[SUMMARY] | [ISSUE & DISPOSITION] | [AUTHORITIES CITED] | [COMMENTARY]
The Upjohn Company (“Upjohn”) is the assignee of U.S. Patent No. 4,916,163 (“the ‘163 patent”), directed to a "micronized glyburide anti-diabetic pharmaceutical composition” where the final composition contains at least seventy percent spray-dried lactose by weight. MOVA Pharmaceutical Corporation (“MOVA”), a generic drug manufacturer, filed an Abbreviated New Drug Application (“ANDA”) covering its bioequivalent form of Upjohn’s anti-diabetic pharmaceutical composition.
In response to MOVA’s ANDA application, Upjohn filed suit against MOVA in the U.S. District Court for the District of Puerto Rico. Upjohn argued that the bioequivalent pharmaceutical composition covered by the ANDA application infringed Upjohn’s patent either literally or under the doctrine of equivalents and that MOVA had engaged in inequitable conduct during the patent application process. The district court granted MOVA’s motion for summary judgment in part, after determining that the bioequivalent composition did not literally infringe Upjohn’s composition. Upjohn did not appeal this ruling. Additionally, the jury found that MOVA’s composition did not infringe Upjohn’s composition under the doctrine of equivalents.
Upjohn appealed the verdict of noninfringement and argued that MOVA's composition of 49% spray-dried lactose and 46-49% Starch 1500 was substantially the same as Upjohn’s composition that contained at least 70% spray-dried lactose. Upjohn asserted that MOVA failed to present evidence proving a difference between a composition containing at least 70% spray-dried lactose and a composition containing a combination of spray-dried lactose and Starch 1500.
MOVA asserted that the record contained ample evidence to support the jury’s finding of non-infringement. In particular, MOVA argued that its expert witnesses had shown that each composition used a different drug delivery mechanism. MOVA further argued that the ‘163 patent was invalid for obviousness in light of the prior art described in two previously issued patents, a textbook, and an article. During the trial, MOVA presented expert testimony that it would have been obvious to manipulate a prior patent that claimed a pharmaceutical composition containing 56.4% spray-dried lactose to produce a formulation containing 70% spray-dried lactose. Upjohn argued that the prior art did not teach any means for producing a composition with at least 70% spray-dried lactose, and consequently, it would not have been obvious to one of ordinary skill in the art to manipulate the claimed 54.6% composition to create the formulation claimed by the ‘163 patent.
Finally, Upjohn challenged the jury’s finding of inequitable conduct and argued that no reasonable jury could have found materiality and intent to deceive on the basis of the evidence in the record. MOVA asserted that the jury could have found inequitable conduct on any of the several grounds presented by MOVA, including misrepresentations of facts, withholding “adverse contrary test data,” and failure to ask subsequently named inventors for any material information relating to patentability.
1. Whether a bioequivalent pharmaceutical compound infringes a patented compound under the doctrine of equivalents if the two compounds use different drug delivery mechanisms.
2. Whether a district court’s ruling of patent invalidity on the grounds of obviousness can be upheld, where the conclusions offered by expert testimony lacked factual support and the record did not contain substantial evidence to prove that the prior art references presented at trial would render the claimed invention obvious to a person of ordinary skill in the art.
3. Whether the district court was correct in finding that a patentee had engaged in inequitable conduct where the party alleging inequitable conduct failed to provide substantial evidence that the patentee intended to deceive the PTO or withheld material information relating to patentability.
1. No. If substantial evidence in the record indicates that the two compounds are not substantially equivalent because they operate using different drug delivery mechanisms, no infringement has occurred.
2. No. If a party fails to provide factual support for the conclusions offered by an expert witness and substantial evidence that the prior art references would render the claimed invention obvious to one of ordinary skill in the art, the record does not contain adequate evidence to support a jury’s finding of obviousness.
3. No. To support a verdict of inequitable conduct, the party alleging inequitable conduct must establish, through clear and convincing evidence, both materiality and intent to deceive the PTO.
Cases Cited by the Court
Other Sources Cited by the Court
Under the doctrine of equivalents, an accused product may still infringe a patented product if the differences between the two products are insubstantial. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 41 USPQ2d (BNA) 1865 (1997). According to the Federal Circuit, the “usual test” for substantiality of differences is whether an element of the accused product or composition performs “substantially the same function in substantially the same way to obtain substantially the same result” as the element in the claimed invention. See Upjohn Co. v. MOVA Pharm. Corp., 2000 U.S. App. LEXIS 22782, *3-4 (Fed. Cir. 2000). Whether the differences between the accused product and the patented product are substantial is a question of fact reserved for the jury, and the jury’s findings of fact will be reversed only upon a finding of clear error. See Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1218, 36 USPQ2d (BNA)1225, 1229-30 (Fed. Cir. 1995).
