Patent Docs

Cyberfone Systems, LLC v. CNN Interactive Group, Inc. (Fed. Cir. 2014)

March 3, 2014

By Michael Borella —

In 2011, Cyberfone sued CNN and 80 other defendants in the U.S. District Court for the District of Delaware for infringement of U.S. Patent No. 8,019,060. On the defendants' motion for summary judgment, the District Court held the claims of the '060 patent invalid under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. In a non-precedential ruling, the Federal Circuit panel of Judges Lourie, Dyk, and Wallach affirmed.

Claim 1 of the '060 patent recites:

A method, comprising:
    obtaining data transaction information entered on a telephone from a single transmission from said telephone;
    forming a plurality of different exploded data transactions for the single transmission, said plurality of different exploded data transactions indicative of a single data transaction, each of said exploded data transactions having different data that is intended for a different destination that is included as part of the exploded data transactions, and each of said exploded data transactions formed based on said data transaction information from said single transmission, so that different data from the single data transmission is separated and sent to different destinations; and
    sending said different exploded data transactions over a channel to said different destinations, all based on said data transaction information entered in said single transmission.

After dispensing with the usual overview of § 101 case law, Judge Dyk, writing for the panel, applied the two-step analysis of Mayo v. Prometheus. First, he concluded that claim 1 involves an abstract idea. He characterized this abstract idea as "collecting information in classified form, then separating and transmitting that information according to its classification." Next, he examined the remaining limitations of claim 1 to determine whether "additional substantive limitations . . . narrow, confine, or otherwise tie down the claim so that, in practical terms, it does not cover the full abstract idea itself."

In its defense, Cyberfone asserted that claim 1 meets both prongs of the machine or transformation test of Bilski v. Kappos, and therefore meets the requirements of § 101 for this reason. Particularly, Cyberfone took the position that claim 1 requires a telephone, contending that it is a specific machine integral to the claimed method. However, in line with reasoning of several Federal Circuit judges, Judge Dyk warned that "[f]or a machine to impose a meaningful limit . . . it must play a significant part in permitting the claimed method to be performed [and] simply implementing an abstract concept on a computer, without meaningful limitations to that concept, does not transform a patent-ineligible claim into a patent-eligible one."

To determine whether the claimed telephone is indeed significant to the claim, Judge Dyk looked to the specification of the '060 patent. He focused on text that states that the invention relates to "a transaction entry device which can selectively operate in a telephone mode and a transaction entry mode." While in the telephone mode, "the transaction entry device operates as a conventional telephone," but in the transaction entry mode, "menus are used to navigate the user to forms which facilitate the entry of data." From this distinction, Judge Dyk concluded that "the telephone does not obtain data when it is functioning as a telephone, only when in an unclaimed mode of operation."

In contrast to Judge Dyk's conclusion, the '060 patent does not state that the telephone and transaction entry modes are mutually exclusive. Rather, at col. 6, line 53 through col. 7, line 14, the '060 patent describes how these modes can be used together. Particularly, the telephone mode requires use of a telephone line for telephony calling, while the transaction entry mode would also use such a telephone line for modem-based data transaction. However, the specification notes that "[i]n telephone mode, one or more lines may be connected so as to allow simultaneous use of the transaction entry device without interfering with the modem connection." Therefore, the '060 explicitly permits the telephone to obtain data when it is functioning as a telephone.

Furthermore, Judge Dyk stated that the obtaining of data is "an unclaimed mode of operation." Perplexingly, the first element of claim recites "obtaining data transaction information entered on a telephone."   Claim 1 goes on to recite how this data is processed and used. Therefore, it is unclear how Judge Dyk attained this interpretation of the claim, especially since the claim itself makes no mention of the device being in either mode. Does Judge Dyk's reasoning, taken to its logical extreme, mean that my cell phone is no longer a cell phone when I use the keypad to enter a number, but suddenly becomes one again when I press "send" to call that number?

Regardless, Judge Dyk went on to state that "the recited telephone can be a range of different machines: a conventional telephone, a portable telephone, [or] a battery operated portable device which is a cross between a laptop computer and a cellular telephone." (Citations omitted.) Based on these broad definitions of the term "telephone," Judge Dyk concluded that "[t]he telephone recited in claim 1 is not a specific machine, and adds nothing of significance to the claimed abstract idea." Cyberfone argued further that the claimed step of "sending said different exploded data transactions over a channel to said different destinations" required a specific machine, but Judge Dyk found this point unconvincing, asserting that "Cyberfone provides no guidance as to what particular machine is required to perform the function of the recited channel."

Finally, Cyberfone attempted to invoke the transformation prong of the machine or transformation test, in that the "exploded data transactions involve such a transformation." Judge Dyk, however, was skeptical, and stated that "the exploding step effects no meaningful transformation because it merely makes the originally-gathered information accessible to different destinations without changing the content or its classification. Nor does the particular configuration of steps — obtaining, separating, and then sending information — confer patentability."

