Patent Docs

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
Top Stories of 2014: #15 to #18

December 31, 2014

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. Today, we count down stories #18 to #15, and then over the next few days, we will work our way towards the top 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.

18. White House Begins to Implement Initiatives to "Foster innovation"

In June of 2013, the White House released a Fact Sheet on the Administration's task force on high-tech patent issues providing seven different legislative recommendations and five executive actions (see "'When the Patent System is Attacked!' — The White House Task Force on High-Tech Patent Issues"). In 2014, the White House took the first steps toward implementing the executive actions. The step that attracted the most attention was the U.S. Patent and Trademark Office's publication of a notice of proposed rulemaking in which the Office proposed changes to the rules of practice that it claimed would "facilitate the examination of patent applications and . . . provide greater transparency concerning the ownership of patent applications and patents." The proposed changes to the rules would require that the "attributable owner" be identified at the time an application is filed (or shortly thereafter), during the pendency of an application when there is a change in the attributable owner (within three months of such change), at the time the issue fee is paid, when maintenance fee payments are made, and if a patent becomes involved in supplemental examination, ex parte reexamination, or a trial proceeding before the Patent Trial and Appeal Board. In February, the White House provided an update on the five executive actions, "announcing major progress" on the initiatives that the Administration declared would help combat so-called "patent trolls." One of the initiatives involved the launching of a new "on-line toolkit" "[t]o help level the playing field and ensure individuals and businesses know their rights and are aware of available resources before entering into costly litigation or settlements." With respect to the White House's initiative to promote transparency concerning patent ownership, Hal Wegner stated in his e-mail newsletter in February that while "attempts to minimize comment [on the proposed rulemaking regarding attributable owner identification] have involved suppression of existing comments as if this will perhaps lead to the public falling asleep at the comment switch," "the leadership of the Patent Office has been sheltered from questioning by the public, while the Administration’s lobbyist group, 'Business Forward', continues to have access to PTO leadership" (emphasis in original).

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

• "White House Seeks to Promote Transparency Concerning Patent Ownership," February 24, 2014
• "The White House Releases Update on "Protecting American Inventors and Innovators"," February 20, 2014
• "USPTO Proposes Rules Changes to Require Identification in Applications and Patents of Attributable Owners," January 28, 2014

17. Federal Circuit Dismisses Consumer Watchdog Appeal for Lack of Standing

In June, the Federal Circuit dismissed an appeal by Consumer Watchdog from a decision of the Patent Trial and Appeal Board affirming the patentability of claims 1-4 of the Wisconsin Alumni Research Foundation's U.S. Patent No. 7,029,913, which is directed to a replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo. In dismissing the appeal, the Federal Circuit determined that Consumer Watchdog had failed to establish an injury in fact sufficient to confer Article III standing because it had failed to identify any alleged injury aside from the Board denying Consumer Watchdog the particular outcome it desired in the reexamination of the '913 patent. Given that Consumer Watchdog had been seeking to invalidate the patent as being invalid for encompassing ineligible subject matter, but for the dismissal for lack of standing, the appeal might have helped elucidate how the Federal Circuit viewed the patent eligibility of subject matter other than nucleic acids after The Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics, Inc.

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

• "Consumer Watchdog v. Wisconsin Alumni Research Foundation (Fed. Cir. 2014)," June 5, 2014
• "Consumer Watchdog Replies to United States Brief on Standing Issue," February 11, 2014
• "United States Argues That Consumer Watchdog Lacks Standing to Appeal Board Decision on WARF Patent," February 6, 2014

16. Federal Circuit Decisions in Terminal Disclaimer Cases Serve as Reminder of Traps for the Unwary

Two decisions by the Federal Circuit in June and December served as a reminder to applicants and practitioners that patent law remains "full of traps for the unwary." In Dinsmore, the Court affirmed a final rejection by the U.S. Patent and Trademark Office, which had refused to accept a reissue declaration in which the patentee indicated that the "error" in the patent that made it defective was the inadvertent filing of a terminal disclaimer. In Japanese Foundation for Cancer Research, the Federal Circuit reversed a District Court determination ordering the U.S. Patent and Trademark Office to withdraw an improperly filed terminal disclaimer. In distinguishing the facts of the instant case from the Court's earlier decision in Carnegie Mellon Univ. v. Schwartz, the Court indicated that Carnegie Mellon had intended to file a terminal disclaimer but had erred in identifying the correct patent serial number, whereas here the issue was whether the Office could withdraw a disclaimer that was intentionally filed (in the correct patent), i.e. where there was not the kind of error in Carnegie Mellon that justified the contrary results.

