Patent Docs

PTAB Update — The Board Grants Its Second Motion to Amend (At Least in Part)

January 8, 2015

By Andrew Williams —

For only the second time, the Patent Trial and Appeals Board ("PTAB" or "Board") granted a motion to amend claims. However, even though these two current motions were only granted-in-part, the fact that some claim amendments were accepted while others were denied can shed even more light on the Board's requirement for such motions. Indeed, this was the first time that the Board provided a real-world example of a claim-amendment hypothetical described in the June 11, 2013 decision from the Idle Free Systems, Inc. v. Bergstrom, Inc. case (IPR2012-00027) (Paper 26) – that of obtaining a claim set with a hierarchy of different scope. The Idle Free opinion posited that if a patent owner moved to substitute three claims (one independent and two dependent), the two dependent claims should (at least facially) not be able to contain any additional new features beyond the independent claim. The reason provided was that these new features would not be responsive to an alleged ground of unpatentability, which would be in violation of 37 C.F.R. § 42.121(a)(2)(i)). Moreover, according to Idle Free, unless the patent owner can show a patentable distinction between the dependent claims and the independent claims, there would be no "meaningful reason" to add the new feature, which is inconsistent with the statutory requirement that "[f]or each challenged claim" a "reasonable number of substitute claims" may be proposed. 35 U.S.C. § 316(d)(1)(B). It is these present two cases that first showed how this theory works in practice.

In actuality, this case involved two separate IPRs to two patents that are continuations of each other. One IPR, Riverbed Technology, Inc. v. Silver Peak Systems, Inc., IPR2013-00402, involved U.S. Patent 8,312, 226, which was a continuation of U.S. Patent 8,370,583 (the subject of the second proceeding, IPR2013-00403). Because the reasoning for both granting and denying the various claim amendments was very similar for both of the cases, we will focus on IPR2013-00402. These cases were unique in that the patent owner did not file either a Patent Owner Preliminary Response or a Patent Owner Response. Instead, the patent owner only filed a motion to amend, seeking to cancel claims 1-12 (3 sets of 4 claims) and substitute claims 13-18 (2 claims for each set). And, unlike the case for the granted motion to amend in International Flavors & Fragrances Inc. v. The United States of America (IPR2013-00124), the petitioner in these cases opposed the motion. But, despite this opposition, the Board found that the patent owner had met its burden with respect to substitute claims 13 and 15, and granted-in-part the motion. The patent owner, on the other hand, did not meet its burden with respect to the other claims.

The technology at issue in these cases related to network memory systems. And, whereas that portion of our readership that tends to be more life-sciences orientated might not have sufficient interest in the specifics, it is important to have at least a basic understanding of the technology at issue. The issue addressed by the patents involved the use of distributed servers instead of centralized servers. The advantage of keeping the information on a centralized server was that it is easier to synchronize the data (think jointly editing a document with several other people on different computers versus a network), but "bandwidth bottleneck" can occur when multiple computers attempt to access data. On the other hand, several distributed servers can be used by remote computers to cut down on this bottleneck, but the procedures to ensure synchronization of data are more complex. Moreover, even though caching can be used by the remote computers in the centralized system, caching is binary, and therefore even a small change to a document will prevent caching from being utilized.

The patentees developed a system that reduced network traffic by using "appliances" linked to the servers and remote computers to determine whether even a portion of the requested data was accessible locally. If a portion of the data was not locally accessible, that portion could be accessed from the central server, with instructions to subsequently store the data with the updated portion on the locally accessible machine. This was accomplished, in part, by the calculation of a hash and the use of both a fine and a course filter, and comparing it to a corresponding signature hash table. For those not familiar with the term, a hash is calculated using a hash function, which converts any piece of data into a digital signature, and can be used to determine if two pieces of data are identical. The patentees developed a way to identify "sync points" by determining the hash values for locations down to the byte level, and performing forward and backward memory comparison to identify the optimum length of matching data. This was advantageous over the prior art, according to the patentees, because the prior art used "pre-segmented data," which was inflexible and did not allow for the identification of very small changes. As a rough analogy to molecular biology, this would be akin to the difference between screening DNA with a hybridization probe that could only identify whether the DNA stretches were identical, and alternatively being able to pinpoint ever base substitution present in the DNA.

To provide a sense of the scope of the amendments made to the "independent" parent claim, claim 13 follows as exemplary:

13. (proposed substitute for claim 4) The source-site appliance of claim 1, wherein the processor is configured to determine whether the transmitted data corresponds to locally accessible data via a process comprising:
    identifying sync points in the transmitted data having matches in the locally accessible data by (i) determining hash values corresponding to different byte locations of the transmitted data, (ii) finely filtering the hash values using a fine filter to determine a finely filtered set of the hash values corresponding to fine sync points, and coarsely filtering the hash values using a coarse filter to determine a coarsely filtered set of the hash values corresponding to coarse sync points, and (iii) determining from the finely filtered set of the hash values and the coarsely filtered set of the hash values, a plurality of hash values matching hash values of the locally accessible data; and
    performing for byte locations with matching hash values, a forward and backward memory comparison between the transmitted data and data representing the locally accessible data, the forward and backward comparison to identify a size of a matching region of the transmitted data with the data representing the locally accessible data, and performing based on results of the forward and backward memory comparison, a determination of a locally accessible portion of the transmitted data corresponding to the matching region that is locally accessible at the destination-site appliance and a non-locally accessible portion of the transmitted data that is not locally accessible at the destination-site appliance; and
    wherein the instruction comprises a retrieve instruction and a store instruction, the retrieve instruction indicating to the destination-site appliance to retrieve the locally accessible portion of the transmitted data corresponding to the matching region from storage locally accessible to the destination-site appliance, and the store instruction indicating to the destination-site appliance to store the non-locally accessible portion of the transmitted data; and
    wherein the processor is further configured to send [a] the non-locally accessible portion of the transmitted data over the wide area network to the destination-site appliance.

Of course, this claim is written in dependent form, but is essentially independent because claim 1 will be canceled. The proposed substitute dependent claims contained additional features beyond changing which claim from which it depends. Claim 14 is exemplary:

14. (proposed substitute for claim 3) The source-site appliance of claim [1] 13 wherein the store instruction further indicates to the destination-site appliance to store another copy of the locally accessible portion of the transmitted data together with the non-locally accessible portion of the data at an index in a database in the storage locally accessible to the destination-site appliance.

The analysis began, as always, by determining whether there was any broadening of claim scope. The PTAB found that each proposed substitute claim contained all of the limitations of the corresponding claim in the original patent, and that no limitations were removed. The petitioner did not challenge the patent owner's assertion regarding claim scope. Next, the Board looked to determine if there was written description support in the original disclosure. Again, petitioner did not challenge this, and the Board concluded that the patent owner made a significant showing that there was written description support. With regard to the interpretations of the new claim terms, the patent owner provided constructions and support for "sync point," "fine sync point," and "course sync point," which the petitioner did not challenge. The Board agreed that these constructions provided the broadest reasonable interpretation of the claims.