For the second time in two months, the Federal Circuit has come down with a non-precedential opinion that serves to further illustrate the Court's position on § 101 and computer-implemented technologies (see Smartgene, Inc. v. Advanced Biological Laboratories, SA). In this case, the plain text of the specification appears to contradict the panel's reasoning. Perhaps the panel used uncited information in the record to reach its conclusion?

One factor that may have worked against Cyberfone is the structure of the claim. Claim 1 requires "obtaining data transaction information . . . from [a] telephone," and "sending . . . exploded data transactions over a channel to said different destinations." However, it is not clear which of these devices (the telephone or the destinations) performs the steps of the claim. In other words, claim 1 could be viewed as a disembodied method, perhaps one that could be performed by a human. In that light, the § 101 rejection of the claim has a stronger basis in precedent.

Regardless, patent drafters might find Judge Dyk's conclusion of the telephone not being a specific device troublesome. It is very common for the specification of a computing-related patent to define a "computing device" or a "communication device" to include embodiments such as a personal computer, tablet computer, cell phone, or any other type of computer with networking capabilities. This is done in order to provide a basis for arguing (e.g., in a Markman brief) that the term should be construed broadly. Will the Federal Circuit adopt the reasoning of this non-precedential opinion to hold such language against the applicant in § 101 analyses?

Cyberfone Systems, LLC v. CNN Interactive Group, Inc. (Fed. Cir. 2014)
Panel: Circuit Judges Lourie, Dyk, and Wallace
Opinion by Circuit Judge Dyk
Patent Profile: VM Institute of Research Receives Patent for Method of Treating Triple Negative Breast Cancer

March 2, 2014

By Josh Bosman —

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,642,270, which is entitled "Prognostic biomarkers to predict overall survival and metastatic disease in patients with triple negative breast cancer." The '270 patent, which is assigned to the VM Institute of Research (Montreal, Canada), contains claims to a method of treating breast cancer in a subject having triple negative breast cancer.

For some time doctors and scientists hypothesized that the diversity observed among breast tumors might be accompanied by diversity in gene expression patterns. Over ten years ago, Perou and colleagues published their work on the "Molecular portraits of human breast tumours" (Perou et al., 2000 Nature 406: 747-52) classifying human breast tumors based their gene expression profiles. This work was soon followed up with studies that linked the gene expression profiles of each breast cancer subtype with patient overall survival and disease free survival. One of the subtypes identified was the basal-like subtype. The basal-like subtype is also described as triple-negative breast cancer because it generally does not express estrogen receptor (ER), progesterone receptor (PR), and expresses only normal, but not amplified, levels of the human epidermal growth factor receptor 2 (HER2). Given the nature of the triple-negative breast tumors, this subtype does not respond to cancer drugs that target ER, PR or HER2 (i.e., Taxol® or Herceptin®), and has poorer overall survival and disease-free survival than other breast cancer subtypes. The triple negative paradox (Carey et al., 2007 Clin Cancer Res. 13(8): 2329-34) is that these tumors often respond well to the initial chemotherapy treatments, and yet patients have significantly poorer overall survival. The work by the inventors of the `270 patent helps to develop effective methods to determine whether a triple negative breast cancer patient is likely to have a recurrence or progress to the aggressive, metastatic disease in order to aid clinicians in deciding the appropriate course of treatment.

The '270 patent provides a method of treating breast cancer in a subject having a triple negative breast cancer. The inventors were able to identify a 12 gene set that correlates with overall survival of the triple negative breast tumors. More specifically, the inventors determined that the expression of STK3, KLF6, CD24 and KRAS, could be indicative of a recurrent triple negative breast tumor.

The '270 patent has one independent claim which recites:

1. A method of treating breast cancer in a subject having a triple negative (TN) breast cancer, the method consisting of the steps:
    (a) quantifying mRNA expression level of biomarkers STK3 and KLF6, and at least one biomarker selected from CD24 and KRAS in a test sample from a subject using a biological assay;
    (b) comparing said mRNA expression level of said biomarkers selected from STK3, KLF6, and at least one of CD24 and KRAS quantified in step (a) to the expression level of said biomarkers quantified using the biological assay in a standard sample indicative of a recurrent TN breast cancer; and
    (c) administering an aggressive cancer treatment regimen to the subject based on an increase in the expression level of the biomarkers between the standard sample and the test sample.

A review of the file history of the '270 patent indicates that a rejection under 35 U.S.C. § 101 rejection was issued in the first Office Action. The Action stated that the claimed invention is directed to non-statutory subject matter because it is not a patent-eligible practical application of a law of nature and because the claimed method does not result in a physical transformation of matter. Specifically, the Action asserted that the claims do not recite additional elements or steps such that the method is sufficient to ensure that the claim amounts to significantly more than the natural principle itself or merely more than mental tasks.