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

• "Japanese Foundation for Cancer Research v. Lee (Fed. Cir. 2014)," December 11, 2014
• "In re Dinsmore (Fed. Cir. 2014)," June 10, 2014

15. Federal Circuit Hears Oral Argument in Ariosa v. Sequenom

In the context of the controversy caused by the U.S. Patent and Trademark Office's Myriad/Mayo guidance, the Ariosa Diagnostics v. Sequenom case worked its way through the appeal process with oral argument before the Federal Circuit taking place in November. A little more than a year earlier, the Northern District of California had granted summary judgment for declaratory judgment plaintiff Ariosa Disgnostocs, finding that Sequenom's claimed method for detecting a paternally inherited nucleic acid of fetal origin was not patent eligible. Among the controversial aspects of the case, was the District Court's determination that Sequenom's argument that there were alternative methods of detecting cffDNA available was unpersuasive because "Sequenom has failed to present any evidence showing that any of these alternative methods are practical and commercially viable" (emphasis added). Regardless of where the Federal Circuit comes down on this case, it will likely make a return visit to next year's list of top stories and likely impact future iterations of the USPTO's guidance on subject matter eligibility.

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

• "Genetic Technologies Ltd. v. Laboratory Corp. of America Holdings (D. Del. 2014)," November 24, 2014
• "Ariosa v. Sequenom — Ariosa's Responsive Brief," November 11, 2014
• "PTAB Decides Inter Partes Review of Patent at Issue in Ariosa v. Sequenom," September 15, 2014
• "Amicus Briefs Urging Reversal Filed in Ariosa Inc v. Sequenom, Inc.," March 6, 2014
• "Sequenom Files Opening Brief in Appeal of Summary Judgment on Section 101 Grounds," January 30, 2014
Hatch-Waxman Watch: Personal Jurisdiction Edition

December 30, 2014

By Andrew Williams —

Is the ability to obtain personal jurisdiction against an ANDA filer for a Hatch-Waxman-type litigation going to become exceedingly more difficult? In the past, jurisdiction against such a defendant was often predicated on general jurisdiction, analyzing whether the party's contacts with the forum "are so continuous and systematic as to render it essentially at home in the forum State." Daimler AG v. Bauman, 134 S. Ct. 746, 761 (2014). The Supreme Court in the Daimler case made the finding of general jurisdiction for a foreign entity more difficult. Consistent with that holding, Judge Sleet in the AstraZeneca AB v. Mylan Pharmaceuticals, Inc. case found that an ANDA filer's contacts with Delaware were insufficient to confer general jurisdiction — contacts that might have been sufficient previously. Nevertheless, Judge Sleet did find that the act of sending the paragraph IV notification to AstraZeneca in Delaware provided sufficient minimum contact for the Delaware court to exercise specific jurisdiction. Because this result is allegedly inconsistent with an outcome from a North Carolina District Court, Mylan sought certification for interlocutory appeal, which Judge Sleet granted on December 17, 2014 (Certification Order). In so deciding, the judge noted the huge volume of Hatch-Waxman cases pending in Delaware, and that therefore "immediate appeal may indeed advance the termination of this and other ligitation." Certification Order at FN 1. Needless to say, if the Federal Circuit disagrees with Judge Sleet's determination, this could have an immediate and sufficient impact on Hatch-Waxman cases in the state of Delaware, and potentially elsewhere.

The present case stems from Mylan's filing of two ANDAs to seek approval to market generic versions of AstraZeneca's ONGLYZA^® and KOMBIGLYZE^TM drug products. The first of these is for saxagliptin hydrochloride tablets, and the latter is for saxagliptin hydrochloride and metformin hydrochloride extended release-release tablets. AstraZeneca filed suit in Delaware, alleging that the District Court had jurisdiction because Mylan "purposefully availed itself of the rights and benefits of Delaware law by engaging in systematic and continuous contacts with Delaware." Nevertheless, AstraZeneca failed to allege in its complaint that Mylan engaged in any specific activities in Delaware related to the present action, other than a generic statement that "this action arises from actions of Mylan directed toward Delaware." Instead, as in many similar cases, AstraZeneca pointed to the "regular[] and continuous[]" business transactions within the state, which included the selling of pharmaceutical products. Because Mylan derived substantial revenue from the sale of such products, it was alleged, Mylan had "availed itself of the privilege of conducting business within the State of Delaware." Moreover, Mylan had been previously sued in Delaware without objecting to personal jurisdiction and even asserting counterclaims (thereby availing itself of the court). This case was filed at about the same time as cases against several other ANDA filers, all of which were consolidated under the heading AstraZeneca AB v. Aurobindo Pharma., Ltd.