Having made these determinations, the Board looked to whether the patent owner met its burden of proof to demonstrate patentability over the prior art. A problem faced by other patent owners in previous IPRs was that they did not demonstrate that the prior art included more than the cited art, but rather included prior art not of record but known to the patent owner. Silver Peak met its burden by providing a "story" of what the prior taught, citing to both art of record and otherwise, and explaining why its proposed substitute claims described "a very different approach." For example, the Silver Peak explained that "pre-existing data de-duplication systems reduced network traffic by dividing data into 'segments' (or 'chunks') and transmitting a 'reference' (or 'token'), rather than the data segment itself, when the destination device already had a copy of the data segment." In contrast, instead of this inflexible approach of searching through all data segments, the patentees developed the method described by the claims. This method of describing the prior art "problem" and the patentees "solution" was deemed to be persuasive by the Board.

The petitioner, in additional to challenging (unsuccessfully) the patent owners characterization of the prior art, alleged that the patent holder did not distinguish the invention over all of the prior art of which it was aware. The Board disagreed with petitioner based on the facts of the case. Moreover, the petitioner argued that the substitution motions were defective because they did not include the testimony of a technical expert. The Board, however, pointed out that even though experts can be helpful, they are not a prerequisite. Each case depends on its facts. As a result, the Board grated the motions to the extent they requested substitution of two of these "independent" claims per patent.

Even though it is certainly instructive to learn what the Board considered to be a sufficient explanation of the prior art such that the burden of proof to amend the claims was met, it is the distinction between the claims that were granted and those that were denied that has additional value. As mentioned above, it was the failure of the patent owner to propose a reasonable number of substituted claims that caused the rejection of these claims. However, the "reasonable number" did not correspond to a one-for-one substitution. Indeed, Silver Peak was proposing one-third less claims than in the original patent. Instead, the patent owner ran afoul of this requirement because it added additional new features to the dependent claims. And, according to Idle Free, when seeking such claims, the patent holder must "establish a special circumstance for adding those features." This amounts to demonstrating why the dependent claims would be patentable over the prior art and the parent (independent) claims. And, as the Board concluded, in part, the "Patent Owner does not explain sufficiently why storing an additional copy would have been non-obvious," when the parent claims included its own storing of a copy of the data.

The Board has explained that it does not want to address such claims of differing scope because the PTAB is more of an adjudicatory than examinational body. In fact, if the patent owner truly wanted such claims, the PTAB explained in Idle Free that the patent owner could utilize some other type of proceeding at the office, such as ex parte reexamination. Interestingly, according to Idle Free,if the patent owner had not sought to add the additional limitations to the dependent claims, but rather only amended the claim on which it depended, those claims would have survived. This is true, even though such claims would be broader in scope than those being sought by the patent holder. It is possible that Silver Peak had a strategic reason for adding such limitations, such as concern that invalidating prior art to the broader claims may have been identified in the future. In such a scenario, adding these limitations may have allowed these narrower claims to survive.
Top Three Stories of 2014

January 7, 2015

By Donald Zuhn —

After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list oftop patent stories. For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants. Previously, we counted down stories #18 to #15, #14 to #11, #10 to #7, and #6 to #4. Today, we count down the top three stories of 2014. As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.

3. AIA Post-Grant Review Proceedings Rise in Popularity

Although they were established in September 2012 when the Leahy-Smith America Invents Act was enacted, the patent community had to wait until 2014 for post-grant review proceedings to really take hold. And when we refer to post-grant review proceedings, we are talking about inter partes reviews (IPRs) and post-grant reviews (PGRs), both of which were set forth in § 6 ("post-grant review proceedings") of the AIA, as well as the transitional program for covered business method patents, a "post-grant review proceeding" set forth in § 18 of the AIA. The lag between enactment and the use of post-grant review proceedings stems from the effective dates and applicability of the provisions of the AIA that established these proceedings. In particular, the provisions for IPRs did not take effect until September 2013, and the provisions for PGRs apply only to patents issued from applications filed after March 15, 2013. In June, we reported that IPR filings had exceeded 1,500. By comparison, in the almost 14-year run of inter partes reexaminations, just over 1900 requests for inter partes reexaminations had been filed (see USPTO statistics). So, the numbers indicate that the AIA's IPRs have been much more popular. In addition, in September we reported on what appears to have been the second filed PGR. We expect that the popularity of post-grant review proceedings will continue into 2015.

For information regarding this and other related topics, please see:

• "PTAB Update — Hatch-Waxman-Watch Edition," December 11, 2014
• "PTAB Update — Amending Claims in an IPR Proceedings ," December 4, 2014
• "Versata Software, Inc. v. Callidus Software, Inc. (Fed. Cir. 2014)," November 20, 2014
• "In re Cuozzo Speed Technologies LLC Federal Circuit Argument — The Patent Office Asks to Have Its Cake and Eat It Too," November 10, 2014
• "PTAB Update — Is "Broadest Reasonable Interpretation" the Appropriate Standard?" October 27, 2014
• "Federal Circuit Schedules Argument for First IPR Final Written Decision – In re Cuozzo Speed Technologies LLC," October 2, 2014
• "PTAB Update — A Review of the First Round of Comments — Part 2," October 1, 2014
• "PTAB Update — A Review of the First Round of Comments (Part 1)," September 18, 2014
• "USPTO Extends Deadline for Comments to Help Improve PTAB Proceedings " September 15, 2014
• "PGR Report — The Attack of 35 U.S.C. § 112," September 11, 2014
• "IPR Update – Prosecution Bars ," September 3, 2014
• "IPR Update — The First Pharma IPR Decisions, July 22, 2014
• "Deputy Directory Lee Announces the Request for Written Comments to Help Improve PTAB Proceedings," July 15, 2014
• "Docs @ BIO — Federal District Court vs. the PTAB," June 26, 2014
• "PTAB Grants First Motion for Leave to Amend in Inter Partes Review," May 27, 2014
• "AIA Trial Roundtables — PTAB Takes Its Show on the Road," April 17, 2014
• "IPR Update — The First Biotech IPR Decisions," March 24, 2014
• "Inter Partes Review — A Look Back," March 16, 2014

2. Supreme Court Decides Alice Corp. v. CLS Bank

In June, the Supreme Court affirmed the Federal Circuit's per curiam opinion in CLS Bank v. Alice Corp. While the decision did not strike down all software patents, and was crafted as an application of the Court's earlier precedent, particularly Bilski v. Kappos and Mayo Collaborative Serv. v. Prometheus Labs., the Court affirmed the patent ineligibility of method claims (directed, according to the Court, to methods for implementing an intermediated settlement that are well-known in the art), system claims involving implementation of the method using a general purpose computer, and computer code for directing a general purpose computer to implement the method. In its Alice decision, the Court applied Justice Breyer's two-step test for § 101 worthiness introduced in Mayo (which would become the focus of the USPTO's revised subject matter eligibility guidance). The story coming in at #8 on this year's list concerned the impact of the Supreme Court's Alice Corp. opinion on subsequent Federal Circuit and Patent Trial and Appeal Board decisions. As we noted in an earlier post in our top stories series, of the nine Federal Circuit and PTAB decisions we covered during the second half of 2014, in only one case did the Federal Circuit conclude that computer-implemented claims had survived a § 101 challenge. Readers can look for more discussion of this top story during our live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015, as well as here and here.

