mask-works-and-designs1400(b). After having considered the entire record in this case, the substantial evidence in the record, the parties' post-trial submissions, and the applicable law, the court concludes that: (A) claims 2 and 10 of the `561 Patent are invalid due to indefiniteness; (B) all asserted claims of the patents-insuit are invalid due to obviousness; (C) the asserted claims are unenforceable due to inequitable
conduct; (D) the asserted claims are not invalid due to double patenting; (E) the defendants' proposed products infringe asserted claims 2, 5, and 10 of the `561 Patent and claim 33 of the '512 Patent; and (F) each of the parties Rule 52(c) motions are granted in part and denied in part. The court's reasoning follows.
A. Indefiniteness
The defendants assert that several claims of the patents-in-suit are invalid due to indefiniteness. A patent claim satisfies the definiteness requirement of 35 U.S.C. § 112 if a person of ordinary skill in the art would understand the bounds of the claim when read in light of the specification. Section 112, paragraph 2, requires that the claims of a patent, "particularly point[] out and distinctly claim[] the subject matter which the applicant regards as his invention." 35 U.S.C. § 112 (2000). "A claim is considered indefinite if it does not reasonably apprise those skilled in the art of its scope." Microprocessor Enhancement Corp. v. Texas Instruments Inc., 520 F.3d 1367, 1374 (Fed. Cir. 2008) (quoting IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1383-84 (Fed. Cir. 2005)).
1. Claims 2 and 10 of the `561 Patent — "formed or is used to form"
The defendants first assert that claims 2 and 10 of the `561 Patent are indefinite because they impermissibly mix two categories of patentable subject matter. Specifically, the defendants assert that claims 2 and 10, both of which are composition claims, impermissibly include a process limitation: "whereby said composition is used to form" for claim 2, and "whereby said therapeutic composition forms or is used to form" for claim 10. Compare '561 Patent at 3:55-56 with id. at 4:20-21 (emphasis added). The court agrees, and concludes that claims 2 and 10 are invalid due to indefiniteness.
The Federal Circuit has addressed the issue of mixing different types of patentable subject matter in two fairly recent cases. In 2004, the Federal Circuit held in IPXL Holdings, L.L.C. v. Amazon.com, Inc. that when a claim impermissibly mixes two or more classes of patentable subject matter, the claim is indefinite. 430 F.3d 1377, 1383-84 (Fed. Cir. 2005). The IPXL Holdings court struck down a claim reciting "a system of claim 2 [including an "input means"] wherein . . . the user uses the input means to either change the predicted transaction information or accept the displayed transaction type and transaction parameters." Id. at 1384 (emphasis added). The court held that the claim was indefinite because the claim recited both an apparatus (the "system") and a method for using that system ("the user uses the input means . . ."). The court concluded:
[I]t is unclear whether infringement of claim 25 occurs when one creates a system that allows the user to change the predicted transaction information or accept the displayed transaction, or whether infringement occurs when the user actually uses the input means to change transaction information or uses the input means to accept a displayed transaction. Because claim 25 recites both a system and the method for using that system, it does not apprise a person of ordinary skill in the art of its scope, and it is invalid under section 112, paragraph 2.
Id. at 1384.
In 2008, however, the Federal Circuit clarified the scope of the IPXL Holdings opinion in Microprocessor Enhancement Corp. v. Texas Instruments Inc., and held that the inclusion of functional language in apparatus claims does necessarily render such claims indefinite:
[T]he use of functional language in a claim may "fail `to provide a clear-cut indication of the scope of subject matter embraced by the claim' and thus can be indefinite." Claim 7 of the `593 patent, however, is clearly limited to a pipelined processor possessing the recited structure and
capable of performing the recited functions, and is thus not indefinite under
IPXL Holdings.
520 F.3d 1367, 1375 (Fed. Cir. 2008) (emphasis in original). Thus, after the
Microprocessor Enhancement Corp. decision, an
apparatus claim may state that the apparatus is capable of performing particular functions. It cannot, however, include functional limitations that create ambiguity as to when the mixed subject matter claim has been infringed, as was the case in
IPXL Holdings.
Claims 2 and 10 of the `561 Patent are composition claims, since the claims specify that they cover "a composition" (claim 2) and "a therapeutic composition" (claim 8). The dispute is over whether the words "is used to form" or "forms or is used to form" constitute an impermissible process limitation or step. The plaintiffs assert that the disputed phrases simply define the claimed compositions and state the intended use of those compositions:
Claims 2 and 10 merely define the two types of compositions discussed throughout the patent and claimed as the inventions covered by the `561 patent — stock solutions and perfusions. A composition that is
used to form an injectable solution is a stock solution — a term the Court construed to mean a concentrated solution. A composition that forms an injectable solution is a
perfusion.
(D.I. 383 at 47 (emphasis in original).)
Based on the evidence presented at trial, the court rejects the plaintiffs' argument and concludes that the asserted claims are indefinite. The disputed claims suffer from precisely the lack of clarity that drove the Federal Circuit's decision in IPXL Holdings — i.e., it is not clear when the mixed subject matter claim would be infringed. Unlike the claims that were upheld in Microprocessor Enhancement Corp., the disputed claim language in this case does not merely provide the context in which the claimed composition is intended to be used. On the contrary, by its own terms, the claimed stock solution actually forms an injectable solution or actually is used to form an injectable solution. Had the patentees wished to state that the composition was merely "capable of" being formed into a perfusion, they could easily have said so explicitly. Indeed, the disputed claims describe the inherent properties and intended subsequent use of the resulting "injectable solution" in precisely these terms, stating that the injectable solution must be "capable of being injected without anaphylactic or alcohol intoxication manifestations. . . ." (`561 Patent 3:57-59.) The court concludes that the inventors did not intend for "forms or is used to form" to have the same meaning as "capable of" appearing in the same claim. Consequently, the court concludes that the disputed phrase, which appears in claims that purport to cover only a "composition," serves as a process limitation in each of the claims in which it appears.
The plaintiffs' post-trial brief on this issue cites only a single ten-line portion of the trial transcript, in which Dr. Kaler, a witness for the plaintiffs, testified that he "read [the disputed words] in a harmonious way by interpreting [`is] used to form[' as] meaning creating a stock solution that subsequently is made into an infusion." ( See D.I. 383 at 47, citing Tr. 522:7-17 (emphasis added).) But neither the plaintiffs nor Dr. Kaler cite any evidence — intrinsic or extrinsic — supporting their assertion that the present-tense terms "forms" or "is used to form" somehow refer to a subsequent or future process.
Furthermore, the plaintiffs themselves assert that "[a] composition that is used to form an injectable solution is a stock solution" while "a composition that forms an injectable solution is a perfusion." (D.I. 383 at 47.) Consequently, both the plaintiffs' construction and the plain language of the claims require two separate compositions (a stock solution and a perfusion) that are necessarily connected by a process step ("is used to form"), rather than a single composition that can be or is intended to be formed into another composition.
Similarly, while the `512 Patent abstract states that the claimed stock solutions " can be used to prepare perfusion solutions," the `561 Patent abstract states the claimed stock solutions " are used to prepare perfusions."
