Patent Docs

Court Report -- Part III

        By Sherri Oslick --

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

Cubist Pharmaceuticals Inc. v. Fresenius Kabi USA LLC
1:14-cv-00914; filed July 11, 2014 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,468,967 ("Methods for Administration of Antibiotics," issued October 22, 2002), 6,852,689 (same title, issued February 8, 2005), 8,058,238 ("High Purity Lipopeptides," issued November 15, 2011), and 8,129,342 (same title, issued March 6, 2012) following a Paragraph IV certification as part of Fresenius' filing of an ANDA to manufacture a generic version of Cubist's Cubicin® (daptomycin for injection, used for the treatment of skin infections caused by certain Gram-positive microorganisms).  View the complaint here.

Merck Sharp & Dohme Corp. v. Hospira Inc.
1:14-cv-00915; filed July 11, 2014 in the District Court of Delaware

Merck Sharp & Dohme Corp. v. Sandoz Inc.
1:14-cv-00916; filed July 11, 2014 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,952,323 ("Carbapenem Antibiotic," issued September 14, 1999) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Merck's Invanz® (ertapenem, used for the treatment of complicated intra-abdominal infections, complicated skin and skin structure infections, community acquired pneumonia, complicated urinary tract infections, and acute pelvic infections, and for the prophylaxis ofvsurgical site infection following elective colorectal surgery).  View the Hospira complaint here.

Acorda Therapeutics Inc. et al. v. Alkem Laboratories Ltd. et al.
1:14-cv-00917; filed July 11, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Alkem Laboratories Ltd.; Ascend Laboratories LLC

Acorda Therapeutics Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00909; filed July 10, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,540,938 ("Formulations and Their Use in the Treatment of Neurological Diseases," issued July 30, 1996), 8,007,826 ("Sustained Release Aminopyridine Composition," issued August 30, 2011), 8,354,437 ("Method of Using Sustained Release Aminopyridine Compositions," issued January 15, 2013), 8,440,703 (same title, issued May 14, 2013), and 8,663,685 ("Sustained Release Aminopyridine Composition," issued March 4, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Acorda's Ampyra® (dalfampridine extended release, used to improve walking in patients with multiple sclerosis).  View the Aurobindo complaint here.

Luitpold Pharmaceuticals, Inc. v. Apotex Corp. et al.
2:14-cv-04409; filed July 11, 2014 in the District Court of New Jersey

• Plaintiff:  Luitpold Pharmaceuticals, Inc.
• Defendants:  Apotex Corp.; Apotex Inc.; Recordati Ireland Ltd.

Infringement of U.S. Patent No. 6,333,044 ("Therapeutic compositions for intranasal administration which include KETOROLAC®," issued December 25, 2001) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Luitpold's Sprix® (ketorolac tromethamine nasal spray, used for the management of moderate to moderately severe pain that requires analgesia at the opioid level).  View the complaint here.

Duchesnay Inc. et al. v. Actavis Laboratories FL, Inc. et al.
2:14-cv-04384; filed July 11, 2014 in the District Court of New Jersey

• Plaintiffs:  Duchesnay Inc.; Duchesnay USA Inc.
• Defendants:  Actavis Laboratories FL, Inc.; Actavis, Inc.; Actavis Pharma, Inc.

Infringement of U.S. Patent No. 6,340,695 ("Rapid Onset Formulation," issued January 22, 2002) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Duchesnay's Diclegis® (doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, used for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Mylan Inc. et al.
1:14-cv-04508; filed July 11, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Mylan Laboratories Ltd.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), 7,053,092 ("5-HT1A Receptor Subtype Agonist," issued May 30, 2006), and 8,642,600 ("Method of Treating Autism," issued February 4, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Merck Sharp & Dohme Corp. v. Fresenius Kabi USA LLC
1:14-cv-00905; filed July 9, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 5,691,336 ("Morpholine Compounds Are Prodrugs Useful As Tachykinin Receptor Antagonists," issued November 25, 1997) following a Paragraph IV certification as part of Fresenius' filing of an ANDA to manufacture a generic version of Merck's Emend® (fosaprepitant dimeglumine for injection, used in the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin, and to prevent nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy).  View the complaint here.

Alza Corp. v. Pack Pharmaceuticals, LLC
2:14-cv-04327; filed July 9, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. RE44,459 ("Method For Lowering Blood Glucose," reissued August 27, 2013), licensed to Pfizer, following a Paragraph IV certification as part of Pack's filing of an ANDA to manufacture a generic version of Pfizer's Glucotrol XL® (glipizide extended release tablets, used to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

Takeda Pharmaceutical Co. Ltd. et al. v. Sun Pharma Global FZE et al.
3:14-cv-04616; filed July 9, 2014 in the District Court of New Jersey

• Plaintiffs:  Takeda Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals America, Inc.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries, Ltd.; Caraco Pharmaceutical Laboratories, Ltd.

Infringement of U.S. Patent Nos. 6,328,994 ("Orally Disintegrable Tablets," issued December 11, 2001), 7,431,942 ("Orally Disintegrable Tablets," issued October 7, 2008), 7,399,485 ("Rapidly Disintegrable Solid Preparation," issued July 15, 2008), and 7,875,292 ("Orally Disintegrable Tablets," issued January 25, 2011) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of plaintiffs' Prevacid® SoluTab (lansoprazole delayed release orally disintegrating tablets, used to treat ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome).  View the complaint here.

In re Patel (Fed Cir 2014)

By Kevin E. Noonan --

The Supreme Court has made a sport of reversing the Federal Circuit over the past decade or so, and other than reserved (and sometimes not so reserved) statements by members of the lower court, the Federal Circuit has (properly) deferred to the Supreme Court's decisions without much protest (albeit occasionally being able to demonstrate the difficulties in implementing the Court's holdings; see Alice Corp. v. CLS Bank Int'l).  In a recent case regarding a U.S. Patent and Trademark Office obviousness determination, the Federal Circuit may have made such a statement in support of its jurisprudence, more by omission than expressly.

The claims at issue involved a composite material as claimed in representative claim 1:

1.    A nonwoven material comprised of fibers having a surface comprising a polyethylene blend, said fibers being selected from the group consisting of monocomponent fibers, bicomponent fibers or mixtures thereof, said nonwoven material having a fuzz/abrasion less than or equal to 0.0214(BW) + 0.2714 mg/cm² when the material comprises monocomponent fibers and said nonwoven material having a fuzz/abrasion less than or equal to 0.0071(BW) + 0.4071 mg/cm² when the material consists of bicomponent fibers, wherein the fibers are from 0.1 to 50 denier and wherein the polymer blend comprises:
    a.    from 26 weight percent to 80 weight percent (by weight of the polymer blend) of a first polymer which is a homogeneous ethylene/α-olefin interpolymerhaving:
        i.    a melt index of from about 1 to about 1000 grams/10 minutes, and
        ii.    a density of from 0.915 to 0.950 grams/centimeter³, and
    b.    from 74 to 20 percent by weight of a second polymer which is an ethylene homopolymer or an ethylene/α-olefin interpolymer having:
        i.    a melt index of from about 1 to about 1000 grams/10 minutes, and
        ii.    a density which is at least 0.01 grams/centimeter³ greater than the density of the first polymer
    wherein the overall melt index of the polymer blend is greater than 18 grams/10 min.

The PTAB affirmed the Examiner's determination that certain claims were obvious over the cited prior art (the Maugans reference, in view of U.S. Patent Application Publication No. 2003/0003830).

