Patent Docs

USPTO Extends Deadline for Comments to Help Improve PTAB Proceedings

September 15, 2014

By Andrew Williams —

If you were planning on letting the U.S. Patent and Trademark Office know how you feel about the use of the "Broadest Reasonable Interpretation" standard for claim construction during PTAB trials or the near impossibility of amending claims in IPRs, you have an additional month. As we have previously reported, the USPTO is seeking feedback on the PTAB trial proceedings established by the Leahy-Smith America Invents Act. This request can be found in a Federal Register Notice from June 27, 2014, entitled "Request for Comments on Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board." Specifically, the USPTO outlined 17 issues, or questions, for which the Office is most interested in receiving public comments. The original deadline for submission was tomorrow, September 16, 2014, the two-year anniversary of the PTAB. However, the period for public comment was extended until October 16, 2014 according to a document found on the Patent Office website entitled "USPTO Extending Comment Period on Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board. The Patent Office stated that the extension was made "[i]n view of stakeholder requests for additional time to submit comments on the new administrative trial proceedings." Comments on all aspects of PTAB trial proceedings are to be e-mailed to TrialsRFC2014@uspto.gov.
Court Report

September 14, 2014

By Sherri Oslick —

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

Millennium Pharmaceuticals Inc. v. Glenmark Pharmaceuticals Ltd. et al.
1:14-cv-01156; filed September 10, 2014 in the District Court of Delaware

• Plaintiff: Millennium Pharmaceuticals Inc.
• Defendants: Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics Inc. USA

Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Glenmarks' filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma). View the complaint here.

Teva Pharmaceuticals USA Inc. et al. v. Sandoz Inc. et al.
1:14-cv-01171; filed September 10, 2014 in the District Court of Delaware

• Plaintiffs: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd; Teva Neuroscience Inc; Yeda Research and Development Co Ltd.
• Defendants: Sandoz Inc.; Momenta Pharmaceuticals Inc.

Teva Pharmaceuticals USA Inc. et al. v. Dr Reddy's Laboratories Ltd et al.
1:14-cv-01172; filed September 10, 2014 in the District Court of Delaware

• Plaintiffs: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd; Teva Neuroscience Inc; Yeda Research and Development Co Ltd.
• Defendants: Dr Reddy's Laboratories Ltd; Dr Reddy's Laboratories Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,232,250 ("Low Frequency Glatiramer AcetateTherapy," issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis). View the Sandoz complaint here.

Fresenius Kabi USA, LLC v. Emcure Pharmaceuticals USA Inc. et al.
1:14-cv-01141; filed September 8, 2014 in the District Court of Delaware

• Plaintiff: Fresenius Kabi USA, LLC
• Defendants: Emcure Pharmaceuticals USA Inc.; Emcure Pharmaceuticals Ltd.

Fresenius Kabi USA, LLC v. Emcure Pharmaceuticals USA, Inc. et al.
1:14-cv-05584 filed September 8, 2014 in the District Court of New Jersey

• Plaintiff: Fresenius Kabi USA, LLC
• Defendants: Emcure Pharmaceuticals USA Inc.; Emcure Pharmaceuticals Ltd.

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 Emcure's 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.

Salix Pharmaceuticals, LTD et al. v. Mylan Pharmaceuticals Inc.
1:14-cv-00152; filed September 8, 2014 in the Northern District of West Virginia

• Plaintiffs: Salix Pharmaceuticals, LTD; Salix Pharmaceuticals, Inc; Glycyx Pharmaceuticals, LTD
• Defendant: Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,197,341 ("Formulations of Balsalazide and Its Derivatives," issued March 6, 2001) and 8,497,256 ("Formulations and Uses of 2-Hydroxy-5-Phenylazobenzoic Acid Derivatives for the Treatment of Males," issued July 30, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Salix's Giazo® (balsalazide disodium, used for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older). View the complaint here.

AbbVie Inc. v. Hetero Labs Ltd. et al.
1:14-cv-01137; filed September 5, 2014 in the District Court of Delaware

• Plaintiff: AbbVie Inc.
• Defendants: Hetero Labs Ltd.; Hetero USA Inc.; Hetero Labs Ltd.; Hetero USA Inc.

Infringement of U.S. Patent No. 8,691,878 ("Solid Pharmaceutical Dosage Form," issued April 8, 2014) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection). View the complaint here.

