Patent Docs

Invitae Files Motion to Dismiss for Lack of Personal Jurisdiction in Myriad Genetics v. Invitae Corp.

December 11, 2013

By Kevin E. Noonan —

It is often to a patentee plaintiff's strategic advantage to file suit in the district in which it resides, to obtain whatever "home court" advantage may attach to that venue. Myriad's choice of filing its post-Supreme Court opinion patent infringement lawsuits reflects this strategy, as does declaratory judgment plaintiffs Counsyl, Quest, and Invitae in filing their lawsuits challenging Myriad's patents in their respective California district courts.

But a requirement for filing any lawsuit is that the court has personal jurisdiction over the defendant, a standard that is readily satisfied for a defendant engaged in nationwide interstate commerce. Personal jurisdiction is not presumed, however, and can be challenged by a motion to dismiss. Which is precisely what Invitae has done as a defendant in Myriad's lawsuit against it, arguing that the company has taken affirmative steps to avoid the jurisdiction of the Utah district court.

Revisiting Civil Procedure I, there are two types of personal jurisdiction: general jurisdiction and specific jurisdiction, both standards governed by the overriding concerns for compliance with the due process clause of the 14th Amendment, first enunciated by the Supreme Court in the International Shoe case (International Shoe Co. v. Washington, 326 U.S. 310 (1945)) that there must be "minimum contacts" with the forum for a court to exercise personal jurisdiction over a party (almost always a defendant, because the plaintiff submits to the jurisdiction of the court by filing suit). As the term suggests, general jurisdiction requires contacts not necessarily related to the specific cause of action, and includes activities such as being engaged in or licensed to do business in a state; controlling property in the state, by ownership or leasehold; employing salesmen, agents, or other employees in the state; or paying state taxes arising from its activities in the state. Specific jurisdiction relates to each states' "long arm" statute, which sets forth activities that raise jurisdiction. And the Federal due process aspect is subject to a three-part test to establish that the exercise of jurisdiction does not "offend traditional notions of fair play and substantial justice": "(1) whether the defendant purposely directed its activities at residents of the forum; (2) whether the claim arises out of or relates to those activities; and (3) whether the assertion of personal jurisdiction is reasonable and fair." 3D Sys., Inc. v. Aarontech Lab. Inc., 160 F.3d 1371, 1378 (Fed. Cir. 1998).

Invitae in its motion to dismiss argues that the Utah district court, which applies the law of the forum state to determine whether it has personal jurisdiction over a defendant, cannot satisfy general or specific jurisdiction standards. Specifically, the motion contests Myriad's allegations in its complaint that Invitae "regularly conducts business in this district and has committed acts in this judicial district which give rise to this action," specifically that it "sells, offers for sale, and has sold genetic testing products to residents of this jurisdiction," an allegation that Myriad made "[o]n information and belief" without setting forth any facts to support the allegation. According to Invitae, this is because Myriad could not supply such facts: Invitae has expressly and intentionally refused to do business with any doctors or patients in Utah and has, in fact, returned samples and requests for its services coming from Utah. According to the motion:

[O]nly certified healthcare professionals from certain states (not including Utah) can order Invitae's genetic tests. To do so, a healthcare professional must submit one of Invitae's requisition forms, as well as a patient blood sample, to Invitae's San Francisco headquarters, which is where Invitae performs its genetic testing services in the United States. None of Invitae's activities related to its genetic testing services is performed in Utah.

(citations to supporting declaration omitted).

The motion goes on to assert that "[i]f a healthcare professional in Utah were to attempt to order genetic testing services from Invitae, such an attempt would be prevented: It would either be blocked by measures Invitae established to prevent website orders from Utah, or by other preventative measures Invitae established to block the acceptance of tests ordered from Utah by phone or fax." The motion further states that two such requests were received by the company, and both were rejected (although neither of these requests involved the BRCA or MUTYH testing that is the basis of Myriad's complaint). The motion then asserts (supported by affidavit evidence) that is has never performed any of the acts that could create general jurisdiction over Invitae by the Utah court.

In its argument, Invitae uses these asserted facts to establish that the Utah court does not have personal jurisdiction over the company, setting forth the standards for general and specific jurisdiction. (In two related footnotes, the brief sets forth the rather circular standard that the Federal Circuit applies its own law to determine whether a court properly exercised personal jurisdiction over a defendant, but that the court defers to the interpretations of the Federal and state courts in the jurisdiction.") According to the brief, under Utah law the state long-arm statute is construed broadly to be co-extensive with the scope of jurisdiction falling within the ambit of 14th Amendment due process, and due process concerns can be satisfied by showing either general or specific jurisdiction. (The brief notes that the due process at issue here falls under the 5th rather than the 14th amendment, because the cause of action arises under a Federal question rather than diversity of citizenship.) Regarding general jurisdiction, Invitae contends that Myriad has an "insurmountable" burden to establish jurisdiction, because the company has purposefully avoided availing itself of the benefits of the laws of the jurisdiction. Indeed, Invitae claims it has done none of the acts recognized in Utah as raising general jurisdiction over a defendant. And in this regard the brief cites several Federal Circuit cases finding no general jurisdiction under circumstances where the defendant had much more extensive contacts with the state than the absence of contacts Invitae has purposefully maintained here, see, Grober v. Mako Products, Inc., 686 F.3d 1335, 1346 (Fed. Cir. 2012); Campbell Pet Co. v. Miale, 542 F.3d 879, 881-884 (Fed. Cir. 2008), as well as cases where the court did find jurisdiction, see LSI Indus. Inc. v. Hubbell Lighting, Inc., 232 F.3d 1369 (Fed. Cir. 2000).