The limitations at issue in this appeal were the recited ranges of weight percentage and density of the first polymer component of the material.  The Examiner found and the PTAB agreed that the recited weight percentage ranges in the prior art (0.5-25 weight percent), although not overlapping with the ranges recited in the claims (26-80 weight percent), did not have a "patentably distinguishable difference" between them, and that the claimed material would have been obvious to one having ordinary skill in the art.  On the other hand, the density ranges in the prior art (0.855 – 0.950 g/cm³) did overlap with the ranges recited in some of the claims.  Further, the PTAB affirmed the Examiner's findings that the applicants had not demonstrated unexpected results that overcame the asserted prima facie obviousness determination.

The Federal Circuit disagreed with the Board's decision, in an opinion by Judge O'Malley joined by Judge Hughes (Judge Rader, originally on the panel did not contribute or join the decision); in its decision, the Federal Circuit vacated the obviousness rejection for all but two of the claims at issue.  After setting out the standards for examination (wherein the Office has the initial burden of asserting a prima facie case of obviousness and the applicant has the opportunity to rebut this determination if and only if the Office has established the prima facie case), the opinion addressed both grounds (weight percent and density) upon which the Office had asserted its putative prima facie case.

Regarding the weight percentage limitation, the panel noted that certain of the claims did and others did not recite weight percentage ranges that overlapped the prior art.  For the claims where the ranges do not overlap, the panel held that the art did not support the asserted obviousness rejection.  Simply put, close is not enough, without some teaching in the art that there was some basis for the skilled worker to believe a material having a weight percentage of 26% would have "the same or similar properties" as one having the 25% taught in the prior art.  The Federal Circuit distinguished the three cases cited by the Board in support of its position: "(1) In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990), (2) Titanium Metals Corp. of America v. Banner, 778 F.2d 775 (Fed. Cir. 1985), and (3) In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)."  Regarding the Woodruff case, the panel perceived that in that case ranges of "about 1-5%" permitted "concentrations slightly above 5%" to be encompassed by the claims, which thus overlapped with prior art that recited a range of ">5-25%."  In the Titanium Metals case, "single points," not ranges, were recited and disclosed by the prior art.  Under these circumstances, "the prior art establishe[d] two measures -- which were themselves not far apart -- and the claim simply adopted a measure between those end points."  The opinion analogized this situation to the case of prior art that recited a range and the claims at issue reciting a value falling with the prior art range.  This situation does not exist with regard to the weight percentages recited in this case (either for the prior art or claimed ranges) and thus the panel held that this case citation did not support the Board's position.  Finally, in the Petersen case, the claimed ranges "either fully or at least partially overlapped" the prior art ranges.  However, while the opinion acknowledges that "[i]t is well-established that a prima facie case of obviousness exists when the claimed and prior art ranges overlap," the further statement that "obviousness exists when the claimed range and the prior art range do not overlap but are close enough such that one skilled in the art would have expected them to have the same properties" was dicta, and thus the Petersen case did not support the Board's obviousness determination.

The opinion does recognize that there will be instances where the art teaches that such ranges are approximate or that values or ranges close to but not encompassed within an expressly recited prior art range can still support a finding of obviousness, but "the PTAB cites to no such evidence" in this case.  Accordingly:

Depending on the technology, even small differences in formulations can be meaningful.  Where differences clearly exist and there is no evidence that they are either not meaningful or one of skill in the art would know to discard the limits set by the prior art, proximity alone is not enough to establish a prima facie case of obviousness.

Turning to the density limitation, the applicants did not dispute that the Office had established a prima facie case of obviousness because here the recited range (0.951 – 0.950 g/cm³) did overlap with the prior art range (0.855 – 0.950 g/cm³).  Thus, the question before the panel was whether the applicants had rebutted the prima facie case by a showing of unexpected results.  Here, the Federal Circuit held that the applicants had not done so.  According to the opinion, the difference in the panel's decision rested in part on the different standards of review; whereas the question of whether the Office had established a prima facie case with regard to the weight percentage issue was one of law, the question of whether applicants had made a sufficient showing of unexpected results with regard to the density issue was one of fact, for which the Federal Circuit was compelled to review the PTAB's decision for substantial evidence.  In this case, applicants had shown but a 15% improvement in performance using embodiments falling within the scope of the range disclosed and claimed in their application, and the Board held and the Federal Circuit affirmed that "Appellants' reliance on the 15 percent improvement in the abrasion performance does not reach the level of unexpected results to overcome the finding of obviousness."  Moreover, the Board held and the Federal Circuit agreed that applicants failed to show unexpected results "over the entire claimed range" (emphasis in opinion).  "Appellants cannot rely on a single point within a large range to prove unexpected results for the entire range," according to the opinion, and "for an applicant to overcome a prima facie case of obviousness through unexpected results in a range that overlaps with a range disclosed in the prior art, the applicant must "show that the [claimed] range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range," citing In re Woodruff.  Because applicants here had not done so, the panel agreed that there was substantial evidence that they did not provide sufficient evidence of unexpected results to rebut the Office's prima facie obviousness determination.

While this outcome is not remarkable, even a cursory review of the cases cited in this opinion reveals that not one were decided after the Supreme Court's decision in KSR v. Teleflex, a case recognized as having changed the standards for deciding when a claim in obvious.  All of the cited cases, including Peterson, Woodruff, Titanium Metals, In re Kumar, 418 F.3d 1361 (Fed. Cir. 2005); In re Oetiker, 977 F.2d 1443 (Fed. Cir. 1992); In re Glaug, 283 F.3d 1335 (Fed. Cir. 2002); In re Piasecki, 745 F.2d 1468 (Fed. Cir. 1984); In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997); In re Clemens, 622 F.2d 1029 (CCPA 1980) and In re Soni, 54 F.3d 746 (Fed. Cir. 1995), are prior to the KSR decision, many of them from the "golden age" of the Court's history when Judges like Markey and Rich were writing the opinions.  Perhaps the most direct indication that the panel was content to remind litigants that its patent jurisprudence is (in large part) alive, well and not reversed by the Supreme Court is the citation of In re Dembiczak, 175 F.3d 994, 998 (Fed. Cir. 1999), a case involving a trash bag imprinted with a large pumpkin logo for discarding leaves in autumn.  This case was almost a poster child for those members of the bar and academy who believed that the Federal Circuit's standards for non-obviousness had become too lax, and yet the panel here cites this case for the black letter proposition that "[w]hether an invention is obvious under 35 U.S.C. § 103 is a legal conclusion based on underlying findings of fact."  Whether the implications recognized here were intentional or accidental may be making too much of this reading of the judicial tea leaves, but it would be refreshing for a court as battered by its superior court over areas where the lower court has an acknowledged special expertise to occasionally provide a reminder of that expertise and the mandate for harmonizing U.S. patent law that it supports.