As a refresher of first-year Civil Procedure jurisprudence, the U.S. Constitution's due process clause requires that a defendant not located within a state must "have certain minimum contacts with it such that maintenance of the suit does not offend traditional notions of fair play and substantial justice." Int'l Shoe Co. v. State of Wash., Office of Unemployment Compensation & Placement, 326 U.S. 310, 316 (1945). There are two ways to satisfy this requirement — the presence of specific or general jurisdiction. As suggested above, general jurisdiction can exist even if the cause of action arises outside of the forum state, provided that the party's contacts with the state are "so continuous and systematic as to render it essentially at home in the forum State." Last term, the Supreme Court in the Daimler case pointed out that being "at home" really only existed for a narrow set of circumstances, such as at the place of incorporation or the principal place of business. This effectively reduced the instances in which general jurisdiction exists. However, a court can still have specific jurisdiction over a case if "the litigation results from alleged injuries that 'arise out of or relate to'" activities that are purposefully directed to residents of the forum. Burger King Corp. v. Rudzewicz, 471 U.S. 462, 472-73 (1985). Therefore, for example, in the Hatch-Waxman contact, any previous contacts that an ANDA-filer may have had with a particular state are irrelevant to the determination of specific jurisdiction. Instead, only contacts related to specifics of the case can be considered.

In the present case, Mylan is a West Virginia corporation. It prepared its two ANDAs in West Virginia and filed them in Maryland (where the FDA is located). Mylan is registered to do business in Delaware, and has appointed a registered agent to accept service of process in Delaware, both of which were required by the state. Otherwise, Mylan allegedly has no property or employees in Delaware. Because of these limited contacts with the state, Mylan challenged personal jurisdiction via a Motion to Dismiss. Departing from previous opinions, Judge Sleet determined that the common ways of finding general jurisdiction in the past were no longer viable in view of Daimler. For example, the Court noted that obtaining substantial revenue from drug sales in the state was no longer sufficient. If Delaware was able to assert general jurisdiction over Mylan, Judge Sleet explained, than that would permit the "exercise of general jurisdiction in every [s]tate," which was precluded by the Daimler case. Moreover, the Court rejected AstraZeneca's argument that Mylan consented to general jurisdiction by registering to do business in the state, because Daimler still requires minimum contacts in such circumstances (which still did not exist). Therefore, the Court found general jurisdiction did not exist.

Nevertheless, Mylan's motion to dismiss was denied because of specific jurisdiction. The only "specific" acts that the Court could point to were the filing of the ANDA and the sending of the notification letter into the state, but these were sufficient. Of course, the ANDA was not filed in Delaware, but Judge Sleet noted that the consequences of this "real act" of filing was (or will be) suffered in Delaware. This is partially because the Federal Circuit had already held that jurisdiction is not conferred in Maryland simply because the FDA is located there. The sending of the notice letter was probably more significant because, according to Judge Sleet, the cause of action arose from the receipt of this correspondence, which trigged the 45-day window to file suit. Moreover, the traditional notions of fair play and substantial justice weighed in favor of exercising specific jurisdiction because Mylan is no stranger to litigation in the state of Delaware. To hold otherwise would force AstraZeneca to bring the lawsuit in Mylan's state of West Virginia (which the Court found contrary to the "balance" established by Congress in the statute). Finally, the Court did consider that there were at least ten generic defendants, and resolution of each of these cases in a single district promoted judicial economy.

