reached
the correct result of no liability for infringement, but for the wrong
reason. According to the briefs, the
defendants are doing only what was claimed in the expired loratidine patent,
not in suit. However, instead of simply
ruling that Schering cannot prevent the practice of the expired patent in
accordance with its teachings, the panel strains to hold that this newly
discovered, previously unknown product cannot be validly patented. That is not the law. I also point out that the issue here is validity,
not infringement.
Note the word
"discovery" in the patent statute.
"The term 'invention' means invention or discovery." 35 U.S.C. §100(a). It was and is well understood that an
inventor may discover something that already existed. That the thing was there, undiscovered, does
not render it "inherently anticipated." The panel's proposed rule may have particular
impact on the discovery of biological products.
Does the panel intend that no newly discovered product found in an
organism can be patented? Such a ruling
does not comport with either the patent statute or the incentive purposes of
the patent system.
Precedent concerning
"anticipation" has dealt with diverse factual situations, applying
the common thread that novel subject matter may or may not be patentable,
depending on whether it is also unobvious, while subject matter that is not
novel cannot be patented. A newly
discovered attribute or property of something that was already known is
patentable only as a method-of-use, but does not impart patentability to the
known product. However, a previously
unknown product does not become unpatentable simply because it existed before
it was discovered. Precedent deals
primarily with application of the law to situations where (1) a single prior
art reference teaches all the elements of a product as claimed; in such case,
the discovery of a new use or function does not render the product itself
patentable; and (2) a single prior art reference does not teach all of the
claimed elements; in such case the factual question arises of whether the
omitted element is shown elsewhere (in which event the issue is obviousness) or
whether the omitted element would have been known to be present in the
reference subject matter, in which case the issue is anticipation. For example, in In re Schreiber, 128
F.3d 1473 (Fed. Cir. 1997) the applicant sought to patent a conical spout to
dispense popped popcorn; the same conical spout was shown in the prior art as
an oil dispenser. The product itself was
thus held unpatentable as anticipated.
In MEHL/Biophile International Corp. v. Milgraum, 192 F.3d 1362
(Fed. Cir. 1999) the prior art showed all of the claimed steps of laser
irradiation of hair follicles, but did not mention hair removal; the court held
that this effect was inherent in the prior art process, and that the same
process steps could not be claimed, the court stating that "nothing in the
claim limits the method's reach to human skin."
In all applications of the law of
anticipation, the initial consideration is whether the thing that is claimed
was disclosed in a single prior art reference.
When all of the elements of the claim are not shown in the prior art,
precedent requires that the missing element was nonetheless known to be present
in the subject matter of the reference, and that the claim is directed to the
known subject matter. Although the panel
now purports to disavow this precedent, such a change of law requires en banc
action of the court. See, for example,
the precedent represented by and cited in such cases as Continental Can Co.
USA v. Monsanto Co., 948 F.2d 1264 (Fed. Cir. 1991), where the law of
"inherency" is applied to subject matter wherein all of the elements
of the claim are not shown in the prior art:
To serve as an anticipation when the reference is silent
about the asserted inherent characteristic, such gap in the reference may be
filled with recourse to extrinsic evidence.
Such evidence must make clear that the missing descriptive matter is
necessarily present in the thing described in the reference, and
that it would
be so recognized
by persons of
ordinary
skill.
. . .
This modest flexibility in the rule that "anticipation" requires that every element of the claims appear in a single reference accommodates situations where the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.
This
requirement, that a person of ordinary skill in the art must recognize that the
missing descriptive matter is necessarily present in the reference, may be
sensible for claims that recite limitations of structure, compositions of
matter, and method steps which could be inherently found in the prior art. Such recognition by one of ordinary skill may
be important for establishing that the descriptive matter would inherently
exist for every combination of a claim's limitation.
No reference shows the claimed
descarbethoxyloratidine, or that a person of ordinary skill would have known that
DCL is formed in vivo upon ingestion of loratidine. Precedent is directly contrary to the panel's
holding that although no one knew of the existence of DCL, it is unpatentable
because it in fact existed.
Whether it is desirable new
policy to bar the patentability of products that have not yet been discovered
is a result I seriously doubt. The court
should speak with one voice on this important question. Thus I must, respectfully, dissent from the
court's refusal to review this case en banc.