Turning to the specific jurisdiction question, Invitae asserts Myriad's burden is equally insurmountable because the company has not purposely directed its activities at residents of the forum nor does Myriad's claim arise out of or relate to those (nonexistent, according to Invitae) activities. Citing Xactware, Inc. v. Symbility Solution Inc., 402 F. Supp. 2d 1359 (D. Utah 2005), Inviate argues that the mere existence of its website, which is accessible to Utah residents, is not enough to establish activities that are "purposely directed" at Utah residents, a conclusion Invitae contends is supported by Federal Circuit precedent. See, Trintec Indus., Inc. v. Pedre Promotional Products, Inc., 395 F.3d 1275, 1279 (Fed. Cir. 2005). And the company's active refusal to accept orders from Utah-based physicians is "a roadblock" that negates any nexus between the company and citizens of Utah. Moreover, the acts complained of by Myriad do nor "arise under" Invitae's activities (that are not in any case purposefully directed towards Utah residents).

And finally, Invitae asserts that exercising personal jurisdiction over the company would be "unreasonable and unfair," citing Asahi Metal Indus. Co. v. Superior Court, 480 U.S. 102 (1987), for requiring courts to consider "the burden on the defendant, the interests of the forum State, and the plaintiff's interest in obtaining relief." With regard to the first factor (or "prong"), Invitae argues that "Invitae is a small start-up company based in San Francisco, California; it has no contacts to this District; and no Invitae witnesses or documents are here. It would be a substantial disruption to the business of this nascent company to force it to litigate this case in Utah, where it has no contacts." And, thus, that the burden mitigates against the Utah court exercising jurisdiction over the company. The second factor also is against the court hearing Myriad's case, because Utah has no interest in the outcome (except, it should be noted, insofar as Myriad resides in the state). The third factor — "the plaintiff's interest in obtaining relief" — can be satisfied elsewhere (in the California declaratory judgment action, where the brief notes Myriad has already made an appearance). Invitae also invokes Federal district court statistics indicating that Myriad is likely to obtain swifter justice in the California court than in Utah "(compare 30.9 month to trial with 38.0 months to trial, for the 12-month period ending June 30, 2013)," a fact even if true not calculated to curry favor in this forum. And Invitae contends that the plurality of other suits brought against other defendants, and its efforts to consolidate them before the Utah court under the Judicial Panel on Multidistrict Litigation is neither relevant nor dispositive to the jurisdictional challenge brought in this motion.

We await Myriad's response, but note that Invitae's affirmative efforts to eschew serving the Utah patient population likely caused it to suffer little reduced business or profit while providing a means at little cost to prevent Myriad from suing in its home court (should the motion be successful). Clever.
News from Abroad: EPO Clarifies Extent to which Methods Involving Use of Human Embryos Are Excluded from Patentability

December 11, 2013

Generally, the European Patent Office does not allow claims to methods involving the use of human embryos for industrial or commercial purposes. It was therefore perhaps not surprising that the Examiner objected to the claims of EP 05028411.6, which related to a method for obtaining pluripotent embryonic stem cells from an embryo. In defence of the claims, the applicant argued that, since the embryo was not destroyed in the method, the claims were allowable following the decision of the Enlarged Board of Appeal G2/06 (the "WARF" Decision).

However, this argument was not accepted. The Examining Division maintained that the overriding consideration as to whether a method involving the use of a human embryo is patentable or not is whether the claimed method is of diagnostic or therapeutic benefit to the embryo. Since the embryo did not benefit from the claimed method, the application was refused.

On appeal it was accepted by the Board of Appeal that, where the claimed method was of diagnostic or therapeutic benefit to the embryo, there would be an exemption from the general exclusion from patentability of methods involving the use of embryos. The applicant tried to rely on this by arguing that the cells obtained by the claimed method could later be used to treat the human that had developed from the embryo from which the cells had been obtained. However, as this future use was not specified in the claim, the Board rejected the argument.