Bristol-Myers Squibb Co. et al. v. Merck & Co Inc.
1:14-cv-01131; filed September 4, 2014 in the District Court of Delaware

• Plaintiffs: Bristol-Myers Squibb Co.; Ono Pharmaceutical Co., Ltd.
• Defendant: Merck & Co. Inc.

Infringement of U.S. Patent No. 8,728,474 ("Immunopotentiative Composition," issued May 20, 2014), licensed to BMS, based on Merck's anticipated manufacture and sale of pembrolizumab for the treatment of cancer. View the complaint here.

Otsuka Pharmaceutical Co., Ltd. V. Zhejiang Huahai Pharmaceutical Co., Ltd., et al.
1:14-cv-05537; filed September 4, 2014 in the District Court of New Jersey

• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Zhejiang Huahai Pharmaceutical Co., Ltd.; Huahai US Inc.; Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC

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 Zhejiang Huahai'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.

Astrazeneca Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc.
1:14-cv-05539; filed September 2, 2014 in the District Court of New Jersey

• Plaintiffs: Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.; Astrazeneca AB
• Defendant: Sagent Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Sagent's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy). View the complaint here.
Conference & CLE Calendar

September 14, 2014

September 16, 2014 – "Section 103 and Obviousness: Capitalizing on CCPA and Early Federal Circuit Precedent — Strategies for Withstanding Obviousness Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EDT)

September 16, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Concord, NH

September 17, 2014 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – 12:00 to 5:00 pm (EDT)

September 18, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Madison, WI

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

September 23, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Alexandria, VA (webcast)

September 25, 2014 – "Charting New Territory: Prosecution and Diligence Strategies in the Wake of the AIA" (American Bar Association Center for Professional Development and Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

September 26, 2014 – IP & Diagnostics Symposium (Biotechnology Industry Organization) – Alexandria, VA

September 30, 2014 – 2014 Intellectual Property Continuing Legal Education Seminar (DuPont and Widener University School of Law) – Wilmington, DE

September 30, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Dallas, TX

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

October 2, 2014 – "USPTO Guidance for Determining Subject Matter Eligibility In View of U.S. Supreme Court's Mayo and Myriad Decisions" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

October 2, 2014 – "Conflicts in Patent Prosecution: Minimizing Risks of Malpractice Liability and Ethics Sanctions" (Strafford) – 1:00 to 2:30 pm (EDT)

October 2, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Denver, CO (webcast)

October 9, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Atlanta, GA

October 20-22, 2014 – Business of Biosimilars (Institute for International Research) – Boston, MA

October 29-30, 2014 - Congress on PIV Litigation (Momentum) – Philadelphia, PA

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

September 14, 2014

The U.S. Patent and Trademark Office will be holding its next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting on Wednesday, September 17, 2014. The latest BCP meeting will be the Office's first Bicoastal BCP (BCBCP) event, with the meeting being held simultaneously in the Madison Auditorium on the USPTO Alexandria Campus (East Coast) and Engineering Building Conference Room of San Jose State University (West Coast). During the inaugural BCBCP, participants will be able to interact with Office personnel in person on both coasts, or alternatively, via webcast.

The agenda for the meeting is as follows:

• Welcoming Remarks (12:00 – 12:10 pm EDT) — Margaret A. Focarino, Commissioner for Patents, USPTO (Alexandria)

• Opening Remarks (12:10 – 12:30 pm EDT) — John Cabeca, Director, Silicon Valley Office, USPTO (San Jose); Jerry Lorengo Director, TC1600, USPTO (Alexandria); Dan Sullivan Director, TC1600, USPTO (San Jose); and Wanda Walker Director, TC1600, USPTO (Alexandria)

• Improper Markush (12:30 – 1:20 pm EDT) — Joe Mallon of Knobbe, Martens, Olson & Bear, LLP (San Jose)

• Break (1:20 – 1:30 pm EDT)

• OPAP Procedure and Tips (1:30 – 2:10 pm EDT) — Kevin Little Office of Patent Application Processing (OPAP), USPTO (Alexandria)

• RCE Statistics and Reduction Initiatives. Brief Overview of AFCP 2.0 & QPIDS, and other Patent Application Initiatives (2:10 – 2:40 pm EDT) — Directors, TC1600 and Silicon Valley Office, USPTO

• Discussion/Lunch (2:40 – 3:40 pm EDT) — Directors, TC1600 and Silicon Valley Office, USPTO

• Break (3:40 – 3:50 pm EDT)

