IPR decision finding mesalamine method claims obvious affirmed, Salix’s appeal of DC non-infringment holding dismissed


Dr. Falk Pharma GmbH v. Generico, LLC et al., Salix Pharm. v. Mylan Pharm.

Docket 2017-2312 (IPR2016-00297, -01386, -01409); 2017-2636, 2018-1320
LOURIE, LINN, WALLACH
June 12, 2019
Non-precedential

Brief summary: Board’s IPR obviousness determination affirmed and Salix’s appeal of DC holding of non-infringement dismissed as moot.

Summary: Dr. Falk and exclusive licensee Salix appealed Board IPR obviousness decision and DC holding of non-infringement of US 8,865,688 directed to “[a] method for maintaining the remission of ulcerative colitis” using a “granulated mesalamine formulation”, administered without food or antacids, where “remission is defined as a” Sutherland Disease Activity Index1 (DAI) “score of 0 or 1”, and “85% to 90% of the mesalamine reaches the terminal ileum and colon.” The FC panel opinion points out that Salix (Valeant) holds NDA No. 22-301 (for the mesalamine product Apriso for which the ‘688 patent is solely listed on the OB). Mylan submitted ANDA 20-7271 including a Paragraph IV notice letter alleging invalidity and/or no infringement, and Salix/Dr. Falk sued. Mylan et al. then filed the IPR challenges. The Board and DC decisions were consolidated into this appeal. The obviousness challenged was based on a combination of five references including two Salix press releases regarding clinical trials, journal articles regarding controlled release delivery systems and the gastrointestinal tract and the use of pellets as a vehicle for treating ulcerative colitis (including “independent of food”). The Board construed the DAI score “consistent with the specification’s express definition” thereof as “the sum of four subscores”, found “all claim limitations…were satisfied by the prior art and that there was a motivation to combine the asserted references with a reasonable expectation of success” (e.g., Salix press release “announces a successful outcome of a Phase III trial to evaluate the safety and efficacy of the same or similar granulated mesalamine formulation for the same disease” with “no indication” that it “had to be administered with food”, “comparative studies are not necessary…especially when the claims at issue do not recite an efficacy requirement related to the effect of food”). In a Markman hearing, the DC construed “the 85% to 90% limitation” as having “its plain and ordinary meaning”, which the DC concluded Salix had not been demonstrated “by a preponderance of the evidence” would be infringed by Mylan’s proposed product. The FC panel first explained its agreement with the Board’s claim construction under both the broadest reasonable interpretation (BRI) and the Phillips standard (FC 2005, for IPRs filed on or after Nov. 13, 2018 (FN6); In re Schwemberger, FC 2010 (patentee as lexicographer); “[W]hile Dr. Falk is correct that the specification at times references a special definition of remission, the claim language does not claim that special definition.”) The FC panel also found that “the Board did not change theories…to show obviousness of the without food limitation” (SAS, FC 2016; e.g., it correctly focused on asking “whether a skilled artisan would have ‘ha[d] a motivation to combine accompanied by a reasonable expectation of success of achieving what is claimed in the patent-at-issue’” and “correctly found Dr. Falk’s evidence as falling outside the scope of the claims” (Int. Bio-Sys., FC 2016)). The FC panel therefore affirmed the Board’s obviousness determination as dismissed Salix’s appeal as moot.

Posted in Claim Construction, Generics / ANDA, Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

Board IPR nonobviousess decision vacated for failing to consider “different limitation”


Packers Plus Energy Services Inv. v. Baker Hughes Oilfield Operations, LLC

Docket 2018-1490 (IPR2016-01099)
LOURIE, LINN, WALLACH
June 10, 2019
Non-precedential

Brief summary: IPR decision of nonobviousness affirmed for certain claims but vacated as one other

