Patent Docs

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)

By Kevin E. Noonan --

Today, the Federal Circuit revisited the patent-eligibility of claims directed to methods for optimizing childhood immunization, in Classen Immunotherapies, Inc. v. Biogen IDEC.  The Federal Circuit's original opinion, handed down in December 2008, was vacated by the Supreme Court in view of that Court's decision in Bilski v. Kappos, and remanded to the Federal Circuit for reconsideration in view of the Supreme Court's instructions on the proper standard to be applied to determine patent-eligibility for method claims.

Today's decision could not be more different from the Federal Circuit's earlier decision.  That decision, in its entirety, was as follows:

In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court's grant of summary judgment that these claims are invalid under 35 U.S.C. § 101.  Dr. Classen's claims are neither "tied to a particular machine or apparatus" nor do they "transform[] a particular article into a different state or thing."  Bilski, 545 F.3d at 954.  Therefore we affirm.

That decision was written by Judge Moore, joined by Judge Newman (who dissented in the Court's en banc In re Bilski decision) and District Court Judge Joseph Farnan, sitting by designation.  Today's opinion was written by Judge Newman, joined by Chief Judge Rader, and Judge Moore penned a furious dissent.  In addition, Judge Rader wrote an opinion containing "additional views" regarding challenges to patent validity sounding in § 101.  The Court in its opinion also addressed not only the § 101 issues raised by the parties but also the denial of summary judgment of invalidity for anticipation and the District Court's determination that the activities of several co-defendants were within the "safe harbor" provisions of 35 U.S.C. § 271(e)(1).  In view of the complexities of these opinions, this post is limited to the majority opinion; future posts will consider Judge Moore's dissent and Chief Judge Rader's "additional views," which are directed to policy implications of § 101 challenges to patent eligibility.

There are three patents in suit:  U.S. Patent Nos. 5,723,283, 6,420,139, and 6,638,739; these patents contain a total of 230 claims asserted in the lawsuit.  Plaintiff designated certain claims as "representative claims," and the panel opinion made its determination on these claims.  The majority opinion draws a distinction between the claims of the '283 patent (which it found were not patent-eligible under § 101) and the claims of the '139 and '739 patents (which the majority found to be patent-eligible).  Claim 1 of the '283 patent can be compared to claim 1 of the '739 patent to illustrate the differences in the claims:

The '283 patent claim:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

The '739 patent claim:

1.  A method of immunizing a mammalian subject which comprises:
    (I)  screening a plurality of immunization schedules, by
        (a)  identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
        (b)  comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),
    (II)  immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

Plaintiff espoused a broad scope for these claims.  According to the majority opinion, plaintiff argued that the claims of the '739 patent were infringed "when a health care provider reads the relevant literature and selects and uses an immunization schedule that is of lower risk for development of a chronic immune-mediated disorder:" specifically:

[T]he '139 and '739 patents in suit are directly infringed when a physician, hospital or other health care provider reads the relevant literature and selects an immunization schedule and immunizes a patient in accordance with the schedule which appears to have minimal risk.

On the other hand, plaintiffs contended that the claims of the '238 patent were infringed "when a person reviews relevant information, whether the person is a producer of vaccines, a health care provider, or a concerned parent," specifically, "the infringer need only assess risk, it is not necessary for the infringer to conduct its own clinical trials or prove the cause of any adverse effects."

Although the majority opinion suggests that there was sufficient knowledge in the prior art that the patentability of these claims is in question, the opinion draws a strict line between such concerns and the question of patent-eligibility.  And the opinion expressly relies on the intervening precedent of Research Corp. Technologies, Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010); Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, _ S. Ct. _ , 2011 WL 973139 (June 20, 2011); and Association for Molecular Pathology v. U.S. Patent & Trademark Office, _ F.3d _, 2011 WL 3211513 (Fed. Cir. July 29, 2011), in reaching its determination on patent-eligiblity.  In reciting the conflicting positions of the parties, the majority opinion appears to be setting forth the basis for its decision:  whether the claims recite merely a mental step or a fundamental scientific principle, or an application of a principle that properly falls within the scope of § 101.

The majority opinion begins its analysis of the patent-eligibility question by reciting the broad scope of the statutory language, citing ancient precedent as well as Diamond v. Chakrabarty for the principle.  According to Judge Newman and Chief Judge Rader, the Supreme Court's decision in Chakrabarty arose at a time when the courts were also considering the patent-eligibility of inventions in "the evolving fields of computer science and technology," including especially Diamond v. Diehr.  In making determinations on patent-eligibility, the majority states that the Supreme Court has directed that "the boundary between abstract principle and practical application may vary with the subject matter."  These principles remain the standard as evidenced by the Supreme Court's decision in Bilski v. Kappos, which the majority opinion cites for the proposition that:

The §101 patent-eligibility inquiry is only a threshold test.  Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act's protection the claimed invention must also satisfy "the conditions and requirements of this title."  §101.  Those requirements include that the invention be novel, see §102, nonobvious, see §103, and fully and particularly described, see §112.

The majority "appli[ed] this distinction [between patent-eligibility and the substantive requirements of patentability] to the Classen patents" in arriving at its decision that the claims of the '139 and '739 patents satisfy the test and the claims of the '238 patent do not.

Turning to the District Court's decision on summary judgment that the claims of all the patents-in-suit did not recite patent-eligible subject matter, the majority states that the lower court's reasoning was based on its determination that "the method claimed in all three patents includes the mental step of reviewing the relevant literature to determine the lower-risk immunization schedule" and that the lower court did not consider whether the claims satisfied the other provisions of the Patent Act.  Citing Application of Prater, 415 F.2d 1393, 1402 n. 22 (CCPA 1969), the opinion states that "the presence of a mental step is not of itself fatal to §101 eligibility" and that there was no "universal rule" governing "all situations that include mental activity."

Classen argued, and the majority appear to agree, that an important distinction between the claims here and the claims in Bilski is that the presence of "immunization" steps in Classen's claims distinguish them from the commodity hedging method claimed by Bilski.  Recognizing the deficiencies in the Supreme Court's Bilski opinion (through the voice of former Justice Stevens, who "observed" that the majority "never provide[d] a satisfying account of what constitutes an unpatentable abstract idea"), the majority turn to the Federal Circuit's own Research Corp. precedent, for the principle that a claim should be disqualified from patent-eligibility only if the characteristic of "abstractness" "should exhibit itself so manifestly as to override the broad statutory categories of eligibile subject matter."  Although this "standard" appears subjective at best, the majority illustrates its application in Research Corp., where the claimed method was "functional and palpable" and thus patent-eligible.

Again turning to its Research Corp. precedent, the majority recites the statements in that case that subject matter eligibility is a "course eligibility filter" that is not the "final arbiter" of patentability (rather, the substantive provisions of §§ 102, 103 and 112 fulfill that role).  "The preferable procedure" is to "apply the substantive conditions and requirements of patentability" if the claims recite one of the statutory classes of invention and are not "manifestly abstract."  Also relevant to the question is whether there is a "commercial application of the technology," which the opinion contends is an indication that the subject matter is not "so abstract as to negate" patent eligibility under § 101.

Using these guidelines, the majority states that the '139 and '739 patent claims are patent-eligible, inter alia, because they recite methods that include "the physical step of immunization on [a] determined schedule" and thus are "directed to a specific, tangible application."  Although again raising the possibility that the claims do not satisfy the substantive provisions of the Patent Act, the majority concludes that finding these claims to be patent-eligible is consistent with Supreme Court precedent that subject matter eligibility should be construed broadly, and that "categorical rules" should not be adopted due to the possibility that such rules might have "wide-ranging and unforeseen impacts" on innovation.

The claims of the '238 patent, on the other hand, are not patent-eligible according to the majority, because they do not recite affirmative immunization steps.  The distinction appears to be that the patent-eligible claims of the '139 and '739 patents recite immunization steps after the appropriate schedule has been arrived at by operation of the other steps of the claim, whereas the claims of the '238 patent do not require any immunization step (except the steps that produce the pattern of immunization-related diseases and disorders recited in the claim).  This distinction is supported by arguments plaintiff made regarding acts constituting infringement, such as alleging that defendant Merck "induced direct infringement by parents when Merck provides and physicians distribute . . . [a] book that advises parents to understand vaccines and vaccination schedules."  Citing AMP v. USPTO, the majority states that "methods that simply collect and compare data, without applying the data in a step of the overall method, may fail to traverse the §101 filter."  That is the case here for the '238 patent claims.

The opinion also makes a distinction, termed "special consideration," when courts make patent-eligibility determinations for "evolving technologies" in order to provide the "liberal encouragement" for innovation resulting from the "permissive approach" to patent-eligibility taken by Congress in implementing the Patent Act and recognized by courts since (including the recent Bilski opinion by the Supreme Court).  Even under this expansive approach, however, the majority found that the '238 patent claim "is directed to the single step of reviewing the effects of known immunization schedules, as shown in the relevant literature" which, while a "first step in the scientific method" is not sufficient to recite patent-eligible subject matter.  The majority found that the method claimed in the '238 patent "do[es] not include putting this knowledge to practical use" and is merely "directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases."  This "abstraction" is not patent-eligible because it "is unrelieved by any movement from principle to application."