The original claim 1 as filed recited:

1. A method of predicting the overall survival (OS) potential of a triple negative (TN) breast cancer in a subject, the method comprising the step:
    (a) comparing expression level of at least one biomarker determined in a test sample from a subject to the expression level of the at least one biomarker in a standard sample indicative of a recurrent TN breast cancer, wherein the at least one biomarker is chosen from ANK3, CD24, EIF1, KLF6, KRAS, KRT1, MAP2K4, SDC4, SLC2A3, STK3, TFAP2C, and WRN; and wherein a difference in the expression level of the at least one biomarker between the standard sample and the test sample is used to predict the OS potential of the TN breast cancer in the subject.

In response, the Applicant amended claim 1 to introduce an additional step of modifying a treatment regimen of the subject based on the results of step (a). The Applicant asserted that with the new step, the method as amounted to "significantly more than the application of a natural principle."

Claim 1 as amended recited:

1. (Currently Amended) A method of predicting the overall survival (OS) potential of a triple negative (TN) breast cancer in a subject, the method comprising the step:
    (a) comparing a mRNA expression level of at least threeone biomarkers chosen from STK3, KLF6, and one of CD24 or KRAS determinedquantified using a biological assay in a test sample from a subject to the expression level of the at least threeone biomarkers quantified using the biological assay in a standard sample indicative of a recurrent TN breast cancer, wherein the at least one biomarker is chosen from ANK3, CD24, EIF1, KLF6, KRAS, KRT1, MAP2K4, SDC4, SLC2A3, STK3, TFAP2C, and WRN; and
    (b) modifying a treatment regimen of the subject based on the results of step (a) wherein a difference in the expression level of the at least one biomarkers between the standard sample and the test sample is used to predict the OS potential of the TN breast cancer in the subject.

In the next and final Office Action mailed July 30, 2013, the Office maintained the rejection of the claims under 35 U.S.C. § 101 because the invention was not a patent-eligible practical application of a law of nature. The Action noted that the claims recited methods steps for detecting or determining and comparing marker levels from samples, but asserted that these steps are routine or conventional, and do not add anything substantial to the claim that amounts to significantly more than observing the natural principle itself. Regarding the step of "modifying a treatment regimen," the Action stated that such a step can be "accomplished mentally by thinking or designing a new treatment plan, and does not set forth any physical steps."

Furthermore, in the final Office Action, the Examiner suggested "amending the claims to recite an active step of administering a specified treatment regimen based on specific results (specific results such as increased or decreased mRNA levels of STK3, KLF6, and CD24 or KRAS relative to specific controls) to a patient population identified by such specific results." Additionally, the Action stated that "prediction of survival rates as correlated to naturally occurring mRNA levels are considered an observation of a naturally occurring principle and an active step must be added to the claimed method that amounts to significantly more than the observation of the natural principle."

On September 17, 2013, in the response to the final Office Action, the Applicant stated "without conceding the correctness of the Examiner's position and for the purpose of expediting prosecution, Claim 1 has been amended to introduce an additional step (c), as suggested by the Examiner." Claim 1 was amended claim 1 as shown below:

1. (Currently Amended) A method of predicting the overall survival (OS) potential of a triple negative (TN) treating breast cancer in a subject having a triple negative (TN) breast cancer, the method comprisingconsisting of the steps:
    (a) quantifying mRNA expression levels of biomarkers STK3 and KLF6, and at least one biomarker selected from CD24 and KRAS in a test sample from a subject using a biological assay;
    (b) comparing [[a]]said mRNA expression level of at least three said biomarkers chosen selected from STK3, KLF6, and at least one of CD24 andor KRAS quantified in step (a) using a biological assay in a test sample from a subject to the expression level of said the at least three biomarkers quantified using the biological assay in a standard sample indicative of a recurrent TN breast cancer; and
    (c[[b]]) modifyingadministering an aggressive cancer treatment regimen ofto the subject based on the results of step (b[[a]]) wherein a difference an increase in the expression level of the biomarkers between the standard sample and the test sample is used to predict the OS potential of the TN breast cancer in the subject.

A notice of allowance was mailed on October 1, 2013.
Court Report

March 2, 2014

By Sherri Oslick —

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

Takeda Pharmaceuticals USA Inc. v. Watson Laboratories Inc. et al.
1:14-cv-00268; filed February 27, 2014 in the District Court of Delaware

• Plaintiff: Takeda Pharmaceuticals USA Inc.
• Defendants: Watson Laboratories Inc.; Actavis Inc.