The applicant then attempted to amend the claims to disclaim "industrial and commercial uses" of the stem cells obtained by the method of the invention. Since the application as filed did not have specific basis for the disclaimer it was necessary for the Board to consider whether the proposed disclaimer fell within the conditions laid down in the Decision G1/03 of the Enlarged Board of Appeal as to whether the disclaimer was allowable. The Board held that the proposed disclaimer did not fall within the specific circumstances laid down in G1/03. It reasoned that the claims without the disclaimer were directed to a method of obtaining embryonic stem cells as a direct product of the method. The proposed disclaimer merely excluded the future use of the obtained stem cells and, as such, the subject matter that the applicant was attempting to exclude was not covered by the original claims and as such could not now be disclaimed without adding subject matter. The appeal was therefore rejected.

It is apparent that, in order to be patentable, a method involving human embryos must be of diagnostic or therapeutic benefit to the embryo itself and that the step giving the benefit must be specified in the claim. Applicants should therefore take care when drafting patent applications to inventions involving the use of human embryos to specify diagnostic and therapeutic benefits in the application. In addition, it may be advisable to state in the description that, for example, stem cells recovered may not be for commercial or industrial usage in order to provide basis for any disclaimer which may subsequently be required.

This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK. Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.
University of Pittsburgh v. Cellerix (PTAB 2013)

December 10, 2013

By Kevin E. Noonan —

The Patent Trial and Appeals Board (PTAB), a creation of the Leahy-Smith America Invents Act that replaced the Board of Patent Appeals and Interferences (BPAI) overruled the Reexamination Unit's decision that the claims of U.S. Patent No. 6,777,231 were invalid for failing to satisfy the written description and enablement requirements of 35 U.S.C. § 112(a) in University of Pittsburgh v. Cellerix (the Third Party Requestor being succeeded in interest by TiGenix SAU) (Appeal 2013-008103; Reexamination Control 95/001,592). All was not well for the University Patent Owner, however, because the Board also reversed the Reexamination Unit's refusal to consider whether the claims of the '231 patent were inherently anticipated by three prior art references, remanding the reexamination under 37 C.F.R. § 41.77(b).

The technology involves stems cells from adipose tissue. Representative claims include:

1. An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

5. A substantially homogeneous population of adipose-derived stem cells, comprising a plurality of the stems cells of claims 1, 3 or 4.

6. The adipose-derived stem cell of claim 1, 3 or 4 which can be cultured for at least 15 passages without differentiating.

11. The adipose-derived stem cell of claim 6, wherein the cell can be cultured in DMEM and 5-15% serum without losing the capacity to differentiate.

12. An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell, wherein the isolated adipose-derived stem cell is substantially free of other adipose tissue cells and extracellular material.

17. The adipose-derived stem cell of claim 12, 14 or 15 which can be cultured for at least 15 passages without differentiating.

22. The adipose-derived stem cell of claim 17, wherein the cell can be cultured in DMEM and 5-15% serum without losing the capacity to differentiate.

23. The substantially homogeneous population of claim 5, wherein adipose-derived stem cells therein can be cultured for at least 15 passages without differentiating.

25. The substantially adipose-derived adipose-derived stem cell of claim 23, wherein the cell can be cultured in DMEM and 5-15% serum without losing the capacity to differentiate.

28. The substantially homogeneous population of claim 26, wherein adipose-derived stem cells therein can be cultured in DMEM and 5-15% serum withoit losing the capacity to differentiate.

The case came to the Board on appeal by the Patent Owner that the Examiner had erred in rejecting claims 11 and 25 for failing the enablement and written description requirements, and cross appeal from the Third Party Requestor that the Examiner erred in refusing to adopt rejection of claims 11, 22, 25, and 28 as being inherently anticipated.

The Board, in an opinion by APJ Lebovitz joined by APJ's Green and Guest, first addressed the Examiner's claim construction, applying the principle that the claims should be given their broadest reasonable interpretation (consistent with the ex parte examination standard). For claims 11 and 25, claims rejected for failure to satisfy the requirements of § 112(a), the Board construed the claims to contain all the limitations recited in each of the patent claims from which the claims depended, which the Board stated were that these cells "must be capable of differentiating into two or more cell types and of being cultured for at least 15 passages without differentiating." According to the Board, the specification defined the meaning of the phrase "without losing the capacity to differentiate" as: "'the capacity to differentiate' means (for the purposes of construing these claims) 'the ability of the [] cell to differentiate into two or more of the cell types [] of a fat cell, a bone cell, a cartilage cell, a nerve cell or a muscle cell.'" (The Board determined that the skilled worker would understand that "DMEM" meant Dulbecco's Modified Eagle's Medium.) The Board noted that the claim does not specify how long the stem cell must retain this capacity to differentiate, but that the Examiner (and the Third Party Requestor) contended that it had to be at least 15 passages. But the Board cited the specification for disclosing that the cells are passaged at least 5, 10, 15, or 20 times. And the Board noted that while claims 6 and 23 recited culturing for 15 passages they did not specify the culture media, and claims 11 and 25 recited culturing the cells in DMEM but not the number of passages. According to the opinion there was no "antecedent basis" that would link the claims together, and that as composition claims (as opposed to method claims) the recited limitations are capabilities not "actual steps [that have been] taken." Thus, there was no justification to construe claims 11 and 25 to require 15 passages.