Summary: Packer Plus (PP) appealed Board IPR decision finding claims 1-29 of Baker Hughes’s (BH) US 6,006,838 directed to oil and gas well assemblies not obvious. PP argued “that the Board erred by construing the limitation ‘over the jetting passageways’ to mean ‘covering the jetting passageways’” by “imposing a structural relationship…rather than the functional relationship” to the claimed assembly. The FC panel found no error with the Board’s construction, explaining that “[t]he plain meaning of ‘over’ is to describe the structural arrangement of one object with respect to another, not the functional relationship thereof”, claim 1 uses “the spatial language of ‘over the jetting passageways’” “in its closed position” (in addition to functional language regarding the “open position”), PP “proferr[ed] no reason why it would be appropriate to rewrite the claims to make the language used to recite the ‘closed’ and ‘open’ positions parallel”, “[n]othing in the specification shows or describes a shiftable sleeve above the jetting passageway but not also covering it”, and “the presence of a single dictionary definition of ‘over’ as meaning ‘above’ does not make that definition a reasonable reading of the limitation in light of the specification” (PPC Broadband, FC 2016). PP also argued the Board erred in not finding obviousness for claims 1, 8 and 16 because it “limited its obviousness analysis to the particular configuration suggested by” BH in its Patent Owner Response (In re Mouttet, FC 2012 (“a proper obviousness analysis ‘does not require an actual, physical substitution of elements’”) but the FC panel disagreed (e.g., PP “nowhere explained…why-in the absence of hindsight-such a person of ordinary skill would have placed the jet nozzles at the one particular place where the shifting sleeve would cover the jetting passageways”, no “sufficient reason to combine”, and “[t]he Board did not limit its construction to a preferred embodiment”). The FC panel explained that “the Board at first recognized that Claim 21 ‘differs’ from Claims 1, 8 and 16” but legally erred in “never separately construed the different limitation recited in Claim 21”. PP argued BH’s three “alternative grounds” for affirmance were not presented to the Board during the IPR (In re Lee, FC 2002), but the FC panel disagreed since “the Board considered each of the facts underlying the alternative grounds, and both parties had the opportunity to address the issues at the Board” (Lee; Click-To-Call, FC 2018; Nike, FC 2016). And the FC panel declined to affirm the nonobviousness decision for claim 21 since, e.g., “the claims do not require a particular type of packer” (Allied Erecting, FC 2016 (“obviousness does not require the bodily incorporation of the teachings of one reference to another reference-an ordinary artisan has the capacity for ordinary creativity when combining references”; KSR, US 2007). The Board’s decision was therefore vacated as to claim 21.

Posted in Claim Construction, Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

Federal Circuit affirms PTAB IPR decision finding Arch/Dana-Farber’s “method of improving chemotherapeutic intervention” claims invalid for obviousness


Arch Dev. Corp., Dana-Farber Cancer Inst., Inc. v. OSI Pharm., LLC and Genentech, LLC

Docket 2018-1485 (IPR2016-01034)
PROST, LOURIE, BRYSON
May 9, 2019

Brief summary: PTAB IPR final written decision finding Arch’s claims invalid for obviousness affirmed.

Summary: The PTAB (“Board”) granted OSI’s IPR Petition and issued a final written decision (FWD) finding Arch’s claims 1-3, 5, and 6 of US 7,838,512 B1 (expired as of April 8, 2015) directed to a “method of improving chemotherapeutic intervention” using “a chemotherapeutic DNA damaging agent” (“chemotherapeutic” being added by Certificate of Correction, see FN10 of FWD) and a “therapeutically effective amount of a low molecular weight tyrosine kinase inhibitor” invalid for obviousness on two different combinations of references. The FC panel affirmed the Board’s FWD without opinion. In the FWD, the Board construed “therapeutically effective amount” as “an amount that would be sufficient to have a desired therapeutic effect” (expired patent reviewed under Phillips (FC 2005), ordinary and customary meaning in light of the claim language, specification and prosecution history) (“[W]e are not convinced that the inventors’ express definition of ‘therapeutically effective amount’ applies to the tyrosine kinase inhibitor…as opposed to the combination of inhibitor and DNA damaging agent”). The Parties disagreed as to whether “the terms ‘enhanc[ing] cell death’ and ‘enhancing apoptosis’ encompass inducing an otherwise immortal cancer cell to differentiate and, eventually, die”, and the Board found that it does based on the ‘512 specification and prosecution history which, “read in the context of the Specification”, “makes clear that inducing differentiation is not the same a cell killing” (Retractable, FC 2011 (“we strive to capture the scope of the actual invention, rather than…allow the claim language to become divorced from what the specification conveys is the invention”)). The Parties agreed “that the preamble of each challenged claim, as well as the ‘thereby’ clause of claims 1-3…are non-limiting.” On obviousness, the Board first found that claims 1-3 and 5 were not shown by a preponderance of the evidence to be invalid for obviousness in view of the first combination of references (e.g., “On balance, we are not convinced that Petitioner has shown, by a preponderance of the evidence, that Honna teaches or suggests cell death or apoptosis as opposed to antiproliferative activity and differentiation.”) But the Board found claim 6, which “recites that the” drugs “act in combination to alter the cell’s response to the [DNA damaging] agent”, invalid in view of that combination and the Board’s construction of “therapeutically effective amount”. The Board also found claims 1-3, 5 and 6 were shown by a preponderance of the evidence to be invalid for obviousness based on the second combination of references (e.g., “a strong indication for combining both drugs”, expert testimony, claims do not “specify that ‘tyrosine kinase inhibition itself causes any particular effect’”, “Patent Owner’s unsupported assertion” (Meitzner, CCPA 1977)).