Infringement of U.S Patent Nos. 7,619,004 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued November 17, 2009), 7,601,758 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics in the Treatment of Gout Flares," issued October 13, 2009), 7,820,681 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued October 26, 2010), 7,915,269 (same title, issued March 29, 2011), 7,964,647 ("Colchicine Compositions and Methods," issued June 21, 2011), 7,964,648 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued June 21, 2011), 7,981,938 ("Colchicine Compositions and Methods," issued July 19, 2011), 8,093,296 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 10, 2012), 8,093,297 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued January 10, 2012), 8,097,655 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 17, 2012), 8,415,395 ("Colchicine Compositions and Methods," issued April 9, 2013), 8,415,396 (same title, issued April 9, 2013), 8,440,721 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued May 14, 2013), and 8,440,722 (same title, issued May 14, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Takeda's Colcrys® (single-ingredient colchicine product, used to prevent and treat gout flares). View the complaint here.

Lyne Laboratories, Inc. et al. v. Roxane Laboratories, Inc.
1:14-cv-10460; filed February 27, 2014 in the District Court of Massachusetts

• Plaintiffs: Lyne Laboratories, Inc.; Fresenius USA Manufacturing, Inc.; Fresenius Medical Care Holdings, Inc.
• Defendant: Roxane Laboratories, Inc.

Infringement of U.S. Patent Nos. 8,591,938 ("Liquid Compositions of Calcium Acetate," issued November 26, 2013) and 8,592,480 (same title, issued November 26, 2013) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Fesenius' Phoslyra® (calcium acetate oral solution, used as a phosphate binder for the reduction of serum phosphorus in patients with end stage renal disease). View the complaint here.

Sanofi et al. v. Glenmark Generics Inc. USA et al.
1:14-cv-00264; filed February 26, 2014 in the District Court of Delaware

• Plaintiffs: Sanofi; Sanofi-Aventis U.S. LLC
• Defendants: Glenmark Generics Inc. USA; Glenmark Generics Ltd.

Sanofi et al. v. Watson Laboratories Inc. et al.
1:14-cv-00265; filed February 26, 2014 in the District Court of Delaware

• Plaintiffs: Sanofi; Sanofi-Aventis U.S. LLC
• Defendants: Watson Laboratories Inc.; Watson Pharma Inc.; Actavis Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012), 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013), and 8,602,215 ("Methods for Reducing the Risk of an Adverse Dronedarone/Beta-Blockers Interaction in a Patient Suffering from Atrial Fibrillation," issued December 10, 2013 following a Paragraph IV certification as part of defendats' filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation). View the Glenmark complaint here.

Meda Pharmaceuticals Inc. v. Perrigo Israel Pharmaceutical Ltd. et al.
3:14-cv-01241; filed February 25, 2014 in the District Court of New Jersey

• Plaintiff: Meda Pharmaceuticals Inc.
• Defendants: Perrigo Israel Pharmaceutical Ltd.; Perrigo Company; L. Perrigo Co.; Impax Laboratories, Inc.

Infringement of U.S. Patent No. 8,518,919 ("Compositions Comprising Azelastine and Methods of Use Thereof," issued August 27, 2013) following a Paragraph IV certification as part of defendats' filing of an ANDA to manufacture a generic version of Meda's Astepro® (azelastine hydrochloride nasal spray, used to treat hay fever and allergy symptoms). View the complaint here.
Conference & CLE Calendar

March 2, 2014

March 5, 2014 – Ninth Annual Federal Judicial Panel (Intellectual Property Law Association of Chicago) – 5:30 to 7:30 pm (CT)

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

March 6, 2014 – "Doctrine of Equivalents: Latest on Patent Prosecution and Litigation" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

March 12-13, 2014 – FDA Boot Camp*** (American Conference Institute) – New York, NY

March 13, 2014 – "Patent Term Adjustments and Extensions: Leveraging Exelixis, Novartis, Other Decisions, and USPTO Rule Changes" (Strafford) – 1:00 to 2:30 pm (EST)

March 20, 2014 – "Parallel Patent Proceedings Before the PTAB and Federal Court Post-AIA — Navigating Litigation Stays, Discovery and Settlements Concurrent with PTAB Review" (Strafford) – 1:00 to 2:30 pm (EST)

March 24-26, 2014 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

March 25, 2014 – 24th Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

March 26, 2014 – "Trade Secret vs. Patent Protection After AIA: Making the Choice — Understanding AIA's Impact on Trade Secrets, Evaluating the Protection Options, Weighing the Benefits and Risks" (Strafford) – 1:00 to 2:30 pm (EDT)

March 26-27, 2014 – Biotech Patenting*** (C5) – Munich, Germany

March 31 to April 2, 2014 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

April 23-25, 2014 – 2014 Spring Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) – Palm Springs, CA

April 28-29, 2014 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY

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
2014 BIO IPCC Spring Conference

February 28, 2014

The Biotechnology Industry Organization (BIO) will be holding its 2014 Spring Intellectual Property Counsels Committee (IPCC) Conference on April 23-25, 2014 in Palm Springs, CA.