These claims fall squarely within the category of indefinite claims discussed in IPXL Holdings, even as that holding was limited by Microprocessor Enhancement Corp. As the court in IPXL Holdings stated, when "two separate statutory classes of invention" are impermissibly mixed, "a manufacturer or seller of the claimed apparatus would not know from the claim whether it might also be liable for contributory infringement because a buyer or user of the apparatus later performs the claimed method of using the apparatus." IPXL Holdings, 430 F.3d at 1384 (citing Lyell, 17 US-PQ2d at 1550). That is precisely the case with claims 2 and 10. Dr. Myrdal's testimony aptly illustrates the ambiguity as to whether additional steps beyond the creation of a suitable stock solution are necessary in order to infringe the disputed claims, and whether particular acts constitute infringement. A manufacturer who creates only a stock solution (seemingly covered by claims 2 and 10) could not know when he would be liable for infringement if the stock solution is only used to form an injectable solution (also seemingly covered by claims 2 and 10) at a later time and in a different place. Certainly, the performance of additional affirmative process steps is necessary in order for the injectable solution to be formed. In the case of both defendants' products, the prescribing information indicates that the perfusion is only stable for four hours and thus must be administered to a patient within that time, meaning that this step is not performed until well after the defendant-manufacturers sell the stock solution. ( See JTX 37 at Hospira0049062; ATX 552 at API-DOC-0000042.)
Moreover, it is quite possible that the stock solution will be discarded before it is ever "used to form an injectable solution." In such a case, it is not clear whether infringement ever occurred. ( See Tr. 894:1-895:18.) The court is persuaded that other competitors and persons of ordinary skill in the art reading the disputed claims would likewise be unable to make "an accurate determination of the `metes and bounds' of protection" provided. See Ex parte Lyell, 17 US-PQ2d 1548, 1550-51 (1990).
The defendants' proposed products aptly illustrate this ambiguity. Apotex's product is sold in two separate vials, one containing docetaxel dissolved in PEG 300 (the "docetaxel vial"), and the other containing polysorbate 80, ethanol, and water (the "diluent vial"). According to the prescribing information, the docetaxel vial is to be diluted twice before it is administered to a patient: first by mixing it with the diluent vial (forming a "premix"), and then again by mixing the premix with a perfusion fluid (e.g., saline or dextrose solution) before it is infused into a patient. ( See PTX 701 at 11.) It is only after the premix is formed that a "composition" exists containing docetaxel, polysorbate 80, and ethanol, as required by claims 2 and 10. Then, it is only when that "premix" is mixed with perfusion fluid that "an injectable solution which contains up to about 1 mg/ml" of docetaxel is formed. Hospira's product, on the other hand, is sold in a single vial that can be used to make a perfusion without the need to make a premix. Like Apotex's premix, however, Hospira's product must be diluted with perfusion fluid — presumably at a later time and in a different place, given the prescribing information — before there is an injectable solution meeting the requirements of the claims.
A person of ordinary skill in the art reading the patents-in-suit could not be sure at what point during these processes the infringement is complete. The natural reading of the claim language is that the infringement is only complete when the product actually "forms or is used to form" the perfusion. On the other hand, if one takes the view that the claims are analogous to those upheld in Microprocessor Enhancement Corp., then the infringement is complete when the Hospira stock solution is prepared (prior to sale) or when Apotex's vials are combined to form the premix (presumably after sale), since those are stock solutions capable of being used to form an "injectable solution" as recited in the claims. As mentioned above, each of those steps is likely to be performed by different individuals at different times in different places. Neither the claims nor the specification provide guidance as to when direct infringement is complete.
Moreover, it is not clear whether the plaintiffs are asserting direct infringement, as discussed in the preceding paragraph, or indirect infringement. As to indirect infringement, the plaintiffs focus one section of their post-trial brief ( See id. at 13) and their Rule 52(c) motion on the defendants' prescribing information, which they say "encourages acts which constitute direct infringement." ( See D.I. 364 at 3-4.) On that basis, infringement would be complete when the product was actually sold with the included prescribing information, and the resulting infringement would be inducement to infringe under § 271(b) — or perhaps, as the plaintiffs also suggest, the sales of the products would constitute contributory infringement under § 271(c) — rather than direct infringement under § 271(a). Of course, the ambiguity over when direct infringement is complete blurs the issue of what acts constitute indirect infringement.
The question of infringement becomes murkier still if the docetaxel vial is discarded prior to dilution, or if the premix either is discarded prior to being formed into an injectable solution or fails to form a solution when mixed with the perfusion fluid. The prescribing information makes clear that these are more than academic possibilities. The premix is only to be stored "for a maximum of 8 hours." (PTX 701 at 11.) Moreover, "[i]f the [premix] or final dilution [ i.e., injectable solution/perfusion] is not clear or appears to have precipitation, these should be discarded." (Id.)
For these reasons, the court concludes that the defendants have established by clear and convincing evidence that claims 2 and 10 of the `561 Patent are indefinite. Those claims are therefore invalid under § 112 ¶ 2.
2. Claims 2, 5, and 10 of the `561 Patent — "anaphylactic manifestations"
The court is not persuaded by the defendants' remaining indefiniteness arguments. The defendants assert that the term "anaphylactic manifestations" is indefinite. The court disagrees, and finds that this term can be construed to have a definite meaning that would be readily understood by a person of ordinary skill in the art. Specifically, the court agrees with the plaintiffs that a person of ordinary skill in the art would readily interpret "anaphylactic manifestations" in the context of the patents-in-suit as a reference to the Grade 4 hypersensitivity reaction known as anaphylaxis and the symptoms associated therewith — particularly shock. ( See Tr. 117:22-119:14 (discussing the various grades of hypersensitivity reactions under the NCI's Common Toxicity Criteria, under which grade 4 is anaphylactic shock).) The term does not extend to all symptoms (e.g., hives and bronchospasms) that are (or can be) associated with anaphylaxis, regardless of whether the patient is actually suffering from anaphylaxis itself. Rather, the term refers to those symptoms when — and only when — the patient is actually suffering from anaphylaxis. In other words, the `561 Patent requires that the formulation be capable of being injected without causing anaphylaxis and, by extension, the symptoms associated with anaphylaxis. With this reasonable construction, the term "anaphylactic manifestations" is not indefinite. B. Anticipation
"[I]nvalidity by anticipation requires that the four corners of a single[] prior art document describe every element of the claimed invention, either expressly or inherently." Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000). The standards for inherent disclosure were recently discussed by the Federal Circuit in Verizon Services Corp. v. Cox Fibernet Virginia, Inc., 602 F.3d 1325 (Fed. Cir. 2010):
"[A] prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference." However, a patent claim "cannot be anticipated by a prior art reference if the allegedly anticipatory disclosures cited as prior art are not enabled." "The standard for what constitutes proper enablement of a prior art reference for purposes of anticipation under section 102, however, differs from the enablement standard under section 11.2." It is well-settled that utility or efficacy need not be demonstrated for a reference to serve as anticipatory prior art under section 102.
Id. at 1337 (internal citations omitted). Whether a prior art reference anticipates a patent claim is a question of fact.
Advanced Display Sys., 212 F.3d at 1281.
1. Safety, Efficacy, Stability, and the Construction of "Perfusion"
The court was not asked to construe "perfusion" at the claim construction phase, since the parties indicated in their joint claim chart that they had agreed to a construction of this term. The parties' proposed construction of perfusion was "a solution suitable for infusion into patients including at least active pharmaceutical ingredient and an aqueous infusion fluid such as physiological saline or glucose." (D.I. 44 at 3.) The parties later realized, however, that there had not been a meeting of the minds on the meaning of the phrase "suitable for infusion into patients" in their agreed construction. The defendants filed a motion in limine seeking to preclude the plaintiffs' experts from testifying at trial as to the construction of "perfusion." ( See D.I. 272.)
At the pretrial conference, the court heard argument on this motion and indicated that it would hear testimony at trial as to the meaning of term "perfusion." The court now recognizes that its decision was based on a misapprehension as to the source of the phrase "suitable for infusion into patients." The parties' lengthy discussion at the pretrial conference regarding the meaning of that phrase caused the court to believe that the phrase appeared either in the claim itself or in a construction that had been adopted as part of the court's Markman order. In reality, however, "suitable for infusion into patients" appears nowhere in the patent or in the court's order. In effect, the parties are not asking the court to construe "perfusion" or clarify a construction that appears in the court's Markman order; rather, they are asking the court to construe a phrase that appears in the parties' claim construction chart.