Under § 103 of the Patent Act, a patent will be not be granted “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person of ordinary skill in the art to which said subject matter pertains.” 35 U.S.C. § 103. To determine whether a patented invention would have been obvious to an artisan of ordinary skill, courts will look at (1) the scope of the prior art, (2) any differences between the prior art and the patented invention, (3) the level of ordinary skill in the field of art, and (4) secondary considerations, including long-felt, but unsatisfied need, or commercial success. See Graham v. John Deere Co., 383 U.S. 1, 17-18, 148 USPQ 459, 467 (1966). While the jury determines the factual underpinnings of the obviousness inquiry, the ultimate determination of obviousness is a question of law reserved for the court. See Mitsubishi Elec. Corp. v. Ampex Corp., 190 F.3d 1300, 1309, 51 USPQ2d (BNA)1910, 1916 (Fed. Cir. 1999).
To prove that a patentee engaged in inequitable conduct before the PTO, the party alleging inequitable conduct must prove, by clear and convincing evidence, that the patentee withheld material information from the examiner, and that the patentee did so with the intent to deceive or mislead the examiner into granting a patent for the claimed invention. See Kingsdown Med. Consultants, Ltd. V. Hollister, Inc., 863 F.2d 867, 872, 9 USPQ2d 1384, 1389 (Fed. Cir. 1988).
The Federal Circuit reviewed the jury verdict of non-infringement to determine if the record contained substantial evidence to support the jury’s findings. Although Upjohn was able to point to “uncontradicted evidence that the MOVA formulation was the bioequivalent of the patented formulation,” the Court held that the record contained sufficient evidence to allow a reasonable jury to conclude that the MOVA formulation did not infringe under the doctrine of equivalents. The Federal Circuit, therefore, reaffirmed the notion that a finding of bioequivalence does not mandate a finding of infringement under the doctrine of equivalents, and affirmed the district court's verdict of noninfringement because the two compositions employed different drug delivery mechanisms.
The Federal Circuit reviewed the district court’s verdict of patent invalidity on the grounds of obviousness to determine if the record contained substantial evidence in support of the jury’s findings of fact, emphasizing that documentary evidence must support conclusions and conclusory opinions given by expert witnesses. The Court stressed that a lack of contemporaneous documentary or factual support for an expert’s opinion or for an expert’s recollection of general scientific knowledge at the time of invention may affect the probative weight of such expert testimony. The Court emphasized that “unsupported oral testimony … must be regarded with suspicion and subjected to close scrutiny,” see Upjohn, at *13 (citing Carella v. Starlight Academy, 804 F.2d 135, 138, 231 USPQ 644, 646 (Fed. Cir. 1986), and furthermore, a lack of factual support for expert opinions “may render the testimony of little probative value in a validity determination.” See Upjohn, at *11 (citing Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2 281, 294, 227 USPQ 657, 665 (Fed. Cir. 1985). The Federal Circuit found that MOVA failed to provide clear and convincing evidence of obviousness and reversed the district court's ruling.
Finally, the Federal Circuit reaffirmed the principle that inequitable conduct requires clear and convincing evidence of both the materiality of the withheld information and the intent to deceive the PTO. The Federal Circuit refused to find that evidence of Upjohn’s failure to include test results from an abandoned formulation in its declaration to the PTO was sufficient to establish that Upjohn intended to deceive the PTO. Without clear and convincing evidence that Upjohn intended to deceive the PTO into granting the ‘163 patent, the Federal Circuit ruled that a reasonable jury could not have found a basis for determining that Upjohn had engaged in inequitable conduct by failing to disclose the test results and reversed the district court's verdict of unenforceability. The Federal Circuit emphasized that inventors are not required to describe or disclose all of their knowledge in the field of the invention, because their duty is to disclose only knowledge of prior art that is material to patentability. Therefore, the Court ruled that Upjohn’s failure to disclose the fact that two subsequently named inventors had general knowledge of spray-dried lactose and its properties could not establish that Upjohn had engaged in inequitable conduct before the PTO, because the patent application had already disclosed the information that the subsequently named inventors knew.
What type of evidence would qualify as "clear and convincing" and how much would be required?
Do differing drug delivery mechanisms always defeat a claim of noninfringement under the doctrine of equivalents?