The conference will offer presentations on the following topics:

Wednesday, April 23:

• Facing the Future of Biotech Patenting: How to Satisfy the Supreme Court and Have Valuable Claims, Too (Pre-Conference Workshop) — Patent Docs author Donald Zuhn of McDonnell Boehnen Hulbert & Berghoff LLP will moderate a panel consisting of Patent Docs author Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP; David Hoffman, Senior Corporate Counsel, IP & Transactions, Genomic Health; Laurie Hill, Vice President & Deputy General Counsel, MedImmune; and Remy Yucel, Director, Central Reexamination Unit, U.S. Patent & Trademark Office (workshop sponsored by McDonnell Boehnen Hulbert & Berghoff LLP)

Thursday, April 24:

• Breakfast with Judge Gajarsa
• Patent Reform is Calling! Who's Answering: Congress or the Courts?
• Biosimilars and Declaratory Judgments: When Should the BPCIA Trump?
• The Great Divide: Induced Infringement of Method/Process Claims- An Industry Divide on What's at Stake in Limelight v. Akamai (working lunch)
• Section 112 – It's Baaack!
• Shedding Light on Claim Construction: Lighting Ballast and Trends in Managing Claim Construction

Friday, April 25:

• The English Rule (Loser Pays): Will Biotech Get Burned?
• Case Law Updates

In addition, there will be a welcome reception at the Bellatrix Restaurant from 5:30 pm to 7:30 pm on April 23, and a dinner reception at The Living Desert from 5:30 pm to 9:30 pm on April 24.

A program agenda for this conference, including a list of speakers and descriptions of the presentations and events can be obtained here.

Registration information can be found here. Additional information regarding the conference can be found at the conference website.
ACI Paragraph IV Disputes Conference

February 28, 2014

American Conference Institute (ACI) will be holding its 8th Annual Paragraph IV Disputes conference on April 28-29, 2014 in New York, NY. The conference will offer presentations on the following topics:

• On the 30th Anniversary of the Drug Price Competition and Patent Term Restoration Act:
Understanding Hatch-Waxman's Transformative Impact on the Pharmaceutical Industry
• Assessing Pharmaceutical Patent Sustainability and Vulnerability: Strategies and Considerations for Brand Names and Generics in Anticipating, Identifying and Determining Which Patents Will Be Ripe for Challenges of Invalidity and Non-Infringement
• Use of IPR and Other PTO Proceedings in a Paragraph IV Challenge: Strategies for Brand Names and Generics in Navigating PTO Proceedings in ANDA Litigation
• The Gauntlet Rethrown: The Paragraph IV Certification and Notice Letter
• Of Prior Art and Double Patenting: Exploring the Dichotomy between the Federal Circuit and PTO on Obvious Findings and the Potential Impact of the Goodlatte Bill on Double-Patenting Type Obviousness
• Let the Games Begin: Advanced Strategies for Drafting and Perfecting Pleadings and Effectively Using Dispositive Motions in Paragraph IV Disputes
• Working With Local Counsel and within Local Rules: Magistrate and Local Counsel Roundtable
• A View from the Bench
• Claim Construction and Markman Hearings: Standards, Jurisprudential Splits and Strategies for Paragraph IV Litigation
• FTC Keynote: Reverse Payment Settlements and Other Antitrust Concerns Impacting Paragraph IV Litigation in the Wake of Actavis — to be presented by Markus H. Meier, Assistant Director, Health Care Division, Bureau of Competition, Federal Trade Commission
• Perils of the Safe Harbor: Understanding How the Resetting of the Boundaries of 271 (e)(1) In the Aftermath of Classen and Momenta is Impacting Paragraph IV Litigation Strategies
• In the Limelight: Strategies and Theories of Inducement, Contributory and Divided Infringement in Paragraph IV Litigation Concerning Method of Treatment Patents
• Assessing GDUFA Implementation and Additional Regulatory Developments at FDA Which Impact Paragraph IV Litigation
• Looking Beyond 180 Days: New Exclusivity Challenges for Brand Names and Generics and Related Implications for Paragraph IV Challenges
• A Pros and Cons Analysis of Launching At Risk and Survey of New Developments in Seeking Injunctive Relief and Damages
• Ethical Considerations for Paragraph IV Matters before the PTO and District Courts: Inequitable Conduct and More

In addition, a post-conference workshop, entitled "The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics — A Hands-On, Practical Approach in the Aftermath of Actavis" will be offered from 9:00 am to 4:00 pm on April 30, 2014.