In re Patel (Fed Cir 2014)
Nonprecedential disposition
Panel: Circuit Judges O'Malley and Hughes (Circuit Judge Raderdid not participate in this decision)
Opinion by Circuit Judge O'Malley

Court Report -- Part II

        By Sherri Oslick --

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

Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc.
1:14-cv-00882; filed July 7, 2014 in the District Court of Delaware

Infringement of U.S. Patent Nos. 8,007,826 ("Sustained Release Aminopyridine Composition," issued August 30, 2011), 8,354,437 ("Method of Using Sustained Release Aminopyridine Compositions," issued January 15, 2013), 8,440,703 (same title, issued May 14, 2013), and 8,663,685 ("Sustained Release Aminopyridine Composition," issued March 4, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Acorda's Ampyra® (dalfampridine extended release, used to improve walking in patients with multiple sclerosis).  View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. Eli Lilly and Company
1:14-cv-00884; filed July 7, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Sanofi-Aventis Deutschland GmbH
• Defendants:  Eli Lilly and Company

Infringement of U.S. Patent Nos. 7,476,652 ("Acidic Insulin Preparations Having Improved Stability," issued January 13, 2009), 7,713,930 (same title, issued May 11, 2010), 7,918,833 ("Pen-Type Injector," issued April 5, 2011), 8,512,297 (same title, issued August 20, 2013), 8,556,864 ("Drive Mechanisms Suitable for Use in Drug Delivery Devices," issued October 15, 2013), 8,603,044 ("Pen-Type Injector," issued December 10, 2013), and 8,679,069 (same title, issued March 25, 2014) following a Paragraph IV certification as part of Lilly's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture an insulin glargine for injection in a prefilled insulin delivery device, comparable to Sanofi's Lantus® and Lantus® SoloSTAR® products (insulin glargine [rDNA origin] for injection, used to treat diabetes).  View the complaint here.

Eli Lilly and Company et al. v. HEC Pharm Co., Ltd. et al.
1:14-cv-01135; filed July 7, 2014 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
• Defendants:  HEC Pharm Co., Ltd.; HEC Pharm USA Inc.

Infringement of U.S. Patent No. 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) following a Paragraph IV certification as part of HEC's filing of an ANDA to manufacture a generic version of Lilly's Effient® (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention).  View the complaint here.  [NB: The case was voluntarily dismissed after defendants converted their Para IV Certification to a Para III Certification.]

Helsinn Healthcare S.A. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
3:14-cv-04274; filed July 7, 2014 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

Infringement of U.S. Patent No. 8,729,094 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 20, 2014) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the complaint here.

Allos Therapeutics, Inc. et al. v. Dr. Reddy's Laboratories, Inc. et al.
1:14-cv-04273; filed July 7, 2014 in the District Court of New Jersey

• Plaintiffs:  Allos Therapeutics, Inc.; Sloan-Kettering Institute For Cancer Research; Southern Research Institute; SRI International, Inc.
• Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

Infringement of U.S. Patent Nos. 6,028,071 ("Purified Compositions of 10-propargyl-10-deazaaminopterin and Methods of Using Same in the Treatment of Tumors," issued February 22, 2000), 7,622,470 ("Treatment of T-cell Lymphoma Using 10-porpargyl-10-deazaaminopterin," issued November 24, 2009), and 8,200,078 (same title, issued October 30, 2012) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Allos' Folotyn® (pralatrexate, used to treat patients with relapsed or refractory peripheral T-cell lymphoma).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Sun Pharmaceutical Industries Ltd. et al.
1:14-cv-04307; filed July 7, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Sun Pharmaceutical Industries Ltd.; Sun Pharma Global Inc.; Sun Pharma Global PZE; Sun Pharma USA; Caraco Pharmaceutical Laboratories, Ltd.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Sanofi et al. v. Amneal Pharmaceuticals LLC et al.
1:14-cv-00875; filed July 3, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi; Sanofi-Aventis US LLC
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amneal Pharmaceuticals Co. India Private Ltd.

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 Amneal's 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 complaint here.

Sanofi et al. v. Unimark Remedies Ltd.
1:14-cv-00876; filed July 3, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi; Sanofi-Aventis US LLC
• Defendant:  Unimark Remedies Ltd.

Infringement of U.S. Patent Nos. 7,323,493 ("Solid Pharmaceutical Composition Containing Benzofuran Derivatives," issued January 29, 2008), 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 Unimark's 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 complaint here.

Novo Nordisk Inc. et al. v. Teva Pharmaceuticals USA, Inc.
3:14-cv-04248; filed July 3, 2014 in the District Court of New Jersey

• Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk Femcare AG
• Defendant:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 7,018,992 ("Hormone Composition," issued March 28, 2006) and  5,860,946 ("Instrument for Inserting a Suppository," issued January 19, 1999) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novo Nordisk's Vagifem® (estradiol vaginal tablets, used to treat atrophic vaginitis due to menopause).  View the complaint here.

Teva Women's Health, Inc. et al. v. Famy Care Ltd. et al.
1:14-cv-04981; filed July 2, 2014 in the Southern District of New York

• Plaintiffs:  Teva Women's Health, Inc.; Teva Branded Pharmaceutical Products R&D, Inc.
• Defendants:  Famy Care Ltd.; Mylan Pharmaceuticals, Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. 8,415,332 ("Methods of Hormonal Treatment Utilizing Ascending-Dose Extended Cycle Regimens," issued April 9, 2013) and 8,450,299 (same title, issued May 28, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Teva's Quartette® (levonorgestrel/ethinyl estradiol and ethinyl estradiol, used for oral contraception).  View the complaint here.

Finally, A Biosimilar Application Has Been Accepted By The FDA

By Andrew Williams --

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug Administration (FDA) has accepted its application to market a version of the protein filgrastim.  Sandoz, a Novartis Group company, already markets a biosimilar filgrastim outside the U.S. under the brand name ZARZIO®.  The reference product is Amgen's NEUPOGEN®, a 175 amino acid recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF), which Amgen reports is identical to the predicted natural DNA sequence of G-CSF from humans, except for the N-terminal methionine required to grow in E. coli.  In addition, because NEUPOGEN® is produced in E. coli, it differs from human G-CSF because it is not glycosylated.  G-CSFs bind to specific cell-surface receptors, thereby acting on hematopoietic cells to stimulate proliferation, differentiation commitment, and some end-cell functional activation.  Endogenous G-CSF is produced by monocytes, fibroblasts, and endothelial cells and regulates the production of neutrophils within the bone marrow.  According to the Amgen's package insert, NEUPOGEN® has several indications, including "to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever"; "for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML"; "to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation"; "for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis"; and "for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia."

Of course, the pharmaceutical industry has been watching these developments closely, and everyone has been wondering when, or even if, a biosimilar application would be accepted.  The BPCI Act was signed into law over four years ago as part of the Affordable Care Act, and with each passing year, there has been questions whether any company would take advantage of this new system.  The FDA did not help matters in 2012 when it released its draft guidance for implementing the follow-on biologic drug pathway mandated by the statute.  In the first place, the FDA was very slow in providing its draft guidance.  It took about two years for the initial draft guidance in 2012, and in fact it was not until earlier this year, nearly an additional two years later, that the FDA followed up with new draft guidance (see "FDA Releases Draft Guidance on Biosimilars").  Moreover, it appeared that the FDA's requirements to show that a drug is either "biosimilar" or "interchangeable" have been too vague, and ultimately might end up being too onerous.  As a result, the concern was that it might be simpler for a company to file a new Biologics License Application ("BLA") instead of a "follow-on" application pursuant to the statute.

One of the main issues is in differentiating whether a follow-on drug is merely "biosimilar," or whether it is "interchangeable."  According to the FDA, a biosimilar drug is a biological product that is highly similar to a reference product with no clinically meaningful differences in terms of safety, purity, and potency.  Interchangeability, on the other hand, means that a biological product is biosimilar, can be expected to produce the same clinical result in any given patient, and the safety and reduced efficacy risks of alternating or switching are not greater than with repeated use of the reference product.  Of course, interchangeability is the desired goal necessary to make the new system work.