For information regarding this and other related topics, please see:

• "USPTO Issues Preliminary Examination Instructions Regarding Alice Corp. v. CLS Bank International," June 25, 2014
• "Thoughts on Alice Corp. v. CLS Bank Int'l," June 19, 2014
• "Supreme Court Issues Decision in Alice Corp. v. CLS Bank," June 19, 2014
• "Supreme Court Hears Oral Argument in Alice Corp. v. CLS Bank Int'l," April 6, 2014
• "Alice Corp. v. CLS Bank Int'l: CLS Bank's Supreme Court Brief," March 10, 2014
• "Alice Corp. v. CLS Bank Int'l: Alice's Supreme Court Brief," March 9, 2014

1. PTO Issues "Comprehensive" Subject Matter Eligibility Guidance Superseding Myriad/Mayo Guidance

In March, the U.S. Patent and Trademark Office issued a memorandum to the Patent Examining Corps, implementing a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012). The Myriad-Mayo guidance was not well received by applicants and practitioners, many of whom were critical of the Office's interpretation of Myriad, Mayo, and a number of other relevant opinions. Over the course of the next nine months, Office representatives addressed issues with the Myriad-Mayo guidance in several public forums. In mid-December, the Office issued revised guidance that supplemented the Office's Alice guidance and superseded the controversial Myriad-Mayo guidance. The differences between the interim guidance and Myriad/Mayo guidance correspond to statements made by Office representatives over the latter half of 2014 (see "Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance"; "USPTO Expected to Issue Revised Myriad-Mayo Guidance in October"; "USPTO Outlines Changes to Myriad-Mayo Guidance at BIO Symposium"; and "USPTO Provides Update on Status of Revised Myriad-Mayo Guidance"). The Office indicated that the interim guidance "offers a comprehensive view of subject matter eligibility in line with Alice Corp, Myriad, Mayo, and the related body of case law," and was responsive to public feedback the Office received concerning the Myriad/Mayo guidance and preliminary Alice Corp. guidance. Readers can look for more discussion of this top story during our live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015, as well as here and here.

For information regarding this and other related topics, please see:

• "Impact of Interim Guidance on Business Method and Software Claims," December 17, 2014
• "USPTO Issues Interim Guidance on Subject Matter Eligibility," December 16, 2014
• "USPTO to Release Revised Subject Matter Eligibility Guidance," December 15, 2014
• "Examination of Myriad-Mayo Guidance Comments — The Coalition for 21st Century Medicine — Part II," December 2, 2014
• "Examination of Myriad-Mayo Guidance Comments — The Coalition for 21st Century Medicine," December 1, 2014
• "BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance," November 13, 2014
• "USPTO Provides Update on Status of Revised Myriad-Mayo Guidance," November 12, 2014
• "Examination of Myriad-Mayo Guidance Comments — University Community Joint Comment," October 28, 2014
• "Examination of Myriad-Mayo Guidance Comments — BIO Joint Comment," October 23, 2014
• "The Indefiniteness of What is "Routine, Well-understood and Conventional" in Assessing Patent Eligibility of Diagnostic Method Claims," October 20, 2014
• "Sherry Knowles Addresses Real World Impact of Myriad-Mayo Guidance at BIO Symposium," October 15, 2014
• " USPTO Outlines Changes to Myriad-Mayo Guidance at BIO Symposium," September 30, 2014
• "USPTO Expected to Issue Revised Myriad-Mayo Guidance in October," September 17, 2014
• "Guest Post: Myriad-Mayo Guidance — Consistency With International Harmonization and TRIPS," August 26, 2014
• "Examination of Myriad-Mayo Guidance Comments — AUTM, COGR, AAU, and APLU," August 21, 2014
• "Examination of Myriad-Mayo Guidance Comments — International Bioindustry Associations," August 11, 2014
• "Examination of Myriad-Mayo Guidance Comments — ACLU," August 5, 2014
• "How to Protect a Product of Nature," August 3, 2014
• "Guest Post: Overview of First Published Comments on Myriad-Mayo Patent Eligibility Guidance," July 13, 2014
• "Docs @ BIO: The Rest of the Story," July 8, 2014
• "Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance," July 1, 2014
• "Docs @ BIO: Bloomberg BNA Issues Report on PTO's Patent Eligibility Guidance," June 30, 2014
• "USPTO Extends Deadline for Providing Feedback on Myriad-Mayo Guidance," June 27, 2014
• "Guest Post: USPTO Public Forum on Patent Guidance: My Thoughts as a Speaker and Attendee," June 11, 2014
• "Guest Post: Myriad — An Obvious and Patent-Friendly Interpretation," June 4, 2014
• "USPTO Holds Forum on Subject Matter Eligibility — Part IV," May 22, 2014
• "USPTO Holds Forum on Subject Matter Eligibility — Part III," May 15, 2015
• "USPTO Holds Forum on Subject Matter Eligibility — Part II," May 14, 2014
• "Guest Post: How to Patent Grapefruit Juice — The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour," May 13, 2014
• "USPTO Holds Forum on Subject Matter Eligibility — Part I," May 12, 2014
• "In re Roslin Institute (Fed. Cir. 2014)," May 8, 2014
• "Sherry Knowles "Speaks Truth to Power" on the PTO's § 101 Guidelines," May 1, 2014
• "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
• "Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)," March 18, 2014
• "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014
Top Stories of 2014: #6 to #4

January 6, 2015

By Donald Zuhn —

After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories. For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants. Previously, we counted down stories #18 to #15, #14 to #11, and #10 to #7. Today, we count down stories #6 to #4 as we work our way towards the top three stories of 2014. As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.

6. Federal Circuit Denies Myriad Motion for Preliminary Injunction

In March, the District Court for the District of Utah denied Myriad Genetics' motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Myriad had filed suit against Ambry for infringement of ten patents relating to genetic diagnostic testing less than a month after the U.S. Supreme Court announced its decision in AMP v. Myriad Genetics in June 2013. Ambry was one of the first companies to announce that it would provide genetic diagnostic testing for the BRCA 1 and BRCA 2 genes after the Supreme Court's Myriad decision. The litigation with Ambry was consolidated with five other infringement suits against Gene-by-Gene, Quest, GeneDx, Invitae, and LabCorp, and three declaratory judgment actions by Quest, Invitae, and Counsyl. Myriad then appealed the District Court's denial of the company's preliminary injunction motion. Last month, the Federal Circuit affirmed the District Court's decision denying Myriad Genetics' motion for a preliminary injunction in In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation. The impact of the Federal Circuit's decision in the case (on the U.S. Patent and Trademark's recent interim subject matter guidance, for example) may well land this story on next year's list.