The agenda for the Paragraph IV Disputes conference can be found here. More information regarding the workshop can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone), $3,110 (conference and workshop), or $1,395 (workshop alone). Those registering by March 14, 2014 will receive a $300 discount for the conference or a $220 discount for the conference and workshop. Those registering by April 11, 2014 will receive a $200 discount for the conference or a $120 discount for the conference and workshop. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of the Paragraph IV Disputes conference.
IPO Webinar on Doctrine of Equivalents

February 28, 2014

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Doctrine of Equivalents: Latest on Patent Prosecution and Litigation" on March 6, 2014 beginning at 2:00 pm (ET). A panel consisting of Daniel McDonald of Merchant & Gould, Andrew Shyjan of MedImmune, and Judith Szepesi of Blakely Sokoloff Taylor & Zafman LLP will analyze recent case law involving the doctrine of equivalents and extract lessons for clearance and freedom-to-operate practice, patent prosecutors, patent owners and defendants.

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.
IPLAC Federal Judicial Panel

February 28, 2014

The Intellectual Property Law Association of Chicago (IPLAC) will be holding its Ninth Annual Federal Judicial Panel from 5:30 to 7:30 pm on March 5, 2014 at the Illinois Institute of Technology Chicago-Kent College of Law in Chicago, IL. Margaret M. Duncan of McDermott, Will & Emery will moderate a panel consisting of The Honorable Sharon Johnson Coleman, The Honorable John W. Darrah, and The Honorable Virginia M. Kendall. The panel will discuss the following topics:

• N.D. Illinois 2013-2014 IP Litigation Trends
• The Supreme Court's IP docket
• Patent Office Litigation and Its Effect on District Courts
• Electronic Discovery

The registration fee for the panel is $30 (IPLAC members) or $35 (non-members). Those interested in registering can do so here.
Oral Arguments in the Supreme Court Octane Fitness, LLC v. ICON Health & Fitness, Inc. Case

February 27, 2014

By Andrew Williams —

On February 26, 2014, the Supreme Court heard oral arguments in two cases dealing with the attorney fee-shifting provision of 35 U.S.C. § 285. In the first case, Octane Fitness, LLC v. ICON Health & Fitness, Inc. (Supreme Court docket number 12-1184), the issue on appeal was what constitutes an "exceptional case" such that attorney fees can be awarded to the prevailing party. The Federal Circuit had developed a two-part test, which included both an objective component ("objectively baseless") and a subjective component ("subjective bad faith"). Except for a few questions from the Justices that would suggest some deference to the Federal Circuit, no one appeared to be advocating for maintaining this test. Instead, the Justices seemed to struggle with what the appropriate standard should be — as Justice Kennedy put it "this is a search for adjectives." The choices for when a case could be considered exceptional seemed to range from "frivolousness," to "objectively baseless," to "gross injustice," to "objectively reasonable," to "just let the District Court decide." There was no clear indication from the questioning where the Court as a whole was leaning on the issue.

Rudolph Telscher, on behalf of Octane Fitness, summed the issue up in his rebuttal as: "What we're all really talking about here is how extreme should the test be for an exceptional case. I mean, that's what this boils down to." However, just what the test should be turned out to be a moving target. Mr. Telscher began by asserting that the test should be whether the case was "meritless." Justice Scalia challenged him on this standard, because in his mind, every non-prevailing case is meritless ("Don't you have to add something to meritless? I mean, every time you win the summary judgment motion, that's a determination that the claim is without merit."). However, he didn't like Mr. Telscher's proffered alternative, "unreasonably weak," either ("[Y]ou realize how differently various District Courts would operate if you just say, what was your phrase? Unreasonably week?"). Mr. Telscher then settled on "objectively unreasonable," which he explained was something less than frivolous. In response to a question by Justice Sotomayor about what the difference would be between his test and the Federal Circuit's "objectively baseless" test, he responded that "baseless" connotes "absolutely no foundation or zero merit," while he believes that the test should be "something less than frivolous." Mr. Telscher also indicted that "without substantial merit" or "low likelihood of success" would be two additional ways to articulate his proffered standard.

Justice Alito challenged Mr. Telscher on whether they should incorporate a subjective standard into the test. Of course, Mr. Telscher did not think that bad faith was required, but that it could be considered in conjunction with a weak case on the merits. The problem Justice Alito had with such a determination was how to articulate it to the district courts ("How am I supposed to determine whether the case is exceptional if the standard is, take everything into account, litigation misconduct, the strength of the case, any indication of bad faith, and decide whether it exceptional? Exceptional compared to what?"). He was concerned that lower court judges might not have the requisite experience with patent attorneys, and after all, "[t]hey are different from other attorneys." This discussion actually appeared to clear things up for Justice Scalia, because he stated that "you really cannot answer the question of what adjectives should be attached to 'meritless,' . . . [because] it is a totality of the circumstances test, that is only one factor and it doesn't have to be an absolute degree of meritlessness." Of course, when pushed by Justice Kagen for all the factors that can be considered in this "totality-of-the-circumstances" test, Mr. Telscher suggested that it should be a non-exhaustive list — "anything that bears on the gross injustice and the uncommon nature of the case."