All eyes will be in the Federal Circuit to see how it addresses this issue of personal jurisdiction. Judge Sleet noted that he was not aware of any other judicial decisions regarding personal jurisdiction in Hatch-Waxman cases that considered the impact of the Daimler case. Because it could impact not only the present case, but may other litigations, the Court found certification appropriate. We will continue to monitor and report on the progress of the interlocutory appeal.
The Uncomfortable Intersection between the Practice of Medicine and Reality

December 29, 2014

By Kevin E. Noonan —

The disconnect between patents and medicine (and more particularly, between physicians who prescribe patented drugs and the pharmaceutical companies who produce them) was illustrated nicely in a recent dustup between doctors working for the National Health Service in the UK and innovator drug company Pfizer over its patented Lyrica^® drug (pregabilin).

As reported on the Biospace GenePool website, the patent protecting the drug itself expired in July 2014, but Pfizer also has a patent on uses of the drug for neuropathic pain (the use most Americans would recognize based on countless viewings of televised commercial advertisements). But it seems that Lyrica^® was first approved for generalized anxiety disorder (GAD) and epilepsy and that the pain indication was disclosed and claimed in a later patent that does not expire until July 2017.

Accordingly, generic versions of pregabilin have been approved only for the GAD and epilepsy indications, and treatment of neuropathic pain with generic pregabilin would be an "off-label" use that would be an act of patent infringement. While drug companies rarely sue doctors, generic drug companies and others who promote such off-label uses can be sued for inducing or contributory infringement (or both) under U.S. law, and while this situation has arisen in Britain it appears that similar grounds of legal liability exist under UK law.

Pfizer addressed these issues in a letter to "physicians" (but, it seems, directed to pharmacists and hospital administrators either in addition to or instead of physicians themselves), setting out what Pfizer characterized as "relatively unusual circumstances":

Re. Lyrica^® (pregabalin) pain patent

I am writing to you to ensure you are informed about the relatively unusual issues surrounding the loss of exclusivity situation for the Pfizer product Lyrica (pregabalin) and so that you can take necessary action to prevent patent infringement by your organisation.

An appendix is attached describing the factual aspects of the situation in detail to ensure that you have the full information available. You will see that, whilst the basic patent for pregabalin has expired and regulatory data protection for Lyrica expired in July 2014, Pfizer has a second medical use patent protecting pregabalin's use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to the invention of its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin's other indications for generalized anxiety disorder (GAD) or epilepsy.

As a result of the pain patent, we expect that generic manufacturers will only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder and not for pain, whilst Pfizer's pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in pain in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected to carry so-called a so-called "skinny label" and will not be licensed for use in pain. In the circumstances described above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer's patent rights. This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is incumbent on those involved to ensure that skinny labeled generic products are not dispensed and used for pain.

In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication. Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government's established policy of rewarding additional research by the granting of a second medical use patent.

We also note that, by issuing guidance, your CCG is able to influence patterns of prescribing and dispensing in your area. We believe these powers must be exercised responsibly and with a view to avoiding the infringement of Pfizer's pain patent.

In view of the above, Pfizer requests that you issue appropriate guidance to prescribing clinicians within your CCG to help to ensure that our pain patent is respected and that all prescribing clinicians are aware of the pain patent situation. There are a number of ways in which this might be achieved, but the simplest solution, we believe, is for clinicians to be advised to prescribe Lyrica^® by brand when prescribing pregabalin to treat neuropathic pain. Pharmacists will then be able to dispense Lyrica^® against such prescriptions and this will ensure that they do not infringe the pain patent. In addition this will mean that patients with pain will be provided with a PIL that describes the use of pregabalin in pain.

Your CCG may also consider reviewing patient records retrospectively (in advance of the availability of generic drugs) and use prescribing decision support mechanisms such as Scriptswitch to support appropriate ongoing prescribing. We are willing to discuss, or assist CCGs with, the development of other solutions.

We should also note that, in our view, (i) CCG guidance instructing or encouraging the usage of generic pregabalin in pain would amount to procurement of patent infringement (an unlawful act); and (ii) your CCG is under an obligation to address the risk of wide scale infringement of Pfizer's patent rights. Pfizer therefore formally reserves all of its legal rights in this regard. If you have any questions in relation to the above please contact Pfizer Ltd on 01304 616161.

Yours sincerely

Ruth Coles

Legal Director

APPENDIX

Lyrica^® (pregabalin) Pain Patent: Statement of Facts

A. Background

1. Regulatory data protection (data exclusivity) for Lyrica^® expired in July 2014 across the European Union. Therefore, generic companies may now submit their applications for marketing authorisations for generic versions of pregabalin.