• Myriad Guidance and CLS Decision (3:50 – 4:50 pm EDT) — Paul Naik Vice President, Intellectual Property, Genentech, Inc. (San Jose); Suzannah K. Sundby, Partner, Canady & Lortz LLP (Alexandria); Jeffery Tung Patent Counsel, Isis Pharmaceuticals (San Jose); June Cohan Legal Advisory, OPLA, USPTO (Alexandria)Jerry Lorengo Director, TC 1600, USPTO (Alexandria); and Dan Sullivan Director, TC1600, USPTO (San Jose)

• Closing Remarks/Discussion (4:50 – 5:00 pm EDT) — John Cabeca, Director, Silicon Valley Office, USPTO (San Jose); Jerry Lorengo Director, TC1600, USPTO (Alexandria); Dan Sullivan Director, TC1600, USPTO (San Jose); and Wanda Walker Director, TC1600, USPTO (Alexandria)

The meeting can be viewed online here. The event number is 642 123 660 and the event password is 12345. Additional information regarding the BCP customer partnership meeting can be found here.
USPTO AIA Roadshow

September 14, 2014

The U.S. Patent and Trademark Office will be hosting seven roadshow events between September 16 and October 9 to increase understanding of the First Inventor to File (FITF) provisions of the Leahy-Smith America Invents Act (AIA). At each roadshow, panelists will discuss FITF statistics to date, the applicability of the FITF provisions on patent applications filed today, the FITF statutory framework and its exceptions, and AIA evidentiary declaration practice useful to invoke these exceptions.

Roadshow events will be held on the following dates:

Tuesday, September 16 — Franklin Pierce IP Center at UNH School of Law (Concord, NH) — 1:00 to 5:00 pm

Thursday, September 18 — University of Wisconsin-Madison, Engineering Hall (Madison, WI) — 1:00 to 5:00 pm

Tuesday, September 23 — USPTO Headquarters (Alexandria, VA) — 1:00 to 5:00 pm

Tuesday, September 30 — Dallas Bar Association Belo Mansion (Dallas, TX) — 1:00 to 5:00 pm

Thursday, October 2 — USPTO Rocky Mountain Regional Office, Byron G. Rogers Federal Building (Denver, CO) — 9:00 am to 1:00 pm

Tuesday, October 7 — Cupertino Community Hall (Silicon Valley, CA) — 9:00 am to 1:00 pm

Thursday, October 9 — Georgia Institute of Technology, Scheller College of Business (Atlanta, GA) — 1:00 to 5:00 pm

The agenda for the roadshows will be as follows:

Introductory Remarks (10 min)
FITF – A Year Plus In Review (20 min)
• Review of examiner training
• Statistics to date
Will My Application Be Examined Under AIA (FITF) Or Not? (75 min)
• 1.55/1.78 statements
• The power of the ADS
• Have you checked your filing receipt?
• Scenarios
Break (15 min)
FITF Overview and Tips on Responding to Prior Art Rejections (60 min)
• 35 USC 102(a)(1) and 102(a)(2) – bases for rejections
• 35 USC 102(b)(1) and 102(b)(2) – exception provisions
• Scenarios
Effective Use of AIA (FITF) Evidentiary Declarations (45 min)
• 37 CFR 130(a) and 130(b)
• Scenarios
Tour of the AIA (FITF) Website and Q&A (15 min)

The roadshows in Alexandria on September 23 and Denver on October 2 will be webcast live through the USPTO website. The September 23 roadshow can be accessed here, using the event number 643 625 972, and event password 12345. Those wishing to call in can use the toll number 1-571-270-7000 and the access code 643 625 972. The October 2 roadshow can be accessed here, using the event number 649 219 415, and event password 12345. Those wishing to call in can use the toll number 1-571-270-7000 and the access code 649 219 415.

The roadshow events are free and open to the public, but seating is available on a first-come, first-served basis. Additional information regarding the roadshows can be found here.
PGR Report — The Attack of 35 U.S.C. § 112

September 11, 2014

By Andrew Williams —

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is jointly assigned to Helsinn Healthcare S.A. and Roche Palo Alto, LLC (collectively "Helsinn"). As a reminder, PGRs are the third type of post-issuance review procedures established by the America Invents Act ("AIA") — the other two being Inter Partes Review and Covered Business Method Patent Review (IPR and CBM, for short). However, the reason that only one other PGR has been filed to date is because this type of proceeding only applies to patents that were examined pursuant to the new First Inventor to File scheme established by the AIA. And because such applications could only be filed on or after March 16, 2013, there are only a limited number of such patents that are presently eligible for PGR. One of the other significant differences between IPRs and PGRs is that the latter is not limited to certain types of prior art validity attacks (such as 102 or 103), but instead any type of validity challenge available in District Court is essentially available in front of the Patent Trial and Appeals Board ("PTAB"). This includes attacks under 35 U.S.C. § 112, such as allegations of a lack of enablement, a lack of written description, and a failure to distinctly claim the invention. Accord took full advantage of this in its petition for PGR2014-00010, in which Accord alleged that Helsinn's patent related to liquid pharmaceutical formulations of palonosetron should not have been issued by the Patent Office.