In making this distinction between the '238 patent claims and the '139 and '739 patent claims, the majority states that "[p]ragmatic thoroughness is thereby achieved, for extensive precedent guides the continuum from abstractness to specificity, in the context of a vast breadth of subject matter.  Aided by this experience, courts may more readily resolve close questions such as are here presented."

With regard to the other questions presented for review the majority declined to consider whether the claims were invalid for anticipation, on the grounds that denial of summary judgment was not generally appealable, citing Kendall v. City of Chesapeake, Va., 174 F.3d 437, 443-44 (4th Cir. 1999), as well as the pragmatic consideration that "there is no record, no factual findings or representations on which such findings might be made, indeed no basis for factual inferences, even on the premises of summary adjudication."  The Court did consider the question of infringement and whether certain of the defendants' (Biogen and GlaxoSmithKline) accused activities fell within the "safe harbor" provisions of 35 U.S.C. § 271(e)(1).  These activities constituted post-approval studies to determine whether immunizations with hepatitis B and Haemophilus influenza vaccines increase the incidence of type 1 diabetes, as well as an allegation that Biogen induced infringement by GSK by "providing instructions and/or recommendations on a proper immunization schedule for vaccines."  Classen argued that the § 271(e)(1) safe harbor is limited to pre-approval activities, and the majority agreed.  Assaying the legislative history and the purported purposes of the Hatch-Waxman Act, the opinion states that the safe harbor only applies to pre-approval activities (which the Biogen and GSK actions clearly were not):

§271(e)(1) provides an exception to the law of infringement in order to expedite development of information for regulatory approval of generic counterparts of patented products.  The statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.

The majority opinion also finds no change in this analysis based on the Supreme Court's decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 207 (2005), which was directed towards "preclinical research" that was, by definition, "pre-approval."  The Supreme Court's Merck decision was directed towards (and limited to) "preclinical research, whether or not ultimately included in a submission to the Food and Drug Administration, [that] is exempted from infringement by §271(e)(1) 'as long as there is a reasonable basis for believing that the experiments will produce "the types of information that are relevant to an IND [investigational new drug application] or NDA [new drug application].'"  Since the accused actions by Biogen and GSK were "not related to producing information for an IND or NDA," the majority concludes that § 271(e)(1) does not provide a safe harbor under the Merck precedent.

Finally, the majority directed that, on remand, the District Court should determine whether allegations of infringement for performing "studies 'to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza . . . and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk'" is properly within the bounds of the right to exclude granted to Classen or whether it is "impermissible under patent principles," i.e., as "preempting the field of study and prevent[ing] any investigation into any immunogen, known or unknown, and to any disease."

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)
Panel:  Chief Judge Rader and Circuit Judges Newman and Moore
Opinion for the court by Circuit Judge Newman; additional views by Chief Judge Rader; dissenting opinion by Circuit Judge Moore

Defendants File Petition for Rehearing in AMP v. USPTO

By Kevin E. Noonan --

Yesterday, counsel for defendants/appellants filed a petition for rehearing before the Federal Circuit in Association for Molecular Pathology v. U.S. Patent and Trademark Office.  Defendants assert a single ground for rehearing, based on the standing issue and particularly related to their allegations that Dr. Harry Ostrer (the only plaintiff found to have standing) no longer has the capacity for "immediately begin[ning] to perform BRCA 1/2-related genetic testing" upon invalidation of the Myriad patents.  This allegation is based on Dr. Ostrer's move from his academic position at New York University to a position at Montefiore Hospital and the Albert Einstein School of Medicine of Yeshiva University.  In addition, defendants ask the Court to dismiss the appeal and the case for lack of standing while not vacating the panel decision on patent-eligibility of claims to isolated DNA.

The gist of defendants' argument is that the panel found Dr. Ostrer (at left) to have standing because "he remains in the same position with respect to his ability and desire to provide BRCA testing as in the late 1990's."  The change in Dr. Ostrer's academic position destroys this predicate for "no change in position" according to defendants.  The petition states that Dr. Ostrer's standing was not personal to him but was based on his relationship with NYU:  "[b]ecause the communication [offering a license] was directed at NYU, involved the testing that was being performed at NYU, and offered to grant a license to NYU," the only basis for Dr. Ostrer to have standing "derived solely from his position at NYU" (emphasis in original).  These assertions are based on Dr. Ostrer's declaration testimony that:

Through the Human Genetics Program and Molecular Genetics Laboratory at the NYU Langone Medical Center that I direct, my staff and I engage in both research and clinical practice relating to genetic relate susceptibility to disease.  . . .  My laboratory has all of the personnel, expertise, and facilities necessary to do various types of sequencing of the BRCA1 and BRCA2 genes and I have a strong desire for my lab to provide such sequencing services.  We could, and would . . . do full sequencing [and other procedures used for diagnostic genetic testing (emphasis in original)].

According to the petition, "[t]hese statements . . . make clear that [Dr. Ostrer's] claim to standing depended entirely on his employment at NYU."  The petition asserts that the panel recognized this, by stating that "his lab has the personnel, facilities and expertise" to perform the testing, and that this had not changed from the time that Myriad offered NYU a license in 1998.  Dr. Ostrer's academic move thus removes the basis for the panel's determination that nothing had changed and at the same time destroyed the basis for the panel's determination that Dr. Ostrer has standing, defendants contend.

Defendants made similar, albeit less extensive, arguments in a letter to the Court the day before the panel rendered its decision (see "Myriad Writes to Federal Circuit on Standing Issue"), and plaintiffs responded a day later with their own letter (see "Standing in AMP v. USPTO: The Plot Thickens"), stating that Dr. Ostrer's "change in circumstances" did not change his capacity to perform the testing but merely the situs where the testing would be performed.  Defendants assert three arguments for why plaintiffs' response is inadequate to preserve Dr. Ostrer's standing to sue.  First, defendants argue that the move eliminates any controversy between Myriad and NYU.  The panel's decision on standing, the petition maintains, was based on Myriad's offer of a license to NYU as an institution, and that was the circumstance that the panel considered not to have changed (because NYU's employee, Dr. Ostrer, asserted the unchanged capacity and intention to practice the claimed invention should Myriad's patents be invalidated).  The petition contains a highlighted portion of Myriad's letter to NYU, illustrating that the offer to license was to the institution and was not personal to Dr. Ostrer:

The petition also notes as significant that, had NYU agreed to the proffered license, the right to perform BRCA testing would not have migrated with Dr. Ostrer when he moved from NYU to Montefiore.  Thus:

If the mere offer of a collaborative license to an institution constitutes a threat sufficient to support declaratory-judgment jurisdiction, then declaratory-judgment jurisdiction must be rooted in the actions being taken at the institution offered the license.

Second, there is no current controversy between Myriad and Montefiore, an institution that has not offered BRCA testing services in the past and with which Myriad has not "communicated" either now or earlier.  Plaintiffs' assertions in their responsive letter that Montefiore has "the same immediate capability" of performing BRCA genetic testing is not evidence, say defendants, and even if true, make Montefiore no different than "hundreds of laboratories around the United States" that have similar capabilities.  That is not enough to provide standing for declaratory judgment, the defendants assert, citing the panel opinion that declaratory judgment jurisdiction requires "affirmative acts by patentee directed at specific Plaintiffs" (emphasis in original).

Finally, defendants' petition contends that plaintiffs' letter to the Court (in response to their own) is insufficient to establish an "immediate controversy," based at least on the fact that in plaintiffs' letter Dr. Ostrer was characterized as having a "wish to engage in [diagnostic BRCA] sequencing" (emphasis in original).  The petition notes that the panel found similar statements from other named plaintiffs to be inconclusive and that such "some day intentions" were insufficient to establish standing for other named plaintiffs, including Drs. Kazazian and Ganguly.  In addition, there is no evidence that Montefiore is willing to permit Dr. Ostrer to perform BRCA-directed genetic diagnostic testing.

The petition asks the Court to dismiss the current appeal, and the underlying declaratory judgment action, for failure of any of the plaintiffs to have standing, saying that the case is moot because Dr. Ostrer's move from NYU will not "make a difference to the legal interests of the parties (as distinct from their psyches, which might remain deeply engaged with the merits of the litigation)," citing Nasatka v. Delta Scientific Corp., 58 F.3d 1578, 1580 (Fed. Cir. 1995).  In addition, defendants argue that "[b]ecause the mootness was caused by plaintiff Ostrer's unilateral action," the panel decision should not be vacated.  This argument is based on the principle that vacating a panel opinion is only appropriate when "mootness arises through no fault of the parties (such as external causes or mere 'happenstance')," citing  United States v. Munsingwear, Inc., 340 U.S. 36, 40 (1950).  The policy behind this standard is that a party subject to an adverse panel decision could otherwise always "seek to eliminate the unfavorable precedent by manufacturing mootness during the course of the appellate process," defendants contend.  The petition cites Tafas v. Kappos, 586 F.3d 1369, 1371 (Fed. Cir. 2009), as an instance where the Court refused to vacate a panel decision unfavorable to a party (the USPTO) when the party's "voluntary act" caused the action to be moot.  Unless there is a countervailing public interest that would be served by vacatur (and defendants argue there is none in this case), the petition argues that the Court should maintain the  patency of the panel decision.