Posted in Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

Federal Circuit affirmed DC claim construction finding that “100% by weight” limitation can include “residual moisture”


E.I. Du Pont De Nemours & Co. v. Unifrax I LLC

Docket 2017-2575
O’MALLEY, REYNA, HUGHES
April 17, 2019

Brief summary: DC finding that “platelets in an amount of 100% by weight” can include “some residual dispersant” and its denial of JMOL based on jury findings of no infringement or anticipation, affirmed.

Summary: Unifrax appealed DC claim construction and denial of its motions for judgment (JMOL following jury decisions) of non-infringement and invalidity of Du Pont’s (DP’s) US 8,607,926 relating to composite laminates incorporated into thermal-acoustic blankets in airplanes. The DC agreed with DP that “100% by weight” in the “comprises platelets in an amount of 100% by weight…and a residual moisture content of no greater than 10 percent by weight” limitation means ‘[t]here is no carrier material…in addition to the inorganic platelets” but that “[t]here may be some residual dispersant”, relying on the ‘926 specification (and its parent ‘027 patent) and prosecution history for support. The DC found that although the 100% limitation was introduced in response to a prior art rejection and DP “did not dispute that this resulted in disclaimer of at least ‘embodiments comprising an inorganic refractory layer containing platelets in an amount less than 100% by weight’”, DP did not disclaim “refractory layers that contain anything at all other than platelets” (e.g., the claims also specified “a residual moisture content”) and “the disclaimer limited the scope of the claimed layers to those containing no carrier material such as a resin or an adhesive”. The FC panel reviewed the DC’s “ultimate determination on claim construction de novo” and “any underlying factual findings related to extrinsic evidence…for clear error” (CardSoft, FC 2015; Markman, US 1996; Phillips, FC 2005; Medrad, FC 2005; Microsoft, FC 2004 (“when the specification ‘makes clear that the invention does not include a particular feature, that feature is deemed outside the reach of the claims” even if those “might be considered broad enough to encompass the feature in question”)). The FC agreed with the DC’s based on the claim’s plain language (e.g., “reference to both ‘100% by weight’ platelets and 10% residual moisture”), the specification (e.g., “‘100% by weight’ is relative to the carrier material in the refractory layer” as it states that “[t]he refractory layer may comprise some residual dispersant.”) and the prosecution history (patentee “understood the claimed language to be relative to carrier material”). The FC panel also found the DC’s consideration of the parent ‘027 patent specification in its claim construction analysis was proper (Wang Labs., FC 1999; Jonsson, FC 1990; Advanced Cardiovascular, FC 2001 (which the FC panel read not to require “the exact claim term at issue” be present in both patents)). The FC panel also found “the jury’s infringement verdict” and no anticipation to be supported by substantial evidence. And under the “‘rule of reason’ analysis”, the FC panel concluded “that the corroborative evidence” of conception and reduction to practice supported “the credibility of” the inventors’ “story”, and therefore the ‘926 patent was entitled to its claimed priority (i.e., prior to the first public use date (NFC, FC 2003)). Thus, the DC’s decision was affirmed. Judge O’Malley’s dissent argued that the claim construction was erroneous and “introduces more ambiguity than it resolves” (e.g., “The ‘100% by weight’ language, coupled with the requirement that the platelets exist in an ‘inorganic refractory layer,’ clearly contemplates that the platelets-i.e., inorganic material-constitute the entirety of the refractory layer.”)

Posted in Anticipation (35 USC 102), Claim Construction, Conception and Reduction to Practice, Infringement | Leave a comment

DC decision vacated and remanded since it should have considered whether assignee AMD should be joined as a necessary party


Lone Star Silicon Innovations, LLC v. Nanya Tech. Corp. et al.