Specifically, the plaintiffs' argue that the court should impose limitations for safety, efficacy, and stability on claim 5 of the `561 Patent (the only asserted claim including the word "perfusion") because of the appearance of "suitable for infusion into patients" in the parties' chart. Of course, the parties' proposed constructions do not bind the court. Consequently, the court need not consider arguments that stem solely from the parties' proposed constructions, even if the parties themselves thought they had agreed on a construction. The parties did not propose alternative constructions of the term "perfusion" at trial, nor are proposed constructions included in either of the parties' post-trial briefs. Instead, the parties' arguments before and during the trial focused on whether the term "perfusion" includes the plaintiffs' proposed
See, e.g., D.I. 289 at 2 ("Hospira's proposal is clearly at odds with any rational understanding of the phrase `suitable for infusion into patients.'"); D.I. 383 at 8 ("At the Pretrial Conference, it became apparent that the parties did not have a common understanding as to what it meant to be "suitable for infusion into patients. . . .").
limitations relating to safety, efficacy, and stability.
Neither the claims nor the specification of the `561 Patent mention the terms "safe," "effective," or any derivatives thereof. The specification does indicate that the claimed perfusion was physically stable for at least 8 hours, but nothing in the specification or otherwise suggests that a solution with less than 8 hours of stability cannot be a "perfusion." The court will not import this statement from the specification to the claims so that it imposes a general limitation on what solutions qualify as "perfusions." See, e.g., Advanced Cardiovascular Systems, Inc. v. Scimed Life Systems, Inc., 261 F.3d 1329, 1338 (Fed. Cir. 2001) ("While it is true that claims are to be interpreted in light of the specification and with a view to ascertaining the invention, it does not follow that limitations from the specification may be read into the claims. . . .") (internal quotation omitted).
Based on the evidence presented at trial, the court concludes that a person of ordinary skill in the art reading the term "perfusion" in the context of the claim would not understand that term to include the plaintiffs' proposed limitations. At the formulation stage, researchers simply cannot know whether a perfusion will be sufficiently safe and effective to be useful in clinical settings. Indeed, this is why clinical trials are necessary before patented pharmaceutical compositions can be marketed to the general public. Under the plaintiffs' proposed construction, a formulator could not know whether his solution was a "perfusion" — and therefore whether it infringed claim 5 — until after clinical trials demonstrated that the solution was sufficiently safe and effective. The court concludes that this is neither true of the term "perfusion" as it is generally used nor of the term as it was used in claim 5.
See, e.g., Tr. 926:25-927:3 (Dr. Myrdal describing how a prior art formulation "worked from a solubility perspective . . . That's what I'm worried about [with] my formulation. It's the chemistry that we're doing. What happens to it afterwards, that's a regulatory affairs issue").
Despite the fact that the word "perfusion" only appears in claim 5, Dr. Park seemed to blur this issue at trial by arguing that all five asserted claims of the patents-in-suit require safety, efficacy, and stability. ( See Tr. 1492:3-11.) Dr. Park's attempt to impose these limitations on all asserted claims is emblematic of the plaintiffs' failure to start with the actual language of the claims in many of its arguments concerning the scope of the asserted claims.
The court agrees with Dr. Myrdal, who explained that a "perfusion," as that term is used in pharmaceutical composition claims, is simply an injectable solution containing the active pharmaceutical ingredient and an aqueous infusion fluid. The word "perfusion" applies to any such solution, regardless of whether later testing and use reveals the composition to be stable for less than eight hours (which is the plaintiffs' proposed cutoff point for stability), unacceptably toxic to patients, or insufficiently effective in treating the condition it was designed to treat. ( See Tr. 929:9-21.) Dr. A. Hilary Calvert agreed, noting that this definition is consistent with the NCI definition of the related term "infusion" ("a method of putting fluids including drugs into the bloodstream"). (Tr. 1031:24-1032:22; HTX 357, at 17 (NCI Glossary).)
In the asserted claims, a perfusion is formed by diluting a "stock solution" as defined in the court's claim construction order with the aqueous infusion fluid. ( See, e.g., Tr. 929:9-16; 1212:16-1213:1; 1214:14-18.) A perfusion is distinguished from other injectable pharmaceutical solutions in that it is administered intravenously rather than through, e.g., an intramuscular or subcutaneous injection. This does not mean, however, that for the purposes of determining invalidity, a person of ordinary skill in the art — which, in this case, is a formulator rather than a clinician ( See section III.C.2, infra) — would ignore prior art injectable cancer drug formulations that were administered by a route other than intravenous infusion.
The plaintiffs' witnesses also seemed to recognize that the word "perfusion" is not generally understood to include the limitations the plaintiffs assert. The `470 patent used the term "perfusion" to describe a docetaxel formulation even before Sanofi "determined whether docetaxel would be safe and effective," yet plaintiffs' witness Dr. Kinam Park did not dispute that this "was a proper use of the word perfusion." (Tr. 1493:21-1494:12.) Similarly, Dr. Howard Burris acknowledged that Taxol is a "perfusion" even though it has "caused death" and "sometimes . . . does not make a difference" in treating a patient's cancer. (Tr. 236:2-18.)
Consequently, the court concludes that the claims do not include limitations relating to safety, efficacy, and stability other than the two explicit limitations that actually appear in the claims: 1) the asserted claims of the `561 Patent require that the injectable solution must be "capable of being injected without anaphylactic or alcohol intoxication manifestations being associated therewith;" and 2) all asserted claims require that the docetaxel be "dissolved" in polysorbate 80 and (in the case of the `561 Patent) ethanol. The court will not shoehorn the plaintiffs' proposed limitations into the claims based on the parties' construction of a single term in a single claim. Consequently, the court rejects the plaintiffs' construction of "perfusion" and their proposed limitations for safety, efficacy, and stability.
The "dissolved" limitation does not require that the resulting composition be stable for any period of time after the initial dissolution is complete, and certainly not for eight hours, as the plaintiffs argue. The plaintiffs note that the specifications of the patents-in-suit state that "the new perfusions are stable from a physical standpoint, that is to say no precipitation phenomenon is seen to appear within approximately 8 hours." `561 Patent 2:43-45. See also `512 Patent 3:42-46. It is axiomatic, however, that courts should not import limitations into the claims from the specification. See, e.g., Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1288 (Fed. Cir. 2009); Kara Technology Inc. v. Stamps.com Inc., 582 F.3d 1341, 1347-48 (Fed. Cir. 2009). But the plaintiffs cite no basis for importing this description as a limitation on the claims beyond the mere presence of the word "perfusion," which only appears in one of the five asserted claims. Even for that claim, the patent gives no indication that the word "perfusion" should be limited by that description. Consequently, the court will not import a stability limitation into the claims.
2. Claim 33 of the `512 Patent and Claims 2 and 10 of the '561 Patent
The defendants assert that claim 33 of the `512 patent and claims 2 and 10 of the `561 patent are anticipated by the GV reference. The following table summarizes the limitations of these claims:
'512 Patent, claim 33 `561 Patent, claims 2 and 10 1) A stock solution comprising . . . 1) A composition consisting essentially of . . . 2) docetaxel 2) docetaxel 3) dissolved in polysorbate 80 3) dissolved in ethanol and polysorbate 80 4) stock solution contains 10 to 4) composition is used to form an injectable 200 mg/ml of docetaxel solution 5) injectable solution contains up to about 1 mg/ml of docetaxel 6) solution is capable of being injected without anaphylactic or alcohol intoxication manifestations The GV reference describes, in relevant part, an experiment in which "taxotere [docetaxel] showed a better solubility in excipient system (polysorbate 80/ethanol, 1:1)" than did two other taxane compounds. (JTX-93 at 996.)