2. The composition of matter (basic) patent for pregabalin has also expired and the Supplementary Protection Certificate (SPC) relating to this patent has lapsed. There may be inaccuracies in some publicly available records — but as far as we are concerned the basic patent and the SPC are no longer relevant.

3. A patent protecting pregabalin's use in pain is in force for the product until July 2017. This patent (sometimes called a 'second medical use' patent) arises from further research and development on pregabalin leading to the invention of its use in pain, after the original invention of the compound for other uses.

4. As you may be aware, Lyrica^® is authorised for treating neuropathic pain, epilepsy, and generalised anxiety disorder. Pfizer's pain patent only provides patent protection in respect of the use of pregabalin to treat pain.

B. Pain patent facts

Broadly speaking, a 'second medical use' patent is one that relates to a new medical use for a known pharmaceutical or biological compound. The use in question may consist of a new condition that can be treated with the compound (i.e. a new indication). Provided the new use meets the usual tests for patentability (i.e. novelty, an inventive step, etc.) then a patent can be granted to protect it. In fact, the use in question does not have to be the second medical use, since it could be the third, fourth, etc, and the same rules would apply.

This has been the case in Europe for many years. Second medical use patents are recognised in Art 54(5) of the European Patent Convention 2000, provided that the specific use is novel (i.e. not comprised in the state of the art). Art 54(5) of the European Patent Convention 2000 is implemented by primary legislation in the UK through section 4A of the Patents Act 1977 (as amended by the Patents Act 2004).

Pfizer's Lyrica pain patent in Europe is number EP 0 934 061. Details can be found on the European Patent Office online register here:

https://register.epo.org/application?number=EP97932617&tab=main

Pfizer believes the patent is valid and that it prevents the sale of pregabalin for use in pain, which is the largest indication for which Lyrica is prescribed (pain comprises the majority of all prescriptions in the UK).

Accordingly, Pfizer believes that appropriate safeguards should be put in place to ensure that the generic product is not dispensed in situations where pregabalin has been prescribed for pain. Pfizer has no issue with generic supply / dispensing of generic pregabalin for the non-pain indications. Both Generics (UK) Limited (trading as Mylan) and Actavis Group PTC ehf have sought to challenge the validity of the pain patent in the English Patents Court. The two sets of proceedings will be heard together at a trial commencing in June 2015. Pfizer believes the pain patent is valid and will be contesting the case vigorously.

C. Generic pregabalin

Whilst Pfizer's pain patent remains in effect, we expect that generic manufacturers will generally only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder, i.e. the two indications for which Pfizer has no patent protection. This would mean that generic pregabalin products will not have relevant information regarding neuropathic pain in the PIL (Patient Information Leaflets) and Summary of Product Characteristics. Pregabalin generics will contain the same active substance as the originator branded medicine, Lyrica^® and (as mentioned above) are generally expected to obtain a licence which will only cover the epilepsy and generalised anxiety disorder indications, based on their ability to demonstrate bioequivalence with Lyrica^®. There will be no clinical superiority of the originator branded medicine Lyrica^® over generic pregabalin.

Pfizer is not involved in the regulatory procedures of generic competitors. However, we have been notified by one generic company (Actavis Group PTC ehf) that it intends to launch generic pregabalin in the UK in December 2014 or January 2015, with an authorisation and label that will only cover the epilepsy and generalised anxiety disorder indications. Other generic companies may be operating to a similar — or even a faster – timeframe.

On 8 December 2014, Pfizer issued infringement proceedings against Actavis Group PTC ehf, Actavis UK Limited, and Caduceus Pharma Limited concerning the proposed launch of their generic pregabalin product. Pfizer also issued an application for interim relief on this date, seeking appropriate precautions to minimise the risk of the Actavis generic pregabalin product being prescribed or dispensed for pain. The interim relief sought by Pfizer does not interfere with Actavis' ability to sell its generic pregabalin product for the epilepsy and generalised anxiety disorder indications for which it is authorised. Pfizer has no issue with Actavis selling its generic pregabalin product for non-patented indications. Indeed, Pfizer proposed to Actavis to engage in a collaborative effort to ensure that its generic pregabalin is not supplied or dispensed for pain and could accordingly be launched without the need for a court dispute.