Having construed these aspects of the claims, the Board then turned to the grounds of rejection under § 112(a). With regard to the written description requirement, the Board rejected the Examiner's conclusion that the claims were unpatentable because the specification failed to describe culturing stem cells that retained the capacity to differentiate upon passage in culture, but rather that cells could be cultured wherein they did not differentiate. According to the Board, the Examiner erroneously found this deficiency because the Examiner interpreted the claim to "require that the cell's capacity to differentiate must be the same at the beginning and the end of the culture," which it was undisputed the specification did not do. Rather, the Board identified specific portions of the specification that provided "explicit written description" for claims 11 and 25. Moreover, the Board found the requirement that the capacity to differentiate be the same at the beginning and the end of the culture as "not reasonable" in the context of the disclosure in the '231 patent specification. The Board also rejected the Requestor's arguments (based on the semantics) that because the claim recited "the" capacity to differentiate that this was a specific capacity that must be maintained. The Board was convinced by the specification expressly disclosing stem cells that retained the capacity to differentiate after 15 passages as in Examples 1 and 3.

With regard to the enablement requirement, the Board once again turned to the disclosure of Examples 1 and 3, which the Board asserted "describe suitable culture conditions [to] meet the claim limitations." The Board further rejected "post-filing evidence of unpredictability" that the Requestor asserted in support of its lack-of-enablement contentions. These included a reference that (the Requestor contended) showed loss of differentiation capacity within four passages (Guilak et al., 2006, J. Cell. Physiol. 206: 229-37); the Board discounted this argument because the Guilak authors did not determine differentiation capacity for more than four passages. And the Board's opinion stated that the '231 claims only required one stem cell to retain the differentiative capacity and that determining or identifying this cell did not constitute undue experimentation.

Similarly, the second reference (Safwani et al., 2011, Biotech Applied Biochem. 58: 261-70) did not disclose that its adipose-derived stem cell culture lost all capacity to differentiate after 15 passages, according to the Board (and indeed there was disclosure in the reference that the cells retained osteogenic and neurogenic capacities over all passages reported). The third reference, Zhou et al. (2011, Cells Tiss. Organs 195: 414-27) was misinterpreted by the Requestor according to the Board's opinion, characterizing the Zhou disclosure as merely reciting that differentiation capacity declined with passage number but not that 15 passages were enough to reduce that capacity to zero. Finally, the Board noted that the cited references were directed to tissue engineering, which may impose requirements for sustained capacity to differentiate that are not required by claims 11 or 25 of the '231 patent. Accordingly, the Board reversed the Examiner's final rejection of claims 11 and 25.

The Board also reversed the Examiner's determination not to adopt rejections urged by the Requestor that claims 11, 22, 25, and 28 were inherently anticipated by the disclosure of any of three references (Hauner et al., 1989, J. Clin. Invest. 84: 1663-70; Van et al., 1976, J. Clin. Invest. 58: 699-704; and Zilberfarb et al., 1997, J. Cell Sci. 110: 801-07). The Hauner and Zilberfarb references were applied to claims 1, 3, and 4 (from which claims 11 and 25 depend) and the Hauner, Van, and Zilberfarb references were applied to claims 12, 14, and 15 (from which claims 22 and 28 depend); the Patent Owner did not appeal these rejection of these claims. Thus, the issue before the Board was whether these references also invalidate these dependent claims.

The Board determined that, while the Hauner reference disclosed a method for obtaining adipose tissue derived stem cells that differed from the methods disclosed in the '231 patent, another reference (Winter et al., 2003, Arthrit. Rheumat. 48: 418-29) disclosed that the stem cells obtained according to the method disclosed by the Hauner reference had the capacity to differentiate into cells from "chondrogenic (cartilage), osteogenic (bone) and myogenic (muscle) lineages." The Board concluded that stem cells isolated according to Hauner "were capable of differentiating into at least osteogenic and chondrogenic lineages[], providing sufficient evidence that the[se stem] cells had the same developmental capacity as those claimed which were isolated [according to the methods disclosed in the '231 patent]." The Board then reviewed the application of the Hauner reference to independent claim 6 (from which claim 11 depends) and concluded that the Patent Owner's arguments against the application of Hauner to these claims paralleled the arguments it had rejected when advanced by Requestor (or the Examiner) in support of rejection under § 112(a). That is, the Patent Owner argued that the Hauner reference disclosed loss of the capacity to differentiate with passage in culture of the stem cells obtained using the Hauner methods, and the Board stated that there was no evidence that the Hauner stem cells lost 100% of cells capable of differentiating after passage in culture. Accordingly, as it had determined in assessing Requestor's arguments, the Board found that the claims of the '231 patent at issue required as few as one cell that retained differentiation capacity and the Patent Owner had not established that the Hauner stem cell cultures contained not one cell retaining differentiation capacity after passage in culture.