The defendants' petition does not address any other issue, suggesting that Myriad has decided not to contest invalidation of the method claims included in the lawsuit.  Perhaps this is because there are other claims remaining to be asserted against a future infringer that are more likely to withstand a patent-eligiblity challenge than the claims in this case, or perhaps it is because of the impending Supreme Court decision in Mayo Collaborative Svcs. v. Prometheus Labs., Inc., which is expected to shed additional light on the patent-eligibility of medical diagnostic method claims regardless of whether they encompass a transformation step.  In any case, defendants' petition provides the Federal Circuit with an opportunity to revisit the standing issue, both as it applies to Dr. Ostrer and to the American College of Medical Genetics and Ms. Ellen Matloff (as argued in plaintiffs' petition).  Reaching a decision of "no standing" in this case would go a long way towards putting the genie of the patent-eligibility of gene patents back in the bottle, perhaps long enough for Myriad's patents to expire and moot the entire controversy.  There are worse outcomes.

Plaintiff(s) File Petition for Rehearing in AMP v. USPTO -- Update

By Kevin E. Noonan --

On Thursday, counsel for plaintiffs/appellees in Association for Molecular Pathology v. U.S. Patent and Trademark Office (who may be simply Dr. Harry Ostrer, the only plaintiff with standing in the case after the panel decision) filed a petition for panel rehearing before the Federal Circuit.  As grounds for rehearing, Plaintiffs list two points of law and fact that they allege were overlooked or misapprehended by the Court.  First, the petition contends that the Court "failed to consider whether the DNA fragments claimed in these patents are products of nature."  Second, the Court is alleged to have erred by not finding that two other named plaintiffs, the American College of Medical Genetics and specifically named plaintiff Ellen Matloff, satisfied the standards for standing enunciated by the Court.

Regarding the first asserted point of error, plaintiffs allege that "DNA fragments" (presumably, genomic DNA) exist in nature and thus are patent-ineligible.  This determination, according to the petition, ignores the "language of the claims" and "the scientific fact that DNA fragments with identical chemical structures are found in nature."  The claims do not define the claimed DNA by structure, plaintiffs contend, but by function:  encoding BRCA 1 or BRCA 2 polypeptides.  The claims thus include "[m]ultiple chemicals with different structures and covalent bonds broken in different places," including "allelic variations," "chemically or biochemically modified" polynucleotides, and nucleotides that are 60% identical to the claimed sequence.  According to the petition, "the many different chemicals described in each claim of the patent have nothing in common . . . except that they serve a particular function, i.e. they encode a particular protein" or protein fragment.  The petition alleges that this is the function the sequences have in nature, and therefore that the failure of the panel majority to declare the claims patent-ineligible on this basis was "an error in claim construction."

The petition further alleges that "DNA fragments identical to those claimed in the patents appear in the body," citing meiosis, double-strand DNA breaks, and the occurrence of fetal and maternal DNA fragments in maternal blood plasma in support of its conclusion that "all of the fragments that make up the BRCA1/2 genes can be found in natural maternal blood" (having the same characteristics -- broken covalent bonds and free 3' hydroxyl groups -- that the majority cites as a sufficient basis for finding the claimed isolated DNA to be "markedly different").  Also cited are instances where DNA fragments are found in blood plasma from cancer patients.  In plaintiffs' view, the purported existence of these DNA "fragments" from these natural sources renders the claimed DNA to be "products of nature" and thus unpatentable.

Finally, the petition cites the methods by which genes have been isolated from genomic DNA -- random fragmentation into vectors and identification of clones encompassing the gene -- as evidence that the claimed DNA fragments are sufficiently identical to what occurs randomly in nature for these fragments to qualify as patent-ineligible "products of nature."  The petition also cites the evidence that the oligonucleotide fragments can be found in other genes and are not specific to DNA (see "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims").  According to the petition, "if the claims cover, even in part, any product of nature, they must be found invalid."

The petition also asserts that the majority erred by basing its decision on evidence regarding the chemical nature of DNA that was "not supported by the record," specifically the fact that covalent bonds are broken in isolating BRCA DNA from the chromosome.  And the petition notes that plaintiffs would be "happy" to provide declarations containing "responsive facts" to explain to the Court what it "simply got wrong."  One has to admire their cheek.

One thing that these arguments reinforce is that what this case needs as a predicate to any further argument is for the Court to construe the claims (see "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?").  While many of the arguments contained in the petition seem fantastical to anyone who has worked in this area of patent law for any time, unless the parties can set forth the evidence and arguments for construing the claims, and the Court has an opportunity to rule on the scope and meaning of disputed claim terms, there can be no basis for the Federal Circuit, or the Supreme Court, to rule affirmatively on the question of whether the subject matter of the composition of matter claims is patent-eligible.

This portion of the petition also seems to indicate that plaintiffs have acquiesced to the majority's decision that cDNA claims are patent-eligible, despite those claims having the same "informational" content as the isolated genomic DNA claims that the petition argues were improperly determined by the majority to be patent-eligible.

With regard to the standing issue, plaintiffs argue that the finding that Dr. Ostrer (at right) has standing confers "organizational standing" on the American College of Medical Genetics, citing "well-established Supreme Court law," specifically Warth v. Selden.  For those who have not reviewed the Warth case, it involved a lawsuit against the town of Penfield, N.Y. by an organization, Metro-Act of Rochester, that alleged housing discrimination.  The Supreme Court found that the plaintiffs did not have standing to sue because none of the plaintiffs could demonstrate any injury in fact.  The relevant "Supreme Court law" recited in Warth is that for an organization to have standing, it must allege that "all or any one" of its members has suffered or been threatened with an immediate injury.

In addition, the petition argues that Ellen Matloff alleged that she "was told by Myriad that she and geneticists at Yale would violate Myriad's patents if they performed the test she wanted to perform."  The petition does not, however, point to any evidence that Ms. Matloff "would immediately begin to perform BRCA1/2-related genetic testing upon invalidation of the Myriad patents," which was the basis for the Court deciding that Dr. Ostrer has standing.  These assertions of standing for other plaintiffs arise in the wake of allegations by defendants that Dr. Ostrer no longer has the capacity for "immediately begin[ning] to perform BRCA 1/2-related genetic testing upon invalidation of the Myriad patents," an allegation denied by plaintiffs.

The one certain consequence of the filing of plaintiffs' petition is that any petition for certiorari will be delayed, making it likely that the Supreme Court will decide the Mayo Collaborative Svcs. v. Prometheus Labs., Inc. case before ruling on the invalidated method claims in the Myriad case.

Court Report

By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Alcon Pharmaceuticals, Ltd. et al. v. Apotex Inc. et al.
4:11-cv-00600; filed August 25, 2011 in the Northern District of Texas

• Plaintiffs:  Alcon Pharmaceuticals, Ltd.; Alcon Research, Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 7,977,376 ("Olopatadine Formulations for Topical Nasal Administration," issued July 12, 2011) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Alcon's Patanase® (olopatadine hydrochloride, used to treat seasonal allergic rhinitis).  View the complaint here.

Cadence Pharmaceuticals, Inc. et al. v. Exela Pharma Sciences, LLC et al.
5:11-cv-00116; filed August 24, 2011 in the Western District of North Carolina

• Plaintiffs:  Cadence Pharmaceuticals, Inc.; SCR Pharmatop
• Defendants:  Exela Pharma Sciences, LLC; Exela Pharmsci, Inc.; Exela Holdings, Inc.

Cadence Pharmaceuticals, Inc. et al. v. Paddock Laboratories, Inc. et al.
1:11-cv-00880; filed August 19, 2011 in the Western District of Michigan

• Plaintiffs:  Cadence Pharmaceuticals, Inc.; SCR Pharmatop
• Defendants:  Paddock Laboratories, Inc.; Perrigo Co.; Paddock Laboratories, LLC

Cadence Pharmaceuticals, Inc. et al. v. Paddock Laboratories, Inc. et al.
0:11-cv-02399; filed August 19, 2011 in the District Court of Minnesota

• Plaintiffs:  Cadence Pharmaceuticals, Inc.; SCR Pharmatop
• Defendants:  Paddock Laboratories, Inc.; Perrigo Co.; Paddock Laboratories, LLC

Cadence Pharmaceuticals Inc. et al.. v. Paddock Laboratories et al.
1:11-cv-00733; filed August 18, 2011 in the District Court of Delaware

• Plaintiffs:  Cadence Pharmaceuticals Inc.; SCR Pharmatop
• Defendants:  Paddock Laboratories Inc.; Perrigo Co.; Paddock Laboratories LLC; Exela Pharma Sciences LLC; Exela Pharmsci Inc.; Exela Holdings Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,028,222 ("Stable Liquid Paracetamol Compositions, and Method for Preparing the Same," issued February 22, 2000) and 6,992,218 ("Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles," issued January 31, 2006), both licensed to Cadence, following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Cadence's Ofirmev® (acetaminophen injection, used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fevers).  View the Paddock (Delaware) complaint here.