Even though Sandoz's filgrastim application was the first announced (by Sandoz) to be accepted by the FDA, it is currently not possible to be certain that it was because such information is not made publically available by the FDA.  Instead, according to the statutory scheme, the application filer and the reference product sponsor are required to participate in a series of exchanges after acceptance to determine which patents are necessary to litigate.  It is only after this process is concluded that a lawsuit can be filed by the reference product sponsor.  This process can take on the order of half a year.  Therefore, we might not know for sure whether the filgrastim application is the first such application until sometime early next year.  We will, of course, continue to monitor the case and provide any updates as they occur.

Court Report

        By Sherri Oslick --

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

GlaxoSmithKline LLC et al. v. Glenmark Generics Inc. USA
1:14-cv-00877; filed July 3, 2014 in the District Court of Delaware

• Plaintiffs:  GlaxoSmithKline LLC; SmithKline Beecham (Cork) Ltd.
• Defendant:  Glenmark Generics Inc. USA

GlaxoSmithKline LLC et al. v. Teva Pharmaceuticals USA Inc.
1:14-cv-00878; filed July 3, 2014 in the District Court of Delaware

• Plaintiffs:  GlaxoSmithKline LLC; SmithKline Beecham (Cork) Ltd.
• Defendant:  Teva Pharmaceuticals USA Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. RE40,000 ("Method of Treatment for Decreasing Mortality Resulting from Congestive Heart Failure," reissued January 8, 2008) based on defendants' manufacture and sale of a generic version of GSK's Coreg® (carvedilol, used to treat congestive heart failure), for some time with label that included a heart failure indication (part of a Section viii carve-out in defendants' ANDA) and based on defendants marketing their product as therapeutically equivalent to and fully substitutable for GSK's COREG® tablets.  View the Glenmark complaint here.

Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA Inc.
1:14-cv-00874; filed July 2, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 6,127,353 ("Mometasone Furoate Monohydrate, Process for Making Same and Pharmaceutical Compositions," issued October 3, 2000) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Merck's Nasonex® (mometasone furoate monohydrate metered nasal spray, used to treat diseases of the upper airways, including allergic and nonallergic rhinitis).  View the complaint here.

ViiV Healthcare UK Ltd. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00868; filed July 2, 2014 in the District Court of Delaware

• Plaintiffs:  ViiV Healthcare UK Ltd.; ViiV Healthcare Co.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent No. 6,294,540 ("Carbocyclic Nucleoside Hemisulfate and its Use in Treating Viral Infections," issued September 25, 2001) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Viiv's Epzicom® (abacavir sulfate and lamivudine, used to HIV infection in humans).  View the complaint here.

Pfizer Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00872; filed July 2, 2014 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.

Teijin Ltd. et al. v. Prinston Pharmaceutical Inc.
1:14-cv-00854; filed July 1, 2014 in the District Court of Delaware

• Plaintiffs:  Teijin Limited; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
• Defendant:  Prinston Pharmaceutical Inc.; Prinston Pharmaceutical Inc.

Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of Prinston's filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout).  View the complaint here.

AstraZeneca AB v. Par Pharmaceutical Inc.
1:14-cv-00845; filed June 30, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 7,951,400 ("Coated Tablet Formulation and Method," issued May 31, 2011) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

Forest Laboratories Inc. et al. v. Aurobindo Pharma USA Inc. et al.
1:14-cv-00833; filed June 27, 2014 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Merz Pharmaceuticals GmbH; Merz Pharma GmbH & Co. KGaA
• Defendants:  Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd.

Infringement of U.S. Patent No. 5,061,703 ("Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia," issued on October 29, 1991), following a paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Forest's Namenda® (memantine hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

UCB Inc. et al. v. Apotex Corp. et al.
1:14-cv-00834; filed June 27, 2014 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Apotex Corp.; Apotex Inc.

Infringement of U.S. Patent No. RE38,551 ("Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of UCB's Vimpat® (lacosamide, used as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy aged 17 years and older).  View the complaint here.

Par Pharmaceutical Inc. v. Novartis Pharmaceuticals Corp. et al.
1:14-cv-00843; filed June 27, 2014 in the District Court of Delaware

• Plaintiff:  Par Pharmaceutical Inc.
• Defendants:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG

Declaratory judgment of non-infringement and invalidity of U.S Patent No. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) in conjunction with Par's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the complaint here.

Senju Pharmaceutical Co., Ltd. et al. v. Lupin, Ltd. et al.
1:14-cv-04149; filed June 26, 2014 in the District Court of New Jersey

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Senju Pharmaceutical Co., Ltd.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Lupin, Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 8,669,290 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 11, 2014) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

Conference & CLE Calendar

July 30, 2014 - "Ask the Office: New Guidance on Functional Claiming" (American Bar Association Section of Intellectual Property Law) - 1:00 to 2:30 pm (ET)

July 30, 2014 - "Alice Corp. v. CLS Bank: Patent Eligibility of Software-Related Inventions" (Strafford) - 1:00 to 2:30 pm (EDT)

August 7, 2014 - "Battling Patent Trolls: Leveraging AIA, State and Federal Legislative Action, and Other Key Developments" (Strafford) - 1:00 to 2:30 pm (EDT)

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

August 18-19, 2014 - Advanced Patent Prosecution Workshop 2014: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

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

August 19, 2014 - "Alice Corp. v. CLS Bank International: General Purpose Computers Cannot Save Inventions Directed to Abstract Ideas" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

August 28, 2014 - "Alice Corp. vs. CLS Bank: What’s Eligible, What’s Not, and What’s Still to be Determined?" (Technology Transfer Tactics) - 1:00 to 2:00 pm (ET)

September 7-9, 2014 - 42nd Annual Meeting (Intellectual Property Owners Association) - Vancouver, Canada.

September 11-12, 2014 - Advanced Patent Prosecution Workshop 2014: Claim Drafting & Amendment Writing (Practising Law Institute) - Chicago, IL

September 18-19, 2014 - FDA Boot Camp (American Conference Institute) - Boston, MA

September 30 - October 1, 2014 - Paragraph IV Disputes Master Symposium (American Conference Institute) - Chicago, IL

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

Webinar on Alice Corp. v. CLS Bank

Technology Transfer Tactics will be offering a webinar entitled "Alice Corp. vs. CLS Bank: What’s Eligible, What’s Not, and What’s Still to be Determined?" on August 28, 2014 from 1:00 to 2:00 pm (ET).  Patent Docs author Dr. Kevin E. Noonan and Patent Docs contributor Dr. Michael Borella of McDonnell Boehnen Hulbert & Berghoff LLP will offer insight and clarify the decision as well as the PTO's recently issued guidelines stemming from the case.  The webinar will address:

• How the Alice Corp. decision impacts the future of:
    -- Software patents
    -- Other business method patents
    -- Patent troll (NPE) activity
• How to conduct a test for patentability according to the Court's ruling
• Determining if your patent claim describes an "inventive step"
• How claims must be drafted to achieve eligibility
• Detailed review of the PTO’s recent Alice-based guidelines for examinations

The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

ACI Paragraph IV Disputes Symposium

American Conference Institute (ACI) will be holding its 2nd Annual Paragraph IV Disputes master symposium from September 30 to October 1, 2014 in Chicago, IL.  ACI faculty will provide insights into:

• PTO Procedures utilization in a Hatch-Waxman scenario: IPR, reissue, and more;
• Teva v. Sandoz and interim Markman strategies;
• The surge in premature notice filings;
• Federal Circuit and PTO discord on obviousness finding;
• Akamai's impact on method of treatment patents;
• New safe harbor expansions and exceptions;
• Exclusivity concerns for combination products, NCEs, and generics; and
• At-risk launches, injunctions, and damages.