Docket 2018-1581, -1582
O’MALLEY, REYNA, CHEN
May 30, 2019

Brief summary: DC decision vacated and remanded since it should have considered whether assignee AMD should be joined as a necessary party.

Summary: Lone Star appealed DC decision that it cannot assert the patents-at-issue since it does not own those. The FC panel found that the DC should have considered “whether Advanced Micro Devices, Inc. (‘AMD’), the relevant patentee, should have been joined” in view of FRCP 19 and FC case law. The patents were transferred to Lone Star under an agreement “purporting to transfer ‘all right, title and interest’ in the patents” but “impos[ing] several limits on Lone Star” including an agreement “to only assert the covered patents against ‘Unlicensed Third Party Entit[ies]’ specifically listed in the agreement”, that “[n]ew entities can only be added if Lone Star and AMD both agree to add them”, that “[i]f Line Star sues and unlisted entity, AMD has the right-without Lone Star’s approval-to sublicense the covered patents to the unlisted target”, and that “AMD can also prevent Lone Star from assigning the patents or allowing them to enter the public domain.” In addition, the FC panel explains, “AMD and its customers can also continue to practice the patents…and AMD shares in any revenue Lone Star generates from the patents through ‘monetization efforts’”. The FC panel opinion explains that 35 U.S.C. § 281 “allows a ‘patentee’ to bring a civil action for patent infringement” (“the original patentee (whether the inventor or original assignee) and ‘successors in title’”), but “not…mere licensees” (AssymetRx, FC 2009 (“we examine the ‘totality’ of the agreement to determine whether a party other than the original patentee has established that it obtained all substantial rights in the patent”); Waterman, US 1891; Alred E. Mann, FC 2010; Morrow, FC 2007). The FC panel wrote that the DC “correctly recognized” that “the agreement ‘substantially curtail[s] Lone Star’s rights” (“the court must determine whether the party alleging effective ownership has in fact received all substantial rights from the patent owner” (Waterman, US 1891 (“[w]hether a transfer of a particular right or interest under a patent is an assignment or a license does not depend upon the name by which it calls itself, but upon the legal effect of its provisions”); A123 Sys., FC 2010 (“whether the ‘totality’ of the transfer agreement reflects a transfer of all substantial rights in the asserted patents to Lone Star”)). The FC panel found the various terms of the agreement to be “fundamentally inconsistent with a transfer of all substantial rights” (e.g., consent requirement “ensures that AMD will always control how the patents are asserted”, requiring Lone Star “to assign the patents back to AMD…before abandoning” (Aspex, FC 2006)). “Lone Star alleged that it possesses the sort of exclusionary rights that confer Article III standing”, and the FC panel agreed, finding that to be “enough to confer standing at the pleadings stage” (WiAV, FC 2010; Lexmark, US 2014 (“whether a party possesses all substantial rights in a patent does not implicate standing or subject-matter jurisdiction”)). The FC panel also agreed with Lone Star that “even if it lacks all substantial rights in the patents, it should be given the opportunity to join AMD as a necessary party”. Therefore, the DC decision was vacated and remanded.

Posted in Article III disputes, Assignment / Ownership | Leave a comment

Recent Pharma-Related Federal Circuit Opinions regarding DC and USPTO IPR Obviousness Decisions


BTG Int. Ltd. and Jannsen Biotech, Inc. et al. v. Amneal Pharmaceuticals LLC, et al.

May 14, 2019
Obviousness affirmed

PTAB IPR decision finding BTGs’s ZYTIGA® (abiratone) Orange Book ‘438 method of treatment patent invalid for obviousness affirmed (e.g., the ‘438 specification requires that “any definition of ‘treatment’ must encompass the full range of therapeutic agent’s effects disclosed; substantial evidence supports the PTAB’s obviousness findings including “a reasonable expectation that prednisone could be used as a therapeutic agent in the treatment of prostate cancer”).


Novartis Pharmaceuticals Corp. et al. v. West-Ward Pharmaceuticals Int. Ltd.