The '219 patent had been asserted in several Hatch-Waxman litigations involving ALOXI®, which is a palonosetron formulation indicated to help prevent nausea and vomiting following chemotherapy. Palonosetron hydrochloride, the active pharmaceutical ingredient, has the following structural formula:

The '219 patent is a member of a family of patents directed to formulations of palonosetron hydrochloride. Importantly, this patent was filed as a continuation-in-part application on May 23, 2013, with a letter that asserted that claim 9 only had support because of a newly added example, and therefore was subject to the AIA. Only claims 1-5 and 8 of the '219 patent are the subject of this petition, with claim 1 reading:

1.    A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:
    palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base;
    from 0.005 mg/mL to 1.0 mg/mL EDTA;
    and from 10 mg/mL to 80 mg/mL mannitol,
    wherein said formulation is stable at 24 months when stored at room temperature.

Claim 8 is the only other challenged independent claim, and it reads identically, except for a stability limitation of 18 months when stored at room temperature. This patent issued on December 3, 2013, and the PGR petition was filed within the requisite nine months.

The petition pointed out that during the prosecution of the '219 patent and its family, the Patent Office had rejected the claimed formulations as obvious. In response, the applicants submitted a declaration from inventor Daniele Bonadeo ("the Bonadeo declaration") and argued that one of skill in the art would not have combined the features of the invention as a matter of routine optimization. Instead of routine, the applicants continued, the claimed formulations were obtained after a sequence of experiments, each of which built upon the others like building blocks. If the experimental sequence had varied, the applicants alleged that they would have obtained a different formulation. The Bonadeo declaration explained that the first two parameters studied were palonosetron concentration and pH. None of the studies described in this declaration, however, occurred at a pH other than 5.0, which makes sense because palonosetron was described as extremely stable at this pH.

Considering that the '219 patent ultimately issued, the applicants were apparently successful in overcoming these obviousness rejections. In other words, the applicants convinced the examiner that a person of ordinary skill in the art would not have found it obvious to combine the teachings in the prior art to derived the claimed inventions. The positions taken by the applicant, however, were utilized by the petitioner, Accord, to allege that a person of ordinary skill in the art would not have, for example, found the specification enabling. This highlights the problem that PGRs pose for patent applicants. Before such procedure, arguments could be made without much fear that they would be coopted by the Office for making alternative rejections. And, if the Office did, there would still an opportunity to provide a response or amend the claims. Even if such arguments were made in district court litigation, the patent would at least enjoy a presumption of validity. Now, all applicants must take extreme caution in making any arguments, because anything said can (and probably will) be used against them at the PTAB.

What follows is an identification of the 35 U.S.C. § 112 arguments made by Accord. Considering that the patent owner has not yet filed any response, and the PTAB has not weighed in, no position is taken here as to the merits of these arguments.

Written Description – Stability

Accord first alleged that the '219 was unpatentable for failing to provide an adequate description of the claimed subject matter being stable at 18 or 24 months when stored at room temperature, as required by 35 U.S.C. § 112(a). Specifically, the petition asserted that the specification does not show that the inventors were in possession of any formulation that would have achieved the stability limitations of the claims. Instead, the argument went, the patent contained general statements that it is possible to increase the stability of the formulations, but did not provide any examples with stability beyond a couple of weeks. Accord included a declaration from Dr. Arnold J. Repta, which explained how a person of ordinary skill in the art would have understood the teaching of the specification. However, Dr. Repta did not include any additional testing of the formulations taught in the application in his declaration.

Enablement

The second assertion made in the petition was that the '219 patent does not enable a pH range for the claimed formation outside of about 4.0 to 6.0, and therefore it is not enabled as required by 35 U.S.C. § 112(a). This is because, according the petition, the only relevant formulation in the specification was disclosed as having a pH of 5.0±0.5. Moreover, the specification was alleged to claim that palonosetron is most stable at pH 5.0. Accord also cited to the Bonadeo Declaration, which was submitted during prosecution by the applicants, which alleged claimed that palonosetron formulations containing mannitol or EDTA required a pH of 4-6. Therefore, according to the petition, because the challenged claims do not recite any pH limitations, they were broader than the teaching of the specification.