For information regarding this and other related topics, please see:

• "In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014)," December 17, 2014
• "Guest Post: Myriad — A Direct and Unexceptional Approach," October 12, 2014
• "Federal Circuit Argument in Myriad Appeal Scheduled," September 25, 2014
• "News from Abroad: Myriad Patent Upheld by Full Federal Court of Australia," September 5, 2014
• "Good News, Bad News and More Inflammatory Rhetoric in Myriad Genetics Case," June 17, 2014
• "Dr. Cook-Deegan Brings the Medical Community Up to Date on the Myriad Case," March 31, 2014
• "Myriad Appeals Adverse Preliminary Injunction Decision," March 20, 2014
• "Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court," March 19, 2014
• "Utah Judge Denies Myriad's Preliminary Injunction Motion," March 11, 2014
• "Gene-by-Gene Cries Uncle, Settles with Myriad Genetics," February 7, 2014

5. Supreme Court Decides Nautilus v. Biosig Instruments –– Overrules Federal Circuit "Insolubly Ambiguous" Standard for Indefiniteness

On June 2, the Supreme Court issued two decisions impacting patent law. In the first, Nautilus, Inc. v. Biosig Instruments, Inc., the Supreme Court reversed the Federal Circuit, overruling the "insolubly ambiguous" standard for patent claim indefiniteness. The Court discerned that § 112 "entails a 'delicate balance,'" wherein "[o]n the one hand, the definiteness requirement must take into account the inherent limitations of language," while on the other hand "a patent must be precise enough to afford clear notice of what is claimed, thereby " 'appris[ing] the public of what is still open to them.'" According to the Court, this inherent ambiguity cannot become so great that it creates a "zone of uncertainty" around the patent claims, which would discourage innovation without any benefit to the public. And the Court was apparently persuaded that "patent applicants face powerful incentives to inject ambiguity into their claims" unless countervailing disincentives (in the form of being put at risk of being invalidated) are in place. Being "[c]ognizant of the competing concerns," the Court announced its test for indefiniteness, stating that "we read §112, ¶2 to require that a patent's claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty," noting that "[t]he definiteness requirement, so understood, mandates clarity, while recognizing that absolute precision is unattainable."

For information regarding this and other related topics, please see:

• "Triton Tech of Texas, LLC v. Nintendo of America, Inc. (Fed. Cir. 2014)," June 16, 2014
• "Nautilus, Inc. v. Biosig Instruments, Inc. (2014)," June 3, 2014
• "In re Packard (Fed. Cir. 2014)," May 18, 2014

4. Supreme Court Decides Limelight v. Akamai — Reverses Federal Circuit in Divided Infringement Case

In the Supreme Court's other June 2 patent-related decision, Limelight Networks, Inc. v. Akamai Technologies, Inc., the Court again reversed the Federal Circuit, determining that a defendant is not liable for inducing infringement of a patent under 35 U. S. C. § 271(b) when no one has directly infringed the patent under § 271(a) or any other statutory provision. The Court declared that "our case law leaves no doubt that inducement liability may arise 'if, but only if, [there is] . . . direct infringement.'" The Court noted that "the Federal Circuit reasoned that a defendant can be liable for inducing infringement under §271(b) even if no one has committed direct infringement within the terms of §271(a) (or any other provision of the patent laws), because direct infringement can exist independently of a violation of these statutory provisions." However, as the Court explained, "there has simply been no infringement of the method [of Akamai's U.S. Patent No. 6,108,703], because the performance of all the patent's steps is not attributable to any one person," and "where there has been no direct infringement, there can be no inducement of infringement under §271(b)." In addition, the Court refused Akamai's request to review the merits of the Federal Circuit's rule from Muniauction, Inc. v. Thomson Corp. for direct infringement under § 271(a), noting that the question presented clearly focused on § 271(b), and not § 271(a).

For information regarding this and other related topics, please see:

• "Limelight Networks, Inc. v. Akamai Technologies, Inc. (2014)," June 2, 2014
Content Extraction and Transmission, LLC vs. Wells Fargo Bank (Fed. Cir. 2014)

January 5, 2015

By Michael Borella —

Patentee Content Extraction and Transmission (CET) owns U.S. Patent Nos. 5,258,855 (the '855 patent), 5,369,508 (the '508 patent), 5,625,465 (the '465 patent), and 5,768,416 (the '416 patent). The '508, '465, and '416 patents are continuations of the '855 patent, and in the words of the Federal Circuit, "share substantially the same specification."

CET filed infringement suits against Wells Fargo Bank, PNC Financial Services Group, Inc. (PNC) and various third parties in the United States District Court for the District of New Jersey. Diebold, Inc., supplier of the allegedly infringing equipment used by the defendants, joined the action as a cross-appellant. Diebold contended that CET engaged in tortious interference and violations of the RICO act due CET's infringement claims being baseless.

In the District Court, PNC filed a Rule 12(b)(6) motion to dismiss the case on the grounds that all asserted claims were invalid as patent-ineligible under 35 U.S.C. § 101. The District Court agreed, dismissing CET's complaint, and also dismissing Diebold's counter-claims against CET, because CET's actions were protected under the Noerr-Pennington doctrine (the act of petitioning the government — including the filing of a lawsuit — is immune from liability unless the litigation is a "sham").

CET appealed to the Federal Circuit and Diebold cross-appealed. Judges Dyk, Taranto, and Chen heard the case, with Judge Chen authoring the unanimous opinion.

Claim 1 of the '855 patent recites:

A method of processing information from a diversity of types of hard copy documents, said method comprising the steps of:
    (a) receiving output representing a diversity of types of hard copy documents from an automated digitizing unit and storing information from said diversity of types of hard copy documents into a memory, said information not fixed from one document to the next, said receiving step not preceded by scanning, via said automated digitizing unit, of a separate document containing format requirements;
    (b) recognizing portions of said hard copy documents corresponding to a first data field; and
    (c) storing information from said portions of said hard copy documents corresponding to said first data field into memory locations for said first data field.

The Court described the claimed invention (of the '855 patent as well as the other three patents) as "a method of 1) extracting data from hard copy documents using an automated digitizing unit such as a scanner, 2) recognizing specific information from the extracted data, and 3) storing that information in a memory." Further, "[t]his method can be performed by software on an automated teller machine (ATM) that recognizes information written on a scanned check, such as the check's amount, and populates certain data fields with that information in a computer's memory."