The conference will offer presentations on the following topics:

• Oyez, Oyez, Oyez!: Review of Key Supreme Court Cases that May Alter the Course of Paragraph IV Litigation
• Brand Name and Generic Interpretations of The Changing Paradigm for Generic Market Entry: Identifying New Due Diligence Concerns Relative to ANDA Drug Targets and Anticipating New Paragraph IV Challenges
• It's All About Timing: Exploring the Surge in Premature Paragraph IV Notice Filings and Its Consequences
• Teva v. Sandoz -- A Debate on the Standard of Review for Claim Construction: De Novo vs. Deferential
• Exploring the Use of Reissue Applications to Amend Invalidity Findings in The District Courts
• Analyzing the Evolving Utilization of IPR and Other PTO Proceedings in Paragraph IV Litigation: Brand Name and Generic Perspectives
• Understanding the Importance of Abiding by Local Rules: A Magistrate's Perspective
• A View From the Bench: The Judges Speak
• Obviousness, Obliviousness and Obscurity: Exploring New Developments Double-Patenting Type Obviousness and Federal Circuit and PTO Discord on Obvious Findings Relative to Prior Art
• Experts, Problems of Proof, Dispositive Motions and Markman Hearings: Addressing Common Dilemmas Encountered in A Paragraph IV Trial
• Understanding How the Supreme Court's Decision in Limelight v. Akamai Will Impact ANDA Litigation Involving Method of Treatment Patents
• FTC Keynote: Reverse Payment Settlements and Other Antitrust Concerns Impacting Paragraph IV Litigation in the Wake of Actavis -- to be presented by J. Maren Schmidt, Attorney, Health Care Division, Bureau of Competition, Federal Trade Commission
• The Ever Shifting Boundaries of the Safe Harbor: Determining the Scope of 271 (e)(1) Protections Relative to Paragraph IV Litigation Post Classen and Momenta
• New Exclusivity Challenges for Brand Names and Generics: Exploring Their Implications for Paragraph IV Challenges
• The Uncertain Future of At-Risk Launches: A Study of Injunctive Relief, Damages and the Impact of Protonix
• Ethical Considerations for Paragraph IV Matters Before the PTO and District Courts: Looking Beyond Inequitable

In addition, two pre-conference workshops will be offered on September 29, 2014.  The first, entitled "PTO Procedures Practice Boot Camp for Paragraph IV Litigators" will be offered from 8:30 am to 12:00 pm, and the second, entitled "May it Please the Court: A Judge’s Perspective on Effectively and Ethically Communicating With the Court In Paragraph IV Matters," will be offered from 2:00 to 5:30 pm.

The agenda for the Paragraph IV Disputes master symposium can be found here.  More information regarding the workshops 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 $2,395 (conference alone), $2,995 (conference and one workshop), or $3,595 (conference and both workshops).  Those registering by August 4, 2014 will receive a $400 discount, and those registering by September 8, 2014 will receive a $200 discount.  Patent Docs readers who reference the discount code "PD200" will receive $200 off the current price tier when registering.  Those interested in registering for the conference can do so here, by e-mailing [email protected], 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 master symposium.

Webinar on Battling Patent Trolls

Strafford will be offering a webinar/teleconference entitled "Battling Patent Trolls: Leveraging AIA, State and Federal Legislative Action, and Other Key Developments" on August 7, 2014 from 1:00 to 2:30 pm (EDT).  Michael L. Kiklis and Scott A. McKeown of Oblon Spivak McClelland Maier & Neustadt will discuss recent developments and new tools to battle so-called patent trolls, including the America Invents Act (AIA), and recent state and congressional action, and discuss the impact of these efforts and offer best practices for combating patent trolls before and during litigation.  The webinar will review the following questions:

• How will the enactment of state laws impact patent troll litigation?
• How can counsel act to proactively minimize the threat of patent troll litigation?
• What defense strategies are effective in combating patent trolls in litigation?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

IPO Names Top 100 Patenting Universities

By Kevin E. Noonan --

The Intellectual Property Owners (IPO) recently published a list of the top 100 universities worldwide granted U.S. patents in 2013.  As reported in the IP Record, these universities are:

(foreign universities in bold)

62% of these universities are U.S. universities, with China (18%) being the foreign country with the largest number of patent-owning universities.  U.S. universities having the largest number of patents are both public (the University of California system, Texas, Wisconsin, Michigan, and Illinois) and private (MIT, Stanford, Columbia and CalTech) and represent universities large and small.  Undisclosed in this Report is any correlation between the number of patents and the amount of grant monies obtained by each of these universities; these results support the sentiment, voiced at the Tech Transfer Summit/North America earlier this week by many tech transfer officials that universities should concentrate on patenting fulfilling the statutory mandate to facilitate technology transfer and commercialization and less on university tech transfer offices being a profit center for their universities.

Stewart Title Guaranty Co. v. Segin Software, LLC (PTAB 2014)

By Michael Borella --

On April 12, 2013, Segin Software sued Stewart Title and several other parties for infringement of U.S. Patent No. 8,165,939.  The defendants filed a petition with the U.S. Patent and Trademark Office requesting post-grant review of claims 1-10 of the '939 patent under the Office's transitional program for covered business method patents.  Among other deficiencies, Stewart Title alleged that the '939 patent failed to meet the patentable subject matter requirements of 35 U.S.C. § 101.

This is the Patent Trial and Appeal Board's first application of the Supreme Court's recent Alice Corp. v. CLS Bank Int'l decision.  The posture of this decision is important -- the Board is not making a ruling about the validity of the '939 patent.  Instead, the Board is determining whether the '939 patent qualifies for post-grant review under the covered business method program.  Still, this decision provides a window into the Board's thinking about the CLS Bank case and its application.

Claim 1 of the '939 patent, the sole independent claim at issue, recites:

1.  A method of tracking and verifying in real time financial transactions defined at a real estate settlement, the steps comprising:
    a) storing, in a database of a settlement financial tracking and verifying computer system, data that includes at least data enumerated on a completed HUD-1 (Housing and Urban Development-1) form associated with a closing upon a piece of real property, wherein said settlement financial tracking and verifying computer system operates automatically and in real time;
    b) selecting from said database, by said settlement financial tracking and verifying computer system, data defining at least one anticipated financial transaction enumerated on said completed HUD-1 form, whereby said anticipated financial transaction represents a transfer of funds to be made;
    c) automatically initiating in real time a fund transferring action defined by said at least one anticipated transaction selected from the group: disbursing funds, and expecting payments;
    d) storing data representative of said initiated fund transferring action in said database as an initiated fund transferring action;
    e) automatically tracking in real time each of said initiated fund transferring actions;
    f) detecting, by said settlement financial tracking and verifying computer system, completion of each of said initiated fund transferring actions whereby a tracked result is generated;
    g) storing in said database, each of said tracked results;
    h) automatically comparing in real time said tracked result with said data representative of an associated one of said at least one anticipated transaction stored in said database; and
    i) automatically alerting in real time a user of said settlement financial tracking and verifying computer system selected from the group comprising a bank, a settlement agent, an attorney, and an auditor when said tracked result differs from said data representative of an associated one of said at least one anticipated transaction.