Forum on the Overhaul of U.S. Patent Law

The National Small Business Association (NSBA) and Washington, DC, Northern Virginia, and Baltimore sections of the IEEE will be holding a forum entitled "The Overhaul of U.S. Patent Law" on August 30, 2011 from 1:00 to 4:30 pm (ET) at the University of California Washington Center, 1608 Rhode Island Avenue, NW in Washington, DC.  Note: The forum was originally scheduled for August 29, but has been postponed due to Hurricane Irene.  Forum speakers and panelists will address the effects of statutory changes in the patent law on the courts, large and small firm patenting, investments in new inventions and new domestic science and engineering jobs creation prospects for U.S. professionals.  Other forum panelists will address the regulatory changes required to implement the new law, the prospects of U.S. Patent Office access to its user fees, and the Office's ability to handle the increasing workload and new tasks necessitated by the new law.  The forum will be moderated by Chris Katopis, former USPTO Director of Congressional Relations.  Speakers and panelists include:

• Paul Michel, Chief Judge (retired), The U.S. Court of Appeals for the Federal Circuit
• Pinchus Laufer, Office of Patent Legal Administration, U.S. Patent & Trademark Office
• John Duffy, University of Virginia School of Law
• Valerie Gaydos, Angel investor, Angel Venture Forum
• Ron Hira, Rochester Institute of Technology, co-author of "Outsourcing America"
• Ron Katznelson, Entrepreneur-inventor and President of Bi-Level Technologies
• Lisa Kuuttila, President & CEO, STC.UNM, at the University of New Mexico
• Henry Nothhaft, Serial Entrepreneur and Author of "Great Again"
• Herbert Schwartz, Patent litigator and author of "Patent Law and Practice"

There is no admission fee for the forum, but those interesting in attending should register at the forum webpage by August 29, 2011.  The forum will also be webcast, and can be viewed here.

AIPF 2011 Annual Meeting

The Association of Intellectual Property Firms (AIPF) will be holding its 2011 Annual Meeting on September 18-20, 2011 in Chicago, IL.  A program for the meeting, including an agenda, descriptions of the scheduled sessions, and list of speakers, can be viewed here.  A schedule of registration fees for the meeting can be found here, and a registration form for the meeting can be obtained here.

Conference & CLE Calendar

August 30, 2011 - The Overhaul of U.S. Patent Law (National Small Business Association and Washington, DC, Northern Virginia, and Baltimore sections of the IEEE) - 1:00 to 4:30 pm (ET)

August 31, 2011 - Expert Analysis of Federal Circuit's Ruling in Myriad Appeal (Technology Transfer Tactics) - 1:00 - 2:00 PM (Eastern)

September 6-7, 2011 - Pharmaceutical Law Academy (IBC Legal Conferences) - London, UK

September 8, 2011 - Patents and the Written Description Requirement: Lessons Learned Since Ariad v. Lilly (Strafford) - 1:00 - 2:30 PM (EDT)

September 11-13, 2011 - 2011 Annual Meeting (Intellectual Property Owners Association) - Los Angeles, CA

September 13, 2011 - Biotechnology/Chemical/ Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) - Alexandria, VA (and webcast)

September 14, 2011 - Compulsory Licensing as an Emerging Global IP Issue (Intellectual Property Owners Association) - Los Angeles, CA

September 14-16, 2011 - 85th Annual Meeting (Intellectual Property Institute of Canada) - Chicago, IL

September 18-20, 2011 - Accelerating Intellectual Property and Innovation in South Africa*** (South African Department of Science and Technology) - Cape Town, South Africa

September 18-20, 2011 - 2011 Annual Meeting (Association of Intellectual Property Firms) - Chicago, IL

September 19-20, 2011 - Tech Transfer Summit Europe*** (Tech Transfer Summit Ltd.) - Paris, France

September 19-21, 2011 - Business of Biosimilars & Biobetters*** (Institute for International Research) - Boston, MA

September 21-22, 2011 - Forum on European Pharmaceutical Regulatory Law*** (C5) - Brussels, Belgium

September 22-23, 2011 - FDA Boot Camp*** (American Conference Institute) - Boston, MA

September 26-27, 2011 - Biosimilars and Biobetters*** (SMi Group) - London, UK

September 26-27, 2011 - Life Sciences Business Development & Acquisitions in Emerging Markets (American Conference Institute) - New York, NYNew York, NY

October 3-4, 2011 - Tech Transfer Summit North America*** (Tech Transfer Summit Ltd.) - Bethesda, MD

October 4-5, 2011 - Maximizing Pharmaceutical Patent Lifecycles*** (ACI) -

October 5-6, 2011 - Biotech Patenting*** (C5) - London, UK

October 24-26, 2011 - Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) - London, UK

October 25-26, 2011 - FDA Boot Camp Devices Edition*** (American Conference Institute) - Chicago, IL

***Patent Docs is a media partner of this conference or CLE

Plaintiff(s) File Petition for Rehearing in AMP v. USPTO

By Kevin E. Noonan --

On Thursday, counsel for plaintiffs/appellees in Association for Molecular Pathology v. U.S. Patent and Trademark Office (who may be simply Dr. Harry Ostrer, the only plaintiff with standing in the case after the panel decision) filed a petition for rehearing before the Federal Circuit.  Patent Docs will make the petition available as soon as possible, including the grounds asserted for granting the petition.  Unless the Federal Circuit denies the petition, this action can be expected to delay the eventual petition for certiorari to the Supreme Court.  If that is plaintiffs' ultimate goal (as has been widely speculated), the only advantage to filing such a petition with the Federal Circuit, besides giving the Court another opportunity to opine, and perhaps do so en banc), is to strengthen plaintiffs' argument that the Federal Circuit cannot or will not decide patent-eligibiity in this case, and that the Supreme Court needs to provide appropriate guidance to the lower court.

Unigene Laboratories, Inc. v. Apotex, Inc. (Fed. Cir. 2011)

By Kevin E. Noonan --

The Federal Circuit today issued its ruling in Unigene Labs., Inc. v. Apotex, Inc., and the decision illustrates the extent of the effects of the Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc. on the Federal Circuit's obviousness jurisprudence.  In addition, the decision provides a contrast between how the Court views chemical obviousness for pharmaceutical formulations today, and the views contained in the Court's opinion in Pfizer, Inc. v. Apotex, Inc.

The case involved litigation over Unigene's drug Fortical®, a nasal formulation of salmon calcitonin for treating post-menopausal osteoporosis.  This drug is an alternative formulation of another salmon calcitonin-based drug, Miacalcin®, sold by Novartis.  The patent-in-suit was Unigene's U.S. Patent No. RE40,812, a reissue of U.S. Patent No. 6,440,392, and specifically asserted claim 19:

A liquid pharmaceutical composition for nasal administration comprising about 2,200 MRC units of salmon calcitonin, about 20 mM citric acid, about 0.2% phenylethyl alcohol, about 0.5% benzyl alcohol, and about 0.1% polyoxyethylene(2) sorbitan monooleate.

The District Court noted that calcitonin was known in the art to be difficult to administer, since it was known to be readily degraded, unstable, and poorly absorbed.  Both Miacalcin® and Fortical® contain 2200 IU salmon calcitonin, but the formulations differ:  the Novartis formulation contains sodium chloride, nitrogen, hydrochloric acid, water, and benzalkonium chloride (to promote absorption), while Unigene's formulation contains 20mM citric acid, polyoxyethylene(2) sorbitan monooleate (also termed "polysorbate 80"), phenylethyl alcohol, and benzyl alcohol.  Unigene received FDA approval of Fortical® under an NDA pursuant to 21 U.S.C. § 355(b)(2) using Miacalcin® as "reference drug."

Litigation ensued after Apotex filed an ANDA containing a Paragraph IV certification.  In its certification, Apotex asserted noninfringement, invalidity, and unenforceability for inequitable conduct.  The District Court found (on summary judgment) that the claims were nonobvious over "forty four prior art references" and that Apotex had not adduced sufficient evidence of an intent to deceive to support the inequitable conduct allegation; in this regard, the Court also refused to breach the attorney-client privilege under the crime-fraud exception.  The key for the District Court's determination of nonobviousness was that the art did not disclose using 20 mM citric acid in the formulation "to achieve 'both shelf stability and enhanced bioavailability' in a nasal salmon calcitonin formulation."  With regard to the other affirmative defenses, the District Court "held that all of Apotex's defenses and counterclaims . . . had been conceded, waived, barred, abandoned, or improperly raised."

The Federal Circuit affirmed in an opinion written by Chief Judge Rader and joined by Judges Moore and O'Malley.  In the opinion, the Court recited several rubrics from KSR that showed the nuances developed by the Federal Circuit in its application of the Supreme Court precedent.  These include:

• "Obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination.  KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)."