Finally, the Board applied the specific limitations recited in claims 11, 22, 25, and 28 and found that there was "sufficient evidence" that the Hauner reference met these limitations as well. In this regard the Board used the "plain and ordinary" meaning of the word "isolated," including a dictionary definition (which seems both unnecessary and contrary to the Federal Circuit's AWH v. Phillips decision).

Having found that Examiner incorrectly refused to adopt the Requestor's ground of rejection that the Hauner reference inherently anticipated these claims, the Board did not reach the question with regard to the Van or Zilberfarb references, and remanded to the Examiner for consideration of this new ground of rejection under 41 C.F.R. § 41.77(b). Procedurally, this decision is not final for judicial review, and the Patent Owner can request rehearing or reopen prosecution.

On remand, the Patent Owner is limited to prosecution solely on the new ground imposed by the Board. The Requestor (or the Examiner), on the other hand, can raise new grounds of rejection, but for the Requestor a new ground of rejection must be in response to amendments or new evidence submitted by the Patent Owner. Under these circumstances it is unlikely that the Requestor will attempt or be permitted to introduce arguments related to invalidity under 35 U.S.C. § 101 (as in the WARF stem cell reexamination; see "Consumer Watchdog Argues That WARF Stem Cell Patent Is Invalid under § 101").

University of Pittsburgh v. Cellerix (PTAB 2013)
Panel: Administrative Patent Judges Green, Lebovitz, and Guest
Decision on Appeal by Administrative Patent Judge Lebovitz
Reaction to the Passage of the Innovation Act (H.R. 3309)

December 9, 2013

By Andrew Williams —

As we reported last week, the House of Representatives passed H.R. 3309, the Innovation Act, by on overwhelming margin. A copy of the final bill can be found here. The next step is consideration by the U.S. Senate, where on December 17th, the Committee on the Judiciary will hold a hearing entitled "Protecting Small Businesses and Promoting Innovation by Limiting Patent Troll Abuse." It is likely that the Senate will consider S. 1720, which was previously introduced by Sen. Leahy. As we have noted in the past, this bill professes to have a similar goal as the Innovation Act, but the two pieces of legislation have several provisions that are not shared by the companion piece, and the provisions that are in common are not necessarily coextensive. It will be interesting to see what impact the passage of the Innovation Act will have on these discussions.

Nevertheless, the reaction from stakeholders in the industry has been overwhelming since the Innovation Act was passed — some positive, some negative. We collect below the reaction of several orgainiziations representing these stakeholders in the industry.

Biotechnology Industry Organization

BIO did not support the Innovation Act, even before it was voted on, because it believed that the Act would undermine biotech research and innovation. As Daniel Seaton noted on BIO's Patently Biotech blog, the Act would ultimately make it more difficult for patent holders with legitimate claims to protect their intellectual property. In general, BIO supported the goals that the Innovation Act was touted as addressing, coming out in support of "increased transparency" and in opposition of "abusive litigation tactics." However, because the Act contained certain provisions that were overly broad, BIO believed that the legislation would have resulted in too many unintended and unknowable consequences. "Provisions in the legislation would erect unreasonable barriers to access justice for innovators, especially small start-ups that must be able to defend their businesses against patent infringement in a timely and cost-effective manner, and without needless and numerous procedural hurdles or other obstacles," BIO stated in a press release.

Mr. Seaton did note, however, that BIO supported three of the amendments introduced on the floor. First, BIO supported Rep. Rohrabacher's amendment that removed the repeal of 35 U.S.C. § 145, which provides for an appeal of an adverse decision at the Patent Office to a U.S. district court. Even though these appeals are rare, "there are legitimate instances where such appeals are important and necessary, because one can introduce new evidence that could not otherwise be considered in deciding the patentability of an invention," Mr. Seaton wrote. BIO also supported and amendment by Rep. Massie, which would have struck the "customer-suit exception" from H.R. 3309, although this amendment was defeated. BIO believed that this provision was ambiguous, and applied to parties beyond end-users and resellers. As a result, the provision will invite "piecemeal adjudication" and could result in "systematic delays." Therefore, as explained by Mr. Seaton, this provision which is supposed to streamline litigation "could end up doing the exact opposite." Finally, BIO supported Rep. Watt's attempt to amend the "loser pays" provision by allowing district courts the discretion to reduce or deny an award if the prevailing party engaged in "dilatory litigation tactics." This amendment was also defeated.