Carter Phillips argued the case on behalf of ICON Health and Fitness. Of course, he was mainly playing prevent defense, suggesting that whatever standard the Court settled upon, the actions of ICON would not fall within that standard. Nevertheless, he advocated for the "objectively baseless" standard, with or without a subjective component. He got some of his toughest questioning from Justice Breyer, who was silent during Octane Fitness' presentation. Justice Breyer made clear his concerns about the patent system, and the quality of patents that were being issued by the Patent Office (especially with regard to software patents). In fact, it appeared to be the opinion of Justice Breyer that if the test was "objectively baseless," it could never be met ("[W]hy cannot I, the district judge, say, I've seen all these things, taken together they spell serious injustice, and therefore I'm shifting the fees. Okay? Why can I not do that even though, as I've just said and repeat, I cannot in honesty say it's frivolous given the standard for patenting that seem to be administered?"). And, echoing a comment made in the Prometheus decision, Justice Breyer suggested that that patent attorneys seem to have the ability to get anything patented ("Patent attorneys are very brilliant at figuring out just how to do this.").

To be fair, Mr. Phillips did not define "objectively baseless" as "frivolous." Instead, it was Mr. Phillips's impression that that "baseless" meant "unjustified and vexatious," which in turn meant that the case had "to have enough merit to be — to satisfy the standards of probable cause" (meaning in this context that the case had to have enough merit to go forward). Nevertheless, Justice Breyer seemed to want to just let the district court decide when a case was "exceptional" — "[w]ell, let's send it back and tell them that they were imposing a standard that was too narrow, that didn't take account of all the circumstances where something could be unusually unjust, and then let them, no clear and convincing, but it's up to you, district judge. You're the expert on litigation. You decide." Mr. Phillips did not like this approach because he was concerned that what would be considered an "exceptional" case would be unevenly applied ("There are lots of disincentives for plaintiffs to bring this case. And at the end of the process, based on a completely indeterminate standard, the district court would then retain authority to say, I conclude what you did here is unreasonable.").

Justice Ginsburg asked why the Court should not just use the same standard as that in the Lanham Act, after all, both statutes use the same language. In Lanham Act cases, an exceptional case is one that is not run of the mill, or uncommon, as Justice Ginsburg suggested. Mr. Phillips had a couple of reasons why this would be inappropriate. First, the two statutes have had two entirely different histories, and therefore two entirely different sets of case-law interpreting them. Second, Mr. Phillips suggested that if the two statutes were to be reconciled, it should be the Lanham Act that should be made to comport with the Patent Act, because the Patent Act came first.

Roman Martinez, Assistant to the Solicitor General, argued on behalf of the United States. It was the United States' opinion that the test should revert back to the understanding of the law back when the 1952 Patent Act was enacted — "to prevent gross injustice." However, with the connotation that "gross injustice" has today, this sounds like a very high barrier to an award of fees, and the Court seemed to struggle with this. As Justice Kagen put it, "[g]ross injustice, I mean that's really really exceptional. That sounds like 'shocks the conscience.'" However, Mr. Martinez assured the Court that the "gross injustice" standard was not so difficult to meet, and that, in the end, it essentially comes down to a totality-of-the-circumstances test, with a list of non-exclusive factors to consider.

It is often difficult to determine the outcome of a case based on the questioning from the bench. This case is no exception, although it is highly unlikely that the Federal Circuit two-part test will stand. We will provide an analysis of the Highmark oral hearing in a future post, and we will, of course, provide an analysis of both opinions when the Court issues them, which should occur before the end of June, 2014.
GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (Fed. Cir. 2014)

February 26, 2014

By Kevin E. Noonan —

The Federal Circuit issued an opinion on Monday in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. illustrating how difficult it can be to overturn a district court determination based on a question of fact, at least when the question involves a chemical compound defined by structural properties supported by a description of how such a compound can be made.

The lawsuit involved the drug dutasteride, sold by GSK under the brand names Avodart^®and Jalyn™ for the treatment of "androgen responsive diseases," and GSK brought suit under the provisions of 35 U.S.C. § 271(e)(2) following ANDA filings by defendants Banner Pharmacaps, Inc., Impax Laboratories, Inc., Mylan, Inc., Mylan Pharmaceuticals, Inc., and Watson Laboratories, Inc. The claim at issue, from Orange Book listed U.S. Patent No. 5,565,467, recited in its entirety "17β-N-(2,5-bis (trifluoromethyl)) phenylcarbamoyl-4-aza-5α-androst-1-en-3-one or a pharmaceutically acceptable solvate thereof." The District Court rendered judgment against all defendants, who had stipulated infringement, ruling that defendants failed to establish by clear and convincing evidence that this claim was invalid for "anticipation, lack of utility, lack of enablement, and inadequacy of the written description."