In Alice Corp. v. CLS Bank Int'l, the Supreme Court set forth a two-prong test for the patent-eligibility of claims under 35 U.S.C. § 101. First, one determines whether a claim is directed to a patent-ineligible law of nature, natural phenomenon, or abstract idea. Then, if the claim appears to be directed to such an exception, one is to determine whether the elements of the claim, considered both individually and as an ordered combination, are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself.

In applying the Alice test, the Court found that the claims were directed to the abstract idea of "1) collecting data, 2) recognizing certain data within the collected data set, and 3) storing that recognized data in a memory." The Court noted that such activities were "well-known" and have been performed by human beings, and banks, for some time. CET argued that the claims were not abstract because they involve a scanner, and "human minds are unable to process and recognize the stream of bits output by a scanner." Nonetheless, the Court did not find that this point distinguished the claims over those of Alice.

Moving on to the second prong of the test, the Court stated that "the asserted patents contain no limitations — either individually or as an ordered combination — that transform the claims into a patent-eligible application." The Court used CET's concession at oral argument "that the use of a scanner or other digitizing device to extract data from a document was well-known at the time of filing, as was the ability of computers to translate the shapes on a physical page into typeface characters" to conclude that "CET's claims merely recite the use of this existing scanning and processing technology to recognize and store data from specific data fields such as amounts, addresses, and dates." As a result, the Court found that there was no inventive concept to CET's use of a generic scanner, and that the claims failed to pass muster under § 101.

CET argued that the District Court erred when it held the claims to be patent-ineligible in the pleading stage of the suit. Invoking Ultramercial, Inc. v. Hulu, LLC, a recent case in which claims were invalidated as patent-ineligible on the pleadings, the Federal Circuit disagreed. In a conclusory fashion, the Court stated that "even when construed in a manner most favorable to CET, none of CET's claims amount to significantly more than the abstract idea of extracting and storing data from hard copy documents using generic scanning and processing technology." Accordingly, the Court found the dismissal of the case proper.

The Court next considered the counts of tortious interference and violations of the RICO act that Diebold brought against CET. Under the Noerr-Pennington doctrine, to overcome a plaintiff's presumptive immunity from liability when bringing a suit, the opposing party must establish that "not only that the litigation was objectively baseless, but also that the defendant subjectively intended to harm the plaintiff through the abuse of a governmental process itself, as opposed to harms flowing from the outcome of that process."

The Court found that CET's acts of filing for patent infringement were not objectively baseless because "the state of the law of § 101 was deeply uncertain at the time CET filed its complaints against Wells Fargo and PNC in 2012." Thus, the suits, though ultimately unsuccessful, were protected by the First Amendment, and Diebold's claims were dismissed.

As the post-Alice jurisprudence of the Federal Circuit continues to grow, some trends are emerging. First, while the Supreme Court found that use of a generic computing device to be insufficient to lift otherwise ineligible claims over the § 101 bar, the Federal Circuit has expanded that reasoning to similar uses of the Internet (Ultramercial) and now generic scanning devices.

Second, this decision illustrates a divide between the Federal Circuit and the USPTO's Patent Trial and Appeal Board (PTAB) regarding application of the Alice test. In U.S. Bancorp v. Solutran, Inc., the PTAB denied Covered Business Method Review (on the basis of alleged patent-ineligibility) of U.S. Patent No. 8,311,945, directed to scanning and processing paper checks.

Claim 1 of that patent recites:

A method for processing paper checks, comprising:
    a) electronically receiving a data file containing data captured at a merchant's point of purchase, said data including an amount of a transaction associated with MICR information for each paper check, and said data file not including images of said checks;
    b) after step a), crediting an account for the merchant;
    c) after step b), receiving said paper checks and scanning said checks with a digital image scanner thereby creating digital images of said checks and, for each said check, associating said digital image with said check's MICR information; and
    d) comparing by a computer said digital images, with said data in the data file to find matches.

The PTAB found that this claim was not directed to an abstract idea because the claim was directed to "a method of processing paper checks, which is more akin to a physical process than an abstract idea." Thus, despite claim 1 reciting "some fundamental economic practices . . . such as crediting an account for a merchant," the additional features of "receiving said paper checks and scanning said checks with a digital scanner and comparing by a computer said digital images . . . are not fundamental economic practices, mathematical algorithms, or basic tools of scientific and technological work."

Consequently, applicants need to be cautious — claims that are found patent-eligible by the USPTO's interpretation of Alice could very well be found the opposite by a reviewing court's interpretation of that case.

Content Extraction and Transmission, LLC vs. Wells Fargo Bank (Fed. Cir. 2014)
Panel: Circuit Judges Dyk, Taranto, and Chen
Opinion by Circuit Judge Chen
Top Stories of 2014: #10 to #7

January 4, 2015

By Donald Zuhn —

After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories. For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants. On New Year's Eve, we counted down stories #18 to #15, and on New Year's Day, we covered stories #14 to #11. Today, we count down stories #10 to #7 as we work our way towards the top three stories of 2014. As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.

10. While FDA Accepts First Biosimilar Application, Some Biosimilar Applicants Try to Bypass BPCIA

In July, Sandoz announced that the U.S. Food and Drug Administration had accepted its application to market a version of the protein filgrastim. The reference product is Amgen's NEUPOGEN®. Sandoz markets a biosimilar filgrastim outside the U.S. under the brand name ZARZIO®. Interestingly, in October, Amgen announced the results of a Phase III clinical trial of its own biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab (sold by AbbVie as Humira®). Amgen and Sandoz were both involved in a BPCIA dispute that was resolved by the Federal Circuit in December. In what some perceived as an attempt to sidestep the requirements of the BPCIA, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. In Sandoz v. Amgen, the Federal Circuit affirmed the District Court's dismissal of Sandoz's suit because "Sandoz did not allege an injury of sufficient immediacy and reality to create subject matter jurisdiction." In other biosimilar developments, the FDA issued a "Guidance for Industry" in August entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." The Guidance provides some grounds for determining the term of market exclusivity under the BPCIA (12 years; Sec. 351(k)(7), codified at 42 U.S.C. 55 262(k)).

For information regarding this and other related topics, please see:

• "Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y. 2014)," December 11, 2014
• "Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)," December 9, 2014
• "Amgen Poised to Enter Biosimilars Market," October 8, 2014
• "FDA Releases Another Prospective Guidance," August 13, 2014
• "Finally, A Biosimilar Application Has Been Accepted By The FDA ," July 28, 2014
• "FDA Releases Draft Guidance on Biosimilars," May 14, 2014
• "Indiana Governor Signs Biosimilar Substitution Bill," April 10, 2014

9. Congress and Tech Sector Wage Battle Against Patent Trolls

Despite having passed patent reform legislation — the Leahy-Smith America Invents Act — in September 2011, many in the patent community expected Congress to pass another piece of patent reform legislation in 2014 — this time addressing patent litigation and the problem of so-called patent trolls. However, after taking up and tabling legislation in March and April, Senator Patrick Leahy (D-VT), Chairman of the Senate Committee on the Judiciary, announced that he was taking the Patent Transparency and Improvements Act of 2013 (S. 1720) off the Committee's agenda because of a lack of "sufficient support behind any comprehensive deal." Meanwhile, the tech sector continued to lobby for patent litigation reform. Congress may take up patent reform again this year.