Intellectual Property Owners Organization

The IPO has not taken a position on the Innovation Act per se, but has been tracking all of the legislative efforts, and has taken positions on some of the provisions found in the Innovation Act in whole or in part. With regard to the fee-shifting provision, the IPO has taken the position that an award should go to the prevailing party unless the "position and conduct of non-prevailing party was objectively reasonable and substantially justified." However, the IPO did agree that such fees should not be required "if exceptional circumstances" make them unjust. In addition, the IPO supports some form or heightened pleading standard for patent infringement. However, unlike the provision found in the Innovation Act, the IPO instead supports modifying Form 18 to include the identification of at least one claim, a statement explaining the infringement of that claim (or claims), and a statement addressing any alleged indirect infringement. Moreover, the IPO does support a stay against customers while a suit is pending against a manufacturer. But, much like with BIO, the IPO believes such a stay should be carefully tailored to avoid unintended adverse consequences. Finally, the IPO supports expanding the current rules for the disclosure of the real party-in-interest, but only to the extent of including the ultimate parent of the owner. The IPO opposes multiple mandatory disclosures, and requiring the disclosure of non-ownership interests, such as direct financial interest, exclusive licensees, and other with the right to enforce the patent.

The IPO did oppose two provisions which had been part of the originally introduced bill, but were not included in the final version that passed. First, the IPO opposed an expansion of the covered business method patent review, which was removed in a Manager's amendment during a mark-up by the committee. In addition, the IPO opposed the repeal of 35 U.S.C. § 145.

All of IPO's positions with regard to these efforts can be found on its website.

America Intellectual Property Law Association

The AIPLA did not come out in support of the Innovation Act, but instead "urged continued progress on patent reform to 'strike the right balance.'" In a press release by the organization, AIPLA Executive Director Q. Todd Dickinson expressed appreciation for the interests and efforts shown by the House in its attempt to improve the U.S. patent system by dealing with certain abusive behavior. However, even if grateful for the sentiment behind the Act, "there remains a lot more work to be done as it moves on to the U.S. Senate," Mr. Dickinson said. The AIPLA noted that the bill had improved since its original introduction, including removal of the expansion of the Covered Business Method Patent Review and the rejection of proposed amendments, such as those that proposed a bonding requirement, which would have "burdened small inventors and start-ups." Mr. Dickinson also noted that the AIPLA looks "forward to continuing to work together with Congress toward a goal of ensuring that any legislation strikes the right balance between restraining abusive behavior while not impairing the legitimate rights of patent owners."
Court Report

December 8, 2013

By Sherri Oslick —

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

Astrazeneca AB et al. v. Aurobindo Pharma Ltd. et al.
3:13-cv-07298; filed December 3, 2013 in the District Court of New Jersey

• Plaintiffs: Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI Inc.; KBI-E Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Astrazeneca AB et al. v. Kremers Urban Pharmaceuticals, Inc. et al.
3:13-cv-07299; filed December 3, 2013 in the District Court of New Jersey

• Plaintiffs: Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI Inc.; KBI-E Inc.
• Defendants: Kremers Urban Pharmaceuticals, Inc.; Kremers Urban Development Co.; Kremers Urban LLC

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988), 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), 7,411,070 (same title, issued August 12, 2008), and 8,466,175 (same title, issued June 18, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the Aurobindo complaint here.

University of Utah Research Foundation et al. v. Laboratory Corporation of America Holdings
2:13-cv-01069; filed December 3, 2013 in the District Court of Utah

• Plaintiffs: University of Utah Research Foundation; Trustees of the University of Pennsylvania; HSC Research and Development Limited Partnership; Endorecherche; Myriad Genetics
• Defendant: Laboratory Corporation of America Holdings

Infringement of U.S. Patent Nos. 5,709,999 ("Linked Breast and Ovarian Cancer Susceptibility Gene," issued January 20, 1998), 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 5,837,492 ("Chromosome 13-Linked Breast Cancer Susceptibility Gene," issued November 17, 1998), 6,033,857 (same title, issued March 7, 2000), 5,654,155 ("Consensus sequence of the human BRCA1 gene," issued August 5, 1997), 5,750,400 ("Coding sequences of the human BRCA1 gene," issued May 12, 1998), 6,051,379 ("Cancer susceptibility mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for determining the haplotype of a human BRCA1 gene," issued October 5, 2005), 7,250,497 ("Large deletions in human BRCA1 gene and use thereof," issued July 31, 2007), and 6,083,698 ("Cancer Susceptibility Mutations of BRCA1," issued July 4, 2000) based on Lab Corporation's manufacture, sale, and offer for sale of its BRCA1/2 Comprehensive Analysis (BRCAssure^SM) and/or BRCA1/2 Deletion/Duplication Analysis (BRCAssure^SM) products. View the complaint here.