In order for a covered business method post-grant review to take place, the Office must determine that "the information presented in the petition . . . if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable."  Further, the patent being challenged in the post-grant review (i) must have been asserted against the petitioner in an infringement action, (ii) must be directed to a business method, and (iii) must not be directed to a technological innovation.

Clearly, the first prong of this test is met.

In considering the second prong, the Board looked to the definition of a business method patent in the America Invents Act -- "a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service."  The Board quickly concluded that the '939 patent, as recited in the preamble of claim 1, was expressly directed to "a method of tracking and verifying in real time financial transactions defined at a real estate settlement."  Along with other references to financial transactions in the body of claim 1, this was enough to convince the Board that the second prong was met.

With respect to the third prong, the Board considered "whether the claimed subject matter as a whole recites a technological feature that is novel and unobvious over the prior art; and solves a technical problem using a technical solution."  In doing so, the Board noted that "mere recitation of known technologies, such as computer hardware, communication or computer networks, software, memory, computer-readable storage medium," "reciting the use of known prior art technology to accomplish a process or method, even if that process or method is novel and nonobvious," and "combining prior art structures to achieve the normal, expected, or predictable result of that combination" was not enough to avoid covered business method classification.

The hardware that claim 1 recites is limited to a "settlement financial tracking and verifying computer system" and a "database."  These, according to the Board were known technologies, and the invention itself was a financial product or service.  Thus, the Board concluded that the goals of the claimed invention were not technical in nature and recitation of the general-purpose hardware was insufficient to characterize the invention as a technical solution to a technical problem.

Once the propriety of the covered business method program was established for the '939 patent, the Board moved on to determine whether it is more likely than not that at least one of claims 1-10 is unpatentable.  In doing so, the Board focused on claim 1, and considered Stewart Title's challenges under 35 U.S.C. §§ 101 and 112.

For the § 101 challenge, the Board applied the two-step patent-eligibility test from Mayo Collaborative Servs. v. Prometheus Labs., Inc. as reiterated in CLS Bank.  This test instructs one to (i) determine whether the claims at issue are directed to a patent-ineligible abstract idea, natural phenomena, or law of nature, and (ii) if this is the case, then consider the elements of the claims individually and as an ordered combination to determine whether there are additional elements that transform the nature of the claim into a patent-eligible application.

For the first step, the Board found the claim directed to "the concept of tracking and verifying the progress of financial transactions between parties to a real estate settlement," and that there was no meaningful distinction this concept and the intermediated settlement that was deemed abstract in CLS Bank.

To justify this conclusion, the Board looked to several statements made in the specification of the '939 patent, including:

• "real property settlement involves many manual steps";
• "tools (including software or other computer based tools) exist to help perform individual settlement steps, [but] many manual operations such as data entry leave numerous possibilities for innocent error";
• "provid[ing] an integrated method . . . for processing all financial details of a real estate settlement or other similar transactions [without] the need for multiple, stand-alone software tools or systems to accomplish most tasks associated with real estate settlement."

Based on these statements, the Board was "persuaded that the concept of tracking and verifying the progress of financial transactions between parties to a real estate settlement . . . is a fundamental economic practice long prevalent in our system of commerce."

Having settled that, the Board turned to the second step in the analysis, which it characterized as determining "whether the claims include an inventive concept, i.e., an element or combination of elements sufficient to ensure that the patent in practice amounts to significantly more than a patent on the abstract idea itself."

Taking guidance from CLS Bank, the Board noted that "that the mere recitation of a generic computer" is insufficient to achieve this goal.  In contrast, the Board also noted that in Diamond v. Diehr, the use of a mathematical relationship or algorithm to improve an industrial or technological process could transform an abstract idea into an inventive application.

Segin Software contended that the recitation of the computer in claim 1 was "integral to the claims" and served to "meaningfully limit the scope of the claims."  The Board, however, was not convinced.  Instead, it looked to substantively the same statements in the specification quoted above to conclude that "software and other computer-based tools were available to help perform" aspects of the claim, and that these functions were "well-understood, routine, conventional activities."

Further, in order for the computer to be "integral to the claimed invention, it must facilitate the process in a way that a person making calculations or computations could not."  The Board acknowledged that implementing the claimed steps on a computer "allows them to be performed faster and more efficiently, with fewer opportunities for fraud or innocent error, than if the steps were performed manually or piecemeal."  But, it was still possible for a person to perform the claimed steps without error, and "simply implementing an abstract concept faster and more efficiently on a computer is not sufficient to transform a patent-ineligible claim into a patent-eligible one."

Finding no limitations that narrowed the claimed invention to sufficiently less than that of the abstract idea incorporated therein, the Board concluded that Stewart Title had established "that it is more likely than not that the claims challenged in the petition are unpatentable under 35 U.S.C. § 101."

IPR Update -- The First Pharma IPR Decisions

By Andrew Williams --

Late last month, while many of us were getting ready to attend the BIO International Convention in San Diego, the Patent Trial and Appeal Board ("Board") issued four related inter partes review opinions, marking what many have called the first set of opinions related to the Pharmaceutical industry.  These cases, which were issued on June 20, 2014, were IPR2013-00116, IPR2013-00117, IPR2013-00118, and IPR2013-00119, and the parties were Gnosis S.P.A., Gnosis Bioresearch S.A., and Gnosis U.S.A., Inc. ("Gnosis") (Petitioner) and either Merck & Cie ("Merck") (Patent Owner in IPR2013-00117) or South Alabama Medical Science Foundation ("SAMSF") (Patent Owner in the remaining three IPRs).  This post will address the Final Written Decisions related to the SAMSF patents.

Even though these cases were heralded as the first Pharma IPR Final Written Decisions, it is important to note a couple of things.  First, even though these parties were also involved in Federal court litigation, which has been stayed pending the outcome of these cases, the accused infringer/petitioner did not file an ANDA.  In fact, these cases involved compositions of natural folate used in the treatment of vitamin deficiencies.  As such, these compositions are not drugs that require approval by the Food and Drug Administration.  In addition, these are not composition-of-matter patents, but rather patents with claims drawn to compositions or methods of treatment.  Nevertheless, these cases did center on the particular chemistry involved, and the pharmaceutical community would be remiss to ignore these decisions and the reasoning espoused by the Board.

The Technology

The technology at issue in these IPRs generally related to compositions containing reduced folates and methods of using such compositions to overcome folate deficiency.  As the Board's decisions explained, the background section of the SAMSF patents explained that folate deficiency has been linked to peripheral vascular disease, various birth defects, and other disorders.  These disorders can result in abnormally high blood levels of homocysteine, which is normally converted to methionine in a folate-dependent step.  To overcome these conditions, folic acid can be added to commercial preparations, sometimes in combination with other vitamins.  The problem is that some individuals do not adsorb folic acid readily from the intestine after oral administration.  As a solution, reduced folates can be used, which are found in nature as, for example, tetrahydrofolic acid ("THFA" or "THF"), 5-methyl-tetrahydrofolic acid ("5-methyl-THFA"), and 5-formyl-tetrahydrofolic acid ("5-formyl-THFA").  The stereoisomer of 5-methyl-THFA that has the L configuration at carbon-6 was shown in the SAMSF patents as:

In contrast to these useful "6S isomers" found in nature, the "unnatural isomer component" can lead to adverse effects.  Therefore, chirally-pure 5-formyl-(6S)-THFA has been commercially produced for use in disease therapy.