United
States Court of Appeals for the Federal Circuit
02-1540,-1541,-1542,-1543,-1544,-1545,-1546,-1547,-1548,-1549,
03-1021,-1022,-1023,-1025,-1027
SCHERING CORPORATION,
Plaintiff-Appellant,
v.
GENEVA PHARMACEUTICALS, INC. and NOVARTIS CORPORATION,
and
TEVA PHARMACEUTICALS USA, INC.,
and
ANDRX CORPORATION, ANDRX PHARMACEUTICALS LLC,
and ANDRX PHARMACEUTICALS, INC.,
and
MYLAN PHARMACEUTICALS, INC.,
and
WYETH, ESI-LEDERLE, WYETH PHARMACEUTICALS, and WYETH
CONSUMER HEALTHCARE (formerly American Home Products
Corporation,
Wyeth-Ayerst Laboratories, and Whitehall Robbins
Healthcare),
and
IMPAX LABORATORIES, INC.,
APOTEX, INC. and NOVEX PHARMA,
COPLEY PHARMACEUTICAL, INC.,
and
GENPHARM, INC.,
Defendants-Appellees.
LOURIE, Circuit Judge, dissenting from denial of petition for rehearing en banc.
I respectfully dissent from the court’s decision not to hear this case en banc. I do so because it is an extraordinary decision, effectively precluding virtually all patents on human metabolites of drugs. It thus qualifies as an issue of exceptional importance, justifying en banc consideration.
The holding of the panel, which
the full court left standing, is that an issued patent on a pharmaceutical
product provides an enabling disclosure of all of that product’s metabolites (i.e.,
compounds that are formed in a patient’s body upon ingestion of the
pharmaceutical product), simply by disclosing that the product can be used by
administration to a human. Because
product patents covering pharmaceutical products generally issue before
clinical trials on the product have revealed the identity or nature of any
metabolites, this decision will preclude protection of those metabolites, as
the issued patent will be effective prior art against such application.
I do not
question that when a pharmaceutical product has been in actual public use
prior to the filing of a patent application on its metabolite, the metabolite
will also have been in public use and hence will be unpatentable. The holding of this case, however, goes much
further, mandating that the mere issuance of the patent on the product--or any
other publication of that product--inherently anticipates claims to the
metabolite merely by disclosing that the product can be administered to a
patient, on the theory that such administration would inevitably cause the
human body to “make” the metabolite. The
decision holds that an enabling disclosure of “how to make” metabolites is provided by the mere
recitation that one can administer a prior art compound to humans.
If U.S.
Patent 4,282,233 really taught how to make metabolites, it might be another
story. However, that patent simply
included a minimal, boilerplate statement of how to use the claimed products,
sufficient to satisfy the requirements of 35 U.S.C. § 112, but far from the
careful and thorough prescribing information required by the FDA. The disclosure of the patent, like similar
disclosures in other such patents, merely stated:
The compounds of the present invention are useful as non-sedating antihistamines. These compounds act as anti-allergic agents in the treatment of such conditions as perennial and seasonal allergic rhinitis and chronic urticaria.
The compounds of the present invention are administered in
pharmaceutical formulations comprising the compound in admixture with a
pharmaceutical carrier suitable for enteral or parenteral administration. The formulations may be in solid form . . .
or in liquid form . . . .
Although the required dosage will be determined by such
factors as the patient’s age, sex, weight and the severity of the allergic
reaction to be treated, the preferred human dosage range is likely to be 4 to
50 mg of the effective compound 1 to 3 times per day. The preferred dosage
ranges for other animals can readily be determined by using standard testing
methods.
’233 patent, col. 4, ll. 42-66. That is hardly an enabling disclosure of how
to make any metabolites, whatever they might turn out to be, sufficient to
anticipate them by inherency. The ’233
patent does not identify or even mention any of the claimed products’
metabolites. Yet the court here
sweepingly holds that the patent anticipates those metabolites.
It may be asked why, if a developer of a new product has a patent on that product, does it also need a patent on its metabolite. However, that is not the patent law question before us. Moreover, another company might hold a patent on the metabolite, having independently invented it before the product patent issued and before the product went into public use. In any event, we deal here with issues of patent law, not policy or equity, and to hold that a patent on a product, with a minimal disclosure of administering it to a human or other subject, anticipates a later application on a metabolite, of which no mention appears whatsoever in the patent, cannot be correct.