For information regarding this and other related topics, please see:

• "More Misinformation Regarding the Patent System and Non-Practicing Entities," December 18, 2014
• "Patent Litigation Reform — Will the Outcome of the Mid-Term Elections Matter, and Is Reform Still Necessary?" October 30, 2014
• "Teva v. Sandoz — Is Deferential Review a Boon for Patent Trolls?" October 14, 2014
• "House Tries One More Time: Targeting Rogue and Opaque Letters Act of 2014 ("TROL Act")," July 17, 2014
• "Patent Reform Legislation Off The Table — For Now," May 21, 2014
• "Senate Judiciary Committee Tables Patent Reform, Again," April 3, 2014
• "Stopping Bad Legislation — The Innovation Alliance Speaks Out," April 2, 2014
• "Stopping Bad Patents — Senator Schumer Takes on the "Patent Trolls"," April 1, 2014
• "New York Times Op-Ed Argues Law Takes Misguided Approach to Software Patents," March 30, 2014
• "Senate Judiciary Committee Takes Up, Then Tables, Patent Reform," March 27, 2014
• "A Rebuttal to The Economist's "Stalking Trolls"," March 13, 2014
• "Senate Legislation Update — The Commerce Committee Gets in the Act," March 5, 2014

8. Courts and PTAB Deal with Fallout of Alice Corp. v. CLS Bank

In June, the Supreme Court issued its opinion Alice Corp. v. CLS Bank International, affirming the Federal Circuit's per curiam opinion in CLS Bank International v. Alice Corp. (stay tuned for more on that decision as we move closer to the top three stories of 2014). However, the impact of the Supreme Court's Alice Corp. opinion on Federal Circuit and Patent Trial and Appeal Board decisions made it to #8 on the list. Patent Docs covered nine such decisions during the second half of 2014, and in only one case (DDR Holdings, LLC) did the Federal Circuit conclude that computer-implemented claims survive a § 101 challenge. Readers can look for more discussion of this top story, as well as the Supreme Court's Alice Corp. decision, during our live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015.

For information regarding this and other related topics, please see:

• "DDR Holdings, LLC v. Hotels.com, L.P. (Fed. Cir. 2014)," December 8, 2014
• "Ultramercial Inc. v. Hulu LLC (Fed. Cir. 2014)," November 16, 2014
• "Ultramercial Inc. v. Hulu LLC — Party Briefs," November 6, 2014
• "Cambridge Assoc., LLC v. Capital Dynamics (PTAB 2014); PNC Bank v. Secure Axcess, LLC (PTAB 2014)," October 16, 2014
• "U.S. Bancorp v. Solutran, Inc. (PTAB 2014)," September 10, 2014
• "Planet Bingo, LLC v. VKGS LLC (Fed. Cir. 2014)," August 27, 2014
• "I/P Engine, Inc. v. AOL Inc. (Fed. Cir. 2014)," August 18, 2014
• "Stewart Title Guaranty Co. v. Segin Software, LLC (PTAB 2014)," July 23, 2014
• "Digitech Image Technologies, LLC v. Electronics For Imaging, Inc. (Fed. Cir. 2014)," July 14, 2014
• "Cyberfone Systems, LLC v. CNN Interactive Group, Inc. (Fed. Cir. 2014)," March 3, 2014
• "SmartGene, Inc. v. Advanced Biological Laboratories, SA (Fed. Cir. 2014)," January 29, 2014

7. Supreme Court Addresses Fee Shifting Determinations in Exceptional Cases

In April, the Supreme Court issued opinions in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc. The issue in both cases centered on the attorney fee-shifting provision of 35 U.S.C. § 285. In Octane Fitness, a mostly unanimous court held that "an 'exceptional' case is simply one that stands out from others with respect to the substantive strength of a party's litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated," the Court leaving the determination of whether a case is "exceptional" to the discretion of the District Court judge. In Highmark, the Supreme Court determined that "an appellate court should apply an abuse-of-discretion standard in reviewing all aspects of a district court's §285 determination," even though "questions of law may in some cases be relevant to the §285 inquiry." The Supreme Court's decisions make it easier for a trial court to shift fees to the non-prevailing party if it believes that the litigation was brought or conducted in an abusive manner, and also make it more difficult for an appellate court to overturn such a determination.

For information regarding this and other related topics, please see:

• ""Standing Out" — A Closer Look at the "Exceptional Case" Standard Articulated in Octane Fitness," April 29, 2014
• "Patent Trolls Beware — Supreme Court Issues Decisions in Octane Fitness and Highmark," April 29, 2014
• "Oral Arguments in the Supreme Court Octane Fitness, LLC v. ICON Health & Fitness, Inc. Case," February 27, 2014
• "Supreme Court to Hear Oral Arguments in Attorney Fee Shifting Cases," February 25, 2014
• "Supreme Court Preview — Highmark Inc. v. Allcare Health Mgmt. Sys., Inc.," February 19, 2014
• "Supreme Court Preview — Octane Fitness, LLC v. ICON Health & Fitness, Inc.," February 13, 2014
Court Report

January 4, 2015

By Sherri Oslick —

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

Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc.
1:14-cv-01508; filed December 23, 2014 in the District Court of Delaware

• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant: Roxane Laboratories Inc.

Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 7,297,703 ("Macrolides," issued November 20, 2007), and 7,741,338 (same title, issued June 22, 2010) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Novartis' Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected). View the complaint here.

Eisai Co. Ltd. et al. v. Roxane Laboratories Inc.
1:14-cv-01511; filed December 23, 2014 in the District Court of Delaware

• Plaintiffs: Eisai Co. Ltd.; Eisai Inc.; Novartis Pharma AG
• Defendant: Roxane Laboratories Inc.

Infringement of U.S. Patent Nos. 6,740,669 ("Crystal Modification of 1-(2,6-Difluorobenzyl)-1H-1,2,3-Triazole-4-Carboxamide and its Use as Antiepileptic," issued May 25, 2004) and 7,750,028 ("Crystal Modifications of 1-(2,6-Difluorobenzyl)-1H-1,2,3-Triazole-4-Carboxamide," issued July 6, 2010) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Eisai's Banzel® (rufinamide oral suspension, used for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in children 4 years and older and adults). View the complaint here.

iCeutica Pty Ltd. et al. v. Lupin Ltd. et al.
1:14-cv-01515; filed December 23, 2014 in the District Court of Delaware

• Plaintiffs: iCeutica Pty Ltd.; Iroko Pharmaceuticals LLC
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent No. 8,679,544 ("Formulation of Diclofenac," issued March 25, 2014) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Iroko's Zorvolex® (diclofenac, used for the management of mild to moderate acute pain and osteoarthritis pain). View the complaint here.