May 13, 2019
Nonobviousness affirmed

DC’s “ultimate determination that the challenged claims would NOT have been obvious” due to no reasonable expectation of success affirmed (e.g., DC “erred in applying this heightened standard” for a motivation to comine since the “law does not require that a particular combination must be the preferred, or most desirable combination described in the prior art in order to provide motivation for the current invention”, no clear error in the DC’s determination of NO reasonable expectation of success (POSA “would not make a determination or reasonable suggestion simply based in isolation upon whether a drug enters phase II”, “no dispute that more than seventy percent of oncology drugs failed at phase II”)).


Endo Pharm. Inc., Mallinckrodt LLC v. Actavis LLC et al.

May 3, 2019
Nonobviousness affirmed

DC holding that Endo’s claims to low “ABUK” oxymorphone were NOT shown to be invalid for obviousness affirmed (DC “did not clearly err” in finding no reasonable expectation of success in combining prior art; “FDA communications recite a goal without teaching how the goal is attained”; “the inventors of the ‘779 patent engaged in extensive experimentation, involving much failure, to ultimately produce the oxymorphone of the Asserted Claims”).


Neptune Genetics, LLC et al. v. Eli Lilly & Company

April 26, 2019
Nonobviousness affirmed

Board IPR decisions finding Lilly’s claims relating to administration of vitamin B12 with pemetrexed were NOT shown to be obvious affirmed (e.g., substantial evidence…that the art did not provide a motivation for a skilled artisan to administer an MMA lowering agent, such as vitamin B12, in addition to folic acid”; Lilly’s statements to the FDA “were made…more than five months after the critical date” (In re Copaxone, FC 2018 (“a patent owner’s own disclosures to the FDA may be considered in assessing the state of the prior art”); FDA’s skepticism weighed in favor of non-obviousness).


Grunenthal Gmbh et al. v. Alken Labs. Ltd., Hikma Pharm., Actavis et al.

March 28, 2019
Nonobviousness affirmed

DC decisions of NONobviousness of Grunenthal’s polymorph claims (e.g., no known or expected polymorphism, no evidence that ‘737 patent synthesis “results in any Form A”, and no guidance as to what conditions “were likely to result in Form A”), no induced or contributory infringement due to Section viii carve-out of “the neuropathic pain indication” and “substantial noninfringing uses for the accused product” (§ 271(c)), and specific utility of the claimed polymorph (as an analgesic) affirmed.


In re: Ikeda Food Research Co. Ltd.

January 29, 2019
Obviousness affirmed (Non-precedential)

Board decision affirming the rejection of claims directed to method for measuring blood glucose using a biosensor as obvious due to inherent disclosure by the prior art affirmed (e.g., while “inherency may supply a missing claim limitation in an obviousness analysis”, “the limitation at issue necessarily must be present[] or the natural result of the combination of elements explicitly disclosed by the prior art” (PAR Pharm., FC 2014), and that “the [US]PTO can require an applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied upon”).

Posted in Generics / ANDA, Obviousness | Leave a comment

Dana-Farber and Genetic Institute researchers named co-inventors on the “Honjo patents” encompassing methods for treating cancer using anti-PD1 antibodies including BMS’s Opdivo® (nivolumab)


Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical Co., Ltd. et al.

Civil Action No. 15-13443-PBS
U.S. District Court, District of Massachusetts
May 17, 2019

Brief summary: DC determines Dana-Farber and Genetics Institute researchers to be co-inventors on the Honjo patents claiming cancer immunotherapy methods using anti-PD1 antibodies (e.g., BMS’s Opdivo® (nivolumab)).