It is not disputed that the GV reference discloses a stock solution containing docetaxel dissolved in both ethanol and polysorbate. Thus, the GV reference discloses elements 1, 2, and 3 of the disputed claims. As to the fourth and final element of claim 33 — that the solution contains 10 to 200 mg/ml of docetaxel — the defendants contend that this concentration is an inherent property of the GV formulation. ( See D.I. 378 at Ex. B.) At trial, Dr. Myrdal and Dr. Robert Michael Williams testified that concentration levels are measured in a "routine experiment" called a solubility study. (Tr. 888:16-819:10; accord Tr. 1193:5-1194:14.) Furthermore, Dr. Williams testified that Sanofi's own data showed that docetaxel inherently has a concentration in polysorbate of approximately 160 mg/ml, within the claimed 10 to 200 mg/ml range. (Tr. 1194:17-1195:11.)
The plaintiffs, on the other hand, cite Table III in the GV reference as evidence that the concentration of docetaxel in the GV reference was 0.13 g/mL ( See JTX-93, at 996 Table III), well below the 10 mg/mL lower limit recited in claim 33. The plaintiffs' witness testified that this concentration was merely "the concentration that inhibit[s] 50 percent of the cell, tumor cell growth or differentiation." (Tr. 1460:1-3.) The witness did not testify, and the GV reference does not state, that this was the highest concentration used in the described experiments. Thus, it is possible that the experiments discussed in the GV reference produced compositions with concentrations within the recited range. Nonetheless, the GV reference does not, on its face, disclose any concentration within that range. While Dr. Williams testified that one "could easily get into that concentration range doing the most routine experiment the formulators would do" (Tr. 1194:14-17), the defendants cite no evidence that such tests were actually done — much less disclosed in the GV reference. The evidence presented at trial was not sufficient to establish by clear and convincing evidence that the claimed concentration is an inherent property of the docetaxel/polysorbate 80 composition described in the GV reference.
Similarly, while the court recognizes that the composition described in the relevant portion of the GV reference could be used to form an injectable solution, claims 2 and 10 of the '561 Patent require that the composition actually be used to form an injectable solution. The court does not dispute that, as Dr. Williams suggested, the "only thing [the composition described in GV] can be used for or useful for would be to form a perfusion in an aqueous solution." (Tr. 1200:3-7.) The law governing anticipation, however, narrowly confines the court's analysis to "the four corners" of the specific prior art reference in question. Inferences as to how the described composition was used might appropriately be considered in an obviousness analysis, but not on the issue of anticipation. In this case, the GV reference does not indicate that the disclosed composition was actually used to create an injectable solution. Consequently, the court concludes that the GV reference does not anticipate the asserted claims.
As noted above, under an alternative construction of "formed or is used to form," the phrase would refer to how the composition could be used subsequently. See Section III.A.1, supra. Were the court to adopt that construction of the claims, the stock solution described in GV would meet this element of the asserted claims.
C. Obviousness 1. Legal Standard 35 U.S.C. § 103(a) provides that a patent may not be obtained "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 to a person having ordinary skill in the art." Obviousness is a question of law that is predicated upon several factual inquiries. Richardson-Vicks v. Upjohn Co., 122 F.3d 1476, 1479 (Fed. Cir. 1997). Specifically, the trier of fact must consider four issues: (1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the differences between the claimed subject matter and the prior art; and (4) secondary considerations of non-obviousness, such as commercial success, long felt but unsolved need, failure of others, acquiescence of others in the industry that the patent is valid, and unexpected results. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
The court's findings and conclusions on obviousness would be the same even if the court accepted the plaintiffs' argument that "is used to form" means "capable of being formed into." ( See section III.A.1, supra.)
A party seeking to challenge the validity of a patent based on obviousness must demonstrate by "clear and convincing evidence" that the invention described in the patent would have been obvious to a person of ordinary skill in the art at the time the invention was made. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359-60 (Fed. Cir. 2007). However, in determining what would have been obvious to one of ordinary skill in the art at the time of invention, the use of hindsight is not permitted. See KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 421, 127 S.ct. 1727, 1742, 167 L. Ed. 2d 705, 724 (2007) (cautioning against "the distortion caused by hindsight bias" and "arguments reliant upon ex post reasoning" in determining obviousness) (emphasis added). In KSR, the Supreme Court rejected a rigid application of the principle that there should be an explicit "teaching, suggestion, or motivation" in the prior art, the nature of the problem, or the knowledge of a person having ordinary skill in the art, in order to find obviousness. See KSR Intern. Co. v. Teleflex Inc., 550 U.S. at 415. The KSR Court acknowledged, however, the importance of identifying "`a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does' in an obviousness determination." Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356-57 (Fed. Cir. 2007) (quoting KSR, 550 U.S. at 418).
"Clear and convincing evidence is evidence that places in the fact finder `an abiding conviction that the truth of [the] factual contentions are `highly probable.'" Alza Corp. v. Andrx Pharms., LLC, 607 F. Supp. 2d 614, 631 (D. Del. 2009) (quoting Colorado v. New Mexico, 467 U.S. 310, 316 (1984)).
2. Level of Ordinary Skill in the Art
A person of ordinary skill in the art with respect to the patents-in-suit holds a bachelor's of science degree with two to four years of experience in pharmaceutics and drug development, or a Ph.D. with commensurate experience to obtain the training and background necessary to understand the development of pharmaceutical formulations. (Tr. 833:1-18; 1437:10-15.) Thus, a person ordinary skill in the art with respect to the patents-in-suit is a formulator, not a clinician.
3. Scope and Content of Prior Art and Differences Between Claimed Subject Matter and Prior Art
As a threshold matter, it is important to understand what the asserted claims of the patents-in-suit invention are not. First, the claims do not cover a new drug. Instead, the claims cover a formulation containing an old cancer drug, docetaxel. Sanofi's U.S. Patent No. 4,814,470 — prior art issued in 1989 — already claimed docetaxel itself and, in fact, also claimed docetaxel in a pharmaceutical formulation. ( See JTX 9, at 10:42-45 ("A pharmaceutical composition which contains [docetaxel] combined with one or more pharmaceutically acceptable, inert or physiologically active diluents or adjuvants.").) In the example disclosed in the `470 patent, docetaxel was formulated in ethanol and Cremophor (also called "Emulphor"). (JTX 9, at 10:5-11.)
Second, the asserted claims are not method or process claims. They are composition claims. Indeed, the asserted claims of the `512 Patent do not even state the compositions are "pharmaceutical" or "therapeutic" in nature or include limitations indicating that it is intended for use in humans. The asserted claims of the `561 Patent, by comparison, include limitations stating that it is "capable of being injected without anaphylactic or alcohol intoxication manifestations" and claim 8, upon which asserted claim 10 depends, specifies that the ingredient is a "therapeutic composition." These terms signal that the "perfusions"/"injectable solutions" that are the end result of the claimed compositions are intended for use in humans. Even these claims, however, cover only a composition with certain properties and limitations described in the remainder of the claims. None of the asserted claims in either patent cover methods of treatment and, excepting the `561 Patent's limitations for anaphylaxis and alcohol intoxication, they do not contain limitations regarding efficacy, toxicity, or other in vivo properties of the drug. Indeed, as the court stated in its anticipation analysis, those properties of a formulation cannot be known until clinical trials are conducted, an event that occurs well after the initial formulation of the drug.