Cadence Pharmaceuticals, Inc. et al. v. Agila Specialties Private Ltd., Inc. et al.
1:14-cv-08000; filed December 23, 2014 in the District Court of New Jersey

• Plaintiffs: Cadence Pharmaceuticals, Inc.; SCR Pharmatop; Mallinckrodt IP
• Defendants: Agila Specialties Private Ltd., Inc.; Agila Specialties Inc.

Cadence Pharmaceuticals Inc. et al. v. Agila Specialties Private Ltd. Inc. et al
1:14-cv-01499; filed December 19, 2014 in the District Court of Delaware

• Plaintiffs: Cadence Pharmaceuticals Inc.; SCR Pharmatop; Mallinckrodt IP
• Defendants: Agila Specialties Private Ltd. Inc.; Agila Specialties 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 Agila's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) 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 Delaware complaint here.

Forest Laboratories LLC et al. v. Breckenridge Pharmaceutical Inc.
1:14-cv-01504; filed December 22, 2014 in the District Court of Delaware

• Plaintiffs: Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
• Defendant: Breckenridge Pharmaceutical Inc.

Infringement of U.S. Patent Nos. 5,763,476 ("Sublingual or Buccal Pharmaceutical Composition," issued June 9, 1998), 7,741,358 ("Crystal Form of Asenapine Maleate," issued June 22, 2010), and 8,022,228 (same title, issued to September 20, 2011) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Forest's Saphris® (asenapine maleate, sublingual, used to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder). View the complaint here.

Fresenius Kabi USA LLC v. Claris Lifesciences Ltd. et al.
1:14-cv-01498; filed December 19, 2014 in the District Court of Delaware

• Plaintiff: Fresenius Kabi USA LLC
• Defendants: Claris Lifesciences Ltd.; Claris Lifesciences Inc.

Fresenius Kabi USA, LLC v. Claris Lifesciences Ltd. et al.
1:14-cv-07953; filed December 19, 2014 in the District Court of New Jersey

• Plaintiff: Fresenius Kabi USA, LLC
• Defendants: Claris Lifesciences Ltd.; Claris Lifesciences Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,476,010 ("Propofol Formulations with Non-Reactive Container Closures," issued July 2, 2013) following a Paragraph IV certification as part of Claris' filing of an ANDA to manufacture a generic version of Fresenius' Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations). View the Delaware complaint here.

Sanofi-Aventis US LLC et al. v. Fresenius Kabi USA LLC
1:14-cv-01496; filed December 18, 2014 in the District Court of Delaware

• Plaintiffs: Sanofi-Aventis US LLC; Aventis Pharma SA; Sanofi
• Defendant: Fresenius Kabi USA LLC

Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi USA, LLC
3:14-cv-07869; filed December 17, 2014 in the District Court of New Jersey

• Plaintiffs: Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendant: Fresenius Kabi USA, LLC

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 5,847,170 ("Taxoids, Their Preparation and Pharmaceutical Compositions Containing Them" issued December 8, 1998) and 7,241,907 ("Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation" issued July 10, 2007) following a Paragraph IV certification as part of Fesenius' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Sanofi's Jevtana® (cabazitaxel injection, used in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen). View the New Jersey complaint here.

Novartis AG et al. v. Actavis, Inc. et al.
2:14-cv-07849; filed December 17, 2014 in the District Court of New Jersey

• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co., Ltd.
• Defendants: Actavis, Inc.; Actavis Elizabeth LLC

Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis). View the complaint here.

AstraZeneca AB et al. v. Actavis Laboratories FL, Inc. et al.
3:14-cv-07870; filed December 17, 2014 in the District Court of Delaware

• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.

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 Actavis' 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 complaint here.

Jazz Pharmaceuticals, Inc. et al v. Watson Laboratories, Inc.
2:14-cv-07757; filed December 11, 2014 in the District Court of New Jersey

• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendant: Watson Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued December 14, 2010 ("Sensitive Drug Distribution System and Method" issued February 22, 2011), 8,263,650 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued September 11, 2012), 8,324,275 (same title, issued December 4, 2012), 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), 7,765,106 (same title, issued July 27, 2010), 7,765,107 (same title, issued July 27, 2010), 7,895,059 (same title, issued February 22, 2011), 8,457,988 (same title, issued June 4, 0213), 8,589,182 (same title, issued November 19, 2013), 8,731,963 (same title, issued May 20, 2014), and 8,772,306 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued July 8, 2014) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
Conference & CLE Calendar

January 4, 2015

January 8, 2015 – "Biosimilars: The Action Finally Starts" (Intellectual Property Owners Association) – 1:00 to 2:00 pm (ET)

January 8, 2015 – "Proving and Avoiding Inequitable Conduct in Patent Prosecution and Litigation — Leveraging Court Treatment Post-Therasense and the AIA's Answer to Inequitable Conduct Issues" (Strafford) – 1:00 to 2:30 pm (EST)

January 13-14, 2015 – Advanced Summit on Life Sciences Patents (American Conference Institute) – New York, NY

January 15, 2015 – "Obviousness Standard After the AIA: Leveraging Latest PTO and Court Guidance — Overcoming Challenges of Obviousness and Attacks on Patent Validity" (Strafford) – 1:00 to 2:30 pm (EST)

January 16, 2015 – 5th Annual Patent Law Conference (University of San Diego School of Law) – University of San Diego

January 20, 2014 – "Top Patent Law Stories of 2014" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

January 22, 2015 – "Preparing for and Navigating PTAB Appeals Before the Federal Circuit — Conducting PTAB Trials With Eye to Appeal, Determining Errors for Appeal, Understanding PTO Practice and Federal Circuit Law" (Strafford) – 1:00 to 2:30 pm (EST)

January 29, 2015 – "IPR Defense: An Overview of Strategic Considerations and Potential Pitfalls From the Patent Owner's Perspective" (American Bar Association Center for Professional Development and Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

January 29, 2015 – "Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Post-Grant and Litigation — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" (Strafford) – 1:00 to 2:30 pm (EST)

February 5, 2015 – "On Sale and Public Use Bars to Patentability After AIA — Minimizing the Risk of Patent Ineligibility or Invalidation" (Strafford) – 1:00 to 2:30 pm (EST)

February 24-25, 2015 – Professional Responsibility and Legal Ethics for Life Sciences Attorneys (American Conference Institute) – Philadelphia, PA

March 5-6, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

***Patent Docs is a media partner of this conference or CLE
IPO Webinar on Biosimilars

January 4, 2015

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Biosimilars: The Action Finally Starts" on January 8, 2015 beginning at 2:00 pm (ET). Kevin Nelson of Duane Morris LLP, Brian Slater of Fitzpatrick, Cella, Harper & Scinto, and Elizabeth Weiswasser of Weil, Gotshal & Manges, LLP will discuss the impact of recent cases and other Biologics Price Competition and Innovation Act (BPCIA) developments, including:

• The Federal Circuit opinion, Sandoz v. Amgen, which involves the blockbuster drug Enbrel and addressed whether a biosimilar developer can seek an early adjudication of questions of validity and infringement of patents before it files a biosimilar application;
• Efforts by Celltrion and Hospira to get declaratory judgment on the invalidity of other biological drug patents; and
• Amgen's complaint, filed in October in the Northern District of California, alleging that Sandoz unlawfully refused to follow BPCIA patent resolution procedures (colloquially known as the "patent dance") regarding its application to the Food and Drug Administration for approval of a biosimilar to Neupogen. Amgen's complaint asserts unfair competition under California law, conversion, and patent infringement.