• "Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention.  Id. at 421"

• "A person of ordinary skill at the time of the invention interprets the prior art using common sense and appropriate perspective.  KSR, 550 U.S. at 421."

The opinion cites the portion of the KSR opinion regarding the relationship between what is "obvious to try" and what is obvious:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill.

The opinion notes that "[a]ccordingly, when design need and market pressure may dictate a commonsensical path using a finite number of identified predictable solutions to one of ordinary skill, deviations from that path are likely products of innovation."  In addition, the opinion notes that the "teaching-suggestion-motivation (TSM)" test provides "one way to identify 'sources of evidence that an ordinary skilled artisan might have found and combined at the time of the invention,'" citing Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364-65 (Fed. Cir. 2008).

Applying these principles, the Court held that "the patent claims a new composition or formulation to deliver an FDA-approved active ingredient.  Thus, the claimed invention is not obvious if a person of ordinary skill would not select and combine the prior art references to reach the claimed composition or formulation," citing Eli Lilly v. Zenith Goldline Pharm., 471 F.3d 1369, 1380 (Fed. Cir. 2006).  Under the circumstances of this case (a reformulation of a known formulation of a known compound), the opinion states that "[a] prima facie case of obviousness in the chemical arts is often based on a known compound, called a 'lead compound,' which serves as a starting point for a person of ordinary skill developing the claimed invention," citing Eisai Co. Ltd. v. Dr. Reddy's Labs., 533 F.3d 1353, 1357 (Fed. Cir. 2008).  Such a lead compound then provides a basis to show "structural similarities" between the prior art and the claimed lead compound.  But for formulation cases "where the patented formulation was made to mimic a previously FDA-approved formulation," the Court says the term "reference composition" is a better way to frame the issue, since the "functional and pharmaceutical properties" of the composition may be more informative ("appropriate") than the chemical structure of the lead compound.  The Court then looks to the comparison between the Norvartis Miacalcin® product, which the Court finds is the substitution of 20 mM citric acid for BZK.

The Court recognized that the art provided "design need and market demand" for a nasal formulation of calcitonin, identifying the "design need" as the bioequivalent formulation, and the market demand for a composition that treats the same symptoms.  The Court's opinion then focused on the citric acid component -- in part from statements made at oral argument -- and says that "the inclusion of 'about 20 mM citric acid' in the composition provides the strongest case for nonobviousness."

Prior art references considered by the District Court and relevant to the panel opinion include U.S. Patent No. 5,912,014 (which named the inventor of the patent-in-suit as an inventor), which disclosed an oral calcitonin formulation comprising enteric coating and further disclosed experiments on the effects of citric acid on bioavailability and absorption in vivo (albeit showing but minor effects).  With regard to this reference, the opinion states that "this court agrees that no reasonable juror could conclude that the '014 patent would give a person of ordinary skill sufficient reason or motivation to use about 20 mM citric acid in a liquid nasal salmon calcitonin composition."  The Court's reasoning distinguished the formulation claimed in the '812 reissue patent from the oral formulations disclosed in the '014 patent on the difference between an oral dosage form and a liquid formulation, and the "significant" differences in route of administration and formulation.  These facts "would not cause a person of ordinary skill to replace BZK in Miacalcin® with 20 mM of citric acid in the normal course of research and development" in the Court's opinion.  In addition, other prior art referenced -- including U.S. Patent Nos. 5,124,315 and 4,476,116 -- showed only a "vague role" played by citric acid in formulations disclosed in those patents.  The Court cited the '116 patent as teaching from using citric acid as disclosed in the '812 reissue patent, because the '116 patent:

[L]ists over fifty examples, including citric acid, of pharmaceutically acceptable chelating agents to serve as absorption agents . . . .  Both parties agree that the '315 patent reports that the compounds listed in the '116 patent yielded "discouraging" test results, and that "only ammonium tartrate is a satisfactory stabilizing agent for liquid nasal compositions containing polypeptides as active ingredient [sic]."  . . .  One of ordinary skill in the art reading the '315 and '116 patents would have considered about 20 mM citric acid undesirable in a liquid nasal formulation containing salmon calcitonin."

Yet another prior art reference, the Day reference, lists benzyl alcohol and phenylethyl alcohol, two other components of the claimed formulation, as "Excipients used in aqueous nasal products."  The Court characterized this reference as follows:

BZK is one of the nine listed preservatives in Day, along with benzethonium chloride, chlorobutanol, methylparaben, phenylmercuric acetate, propylparaben, and thimerosal.  Citric acid is not included in the list of preservatives, but appears instead as a pH adjuster or buffer.  The Day reference also lists polysorbate 20 and 80 as one of three surfactants used as excipients in aqueous nasal products.  With reference to this prior art, there is no evidence to support the conclusion that a person of ordinary skill would expect a combination of citric acid, benzyl alcohol, phenylethyl alcohol, and polysorbate 80 to contain a buffer, pH adjuster, preservative, and surfactant, but no absorption enhancer or excipient to promote bioavailability.

Finally, the opinion states that the affirmatively recited limitation "about 20.0 mM citric acid" "alone supports" the District Court's nonobvious determination:

When used as an absorption enhancer in the '116 patent, citric acid was one of over fifty options.  See KSR, 550 U.S. at 421.  Further, when the prior art used citric acid at about 20 mM, as in the '315 patent, it was used only as a buffer.  There is no genuine dispute of material fact that a person of ordinary skill attempting to make a liquid composition to deliver salmon calcitonin into a human body through nasal administration, would not have considered using about 20 mM citric acid with the narrowly claimed amounts of benzyl alcohol, phenylethyl alcohol, and polysorbate 80, because the formulation would not be expected to perform properly to meet the specificity of a pharmaceutical use.  Thus, even accepting that there was a design need and market pressure to develop a pharmaceutical formulation that is bioequivalent to Miacalcin®, there is no evidence in the record that claim 19 would be an obvious solution to those motivations.

This outcome is in contrast with the decision in Pfizer v. Apotex, issued in the shadow of the (then) impending KSR decision.  That case involved a novel formulation of a known compound, amlodipine, as a besylate salt, sold under the trademark Norvasc® for treating hypertension and chronic stable and vasospastic angina.  The patent in the Pfizer case, U.S. Patent No. 4,879,303, claimed the besylate salt, while prior art (U.S. Patent No. 4,572,909) disclosed the maleate salt of the active ingredient, 2-[(2-aminoethoxy)methyl]-
4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine.  In Pfizer, the Federal Circuit reversed a District Court finding of nonobviousness (determined under the TSM test), relying in part on a reference (Berge) that disclosed 53 FDA-approved anions for making pharmaceutically-acceptable salts, including the anion -- benzene sulphonate -- used to make amlodipine besylate.  There, the choice of salt was considered merely to reflect a design choice and the beneficial and purportedly unexpected properties were discounted by the panel.  In today's opinion, the Court appears to have returned to its prior tendency to understand that the pharmaceutical formulation arts are sufficiently unpredictable that there is a real threat of hindsight reconstruction in the face of successful novel formulations of known compounds.  As Judge Rader stated in his dissent to the Court's refusal to rehear the Pfizer case en banc, "[w]ith unpredictable pharmaceutical inventions, this court more wisely employs a reasonable expectation of success analysis," and since salt selection is unpredictable, there would be no reasonable expectation of success (as three District Court judges had previously found).

Thus, the Federal Circuit appears to have absorbed the thrust of the Supreme Court's KSR opinion, to give more credence to the skilled worker's capacity to recognize beneficial combinations of the prior art, and to consider whether the totality of the teachings of the art support the conclusion that even if it would be obvious to try, a novel formulation is "not obvious if a person of ordinary skill would not select and combine the prior art references to reach the claimed composition or formulation."

Unigene Labs., Inc. v. Apotex, Inc. (Fed. Cir. 2011)
Panel: Cheif Judge Rader and Circuit Judges Moore and O'Malley
Opinion by Chief Judge Rader

Biotech/Pharma Docket

By James DeGiulio --

Allergan Secures Infringement Ruling Against Generics in Combigan Patent Suit

Allergan has successfully secured an infringement ruling against Sandoz, Alcon, Apotex, and Watson Laboratories in the consolidated patent suit over four patents covering the glaucoma medication Combigan.  Allergan has spent several years aggressively protecting its patents for Combigan, which is used to lower intraocular pressure in patients with glaucoma or ocular hypertension.  Four patents have been listed in the Orange Book for Combigan:  U.S. Patents Nos. 7,030,149, 7,320,976, 7,323,463, and 7,642,258.

In April 2009, Allergan brought suit in the U.S. District Court for the Eastern District of Texas against Sandoz in response to the ANDA Sandoz filed seeking approval to market a generic version Combigan (see "Court Report," April 12, 2009).  More generic drugmakers filed ANDAs over the glaucoma drug, which spurred Allergan suits against Hi-Tech and Alcon in 2009 (see "Court Report," June 14, 2009, November 15, 2009), and Apotex and Watson in 2010 (see "Court Report," June 20, 2010, September 12, 2010).  In June 2010, Allergan and Hi-Tech settled their case, resolving the infringement claims (see "Biotech/Pharma Docket," June 20, 2011).