Biogen Idec MA Inc. v. Japanese Foundation for Cancer Research et al.
1:13-cv-13061; filed December 2, 2013 in the District Court of Massachusetts

• Plaintiff: Biogen Idec MA Inc.
• Defendants: Japanese Foundation for Cancer Research; Kyowa Hakko Kirin Co., Ltd.; Toray Industries, Inc.; Bayer Pharma AG

Review of the decision of the Patent Trial and Appeal Board awarding priority of invention to the Japanese Foundation for Cancer Research in the interference between U.S. Patent Application No. 08/253,843 ("DNA Sequences, Recombinant DNA Molecules and Processes for Producing Human Fibroblast Interferon-like Polypeptides," filed June 3, 1994), assigned to Biogen Idec and U.S. Patent Application No. 08/463,757 (filed June 5, 1995), assigned to Japanese Foundation for Cancer Research. View the complaint here.

Idenix Pharmaceuticals Inc. et al. v. Gilead Sciences Inc. et al.
1:13-cv-01987; filed December 1, 2013 in the District Court of Delaware

• Plaintiffs: Idenix Pharmaceuticals Inc.; Universita Degli Studi di Cagliari; Centre National de la Recherche Scientifique; L' Universite Montpellier II
• Defendants: Gilead Sciences Inc.; Gilead Pharmasset LLC

Infringement of U.S. Patent No. 7,608,600 ("Modified 2' and 3' Nucleoside Prodrugs for Treating Flaviviridae Infections," issued October 27, 2009) based on Gilead's anticipated manufacture, sale, and offer for sale of its sofosbuvir product, a 2'-methyl nucleoside for the treatment of hepatitis C virus infection. Also, adjudication of priority of invention of the '600 patent relative to Gilead's U. S. Patent No. 8,415,322 ("Modified Fluorinated Nucleoside Analogues," issued April 9, 2013). View the complaint here.

Idenix Pharmaceuticals, Inc. et al. v. Gilead Sciences, Inc.
1:13-cv-13052; filed December 1, 2013 in the District Court of Massachusetts

• Plainitffs: Idenix Pharmaceuticals, Inc.; Universita Degli Studi Di Cagliari
• Defendant: Gilead Sciences, Inc.

Infringement of U.S. Patent Nos. 6,914,054 ("Methods And Compositions For Treating Hepatitis C Virus," issued July 5, 2005) and 7,608,597 ("Methods And Compositions For Treating Hepatitis C Virus issued October 27, 2009) based on Gilead's anticipated manufacture, sale, and offer for sale of its sofosbuvir product for the treatment of hepatitis C virus infection. View the complaint here.
Conference & CLE Calendar

December 8, 2013

December 9, 2013 – Biotechnology/Chemical/Pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – 9:00 am to 2:45 pm (ET)

December 9-10, 2013 – Patent Infringement Litigation Summit (Legal iQ (IQPC)) – San Francisco, CA

December 10-11, 2013 – Advanced Forum on Patent Litigation*** (American Conference Institute) – New York, NY

December 10-11, 2013 – International Patent Litigation (IBC Legal) – London, UK

December 12, 2013 – "Using Competitive Technical Intelligence Techniques to Assess University Patents" (Technology Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

December 12, 2013 – "Patent Exhaustion and Licensing Strategies — Leveraging Recent Decisions for Structuring Patent Licenses and Resolving Litigation" (Strafford) – 1:00 to 2:30 pm (EST)

December 16, 2013 – "Means-Plus-Function Patent Claims After the AIA — Assessing Benefits and Risks, Surviving AIA's PGRs, IPRs and Reissue" (Strafford) – 1:00 to 2:30 pm (EST)

January 8-12, 2014 – National CLE Conference (Law Education Institute, Inc.) – Vail, CO

January 21, 2014 – "Top Patent Law Stories of 2013" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

January 22-23, 2014 – Patent Reform*** (American Conference Institute) – New York, NY

March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

***Patent Docs is a media partner of this conference or CLE
USPTO BCP Customer Partnership Meeting

December 8, 2013

The U.S. Patent and Trademark Office will be holding its next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting on Monday, December 9, 2013. The agenda for the meeting is as follows:

Morning Session

• Meet and Greet (8:30 – 9:00 am ET) — Wanda Walker, Jerry Lorengo, and James Wilson (Acting), Directors, TC1600 SPEs

• Opening Remarks (9:00 – 9:30 am): Bruce Kisliuk, Deputy Commissioner for Patent Administration

• BCP Website (9:30 – 9:35 am): Suzannah K. Sundby of Gambrell & Russell, LLP, Chair of the Biotech Committee of the AIPLA

• Making a Prima Facie Case (in Polymorph Cases) (9:35 – 10:30 am): Bennett Celsa, QAS, TC1600 & Janet Andreas, SPE, Art Unit 1625

• Break (10:30 – 10:45 am)

• Developments in the Patent Prosecution Highway (PPH) (10:45 – 11:45 am): Mark Powell, Special Advisor to the Commissioner for Patent

• Lunch (11:45 – 1:30 pm)

Afternoon Session

• Two Recent Supreme Court Cases: Bowman v. Monsanto and Association for Molecular Pathology v. Myriad Genetics (1:30 – 2:30 pm): Roberte Makowski, Ph.D., J.D., Senior Counsel, BASF

• Closing Remarks/Discussion (2:30 – 2:45 pm): Wanda Walker, Jerry Lorengo, and James Wilson (Acting), Directors, TC1600 SPEs

The meeting can be viewed online here. Additional information regarding the BCP customer partnership meeting, including instructions for viewing the meeting online, can be found here.
Supreme Court Grants Cert. in Alice Corp. v. CLS Bank Intl.