The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Webinar on On Sale and Public Use Bars

January 2, 2015

Strafford will be offering a webinar/teleconference entitled "On Sale and Public Use Bars to Patentability After AIA — Minimizing the Risk of Patent Ineligibility or Invalidation" on February 5, 2015 from 1:00 to 2:30 pm (EST). Daniel G. Brown of Latham & Watkins, Thomas L. Irving and Dr. Amanda K. Murphy of Finnegan Henderson Farabow Garrett & Dunner will examine the on sale and public use bars to patent eligibility and the impact of the AIA on these statutory bars, and discuss recent court treatment and offer best practices to minimize the risk of patent ineligibility or invalidation. The webinar will review the following questions:

• How do AIA changes impact the on sale bar and the public use bar?
• How are courts treating the on sale bar and the public use bar?
• What best practices can counsel employ to adapt patent prosecution and enforcement strategies?

The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those registering by January 16, 2015 will receive a $50 discount. Those interested in registering for the webinar, can do so here.
Top Stories of 2014: #14 to #11

January 1, 2015

By Donald Zuhn —

After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories. For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants. Yesterday, we counted down stories #18 to #15, and today we count down stories #14 to #11 as we work our way towards the top three stories of 2014. As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.

14. Supreme Court Hears Oral Argument in Teva v. Sandoz — Will Decide Deference for Claim Construction Determinations

In March, the Supreme Court granted certiorari in Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. to resolve the question of "[w]hether a district court's factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) requires." In October, the Court heard oral argument in the case. 2015 will bring a decision from the Court as to whether appellate courts should afford any deference to a trial court's claim construction determination, and regardless of the Court's decision, Teva v. Sandoz will likely make a return trip to our top stories list (although coming in perhaps a little higher than #14 on next year's list).

For information regarding this and other related topics, please see:

• "Teva v. Sandoz — Is Deferential Review a Boon for Patent Trolls?" October 14, 2014
• "Teva v. Sandoz — Supreme Court Preview," October 9, 2014
• "Supreme Court Preview — Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. — The End of Cybor Corp.?" September 29, 2014
• "Supreme Court Grants Certiorari in Teva Pharmaceuticals v. Sandoz," March 31, 2014

13. Federal Circuit Decides Novartis v. Lee — RCE Tolls B Delay Clock Regardless of When Filed

In January, the Federal Circuit affirmed a determination by the District Court for the District of Columbia that challenges of patent term adjustment (PTA) determinations by the U.S. Patent and Trademark Office for fifteen Novartis patents were untimely asserted, and with respect to three other Novartis patents, reversed the District Court's ruling that the Patent Office's interpretation of 35 U.S.C. § 154(b)(1)(B) was contrary to law. With respect to the first fifteen patents, the Court noted that Novartis did not file suit within 180 days of denial of reconsideration of the Office's PTA determination, and that Novartis had failed to demonstrate why the 180-day rule should be equitably tolled. The three other patents at issue involved the impact of an RCE filing on the calculation of B Delay. For these patents, the Federal Circuit agreed with the Office that no PTA time is available for any time in continued examination, even if the continued examination was initiated more than three calendar years after the application's filing (in other words, for an RCE filed more than three years after the application filing date). The Court, however, agreed with Novartis that the"time consumed by continued examination should be limited to the time before allowance, as long as no later examination actually occurs. In June, the U.S. Patent and Trademark Office published a notice of proposed rulemaking to implement the Federal Circuit's decision in Novartis v. Lee.

For information regarding this and other related topics, please see:

• "USPTO Proposes Rules Changes in View of Novartis v. Lee," July 16, 2014
• "Novartis AG v. Lee (Fed. Cir. 2014)," January 15, 2014

12. Supreme Court Decision Impacts Patentees in License Agreements

In January, the Supreme Court held in Medtronic, Inc. v. Mirowski Family Ventures, LLC that when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee. The decision by the Supreme Court reversed a Federal Circuit decision from 2012. As we noted in our summary of the Medtronic decision, the case potentially disrupts the balance of power between a patent holder and a licensee. In particular, we suggested that licensees may be emboldened to force patent holders to prove that licensed products or processes infringe the patents at issue, noting that a licensee would have little risk in doing so because a patent holder would not be able to assert counterclaims. Therefore, the best that can be hoped for from the patentee's point of view would be to maintain the status quo, which could end up creating a disincentive for patent holders from entering into licensee agreements.

For information regarding this and other related topics, please see:

• "Medtronic, Inc. v. Mirowski Family Ventures, LCC (2014)," January 22, 2014

11. Federal Circuit Extends Scope of Obviousness-type Double Patenting and Reaffirms Doctrine's Continued Application

The Federal Circuit issued two opinions in 2014 that address the judicially created doctrine of obviousness-type double patenting. In April, the Court decided in Gilead Sciences Inc. v. Natco Pharma Ltd. that a patent (in this case Gilead's U.S. Patent No. 5,763,483) that issues after but expires before another patent (Gilead's U.S. Patent No. 5,952,375) can qualify as a double patenting reference for the other patent. Instead of focusing on the issue date, as Gilead argued it should do, the panel majority in Gilead v. Natco focused on the date at which time the invention fell into the public domain. The majority argued that doing otherwise would encourage "significant gamesmanship" during prosecution, explaining that "if the double patenting inquiry was limited by issuance date, inventors could routinely orchestrate patent term extensions by (1) filing serial applications on obvious modifications of an invention, (2) claiming priority to different applications in each, and then (3) arranging for the application claiming the latest filing date to issue first." Thus, in Gilead, the majority fashioned a rule that "the earliest expiration date of all the patents an inventor has on his invention and its obvious variants" should be used for an obviousness-type double patenting analysis. In September, in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, the Federal Circuit rejected the Kennedy Trust's argument that because of the Uruguay Round Agreement Act (URAA), which implemented a 20-year patent term, the statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist. Instead, the Court noted that the doctrine also serves to prevent an inventor from securing a second, later expiring patent for the same invention, and that patents claiming overlapping subject matter that were filed at the same time still can have different patent terms due to examination delays at the USPTO.

For information regarding this and other related topics, please see:

• "AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014)," September 4, 2014
• "Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014)," April 8, 2014

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