D. What it means

The Lyrica^® pain patent situation is a legal issue rather than a clinical one. Pfizer believes the supply of generic pregabalin for use in the treatment of pain, whilst the pain patent remains in force in the UK, would be infringing Pfizer's patent protection and would constitute an unlawful act. The patent may also be infringed, even unwittingly, by pharmacists and others in the supply chain. This may occur if either the pain indication or the brand Lyrica is not stated on the prescription and generic pregabalin is dispensed and used to treat pain — as opposed to epilepsy or GAD. Without information, guidance and a practical solution, Pfizer believes that multiple stakeholders may contribute to IP infringement, an unlawful act, which also runs contrary to the established policy of rewarding additional research by the granting of a second medical use patent.

The result, according to Biospace, has been "scorn" from UK physicians, while characterizing the notice as an "over-reaching legal decree." Quoting Cory Doctorow from the Boing Boing weblog, the site complains that Pfizer wants doctors to prescribe Lyrica^® for pain instead of generic pregabilin, "even though the two drugs are identical" and the branded version "costs much more." Quoting additionally from Boing Boing:

Weirder still is that Pfizer wants to make their stupid problem into everyone else's stupid problem. The fact that it's hard to enforce this kind of secondary patent is Pfizer's business, not doctors'. Doctors' duty is to science and health, not Pfizer's profit-margins. Scientifically, there's no difference between the two compounds. Doctors who prescribe generics leave their patients (or possibly the NHS) with more money to pursue their other health goals.

If your dumb government monopoly is hard to enforce, maybe you shouldn't be banking on it. But in the world of corporatist sociopathy, where externalising your costs on others isn't just a good idea, it's your fiduciary duty to your shareholders, Pfizer's actions are practically inevitable.

Of course the reality is much different. Pfizer doesn't have a problem, it has a presumptively valid patent on another, different use for its branded drug than the use for which pregabilin was initially approved. While drug development itself is expensive, an additional, typically much greater expense is imposed by regulatory agencies, which require that the innovator drug company demonstrate that the drug is safe and effective. While establishing safety is relatively straightforward, demonstrating effectiveness has the inherent requirement of being effective for what. The second use in this case was likely to have been not self-evident; anxiety and epilepsy are not intrinsically associated with neuropathic pain, and Pfizer would have had to both recognize that use and establish efficacy in order to get regulatory approval for that use. The reward for that effort and cost was patent protection for the use, which is what raises the possibility of patent infringement liability now.

In addition, while the physicians themselves will (likely) not be sued, pharmacists and hospital administrations might be (and, frankly, even if Pfizer has no intention of suing either making them aware of the legal consequences is fair and responsible exercise of their patent and regulatory exclusivity).

So why this tempest in this particular teapot? As usual, it comes down to experience, and physicians will always want to treat as many patients as possible as effectively (and cheaply) as possible. However, the physician's experience typically does not include any understanding regarding how medicines actually get developed, approved and marketed. It is unfortunate that the politics of medical care provides an incentive for individuals providing care to oppose individuals providing the new drugs that improve our ability to treat and cure patients (which should be the goal for all of us).

But acting on the incentive to demonize biotech and pharmaceutical companies is self-defeating. Generic drug companies, for all their benefits, do not invest the time and resources to produce any new drugs; without innovator biotechnology and pharmaceutical companies, generic drug makers would have nothing to copy or sell. It would be well for physicians to consider where novel therapies will come from without companies with experience in obtaining (and financing) regulatory approval of such drugs, protecting them with patents, and having the business resources to bring such drugs to market. It is certainly the case that these companies are for-profit (it's capitalism, after all), but the costs of R&D and regulatory approval, as well as scale-up, production, and distribution are realities that cannot be ignored.

That is where experience, specific experience with drug development, is invaluable. Frankly, it is precisely because most physicians lack this experience that makes it easy to allude to corporate "greed" to explain outcomes they do not support. (Similarly, in this way there are many (including apparently the Chief Justice) who attribute support of the patent system by patent attorneys as being self-serving, not realizing that efforts to complicate the system work only to our economic benefit. Of course, that realization would prompt the thought that perhaps our motivations are not as self-serving as they may presume, leading to questions that might upset their comfortable presumptions.)

Relying on assumptions, and believing that donning a white coat relieves you of the responsibility for actually knowing something before voicing an opinion, results in the kind of uninformed outrage expressed by the UK physicians. Ultimately this is just a waste of time and a venting of spleen that may make these doctors feel superior but does nothing to help patients or patient care. Which is presumably supposed to be the point.

recent posts

about