On appeal, Defendants challenged the District Court's claim construction with regard to the scope and meaning of the term "a pharmaceutically acceptable solvate thereof" as that construction was relevant to their written description defense. The Federal Circuit affirmed, in an opinion by Judge Taranto joined by Judges O'Malley and Wallach. Curiously, the opinion did not resolve defendants' challenge to the District Court's interpretation of the term "solvate." Instead, the Court set forth its understanding of the meaning of the term, specifically that a solvate "is something that originates in a 'solution,' which is a mixture of two substances: a 'solute' dissolved in a 'solvent.'" This definition is consistent with the positions of both parties, according to the opinion, and in addition that the parties agree that a solvate can be in the form of a crystal. The disagreement between the parties concerned whether a solvate must be in a crystalline form (defendants' position) or not (GSK's position. While there was "considerable extrinsic evidence" supporting defendants' position, the District Court relied upon the express teachings in the '467 patent specification in deciding that the claimed solvates were not limited to crystalline forms, wherein a solvate was defined as:

A complex formed by dutasteride with a solvent in which dutasteride is reacted or from which it is precipitated or crystallized.

Solvates according to the specification can be produced "by a reaction of dutasteride with a solvent; by precipitation of a complex from a solution of dutasteride and a solvent; by crystallization of a complex from a solution of dutasteride and a solvent," without a requirement that the solvate produced by any of these methods be in the crystalline form.

Adequacy of a specification's written description is a question of fact (reviewed for clear error by the Federal Circuit), and accordingly the Federal Circuit's opinion set forth the District Court's factual findings in support of its decision that defendants had failed to establish invalidity on these grounds. Specifically, the opinion set forth the District Court's findings that methods for producing solvates of steroid compounds (like dutasteride) were well known in the art and that the "universe of solvents thought to be pharmaceutically acceptable was well-known and relatively small." While it was impossible to predict whether any particular solvate produced according to these well-known methods would be pharmaceutically acceptable, the District Court found that methods for determining pharmaceutical acceptability were also well known in the art. Regarding the adequacy of defendants' challenge, the District Court found that:

There is no reason why a person skilled in the art would not credit a patentee with possession of a solvate merely because the patentee did not disclose solvates formed by each solvation process, i.e., reaction, precipitation, crystallization.

In the Federal Circuit's opinion, Judge Taranto noted the limited scope of the issue on appeal, and that defendants had not properly included a challenge on whether the specification adequately described the range of pharmaceutically acceptable solvates encompassed by the '467 patent claim. Under either plaintiff's or defendants' claim construction, the Court found that the term "solvate" was one "defined by structure and by the process of creating it" rather than by its function. The Federal Circuit recognized that the District Court construed the term to comprise "any complex of dutasteride and solvent" that resulted from any of the described methods:

In either event [plaintiff's or defendants' claim interpretation], the written description, which presents materially the same interpretive choice, describes the same class by identifying a particular structure obtained by particular processes. No matter which construction is adopted, the term "solvate" involves no performance property (the claimed compound need not perform an identified function or produce an identified result) and hence raises no issue of insufficient structural, creation-process, or other descriptions to support such a property.

Turning to the specification, the opinion asserts that the language defines the genus of pharmaceutically acceptable solvates as "a complex of dutasteride molecules and solvent molecules, with dutasteride being, as the district court found, 'the key structural component'" and "one that is created by an identified process — specifically, by dissolving dutasteride (the solute) in a solvent." Noting the parties dispute the meaning of these teachings from the specification, the opinion states that "under each side's construction and reading of the specification, the description matches the claim, and regardless of which side is right, the description remains entirely based on structure of the compound and its process of creation." Citing Ariad v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), and Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353, 1366-67 (Fed. Cir. 2011), the opinion notes that this structural description is consistent with the Court's written description jurisprudence. Here, the Court finds that claim scope is "no broader" than what is described in the specification, "whether [that scope] is narrow or broad, as the parties dispute," and that the term "solvate" is structural nor functional in nature (a "critical" distinction according to the opinion, albeit a sentiment followed by statements regarding the adequacy of the description to "make and use" the invention that seemingly introduces questions of enablement into the written description analysis). The Court draws this "structural vs. functional" difference in distinguishing case law cited by defendants in support of their position, because "[h]ere, []under any of the parties' preferred claim constructions, 'solvates' of dutasteride are not distinguished by a particular performance property." Accordingly, the panel could find "no basis" for overturning the District Court's finding that the claims were adequately described.

GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (Fed. Cir. 2014)
Panel: Circuit Judges O'Malley, Wallach, and Taranto
Opinion by Circuit Judge Taranto

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