The Patents

The three patents involved in the IPRS of the three SAMSF patents were all related via continuation applications, and therefore share a specification.  These patents described the use of natural isomers of reduced folates in dietary vitamin preparations, in particular 5-methyl-THFA.  Claim 37 of U.S. Patent No. 5,997,915, subject of IPR2013-00116, is representative for those reviewed in that patent:

37.  A method of increasing a human subject's dietary intake of folate comprising administering to the human subject a composition for human consumption comprising:
    one or more natural isomers of reduced folate selected from the group consisting of (6S)-tetrahydrofolic acid, 5-methyl-(6S)-tetrahydrofolic acid, 5-formyl-(6S)-tetrahydrofolic acid, 10-formyl-(6R)-tetrahydrofolic acid, 5,10-methylene-(6R)-tetrahydrofolic acid, 5,10-methenyl-(6R)-tetrahydrofolic acid, 5-formimino-(6S)-tetrahydrofolic acid, and polyglutamyl derivatives thereof; and
    a nutritional substance for human consumption being an essential nutrient preparation, the essential nutrient preparation comprising a vitamin other than ascorbic acid, wherein the vitamin is present in an amount equal to or greater than 25% of the daily requirement for the vitamin per customarily consumed quantity of said essential nutrient preparation.

All of the remaining claims under consideration required that the one or more natural isomers of reduced folate be "substantially chirally pure 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof."  After a Motion to Amend was granted, cancelling all but one claim of U.S. Patent No. 6,673,381 (subject of IPR2013-00118), the only remaining claim of that patent was claim 32, dependent from claim 22:

22.  A method for treating and/or preventing vascular disease in a subject, said method comprising administering, to the subject, a composition which comprises:
    one or more natural isomers of reduced folate selected from the group consisting of (6S)-tetrahydrofolic acid, 5-methyl-(6S)-tetrahydrofolic acid, 5-formyl-(6S)-tetrahydrofolic acid, 10-formyl-(6R)-tetrahydrofolic acid, 5,10-methylene-(6R)-tetrahydrofolic acid, 5,10-methenyl-(6R)-tetrahydrofolic acid, 5-formimino-(6S)-tetrahydrofolic acid, and polyglutamyl derivatives thereof; and
    a nutritional substance selected from the group consisting of a food preparation, an essential nutrient preparation, and combinations thereof;
    wherein, when the nutritional substance is a food preparation, the food preparation comprises two or more food components and each gram of said food preparation has a natural molar amount, N, of said one or more natural isomers of reduced folate, wherein N is greater or equal to zero and wherein each gram of said composition has a total molar amount, T, of said one or more natural isomers of reduced folate greater than N; wherein, when the nutritional substance is an essential nutrient preparation, the essential nutrient preparation comprises a vitamin other than ascorbic acid.

32.  A method according to claim 22, wherein each of the one or more natural isomers of reduced folate is substantially chirally pure.

Similarly, after a Motion to Amend canceled all but one claim of U.S. Patent No. 7,172,778 (subject of IPR2013-0011), the only remaining claim of that patent was claims 15, dependent from claim 1:

1.  A composition comprising:
    one or more natural isomers of reduced folate in an amount effective for the treatment and/or prevention of vascular disease and/or in an amount effective for reducing a female's risk of having a miscarriage and/or of having a fetus with a neural tube defect, a cleft lip defect, and/or a cleft palate defect, wherein said one or more natural isomers of reduced folate is selected from the group consisting of (6S)-tetrahydrofolic acid, 5-methyl-(6S)-tetrahydrofolic acid, 5-formyl-(6S)-tetrahydrofolic acid, 10-formyl-(6R)-tetrahydrofolic acid, 5,10-methylene-(6R)-tetrahydrofolic acid, 5,10-methenyl-(6R)-tetrahydrofolic acid, 5-formimino-(6S)-tetrahydrofolic acid, and polyglutamyl derivatives thereof; and
    a nutritional substance selected from the group consisting of a food preparation, an essential nutrient preparation, and combinations thereof;
    wherein, when the nutritional substance is a food preparation, the food preparation comprises two or more food components and each gram of said food preparation has a natural molar amount, N, of said one or more natural isomers of reduced folate, wherein N is greater or equal to zero and wherein each gram of said composition has a total molar amount, T, of said one or more natural isomers of reduced folate greater than N; wherein, when the nutritional substance is an essential nutrient preparation, the essential nutrient preparation comprises a vitamin other than ascorbic acid.

15.  A composition according to claim 1, wherein each of the one or more natural isomers of reduced folate is substantially chirally pure.

Obviousness

All of the reviewed claims of SAMSF's patents were invalidated as obvious in view of two or three cited references.  The first of these references was Serfontein, European Patent Application EP 0 595 005 A1, which disclosed "a pharmaceutical preparation for lowering levels of homocysteine," which included "folate or a suitable active metabolite of folate or a substance which releases folate in vivo."  The only difference between Serfontein and the claims at issue, according to the Board, was that the cited reference did not explain what "a suitable active metabolite of folate" was, nor did it provide any examples other than folate or folic acid.  The second reference cited to overcome this deficiency was Marazza, U.S. Patent No. 5,194,611.  Marazza was described as teaching methods for the chiral resolution of 5-methyl-THF into its (6R) and (6S) diastereomers.  The final reference, Ueland (Ueland et al., Plasma Homocysteine, a Risk Factor for Vascular Disease: Plasma Levels in Health, Disease, and Drug Therapy, J. Lab. Clin. Med. 114:474-501 (1989)), was only cited against claim 15 of the '778 patent in combination with the other two references.  Ueland is described as teaching homocysteine metabolism.

The sole argument made by the petitioner against all of the claims at issue was that Marazza identified chirally-pure 5-methyl-(6S)-THFA as being a naturally occurring metabolite of folate that one of skill in the art would have had reason to use as the "suitable active metabolite of folate" described in the Serfontein reference.  Ueland was merely cited in the one case as identifying increased 5-methyl-THFA intracellular pools as the mechanism for reducing homocysteine.  Instead of rejecting Gnosis's arguments for failing to establish why one skilled in the art would combine these two (or three) references, the Board invalidated the claims as obvious because SAMSF was unable to provide evidence why one skilled in the art would not find this combination obvious.  In other words, not only was there no presumption of validity in this IPR proceedings (as expected), but the patent holder appeared to have the increased burden of proving the validity of its own patent.

SAMSF did make several arguments that the Board rejected.  First, in order to explain why these references would not have been combined, SAMSF argued that one skilled in the art would not have been motivated to look to other forms of folate because of the widespread acceptance of folic acid to treat folate deficiencies.  The Board responding by pointing out that a person of ordinary skill in the art would not "have avoided alternatives simply because a standard is known to be suitable and to work well."  Second, SAMSF argued that folinic acid (5-formyl-THFA) was indicated for use in cancer treatment, no folic acid deficiency.  In response, the Board pointed out that just because "folinic acid is not indicated for treating folate deficiency," it "does not follow  . . . that folinic acid is not suitable for treating deficiency."  Finally, SAMSF pointed out that the prior art taught that reduced folates were inferior to folic acid in several properties, such as bioavailability, substrate activity, disruption of folate metabolism, stability, and commercial availability.  In all cases, the Board found SAMSF's arguments unpersuasive because SAMSF did not provide credible evidence why such inferior properties would have discouraged skilled artisans from using these reduced folates for dietary purposes.