On August 22, after a bench trial, Judge T. John Ward issued a Judgment and Injunction, ruling that Sandoz, Alcon, Apotex, and Watson infringed all four Allergan patents in their efforts to market generic versions of Combigan.  Judge Ward also confirmed that the four patents are valid and enforceable.  The generics were enjoined from gaining approval of their ANDAs and thus from entering the market with their own versions of brimonidine tartrate/timolol maleate ophthalmic solution until after the last of the '149, '976, '463, and '258 patents expires.

Novartis and Apotex Resolve Patent Dispute over Myfortic

Novartis has resolved an infringement suit against Apotex over the patents covering Myfortic.  Novartis' Myfortic is an immunosuppressant drug used to prevent patient's bodies from rejecting transplant organs.  These types of drugs have been successfully used to protect against transplant rejection, but have been criticized recently by the FDA for their potential associated side effects, including kidney disease.

On November 3, 2009, Novartis brought suit in the U.S. District Court for the District of New Jersey after Apotex submitted an ANDA in June 2009 seeking approval for delayed-release tablets in 180- and 360-milligram doses (see "Court Report," November 15, 2009).  Novartis accused Apotex of infringing U.S. Patent Nos. 6,025,391, 6,172,107, and 6,306,900, which Novartis listed as covering treatments using mycophenolate salts, the active ingredient in Myfortic.  Novartis sought to have the District Court permanently enjoin Apotex from marketing and selling its generic version of Myfortic, as well as an order that any approval of Apotex's ANDA would not be effective until after the patents expire in April 2017.  Apotex refuted the infringement allegation by challenging the validity of the patents, stating in its claim construction brief, filed in December 2010, that Novartis barely provided any evidence to support its position that its patent claims were valid.  Novartis also has a case pending against Teva in Delaware over a generic Myfortic (see "Court Report," May 8, 2011).

The District Court was first notified that the parties had reached a settlement on June 29.  On August 18, Judge Peter G. Sheridan granted Novartis' stipulation of dismissal, ending the litigation between the two parties.  The parties stipulated to dismissal under Federal Rules 41(a)(1)(A)(ii) and 41(c).  Terms of the agreement were not disclosed in the order.

Novartis Settles with Macleods in Famvir Patent Dispute

Novartis has agreed to settle a suit with Macleods Pharmaceutical, ending its infringement dispute with Macleods of its plan to market a generic version of the herpes treatment Famvir.  On April 1, 2010, Novartis filed suit in U.S. District Court for the District Of Columbia, alleging that Macleods infringed U.S. Patent No. 5,866,581 when it filed an ANDA seeking approval for a generic version of the herpes treatment (see "Court Report," April 11, 2010).  Novartis was also engaged in a Famvir infringement suit against Roxane Laboratories in the District of New Jersey (see "Court Report," May 18, 2008), but that case settled in June.  Novartis remains in litigation with Teva over its generic form of Famvir.

On August 22, Judge James E. Boasberg signed an order dismissing the case without prejudice after both parties filed a stipulation of dismissal under Federal Rules 41(a)(1) and 41(c), indicating that they would reach a settlement agreement.  Further details about the settlement were not immediately available.

CyberSource and the Tragedy of Bad Analogies

Is DNA patent-ineligible because it is like software?

By Kevin E. Noonan --

Recently, in CyberSource Corp. v. Retail Decisions, Inc., a panel of the Federal Circuit invalidated claims to software directing the performance of a process for preventing fraud in Internet purchases.  While this type of decision is generally not germane to the topics discussed on Patent Docs, the majority's rationale for its decision affirming the District Court, and its make-up (comprising author Judge Dyk and Judge Bryson), in view of their views on the patent-eligibility of DNA, suggest that a closer look at this decision is warranted.  This is particularly the case in view of the penchant for pundits, commentators, and advocates (particularly the ACLU) to take literally the metaphor that DNA is like software, ignoring the many ways in which it is not.

The case involves U.S. Patent No. 6,029,154, containing inter alia the following method and software ("Beauregard") claims:

2.  A computer readable medium containing program instructions for detecting fraud in a credit card transaction between a consumer and a merchant over the Internet, wherein execution of the program instructions by one or more processors of a computer system causes the one or more processors to carry out the steps of:
    a)  obtaining credit card information relating to the transactions from the consumer; and
    b)  verifying the credit card information based upon values of plurality of parameters, in combination with information that identifies the consumer, and that may provide an indication whether the credit card transaction is fraudulent,
    wherein each value among the plurality of parameters is weighted in the verifying step according to an importance, as determined by the merchant, of that value to the credit card transaction, so as to provide the merchant with a quantifiable indication of whether the credit card transaction is fraudulent,
    wherein execution of the program instructions by one or more processors of a computer system causes that one or more processors to carry out the further steps of:
        obtaining information about other transactions that have utilized an Internet address that is identified with the credit card transaction;
        constructing a map of credit card numbers based upon the other transactions; and
utilizing the map of credit card numbers to determine if the credit card transaction is valid.

3.  A method for verifying the validity of a credit card transaction over the Internet comprising the steps of:
    a)  obtaining information about other transactions that have utilized an Internet address that is identified with the credit card transaction;
    b)  constructing a map of credit card numbers based upon the other transactions and;
    c)  utilizing the map of credit card numbers to determine if the credit card transaction is valid.

The District Court granted summary judgment of invalidity that the claims were patent-ineligible under Bilski, based on the method claims reciting, in the Court's opinion, "an unpatentable mental process for collecting data and weighing values [which did] not become patentable by tossing in references to [I]nternet commerce."  Claim 2 was patent-ineligible, according to the District Court, because "simply appending 'A computer readable media including program instructions . . .' to an otherwise non-statutory process claim is insufficient to make it statutory."

Considering the lower court's decision on the method claim first, the panel agreed that this claim was patent-ineligible because it failed the Bilski "machine-or-transformation" test.  Relevant to this determination was the patentee's concessions that "the 'Internet address' recited in step (a) of claim 3 'may be, for example, an Internet protocol (IP) address or an e-mail address for the particular credit card transaction;'" the "'map of credit card numbers' recited in step (b) can be as simple as a list of credit card transactions relating to a particular IP address;" and that "step (c) does not limit claim 3 to any specific fraud detection formula or mathematical algorithm, but rather broadly purports to encompass any means of 'utilizing the map of credit card numbers to determine if the credit card transaction is valid.'"  As in Bilski, the panel found that the claimed methods were merely directed to "obtain[ing] and compar[ing] intangible data pertinent to business risks."  The claims "plain language" did not involve any machine, and "[t]he mere collection and organization of data regarding credit card numbers and Internet addresses is insufficient to meet the transformation prong of the test," said the Court.  And the recitation of "the Internet" as a limitation was a "mere data-gathering step" according to the panel that did not render the claim patent-eligible.

At this point in the opinion, there is little that is surprising to anyone following the Federal Circuit and Supreme Court decisions in Bilski.  Claims such as claim 3 in the '154 patent have been at risk since the Federal Circuit's en banc Bilski decision, since such claims recite neither a transformation of an article into a different state or thing nor reciting a particular machine.  The panel extends this analysis by considering whether this claim recites an invention that is patent-eligible, despite failing the machine-or-transformation test, pursuant to the Supreme Court's holding that the test is not exclusive.  The panel concludes that this claim does not fall into that exceptional category; rather, the claim recites "an unpatentable mental process -- a subcategory of unpatentable abstract ideas," citing Gottschalk v. Benson, 409 U.S. 63 (1972), and Parker v. Flook, 437 U.S. 584 (1978).  "[M]ethods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas -- the 'basic tools of scientific and technological work' that are open to all," in the panel's opinion, citing Benson at 67.  To the panel, it was "clear that unpatentable mental processes" are what is claimed in claim 3 of the '154 patent ("[a]ll of claim 3's method steps can be performed in the human mind, or by a human using a pen and paper"), and hence the claim was not patentable.

The panel then turned to the "computer-readable medium" claim, which it characterized as a "Beauregard" claim (derived from In re Beauregard, 53 F.3d 1583 (Fed. Cir. 1995)) that is "a claim to a computer readable medium . . . containing program instructions for a computer to perform a particular process."  The panel considers this claim to be "nothing more than a computer readable medium containing program instructions for executing the method of claim 3."  CyberSource contended that an important distinction between claims 2 and 3 of the '154 patent was that claim 3 was directed to a process and claim 2 was directed to a manufacture.  The panel rejected this distinction as being meaningless for patent-eligibility, despite the fact that claim 2 clearly does not claim a "law[] of nature, physical phenomenon or abstract idea[]."  Instead, the opinion says that the Court "looks to the underlying invention for patent-eligibility purposes . . . [r]egardless of what statutory category . . . a claim's language is crafted to literally invoke" (a statement seemingly at odds with the principle that a patentee is free to claim an invention in any language that satisfies the requirements of 35 U.S.C. § 112, second paragraph.  In re Steppan, 394 F.2d 1013 (CCPA 1967).  In this case, the Court based its decision on In re Abele, 684 F.2d 902 (CCPA 1982), where a claim directed to "an apparatus for displaying data" was equivalent to held to be an unpatentable method claim.  And the panel distinguishes its decision in this case with the extensive line of cases, represented by In re Alappat, 33 F.3d 1526, 1545 (Fed. Cir. 1994), to the effect that programming a general-purpose computer to perform a specific algorithm "creates a new machine, because a general purpose computer in effect becomes a special purpose computer once it is programmed to perform particular functions pursuant to instructions from program software."  Further, the panel imposes the machine-or-transformation test on claim 2 of the '154 patent, a test heretofore only used to determine the patent-eligibility of method claims. 