Both at trial and in their post-trial briefing, the plaintiffs focused their nonobviousness arguments on one aspect of the claimed invention — the substitution of polysorbate 80 in place of Cremophor in the docetaxel formulation. ( See, e.g., D.I. 383 at 26 (asserting that in order to establish obviousness, the "[d]efendants must prove that it would have been obvious to formulate taxanes using polysorbate 80 for intravenous administration despite the established use of Cremophor at the time . . .").) That issue dominated the parties' invalidity arguments at trial. Consequently, while the court concludes that the prior art renders every element of the asserted claims obvious, it will focus its discussion on the switch from Cremophor to polysorbate 80.
Even though the plaintiffs do not seem to seriously dispute the obviousness of the other limitations, Dr. Williams' testimony included a thorough limitation-by-limitation analysis on how each limitation of the asserted claims was either anticipated or rendered obvious by one or more of these prior art references. See Tr. 1173-1225. The court found his testimony highly persuasive. By contrast, the plaintiffs' witnesses who testified on invalidity, particularly Dr. Park, focused inordinately on the safety, efficacy, and stability (or lack thereof) of the prior art formulations rather than on the limitations that actually appear in the asserted claims.
The only limitation for which the court did not find Dr. Williams' testimony persuasive was the "essentially free of ethanol" limitation in claim 7. Dr. Williams' analysis of this element appears to have been based at least in part on accepting arguendo the plaintiffs' interpretation of the "essentially free" limitation — an interpretation that the court rejects for the reasons stated in section III.F.5, infra. Nonetheless, the court agrees with the defendants that the prior art renders this limitation obvious. In particular, the specification and claims of the prior art `470 Patent — the first to claim docetaxel — disclose and contemplate both ethanol-containing and essentially ethanol-free stock solutions and perfusions. E.g., '470 Patent at 9:17-40; id. at 10:41-44 (claim 6). Consequently, the court concludes that that the `470 Patent renders this limitation obvious. Moreover, even if the court were to find that the prior art did not render this limitation obvious, the court concludes that the defendants' products are not "essentially free of ethanol" and thus do not infringe. See section III.F.5, infra.
Both polysorbate 80 and Cremophor are surfactants. Since taxanes are poorly soluble in water, surfactants are included in taxane formulations to help dissolve the taxane in water and keep it in solution. ( E.g., Findings of Fact ¶ 88, supra; Tr. 848:19-25.) Early formulations of the first taxane to be developed, paclitaxel, included a 50:50 mixture of ethanol and Cremophor. ( E.g., Findings of Fact ¶ 91, supra.) The preferred embodiment of the stock solution in the first patent claiming docetaxel, which is prior art to the patents-in-suit, also contained a 50:50 mixture of ethanol and Cremophor. ( See, e.g., Tr. 836:8-17; JTX 9 at 10:5-8.)
During the years preceding the filing of these applications, a number of prior art references appeared disclosing formulations of taxanes (including docetaxel) and other poorly water-soluble cancer drugs with either Cremophor or polysorbate 80. A number of these references anticipated the switch from Cremophor to polysorbate 80 that the plaintiffs assert was the "innovation" of the asserted claims. The court discusses these prior art reference below.
a. Prior Art Taxane Formulations
The set of prior art references that plaintiffs identify as the departure point for the claimed invention consists of Cremophor-based taxane formulations. Researchers' experience with Cremophor-based paclitaxel formulations is summarized in the Rowinsky reference (JTX 15), a 1990 research review article that both patents-in-suit cite as prior art illustrating the problem the patents-in-suit were designed to address. (`512 Patent 2:12-47; `561 Patent 1:40-2:7.) While most of Rowinsky is devoted to discussing the promising anti-tumor activity of a paclitaxel formulation (JTX 15 at 1247), the reference also describes how researchers encountered a high incidence of anaphylaxis during the Phase I clinical trials for the paclitaxel-Cremophor formulation. According to Rowinsky, these incidents "threatened the prospects of taxol's further development." (JTX 15 at 1251; Tr. 111:19-112:19.) Rowinsky notes that "other drugs formulated in cremophor . . . have been associated with similar hypersensitivity reactions." (JTX 15 at 1253.) The reference also states, however, that "it is . . . unclear whether taxol itself or its cremophor vehicle is principally responsible for hypersensitivity reactions." (Id.)
The patent first claiming docetaxel was U.S. Patent No. 4,814,470, issued in 1.989 with a 1986 original foreign filing date. ( See JTX 9 (hereinafter "the `470 Patent").) As noted above, the only preferred embodiment of a stock solution disclosed in the `470 Patent contained a 50:50 mixture of ethanol and Cremophor. The patent's specification made clear, however, that a wide variety of other formulations may be possible:
The present invention also provides pharmaceutical compositions containing [docetaxel] in combination with one or more pharmaceutically acceptable, inert or physiologically active, diluents or adjuvants.
These compositions may be presented
in any form appropriate for the administration route envisaged. The parenteral route, and especially the intravenous route, is the preferential route for administration.
The compositions according to the invention for parenteral administration may be aqueous or nonaqueous sterile solutions, suspensions or emulsions. Propylene glycol, vegetable oils, especially olive oil, and injectable organic esters, e.g. ethyl oleate, may be used as the solvent or the vehicle. These compositions may also contain adjuvants, especially wetting agents, emulsifiers or dispersants. The sterilization may be carried out in several ways, e.g. using a bacteriological filter, by incorporating sterilizing agents into the composition, by irradiation or by heating. They may also be in the form of sterile solid compositions which may be dissolved or dispersed in sterile water or any other injectable sterile medium.
(`470 Patent 9:17-40.)
The plaintiffs argue that the "innovation" of the formulation claimed in the patents-in-suit was that using polysorbate 80 instead of Cremophor "allows . . . docetaxel to be administered to patients without the life-threatening anaphylaxis associated with the prior Cremophor-based formulation." (D.I. 383 at 1. See also, e.g., Tr. 21:11-22.) This statement obscures the multipronged approach, of which the claimed formulations were only a part, that researchers took to address the anaphylaxis that occurred in Cremophor-based taxane formulations.
Researchers considered at least three alternative solutions to the anaphylaxis issue: pretreatment regimens, alternative schedules, or a reformulated preparation. ( See PTX 553 at 607.) Clinicians tried premedication first, which solved the immediate problem by significantly reducing the incidence and severity of hypersensitivity reactions. (Tr. 215:2-20; JTX 15 at 1251, 1253-54.) To this day, in fact, a paclitaxel-Cremophor formulation (brand name Taxol) is marketed and administered to patients after premedication. (Tr. 1189:5-13.) While the Taxol clinical trials continued with premedication, research continued into new taxane formulations.
The premedication approach had the virtue of avoiding the delays that would ensue from halting the clinical trials altogether while researchers searched for a new, better-tolerated formulation. The court is persuaded by the testimony of Dr. Calvert, who testified that reformulation would have set back work on a promising cancer medicine for "several years." (994:25-995:14.) Dr. Calvert, who was actually involved in paclitaxel clinical trials at the time, explained that nobody "wanted to stop the momentum and back off in using this drug for the several years it would have taken to undertake a reformulation exercise." (Id.) Such delays would have been inevitable, as Dr. Williams explained, since reformulation "would require that all of the preclinical and clinical testing would have to be done over again." (Tr. 1188:7-1189:4.)