December 6, 2013

By Michael Borella —

Today the Supreme Court granted certiorari in Alice Corp. v. CLS Bank Intl., opening the door once again for the Justices to further carve out the landscape of patent-eligible software and business method claims.

Triggering the Court's review was the Federal Circuit's six-opinion en banc decision this May, which illustrated a severe intra-circuit split. Judge Lourie's concurrence was an attempt to synthesize the high court's 2012 Mayo v. Prometheus ruling into a procedure for analyzing claims that incorporate abstract ideas. However, it was roundly criticized for failing to produce an objective, workable standard. Chief Judge Rader wrote separately taking a somewhat more pragmatic approach, but one that exhibited a degree of internal inconsistency. As a result, the Federal Circuit was unclear as to whether prior art should be considered in a 35 U.S.C. § 101 analysis, whether such an analysis should be applied to claims as a whole or to claim elements on a piecemeal basis, and whether recitation of general-purpose computer hardware (either as a claim element or as the statutory type of the claim) made a claim any less abstract.

Judges Lourie and Rader continued their dialog a few weeks later in Ultramercial, Inc. v. Hulu, LLC. While both agreed that the claims at issue in this case were patent-eligible, Chief Judge Rader's majority opinion seemed limited to the facts of the case, and Judge Lourie's concurrence was terse and conclusory. In late summer, the judges went at it again in Accenture Global Services, GmbH v. Guidewire Software, Inc. This time, Judge Lourie wrote a majority opinion holding the claims invalid under 35 U.S.C. § 101, while Chief Judge Rader dissented. Notably, the majority held that the claims, which recited disembodied functionality, where patent-ineligible even though they were couched in the language of a system or device.

The Federal Circuit's post-Prometheus 35 U.S.C. § 101 jurisprudence is unsettling in its subjectivity. Prometheus instructs us to "identify and define whatever fundamental concept appears wrapped up in the claim." However, few guidelines for doing so exist. Two individuals could easily obtain two different variations of such an inventive concept for the same claim, one leading to the conclusion that the claim meets the requirements of § 101, the other not.

The Supreme Court has an opportunity to clarify the law of § 101, and perhaps even to provide an analysis that addresses the issues that split the Federal Circuit. But with the recent Prometheus decision looming in the near past, doing so may be a delicate proposition. The problems with the Alice, Ultramercial, and Accenture cases stem from Justice Breyer's Prometheus opinion and the guidance therein. While it may seem aesthetically pleasing to conduct a § 101 analysis by dividing a claim into abstract and non-abstract parts as Justice Breyer suggested, doing so in practice has proven to be highly problematic. Nonetheless, out of concern for judicial consistency, the Court may not want to walk back Prometheus or otherwise overturn Breyer's approach just yet.

The question presented by Alice is "Whether claims to computer-implemented inventions — including claims to systems and machines, processes, and items of manufacture — are directed to patent-eligible subject matter within the meaning of 35 U.S.C. § 101 as interpreted by this Court?" This is an extremely broad issue statement that goes well beyond the dispute inside the Federal Circuit. Already, the news and blogs are predicting that this case could result in the death of software and business method patents. Not so fast, people. First of all, the Court already rejected categorical exclusion of software and business methods from patent-eligibility just three years ago in Bilski v. Kappos. Second, the Court routinely decides cases on much narrower grounds than those encompassed by the question presented.

It is possible, if not likely, that the Supreme Court will provide an opinion focused on the facts of the case, narrow in scope, and just different enough from Prometheus to oblige the Federal Circuit to conduct yet another round of § 101 soul searching.
Webinar on Top Patent Law Stories of 2013

December 6, 2013

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT). Patent Docs co-authors and MBHB attorneys Donald Zuhn and Kevin Noonan will take a look back at the top patent stories of 2013, many of which will likely impact patent applicants and practitioners in the coming year.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.
Chisum Patent Academy Patent Law Seminar

December 6, 2013

The Chisum Patent Academy will be offering its next Advanced Patent Law Seminars on March 5-7, 2014 in Cincinnati, OH, and on August 13-15 and August 18-20, 2014 in Seattle, WA. The seminar is co-taught by Donald Chisum, author of the treatise Chisum on Patents (LexisNexis), and Janice Mueller, who was a tenured full Professor at the University of Pittsburgh School of Law from 2004-2011. The registration fee for the seminar is $2,000; a maximum of ten registrations will be accepted for each seminar. Those interested in registering for the seminar can do so here. Additional information regarding the seminar can be obtained here or by e-mailing info@chisum.com.