But as with method claims, at least part of the panel's difficulty with determining that claim 2 was patent-eligible is that it recites no specific algorithm and thus does not "impose meaningful limits on the claims scope."  "[M]erely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test," the opinion concludes, citing Benson as controlling authority.  The opinion also distinguished its own precedent, including SiRF Tech., Inc. v. Int'l Trade Comm'n, 601 F.3d 1319 (Fed. Cir. 2010), and Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010), on the grounds that, unlike in those cases the use of a computer was not required to practice the method ("the method could not, as a practical matter, be performed entirely in a human's mind").

The relevance of the Court's decision in CyberSource to the question of the patent-eligibility of DNA is rooted in two aspects of that decision:  first, that the Court is empowered to look to the "underlying invention" untethered to the expressly recited claim language, and to the argument that DNA is nothing more than information, essentially the software that directs protein production in a cell.  To develop the analogy, here the "computer" would be a cell that produces a protein according to the instructions contained in the DNA, so that a claim such as Myriad's claim to the BRCA 2 gene in U.S. Patent No. 5,837,492 could be cast in the following language:

An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2, wherein said molecule is capable of directing a cell to execute a genetic program comprising the steps of:
    a)  transcribing the DNA molecule to produce mRNA; and
    b)  translating the mRNA to make the BRCA2 polypeptide.

The fact that such a claim is not asserted (or even contained) in the Myriad patents-in-suit in AMP v. USPTO is unavailing to preclude such an analysis, since the "underlying invention" is isolation of a gene that has the capacity to direct the production of a BRCA polypeptide in a cell.  This capacity is another one of the essential biological features inherent in any nucleic acid encoding a complete BRCA polypeptide; indeed, the same arguments that have been made regarding the requirement for the "information" in an isolated DNA to be identical to the "information" in the gene in situ in a chromosome could be made for the capacity to direct production of the encoded protein.  And the same argument that the distinctions recognized by the majority opinion in the Myriad case should be ignored, substantially because the information is the "underlying invention" (or perhaps more in the language of patent law, provides the molecule's utility) could be made here.

DNA is not a software program, of course:  the information content is not patented (as opposed to the patenting of a program) and said information is embodied in a biological molecule having a distinctive structure that is different from its structure as found in nature (including the difference that useful quantities of the isolated DNA can be specifically made).  Perhaps the analogy can be extended by treating the specific disclosed sequence (SEQ ID NO. 2 for BRCA 2 in the '492 patent as a specific algorithm, and thus limiting the scope of the claim to be sufficiently definite and specific to avoid the conclusion the Court reached for the software claims in the '154 patent in CyberSource.

But the metaphor/analogy between DNA and software is not something that will go away, especially in view of 50 years of molecular biologists presenting the metaphor as a way to explain to the layman the significance of the discoveries and inventions that have resulted from this still relatively new science.  If the Myriad and CyberSource decisions have taught us anything, it is that it is time to move past facile and inapt analogies in making decisions on patent eligibility.

Is Claim Construction the Key to Patent-eligibility of Isolated DNA?

By Kevin E. Noonan --

Judge Giles Sutherland Rich famously said that, in patent law, "the name of the game is the claim."  One of the weaknesses in the "gene patenting" debate, as well as in the District Court's opinion in AMP v. USPTO (the Myriad case), is the lack of clarity about the scope and meaning of the claims of the challenged patents.  The District Court did not bother to hold a Markman hearing to construe the claims, and thus neither that Court nor the Federal Circuit in reviewing Judge Sweet's decision brought any clarity to what the parties were arguing about, instead drawing generally inapt analogies to what other claims in other patents might claim.  The type and number of claims at issue are sufficiently similar, having generally the same structure and using the same language that claim construction might help, and the language used is certainly no more arcane than in any other patent case.

Construing claim language to determine the scope and meaning of the claims is a matter of law for the district court in the first instance (Markman v. Westview Instruments, Inc., 52 F.3d 1321 (Fed. Cir. 1995) (en banc), aff'd 517 U.S. 370 (1996)).  The Federal Circuit reviews claim construction de novo, giving no deference to either the district court's ultimate construction of claim terms or any factual determinations underlying the court's legal determination of claim scope (Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)).  The way courts are to perform claim construction was set forth (most recently) by the en banc Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).  This procedure can be summarized in a few simple rules.  First, claim terms are to be given their "ordinary and customary" meaning as understood by those with skill in the art.  Id. at 1313.  Next, the specification is consulted to determine whether the patent applicant has acted as his or her own lexicographer, a capacity recognized as black letter patent law (see Autogiro Co. Amer. v. U.S., 384 F.2d 391 (Ct. Claims 1967).  This ability to define terms is limited only insofar as the applicant attempts to define a commonly accepted term in a way that is "repugnant" to its meaning in the art.  In re Hill, 161 F.2d 367 (CCPA 1947).  In the event that there is any ambiguity about the "ordinary and customary" meaning of a claim term, resort to the specification is preferred under Phillips as "the single best guide to the meaning of a disputed term."  Id. at 1315 (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).  Finally, the prosecution file history should be consulted to ensure that a patentee cannot advance a narrow construction of a term during patent prosecution, only to argue a broader construction in an infringement action.  Phillips at 1317.

With these concepts and principles in mind, generally two types of claims were at issue in the Myriad case:

1.  Isolated DNA claims (as well as claims to oligonucleotides); and
2.  Diagnostic method claims.

(The one other claim at issue, claim 20 of U.S. Patent No. 5,474,282, is in some ways sui generis to the other claims, being directed to methods for screening chemical compounds for anti-cancer properties.)  Claim 1 of U.S. Patent No. 5,837,492 is representative of the first type of claim:

An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.

(Claims 1 and 7 of the '282 patent; claims 6 and 7 of the '492 patent; and claim 1 of U.S. Patent No.  5,693,473 are variants of this general claim type.)  The italicized words and phrases in the exemplary claim need construing, the other terms being expressly defined with regard to other terms in the claims (e.g., the amino acid sequence of the BRCA2 polypeptide is defined as SEQ ID NO: 2; as a consequence, any ambiguity in the meaning of this term devolves to any ambiguity in the nature of the expressly recited sequence).

Of the italicized terms, the parties and the Federal Circuit focused most attention on the term "isolated."  This term has a meaning accepted by the Patent Office (and in the biotechnology arts) with regard to nucleic acids, wherein the term means "isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it."  Utility Examination Guidelines, 66 Fed. Reg. 1094 (2001).  An associated definition is found in the specification of the patents in suit:

"Isolated" or "substantially pure".  An "isolated" or "substantially pure" nucleic acid (e.g., an RNA, DNA or a mixed polymer) is one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins.  The term embraces a nucleic acid sequence or protein which has been removed from its naturally occurring environment, and includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems.

Some in the gene patenting debate have characterized this meaning as encompassing isolation of total genomic DNA as falling within the scope of the claim; indeed this interpretation is one of the bases for the argument that Myriad's claims may inhibit "whole genome sequencing" methods, as Chris Hansen of the ACLU argued during oral argument in Myriad (see "AMP v. USPTO: Oral Argument at the Federal Circuit").  This interpretation is only persuasive, however, if the phrase "many other human genome sequences" is eliminated from the list of cellular components from which the BRCA-encoding DNA is separated.  Thus, the ordinary and customary meaning of the term "isolated" is reinforced by the express meaning of the term as recited in the specification.  And as interpreted using this meaning, the distinctions drawn in the majority and concurring opinions in Myriad, between what is isolated and what is "merely" purified, become less relevant, since DNA is understood both to be "purified" from other cellular components and "isolated" from other human genome sequences.