The foreign priority application that led to the patents-in-suit was filed on July 8, 1991. By that time, at least two prior art references disclosed compositions containing a taxane and polysorbate 80. The lead author of the first reference, the GV reference, was also one of the co-inventors of the prior `470 Patent. ( See JTX 9 JTX 93.) As discussed in the court's anticipation analysis, the GV reference discloses a composition containing docetaxel dissolved in ethanol and polysorbate 80. The GV reference described both the docetaxel compound and the polysorbate-based solution in a favorable manner, stating that the compound "showed a better solubility" in the polysorbate-containing stock solution "than the two others most active compounds. . . ." (JTX 309 at 996.) The GV reference thus disclosed a docetaxel formulation containing polysorbate 80 instead of Cremophor, the switch that forms the very core of the alleged invention. As Dr. Williams stated, a formulator reading the GV reference would find this description in the conclusion of the polysorbate-ethanol excipient system to be "the most important piece of information" in the paper. (Tr. 1247:15-21.)
In fact, the GV reference disclosed the very same "1:1" formulation that Sanofi first brought to clinical trials in June 1990 — a 50:50 formulation of ethanol and polysorbate 80. (Tr. 471:15-24.) The plaintiffs argue that the GV reference is not invalidating because it describes only in vitro testing. The court rejects this argument for two reasons. First, the court is persuaded by the testimony of Dr. Myrdal and Dr. Williams that GV in fact discloses a pharmaceutical formulation rather than an in vitro solution. Dr. Myrdal noted that GV used the phrase "excipient system," which is clearly "a pharmaceutical system" given the context in which the phrase appears. (Tr. 841:9-21.) Dr. Williams explained that 50% ethanol "is toxic to cells in in vitro testing" and 50% polysorbate "is a cell membrane disrupting molecule, and that's also toxic." (Tr. 1191:14-1192:11.) Furthermore, even if the reference did refer only to in vitro testing, the claims in question contain no limitations restricting themselves to in vivo solutions. The person of ordinary skill in the art with respect to the asserted claims is a formulator, and a formulator searching the prior art surely would not overlook a reference to docetaxel formulations in the Journal of Medicinal Chemistry.
This reference does not "compar[e] the solubility of docetaxel in polysorbate 80/ethanol to the solubility of docetaxel in any other solvent," but rather provides the "relative solubility of docetaxel . . . in polysorbate 80/ethanol, compared to the solubility of two other [taxane] compounds . . . in that same polysorbate 80/etd on a conviction. Whether in this case the prosecutor's involvement violated rule 3.4 (g) is a determination, if it is to be made (for there has been no previous guidance on the issue), for the Board of Bar Overseers (board) in the first instance. However, even if the board were to conclude that the prosecutor's involvement in this reward program was unethical (again, we do not suggest that the board undertake any investigation in this case), that decision may not be used collaterally to attack the defendant's conviction; the board's decision would have no bearing on the defendant's claims that the prosecutor's conduct amounted to structural error and violated his due process rights.
Our rule does not prohibit prosecutors from providing something of value to a witness in exchange for the witness's testimony founded on a promise of truthful cooperation. See, e.g., Commonwealth v. Sullivan, 410 Mass. 521, 523-524 (1991) (promise of dismissal); Commonwealth v. Ciampa, 406 Mass. 257, 259, 261 (1989) (promise of leniency); Commonwealth v. DeBrosky, 363 Mass. 718, 730 (1973) (grant of immunity).
Contrary to the defendant's claim, we conclude that there is no Federal or State due process violation in this case. Federal courts considering whether a fact witness may be paid for his or her testimony when payment is contingent on the content of the testimony or the outcome of the case have analyzed the issue in terms of witness competency and due process. See 27 C.A. Wright V.J. Gold, Federal Practice and Procedure, supra at § 6005, at 69-70 n. 86. See also United States v. Davis, 261 F.3d 1, 38 (1st Cir. 2001). In terms of witness competency, pecuniary interest in the litigation is an "acceptable basis for attacking witness credibility, but . . . has been eliminated as a basis for disqualification." 27 C.A. Wright V.J. Gold, Federal Practice and Procedure, supra at § 6005, at 69-70. See 2 J. Wigmore, Evidence § 577 (3d ed. 1940).
With respect to a defendant's due process rights, where the payment for a witness's testimony is not contingent on the outcome of the case, Federal courts have required four procedural safeguards to permit the witness to testify:
"First, a witness-fee payment arrangement must be disclosed to each defendant against whom the witness will testify before the proceeding at which the witness testifies. . . . Second, the defendant must be afforded an opportunity to cross-examine the witness about the fee arrangement. Third, the court must instruct the jury about the heightened scrutiny to be given testimony provided under a fee payment arrangement. . . . And finally, there can be no indication that the government is sponsoring or suborning perjury." (Citations omitted.)
United States v. Levenite, 277 F.3d 454, 462 (4th Cir.), cert. denied, 535 U.S. 1105 (2002). See Hoffa v. United States, 385 U.S. 293, 298, 310-312 (1966) (rejecting claim that government's use of informant who was compensated for his testimony violated defendant's due process rights; even though witness had motives to lie [State and Federal criminal charges pending against him that were dropped or not pursued after witness testified], procedural safeguards including cross-examination and comprehensive jury instructions properly guided jury in determining witness's credibility). Indeed, where procedural safeguards are in place, Federal courts considering the issue of payment to fact witnesses contingent on a witness's testimony "have almost always held that such payments present an issue of credibility to be resolved by the trier-of-fact, but do not affect competency" or result in a due process violation. 27 C.A. Wright V.J. Gold, Federal Practice and Procedure, supra at § 6005, at 70 n. 86. See United States v. Davis, supra (payment to witness for testimony did not render witness incompetent); United States v. Cresta, 825 F.2d 538, 545-547 (1st Cir. 1987), cert. denied sub nom. Impemba v. United States, 486 U.S. 1042 (1988) (testimony of informant who received significant payments and benefits admissible against defendants). The Federal courts have so held even where the payment was contingent on the outcome of the case. See, e.g., United States v. Wilson, 904 F.2d 656, 659 (11th Cir. 1990), cert. denied sub nom. Bogus v. United States, 502 U.S. 889 (1991) (government witnesses paid statutory reward for their testimony contingent on effect of testimony); United States v. Spector, 793 F.2d 932, 934, 936-937 n. 3 (8th Cir. 1986), cert. denied, 479 U.S. 1031 (1987) (witness given use immunity and consideration in form of money contingent on whether testimony resulted in successful prosecution); United States v. Grimes, 438 F.2d 391, 395-396 (6th Cir.), cert. denied, 402 U.S. 989 (1971) (government informer paid for testimony contingent on conviction of defendants); Hughes, Agreements for Cooperation in Criminal Cases, 45 Vand. L. Rev. 1, 25 (1992) ("the suggestion of some older cases that an agreement with a witness should only demand full and truthful testimony and should in no way be contingent on the success of the prosecution seems to have crumbled"). The procedural safe-guards ensure that "no unnecessary barriers will be imposed on the [prosecutor's] ability to bargain for truthful testimony, and at the same time [will] ensure[] the jury will be able to determine what weight, if any, in light of all the evidence, to give to the witness's testimony." State v. McGonigle, 401 N.W.2d 39, 42 (Iowa 1987). Where a payment to a witness is contingent on the outcome, additional safeguards are required. See United States v. Levenite, 277 F.3d 454, 462-463 (4th Cir.), cert. denied, 535 U.S. 1105 (2002). As we prohibit contingency-of-outcome payments, we need not consider these additional safeguards.