SAMSF also provided evidence of objective indicia of non-obviousness, or so-called secondary considerations, based on the sales of five products: Néevo prescription prenatal vitamins, NéevoDHA® prescription prenatal vitamins, Mentanx® medical food, Cerefolin® medical food, and CerefolinNAC® medical food.  The sale of these products demonstrated, according to SAMSF, commercial success, licensing, copying, long-felt but unmet need, discovering and solving an unrecognized problem, unexpected results, skepticism, and praise.  The Board did not challenge these allegations, but instead found that there was no nexus between the evidence and the claimed invention.  SAMSF's inventors had identified that chirally-pure 5-methyl-(6S)-THFA could be used in combination with other vitamins in dietary preparations to treat disorders related to folate deficiencies.  It was the opinion of the Board that SAMSF did not identify the novel elements in the reviewed claims that would anchor them to the objective evidence.  Instead, the claims were doomed because SAMSF apparently relied on the administration of 5-methyl-(6S)-THFA for its nexus, and this aspect, according to the Board, was taught by Marazza (even though Marazza did not anticipate the claims).  The lesson to be learned in attempting to establish a nexus in an IPR proceeding is to not appear as though your argument rests on only part of a combination claim (even if the combination is novel).

In total, the Board found that all of the reviewed claims of these three patents invalid as obvious in view of the cited art.  The fourth IPR, in which Merck was the patent holder, had a similar outcome with similar cited art.  Nevertheless, because that patent was unrelated to SAMSF patents, there were some unique issues in that case that we will address at a later date.  In addition, we will continue to monitor these pharma and biotech cases and provide periodic updates.

USPTO Seeks Public Input on Application Pendency

By Donald Zuhn --

Earlier this month, the U.S. Patent and Trademark Office published a notice in the Federal Register (79 Fed. Reg. 38854) requesting comments from the public regarding optimal patent first action and total pendency target levels.  The Office noted that the current targets for first action and total pendency, which were established with stakeholder input in the USPTO 2010–2015 Strategic Plan, were ten months and twenty months, respectively.

The Office defines average first action pendency (or average first office action pendency) as the average number of months from the patent application filing date until the date a first office action is mailed by the USPTO.  Average total pendency is defined by the Office as the average number of months from the patent application filing date until the date the application either issues as a patent or goes abandoned.

The Office has achieved significant reductions in pendency since the current pendency targets were set.  In particular, average first action pendency has been reduced from 25.7 months in FY 2010 to the current average first action pendency of 18.1 months (a 30% reduction), and average total pendency has been reduced from 35.3 months in FY 2010 to the current average total pendency of 28.1 months (a 20% reduction).

On page 38855 of the notice, the Office sets forth seven issues related to patent application pendency on which the public is invited to submit comments.  Briefly, the Office seeks public input regarding:

1.  Whether the current pendency targets are "the right agency strategic targets for the USPTO, stakeholders, and the public at large";

2.  Whether the Office should measure the percentage of applications that satisfy pendency targets rather than determine the average pendency for all applications;

3.  Whether the Office should consider using technology-specific patent pendency targets;

4.  Whether pendency targets should be tied to PTA provisions (such as the requirement under 35 U.S.C. § 154(b)(1)(A)(i) that a first action be issued within 14 months of the application filing date or national stage commencement date);

5.  Whether the benefits of a prompt first Office action might outweigh the potential concerns of the Office action being issued too quickly;

6.  Whether recent significant case law decisions, adjusted fee levels, and "activity in the global IP arena" might impact pendency; and

7.  Whether there are other activities where pendency or timeliness should be measured and reported (e.g., regarding RCEs).

More complete descriptions of the issues above can be found in the notice.

Written comments regarding optimal pendency targets can be submitted by e-mail to [email protected].  The deadline for submitting comments is September 8, 2014.

Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second

By Donald Zuhn --

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2014.  The report, which is prepared by the NVCA and PriceWaterhouseCoopers LLP using data from Thomson Reuters, indicates that venture capitalists invested $12.968 billion in 1,114 deals in the second quarter, which constituted a 34% increase in dollars and a 13% decrease in deals as compared with the first quarter of 2014, when $9.710 billion was invested in 985 deals (see chart below, which shows total venture funding from the first quarter of 2011 through the second quarter of 2014; data from MoneyTree Reports; click on chart to expand).  The nearly $13 billion invested in the second quarter was the highest quarterly total since the fourth quarter of 2000, and comes on the heels of a first quarter which saw funding at its highest levels in thirteen years.

Venture funding in the biotechnology sector rose from $1.090 billion in the second quarter of 2014 to $1.840 billion in the second quarter of 2014 (see chart below, which shows venture funding for the biotech (blue), medical devices (red), and software (green) sectors since the first quarter of 2011; data from MoneyTree Reports; click on chart to expand).  In addition to experiencing a 69% increase in dollars, the biotech sector also saw a 7% increase in deals, with 122 deals in the second quarter of 2014.  Funding in the biotech sector was also up from the second quarter of 2013, when $1.469 million was invested.

While the biotech sector secured enough funding to place second among the seventeen sectors tracked by the NVCA, the biotech sector received only 30% of the $6.060 billion in funding that was poured into the software sector in the second quarter -- only the fourth time since 1995 that the software sector broke the $6 billion mark in a single quarter.  The software sector has now captured the top spot for nineteen straight quarters, with the biotech sector finishing second in all but two of those quarters (the industrial/energy sector knocked the biotech sector to third in the second quarter of 2010 and first quarter of 2011), and the software sector has received more than $2 billion in funding for nine consecutive quarters.

Medical device and equipment investment increased by 8% with respect to dollars and deals in the second quarter, with $649 million being invested in 73 deals.  However, in contrast with the three sectors above, nine of the seventeen sectors tracked by the NVCA saw decreases in dollars invested in the second quarter.

NVCA President and CEO Bobby Franklin noted that "[n]ot since the early 2000s have we witnessed this level of quarterly investment activity," adding that "[b]efore alarmists declare a repeat of the dot-com bubble, it's important to keep in mind that a lot of this activity was driven by a handful of eye-popping investment rounds, including a record-setting funding round of $1.2 billion."

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

• "Software Sector Leads First Quarter Venture Funding to Thirteen Year High; Biotech Sector Finishes Second (Again)," April 30, 2014
• "Biotech Venture Funding Rebounded in 2013 After Strong Fourth Quarter," January 26, 2014
• "Biotech Venture Funding Sees Second Quarter Rebound," July 22, 2013
• "Biotech Venture Funding Down 33% in First Quarter," April 30, 2013
• "Annual Venture Funding Drops for First Time in Three Years," February 4, 2013
• "Biotech Venture Funding Up 64% in Third Quarter," October 29, 2012
• "Venture Funding in Life Sciences Sector Drops 9% in Second Quarter," July 22, 2012
• "Biotech Venture Funding Drops 43% in First Quarter," May 3, 2012
• "Venture Funding Increased 22% in 2011," February 2, 2012
• "Life Sciences Venture Funding Drops in Third Quarter," October 27, 2011
• "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
• "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
• "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011

• "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010

• "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010

• "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010

• "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
• "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 2009

• "First Quarter Venture Capital Funding at 12-Year Low," April 23, 2009

• "NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009," February 16, 2009