In addition, since claims must be construed as a whole, giving each limitation meaning and avoiding surplusage, what is "isolated" is a nucleic acid encoding an amino acid sequence "set forth" in the specification as SEQ ID NO: 2.  Thus, properly interpreted, the claim is limited to DNA molecules that encode the BRCA 2 polypeptide.  The only other claim term that could expand the scope of these claims to extend to nucleic acids other than those encoding the BRCA proteins (and only those having the specifically recited amino acid sequences) is the word "comprising."  However, using another well-recognized rubric of claim construction, this word cannot be used to expand the scope of the claim to extend to human genomic DNA per se:  first, because "claims should be so construed, if possible, as to sustain their validity," Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed Cir. 1999); see also Klein v. Russell, 86 U.S. (19 Wall.) 433, 466, 22 L. Ed. 116 (1873), but also because claims are interpreted in light of the specification, United States v. Adams, 383 U.S. 39, 49, 15 L. Ed. 2d 572, 86 S. Ct. 708, 174 Ct. Cl. 1293 (1966).  The specification of the Myriad patents claiming DNA encoding BRCA1 and BRCA2 disclose the patentees' efforts to identify, isolate, and purify BRCA-encoding DNA.  Thus, the proper interpretation of these claims is directed to DNA (and in particular, cDNA) encoding the BRCA proteins.

Turning to the diagnostic method claims, claim 1 of U.S. Patent No. 5,753,441 is representative:

A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

(Claims 1 of U.S. Patent No. 5,709,999; claim 1 of U.S. Patent No. 5,710,001; and claims 1 and 2 of U.S. Patent No. 6,033,857 are variants of this general claim type.)  Here, the claim term "comparing" has no specific definition in the specification; however, Example 9, entitled "Analysis of BRCA 1 Mutations" sets forth the general method for extracting DNA from blood or tumor samples from patients with breast or ovarian cancer to detect mutations.  The relevant claim term to be construed is thus from a tissue sample from said subject, and whether this implies a necessary transformation step to ascertain the individual patient's BRCA gene sequence.  Both the District Court and the Federal Circuit treated this claim as if it had been construed to encompass mere inspection of and comparison between two sequences (i.e., printouts of the germline and patient sample sequences) that did not require a patient sample to be assayed to obtain the sequence.  While not a necessarily unreasonable interpretation (since these claims do not expressly recite limitations drawn to obtaining a sample and determining the BRCA gene sequence therefrom), it is not the only interpretation.  What is missing from any judicial analysis of the diagnostic method claims at issue is whether the skilled worker would understand the claim not to require these steps, and whether the specification mandates interpretation of the claim to include these steps.  (The prosecution file history may also be informative as to what the patentee understood the invention to be and, more importantly, represented that understanding to the patent examiner, with regard to the scope of these claims.)

The danger in ignoring and failing to perform the fundamental and threshold exercise of construing the claims at issue in patent litigation is clearly illustrated in the briefs (both from the parties and the amici) and the decisions of both the District Court and the Federal Circuit.  The Courts' analyses are understandably adrift without the anchor of having decided what the claims mean, turning them into a "nose of wax" to be susceptible to whatever argument is being advanced.  Although it is perhaps too late to do so now, if the Federal Circuit grants rehearing or en banc review, it would be well if the Court mandated that the parties provide the equivalent of their Markman briefs, to enable the Court as a threshold matter to determine what the claims mean as a matter of law.  Without that, it is hard to see how the Federal Circuit, or the Supreme Court if it grants certiorari, will have any reasoned basis for coming to a decision as to whether these claims recite patent-eligible subject matter.  That outcome may be good for arguments based on emotion and rhetoric, but it won't be good for deciding this fundamental question of patent law.

WFU Law Professor Says Federal Circuit Failed as "Keeper of the Constitution" in AMP v. USPTO

By Donald Zuhn --

In an article published in The Huffington Post on Sunday, Wake Forest University Law Professor Simone Rose accuses the Federal Circuit of failing in its duty as "keeper of the Constitution" with respect to the Court's July 29 decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office.  Noting her background as a former registered patent attorney, Professor Rose writes that one question came to mind as she read the majority and concurring opinions, namely "[h]ow can the court allow chemical differences to supersede biological equivalence when the specific utility of the invention, namely detecting mutations linked to breast and ovarian cancer, depends on biological identity?"  She argues that "[c]hemically modifying an isolated gene [i.e., "breaking . . . chemical bonds during the isolation process"] does not alter its biological heart (nucleotide sequence)," and that "[a]ccurately detecting BRCA mutations would be impossible without this biological identity."

As for the focus by the majority and concurring opinions on long-standing USPTO practice in issuing gene patents and on the impact an affirmance would have had on the biotech industry, Professor Rose (at left) contends that while "promoting innovation is a laudable goal, the Federal Circuit's broadening of what constitutes patent-eligible subject matter missed the bigger Constitutional target."  According to the Professor, the Constitution's Patent Clause requires that the granting of exclusive rights under the patent system be balanced against providing access to basic knowledge.  She therefore concludes that "[p]atenting products of nature such as isolated genes and gene sequences prevents access to these basic research tools during the term of the patent," and "[t]his impedes rather than promotes progress and is therefore in direct violation of the IP clause."

Professor Rose argues that federal courts have an obligation, as "keepers of the Constitution," to ensure that their analysis of 35 U.S.C. § 101 and controlling case law is "in harmony with the Constitutional mandate to promote progress of the useful arts."  She contends that in AMP v. USPTO, "[t]he Federal Circuit should have taken this role seriously and upheld the lower court's invalidation of the BRCA isolated genes and gene sequence patents as patent-ineligible subject matter."

Interestingly, for Professor Rose, the end result of the invalidation of Myriad's patents would be Congress weighing in on the issue of gene patenting.  Unlike the majority and concurring opinions, which state that if the law is to be changed, it is up to Congress and not the courts to change it, Professor Rose believes that a finding by the Federal Circuit of invalidity would have permitted (or encouraged) Congress to step in and "legislate a new 'Constitutional' framework of exclusive rights for this subject matter."  Looking forward, the Professor says that she remains "hopeful" that the Federal Circuit sitting en banc or the Supreme Court "will be mindful of its role as the keeper of the Constitution and interpret the Patent Act's subject matter limitation to exclude the BRCA genes as patent-ineligible products of nature."  She argues that an "appropriate legislative dialogue" on a solution that balances access and innovation can only begin after the courts determine that gene patents should be excluded as patent-eligible subject matter.

Court Report

By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Sandoz Inc. v. Novo Nordisk, Inc. et al.
2:11-cv-13594; filed August 17, 2011 in the Eastern District of Michigan

• Plaintiff:  Sandoz Inc.
• Defendants:  Novo Nordisk, Inc.; Novo Nordisk A/S

Declaratory judgment of invalidity, unenforceability, and non-infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) in conjunction with Sandoz's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novo Nordisk's Prandin® (repaglimide, used to treat non-insulin dependent diabetes mellitus in combination with metformin).  View the complaint here.

Allergan, Inc. et al. v. Hi-Tech Pharmacal Co., Inc.
1:11-cv-00650; filed August 17, 2011 in the Middle District of North Carolina

• Plaintiffs:  Allergan, Inc.; Duke University
• Defendant:  Hi-Tech Pharmacal Co., Inc.

Infringement of U.S. Patent Nos. 7,351,404 ("Method of Enhanced Hair Growth," issued April 1, 2008), 7,388,029 ("Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins," issued June 17, 2008), and 6,403,649 (""Non-Acidic Cyclopentane Heptanoic Acid,2-Cycloalkyl Or Arylalkyl Derivatives As Therapeutic Agents, issued June 11, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Allergan's Latisse® (bimatoprost topical solution/drops, 0.03%, used to treat inadequate or not enough eye lashes).  View the complaint here.

Endo Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. et al.
1:11-cv-00717; filed August 16, 2011 in the District Court of Delaware

• Plaintiff:  Endo Pharmaceuticals Inc.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.; Matrix Laboratories Ltd.; Matrix Laboratories Inc.

Infringement of U.S. Patent Nos. 5,464,864 ("Use of Tetrahydrocarbazole Derivatives As 5HT₁ Receptor Agonists," issued November 7, 1995), 5,637,611 ("Medicaments," issued June 10, 1997), and 5,827,871 ("Medicaments 1,2,3,4,-Tetrahydrocarbazoles and 5-HT1 Agonist Use Thereof," issued October 27, 1998), assigned to Endo, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Endo's Frova® (frovatriptan succinate, used to treat migrane attacks with our without aura).  View the complaint here.

Pfizer Inc. et al. v. MSP Singapore Co. LLC
1:11-cv-00713; filed August 15, 2011 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Pfizer Ireland Pharmaceuticals; Warner-Lambert Co.; Warner-Lambert Company LLC
• Defendant:  MSP Singapore Co. LLC

Pfizer, Inc. et al. v. Macleods Pharmaceuticals LTD
1:11-cv-05662; filed August 15, 2011 in the Southern District of New York

• Plaintiffs:  Pfizer Inc.; Pfizer Ireland Pharmaceuticals; Warner-Lambert Co.; Warner-Lambert Company LLC
• Defendant:  Macleods Pharmaceuticals LTD

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,969,156 ("Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)," issued October 19, 1999) following a Paragraph IV certification as part of MSP's filing of an ANDA to manufacture a generic version of Pfizer's Lipitor® (atorvastatin calcium, used to treat high cholesterol and heart disease).  View the MSP complaint here.

Abbott Laboratories et al. v. Teva Pharmaceuticals USA Inc. et al.
1:11-cv-00712; filed August 12, 2011 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000), and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia).  View the complaint here.