In analyzing the defendant's due process challenge, we adopt the Federal procedural safeguards and conclude that they were satisfied in this case. Here, there is no dispute that the defendant's attorney was informed prior to trial about the money paid to and promised to Andrade and Rodriguez pursuant to the reward program of a third party. At trial, the defendant's attorney was permitted to (and did) cross-examine these witnesses on the payments and expected payments, and the terms of receipt. He also cross-examined a witness who headed the rewards program. When Andrade and Rodriguez testified, the judge instructed the jury in each instance to scrutinize the testimony with "particular care" because the reward was "contingent on there being a guilty verdict." The judge repeated this instruction in her final charge to the jury, which contained comprehensive instructions concerning witness credibility. Finally, there was no suggestion that the chamber of commerce or the prosecutor was sponsoring or suborning perjury. Other considerations bear on our conclusion, such as the fact that, in this case, the reward did not come directly from the prosecutor but, rather, from the chamber of commerce. Also, both Andrade and Rodriguez were competent to testify despite the payments and pending financial incentives, and were not facing the possibility of any type of criminal liability themselves as may be the case with some witnesses, such as accomplices or informants, cf. Commonwealth v. Ciampa, 406 Mass. 257, 258, 259 (1989) (consideration under plea agreement given to admitted accomplice in crime), which may present one with a greater incentive to lie. We add that, while there were some inconsistencies between the testimony provided by Andrade and Rodriguez, compared to that given by Reis, many details corroborated each other. In these circumstances, we reject the defendant's claim of a due process violation.
For these same reasons, we reject the defendant's contention that the existence of the reward program interferes with "the concept of ordered liberty," see Palko v. Connecticut, 302 U.S. 319, 325-326 (1937), or resulted in a proceeding whereby the "criminal trial [could not] reliably serve its function," Sullivan v. Louisiana, 508 U.S. 275, 281-282 (1993), thereby amounting to an error structural in nature. On this record, payments to Andrade and Rodriguez pursuant to the reward program simply do not pose a fundamental problem of fairness that would amount to structural error.
While the contingent monetary rewards in this case neither violated due process nor constituted structural error, we declare, exercising our superintendence authority, that prosecutors in the future may not provide (or participate in providing) monetary awards to witnesses contingent on a defendant's conviction. In so declaring, we recognize that, to prove the crime charged, prosecutors often need to procure the cooperation and truthful information or testimony of reluctant witnesses. The interests of justice, however, are not well served when a witness's reward is contingent on the conviction of a defendant rather than the provision of truthful information or testimony.
As to the defendant's claim that there was a violation of the gratuity statute, G.L. c. 268A, § 3 (c) and ( d), like its Federal counterpart, 18 U.S.C. § 201(c)(2) and (3) (2006), provides an express mechanism for its enforcement, namely, criminal prosecution, imposition of a fine, or both. See note 19, supra. See also Scaccia v. State Ethics Comm'n, 431 Mass. 351, 355 (2000) (where language of Federal and Massachusetts gratuity statutes "virtually identical," it is permissible to look to Federal law in construing Massachusetts gratuity statute). Even if we were to assume that the Massachusetts gratuity statute would apply, but see United States v. Lara, 181 F.3d 183, 197 (1st Cir.), cert. denied, 528 U.S. 979 (1999) (Federal gratuity statute "does not apply at all to the federal sovereign qua prosecutor"), its violation may not be used collaterally to attack the defendant's conviction and to exclude testimony. See United States v. Smith, 196 F.3d 1034, 1040 (9th Cir. 1999), cert. denied, 529 U.S. 1028 (2000) (Federal gratuity statute provides enforcement mechanism and may not be transformed into exclusionary rule); United States v. Lara, supra at 198, and cases cited (appropriate penalty for violation of Federal gratuity statute is fine or imprisonment as prescribed by statute, not application of exclusionary rule).
Pursuant to St. 1962, c. 779, § 1, the version of the gratuity statute applicable to this case, G.L. c. 268A, § 3, provides, in pertinent part:
"(
c) Whoever, directly or indirectly, gives, offers or promises anything of substantial value to any person, for or because of testimony under oath or affirmation given or to be given by such person or any other person as a witness upon a trial . . . before any court . . . or
"(
d) Whoever, directly or indirectly, asks, demands, exacts, solicits, seeks, accepts, receives or agrees to receive anything of substantial value for himself for or because of the testimony under oath or affirmation given or to be given by him or any other person as a witness upon any such trial, hearing or other proceeding, or for or because of his absence therefrom; shall be punished by a fine of not more than three thousand dollars or by imprisonment for not more than two years, or both.
"Clauses (c) and (
d) shall not be construed to prohibit the payment or receipt of witness fees provided by law or the payment by the party upon whose behalf a witness is called and receipt by a witness of the reasonable cost of travel and subsistence incurred and the reasonable value of time lost in attendance at any such trial, hearing or proceeding. . . ."
2. Sufficiency of the evidence. The Commonwealth proceeded against the defendant on both principal and joint venture liability, and the jury returned a general verdict, finding the defendant guilty of murder in the second degree. The defendant moved for required findings of not guilty at the close of the Commonwealth's case and again at the conclusion of all the evidence, arguing that there was insufficient evidence to warrant a finding that he was the shooter, and thus acted as a principal. He makes this same argument on appeal. In addition, he contends that there was insufficient evidence of a joint venture because Fagbemi tried to stop the defendant.
In assessing the defendant's claims, we apply the well-established standard set forth in Commonwealth v. Latimore, 378 Mass. 671, 676-677 (1979). Under that standard, the "question is whether, after viewing the evidence in the light most favorable to the prosecution, any rational trier of fact could have found the essential elements of the crime beyond a reasonable doubt" (emphasis in original). Id. at 677, quoting Jackson v. Virginia, 443 U.S. 307, 319 (1979). Questions of credibility are to be resolved in the Commonwealth's favor, and circumstantial evidence is sufficient to establish guilt beyond a reasonable doubt. Cramer v. Commonwealth, 419 Mass. 106, 110 (1994). To the extent that conflicting inferences may be drawn from the evidence, it is for the jury to decide which version to credit. Id.
The defendant does not challenge the sufficiency of the evidence as to the elements of murder in the second degree. Rather, he claims that he could not have been convicted as a principal because there was insufficient evidence to warrant a finding that he had been the shooter.
In Commonwealth v. Zanetti, 454 Mass. 449, 468 (2009), we stated that, in an appeal following a conviction, we will "examine whether the evidence is sufficient to permit a rational juror to conclude beyond a reasonable doubt that the defendant knowingly participated in the commission of the crime charged, with the intent required to commit the crime, rather than examine the sufficiency of the evidence separately as to principal and joint venture liability." Thus, it does not matter who shot the victim. The jury reasonably could have inferred the defendant knowingly participated in the shooting by committing the shooting himself (crediting the testimony of Andrade and Rodriguez) or by supplying Fagbemi with the means to commit the shooting (handing him the gun), with the intent that Fagbemi do so (crediting Reis's testimony). The fact that the Commonwealth's evidence permitted alternate versions is not of legal significance so long as each version is legally supportable under the Latimore standard.
Our recommended jury instruction is to be used in future cases and has no bearing on cases already tried. Commonwealth v. Zanetti, 454 Mass. 449, 467 n. 21, 470 (2009) (Appendix).
Concerning the efforts of Fagbemi to stop the defendant, to the extent that this evidence may have affected the defendant's intent, the defendant overlooks the critical timeline established by the Commonwealth's evidence, which places Fagbemi's initial protestations before the chase of the victim to Reis's home. Based on the Commonwealth's evidence concerning what transpired after the chase, the jury reasonably could have inferred, even if the defendant had not been the shooter, that he shared the requisite mental state for murder in the second degree and knowingly participated in the commission of the crime. See Commonwealth v. Zanetti, supra at 470 (Appendix). The judge correctly denied the defendant's motions for required findings.
The Commonwealth's position did not deteriorate after it closed its case. See Commonwealth v. Basch, 386 Mass. 620, 622 n. 2 (1982).