Summary: Dana-Farber alleged Dr. Freeman (Dana-Farber) and Dr. Wood (GI) should have been named on Ono’s patents (the “Honjo patents”, to which BMS is exclusive licensee) directed to methods of cancer immunotherapy using anti-PD1 antibodies. The Honjo patents are described in the DC opinion as including US 7,595,048; 8,168,179; 8,728,474; 9,067,999; 9,073,994; and 9,402,899. The earliest priority date of the Honjo patents (on which Dr. Honjo (a 2018 Nobel Prize winner for this invention) is an inventor with two other individuals) is July 3, 2002. The dispute centers on whether the collaboration between Dr. Honjo at Kyoto University in Japan and Drs. Freeman and Wood at Dana-Farber and GI, respectively, between “at least October 1999[] until at least September 2000 through numerous meetings, joint authorship of scientific journal articles, and sharing of experimental results and ideas” (Dr. Honjo and Dr. Wood began their collaboration in September 1998) was of sufficient significance to qualify Drs. Freeman and Wood as inventors on the Honjo patents. The DC opinion explains that Dr. Honjo had complained to GI that he should have been included as an inventor on GI’s patent application naming Dr. Freeman in 1999 (an “angry exchange”), but how this argument resolved is not addressed in this opinion. The DC opinion provides much detail regarding the nature of the collaboration between the parties, including the discovery of the PD-1 receptor by Dr. Honjo in the early 1990s (published in 1992), Dr. Honjo’s knockout mouse experiments and 1999 Immunity publication describing “PD-1 as ‘a negative regulator of immune responses’”, Dr. Honjo’s unsuccessful ligand search, the efforts between Dr. Honjo and Dr. Wood to identify the PD-1 L1 ligand, Dr. Freeman’s discovery of “the 292 Ligand” (“B7-4”, ultimately “PD-L1”) and work with GI regarding the same (and provisional patent application regarding the same), Dr. Wood’s determination that “PD-1 and 292 bound together” (recognized by Dr. Honjo to be the result of a “strong collaboration”), collaboration meetings between Drs. Freeman, Wood and Honjo at GI, Dr. Freeman’s and Dr. Wood’s joint patent application claiming “methods of modulating the immune response via activating or blocking the PD-1/PD-L1 pathway” which they “did not tell Dr. Honjo about”, Dr. Freeman’s discovery of PD-L2 in 1999, the 2000 J. Exp. Med. including all three researchers as authors and including Dr. Freeman’s statement regarding “the possibility that some tumors may use PD-L1 to inhibit an anti-tumor response”, their independent development of anti-PD1 antibodies during 1999-2000, Dr. Honjo’s in vivo tumor model studies in 2000 using Dr. Freeman’s antibodies (Dr. Honjo stating “Needless to say, we will do [the experiments] as collaboration”), additional meetings in 2000, the dispute regarding inventorship on Drs. Freeman’s and Wood’s provisional application (“GI ultimately decided not to add Dr. Honjo”), the “effective[] end[]” of the collaboration in 2001, and Dr. Honjo’s / Ono’s patent application filing in 2002 (which led to the Honjo patents). The opinion also notes that Dr. Honjo acknowledged Dr. Freeman as a “[m]ajor outside collaborator” during his 2018 Nobel Prize lecture.

Medarex (acquired by BMS) then exclusively licensed the Honjo patents and began nivolumab clinical trials. The DC opinion explains that Dr. Freeman “learned about the ‘048 Patent in 2010” but “did not realize the patent used his discoveries until sometime between 2012 and 2014”, and Dana-Farber initiated the lawsuit in 2015 (no laches as explained near the end of the opinion, e.g., the suit was filed within six years of the ‘048 Patent issuance). Each party presented expert testimony regarding the contributions of each party to the research and their opinion regarding inventorship. The DC reviewed the law of joint inventorship (35 USC § 116(a), § 256(a) (correction of inventorship); Vapor Point, FC 2016 (“inventor…may bring a cause of action to correct inventorship”); Eli Lilly, FC 2004 (“only if he contributes to the conception”, need not be “equal in importance”); In re VerHoef, FC 2018 (“Conception ‘requires a ‘definite and permanent idea of an operative invention, including every feature…”, “essential feature”); Nartron, FC 2009 (not “an idea of a result to be accomplished”); Fallana, FC 2012 (“Collaboration is a key requirement…”); Symantec, FC 2008 (inventor testimony must be corroborated under “rule of reason”) (see also Apator, FC 2018, distinguished from this case)). Given all of the facts and legal standards described above, the DC determined that Drs. Freeman and Wood were co-inventors of the methods claimed in the Honjo patents (e.g., “There is no question that the three collaborated”, “clear and convincing evidence”, “while the fact that Dr. Freeman and Dr. Wood were not present during Dr. Iwai’s in vivo mouse tumor model experiments is relevant to determining how significant their contributions were to conception, it is not dispositive” (“Vanderbilt University is controlling” (FC 2010), “Dr. Freeman and Dr. Wood made significant contributions to conception…through their discovery of PD-L1 and PD-L2, their discoveries of blocking antibodies”, etc.). The DC therefore entered judgment in favor of Dana-Farber. FN1 explains that GI’s parent companies Wyeth and Pfizer settled with Defendants “on the eve of trial.”

Posted in Inventorship | Leave a comment