3. Prosecutor's closing argument. The defendant challenges portions of the prosecutor's argument. He failed to object at trial on the grounds he now raises. We therefore review his claims to determine whether there was error and, if so, whether it gave rise to a substantial risk of a miscarriage of justice. Commonwealth v. Cifizzari, 397 Mass. 560, 578 (1986). We consider these remarks "in the context of the whole argument, the evidence admitted at trial, and the judge's instructions to the jury." Commonwealth v. Whitman, 453 Mass. 331, 343 (2009).
The defendant first contends that the prosecutor improperly shifted the burden of proof to the defendant by suggesting in his argument that there was evidence that could not be heard because of fear of the defendant. For instance, the prosecutor asked who was the fourth man who drove off in the victim's automobile and why had he not come forward, and why had Reis taken so long to provide police with a formal statement. In the context of the argument in its entirety and the evidence at trial, the remarks were permissible and did not reflect burden shifting.
Concerning the "fourth man" the defendant claims the following remarks were improper:
"[W]e have also heard about this fourth man, the so-called driver of the car. . . . Apparently responsible for driving the car back to [the victim's] family's home. The act, I would submit, of a friend. Was it Casey DePina? I suppose we don't really know. Was it Barry Souto? I suppose we don't know. But where is that fellow?
"Casey DePina was interviewed by the police. Barry Souto you heard was interviewed for a short term until he closed the door on the police. Where is that fellow to tell the story about how his friend died? We're talking two and a half years later. Where is he? When you think about a friend not being able to come forward, for whatever reason, to talk about how his own friend died, you may have an idea of what [the former president of the chamber of commerce] was telling you when he said that the Chamber of Commerce that he ran had a reward program . . . established to try to solve unsolved homicides. . . . Again, I invite you to look at the evidence, please."
As to Reis, the defendant argues impropriety in the following statements:
"[Reis] only came forward, as you recall, in December of last year. I suggest to you if she was showing signs of nervousness that night and that next morning, it had another cause [other than an investigation concerning drugs]. But I know you don't welcome that either. A reward, the arrangement, her being taken out of that neighborhood. Think, if you will, of that fourth person, that friend who we never heard from. Think about the event."
The prosecutor did not expressly state or suggest that the "fourth man" was absent from trial because he feared the defendant. Rather, he noted the man's absence "for whatever reason" and then alluded to the need for the chamber of commerce's reward program. In context, the remarks suggested that witnesses are not cooperative with police, not that this witness did not come forward because of intimidation by, or fear of, the defendant. The subject matter was an appropriate one on which to comment because the jury had heard from Reis, Andrade, and Rodriguez that this other man had been present during the commission of the crime, and the defendant's trial counsel, in her closing argument, accused the police of having conducted a "shoddy investigation" and of ignoring evidence of other suspects. The prosecutor's hypothetical questions and statements concerning the "fourth man" were a fair response to this argument. They also had support in the record, as there was evidence that police attempted to identify and speak with the other man present on the night of the shooting but either received no cooperation or their efforts were to no avail. It is not improper for counsel to respond to arguments raised by the defense, see Commonwealth v. Anderson, 411 Mass. 279, 286 (1991), and to make an argument presented by way of reasonable inferences that could be drawn from the evidence, see Commonwealth v. Ruiz, 442 Mass. 826, 835 (2004).
Concerning Reis, the defendant's trial counsel attacked her credibility in her closing argument, calling Reis a "crack cocaine dealer" who "changes her story" and took years to come forward. The challenged remarks of the prosecutor were a fair response to this argument and had an evidentiary basis in the record. In addition to Reis's testimony that she delayed coming forward because she was scared, there was testimony from a police officer that he tried to speak with Reis the day following the shooting but could not obtain information from her because she was shaking, was stuttering, and was extremely nervous. Also, Reis testified that, on the day after the shooting, Fagbemi and Wallace approached her while she was on her way to work and exchanged words with her and, on another occasion, the defendant's mother approached her and made a statement to her. From this evidence, the jury reasonably could have inferred (although the prosecutor did not specify) that Reis was not forthcoming with police in a timely manner because she was scared on account of the crime itself, the defendant, the defendant's family members, or a combination of these factors. See Commonwealth v. Pina, 430 Mass. 266, 270 (1999). The remark concerning Reis was not improper.
The defendant next contends that the prosecutor improperly shifted the burden of proof to him by emphasizing in his closing "what the defense did not do at trial." Specifically, he points to the prosecutor's narrow focus on the facts that Reis and Andrade were cross-examined as having been inconsistent concerning only one factual matter. The defendant examines these remarks in isolation. Taken in context, it is clear that the remarks were intended to demonstrate how the accounts of Reis and Andrade (and Rodriguez), in the main, were consistent and corroborated each other. In addition, the argument served as an attempt to show that the inconsistencies that did exist involved peripheral matters of no consequence.
To the extent that the remarks may have implied the unstated observation that, by contrast, the defendant left the balance of the Commonwealth's evidence from these witnesses uncontested, this indirect implication does not approach the sort of burden shifting that results from direct comment on a defendant's failure to contradict testimony. See, e.g., Commonwealth v. Amirault, 404 Mass. 221, 240 (1989) (prosecutor may not comment on defendant's failure to contradict testimony; prosecutor's closing argument improper where he claimed defendant "was unable to point to one single thing in the whole world that would account for why all these children and parents have turned against him"). Any potential for harm, however, was adequately cured by the judge's clear, strong, and correct instructions on the presumption of innocence; the Commonwealth's burden of proof; the considerations, including the existence of inconsistent statements and the impeachment or contradiction of some of a witness's testimony, involved in assessing witness credibility; and the fact that the closing arguments of counsel are not evidence. See Commonwealth v. Cohen, 412 Mass. 375, 389 (1992). In these circumstances, there is no substantial risk of a miscarriage of justice.
4. Jury instructions. We reject the defendant's contention that the judge erroneously failed to instruct the jury on withdrawal from a joint venture. Although the defendant did not request this instruction at trial, he argues that the judge nonetheless should have given it and that he was deprived of a substantial defense by his trial counsel's failure to request it. The defendant contends that the evidence was sufficient to warrant the instruction because the jury could have found that he withdrew from the joint venture when he stopped at the end of Reis's driveway and handed over the gun to his brother, who had earlier "appeared to resist . . . escalation."
"Before a judge is required to give a requested instruction, there must be some basis in the evidence, viewed in the light most favorable to the proponent, supporting the requested instruction." Commonwealth v. Cook, 419 Mass. 192, 201 (1994), and cases cited. "In order to support a theory of withdrawal or abandonment of a joint venture, `there must be at least an appreciable interval between the alleged termination and [the commission of the crime], a detachment from the enterprise before the [crime] has become so probable that it cannot reasonably be stayed, and such notice or definite act of detachment that other principals in the attempted crime have opportunity also to abandon it. `" Id. at 202, quoting Commonwealth v. Fickett, 403 Mass. 194, 201 (1988).
Here, there was no evidence that the defendant announced or notified his brother that he intended to withdraw. See Commonwealth v. Cook, supra; Commonwealth v. Branch, 42 Mass. App. Ct. 181, 185 (1997). While there was testimony from Reis that the defendant and Fagbemi "exchanged words" before the defendant handed the gun over to Fagbemi, there was no evidence concerning what was said.
Nor was there an "appreciable interval" between the alleged withdrawal and the crime. See Commonwealth v. Cook, supra. See also Commonwealth v. Serrano, 74 Mass. App. Ct. 1, 4 (2009); Commonwealth v. Branch, supra. The victim was shot within seconds of the defendant's arrival at the end of Reis's driveway and the exchange of the gun. For these reasons, there was an insufficient basis in the evidence to support a withdrawal instruction, and there was no error in its omission or in defense counsel's failure to request it.
Judgments affirmed.