"Regards as the Invention"

35 U.S.C § 112(b) requires that a patent "conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention." Accord challenged the claims of the '219 patent as not including the invention as regarded by the inventors. Specifically, the petition alleges that the Bonadeo Declaration made clear that palonosetron was extremely stable at a pH of 5.0, and that there was no hint that a pH outside of the range of about 4.0 or 6.0 would be suitable. A similar argument was made about the language found in the specification. The petitioner concluded by pointing out that, even though the inventors believed that the inventive formation should be in a range of 4.0 to 6.0, such a limitation was not included in the claims.

Written Description – pH Range

Finally, Accord made a similar argument when alleging that the specification did not support claims that did not include a pH range of 4.0 to 6.0. Citing to the Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998), line of cases, the petitioner alleged that the pH range was an essential or critical feature which was omitted from that claims. In other words, Accord alleged that the broad claims without a pH limitation were invalid because the "entirety of the specification" demonstrates that the invention was of much narrower scope.

Of course, similar to an IPR, the patent owner now has a chance to submit a preliminary response to the petition. The standard used for instituting a PGR differs from that required for an IPR. Instead of the "reasonable likelihood" standard, a PGR will only be instituted when it is more likely than not that at least one of the claims challenged is unpatentable. In essence, this should be a slightly more stringent standard, because with both positions being equally likely, an IPR petition would have a reasonable likelihood of demonstrating claims as unpatentable, but a PGR petition would not be more likely than not to demonstrate unpatentable claims. However, it remains to be seen if less PGRs are instituted than IPRs. We will continue to monitor PGR2014-00010, and provide updates as warranted.
Court Report — Part III

September 11, 2014

By Sherri Oslick —

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

Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC
1:14-cv-01119; filed September 3, 2014 in the District Court of Delaware

• Plaintiffs: Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
• Defendant: Sigmapharm Laboratories LLC

Infringement of U.S. Patent Nos. 5,763,476 ("Sublingual or Buccal Pharmaceutical Composition," issued June 9, 1998) and 7,741,358 ("Crystal Form of Asenapine Maleate," issued June 22, 2010) following a Paragraph IV certification as part of Sigmapharm'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.

Cephalon, Inc. v. Nang Kuang Pharmaceutical Co., LTD et al.
1:14-cv-05180; filed September 3, 2014 in the Eastern District of New York

• Plaintiff: Cephalon, Inc.
• Defendants: Nang Kuang Pharmaceutical Co., LTD; Canada NK-1, LLC

Cephalon, Inc. v. Nang Kuang Pharmaceutical Co LTD et al.
1:14-cv-01117; filed September 2, 2014 in the District Court of Delaware

• Plaintiff: Cephalon, Inc.
• Defendants: Nang Kuang Pharmaceutical Co LTD; Canada NK-1 LLC

Cephalon, Inc. v. Sagent Pharmaceuticals Inc. et al.
1:14-cv-01116; filed September 2, 2014 in the District Court of Delaware

• Plaintiff: Cephalon, Inc.
• Defendants: Sagent Pharmaceuticals Inc.; Sagent Agila LLC

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013), 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013), 8,609,863 (same title, issued December 17, 2013), and 8,791,270 (same title, issued July 29, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma). View the Sagent complaint here.

United Therapeutics Corp. v. Teva Pharmaceuticals USA, Inc.
3:14-cv-05498; filed September 2, 2014 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,765,117 ("Process for Stereoselective Synthesis of Prostacyclin Derivatives," issued July 20, 2004), 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2014), 7,999,007 ("Buffer Solutions Having Selective Bactericidal Activity Against Gram Negative Bacteria," issued August 16, 2011), 8,653,137 (same title, issued February 18, 2014), and 8,658,694 (same title, issued February 25, 2014) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of United's Remodulin® (treprostinil sodium injection, used to treat pulmonary arterial hypertension). View the complaint here.

United Therapeutics Corp. v. Sandoz, Inc.
3:14-cv-05499; filed September 2, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2014) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of United's Remodulin® (treprostinil sodium injection, used to treat pulmonary arterial hypertension). View the complaint here.

Mission Pharmacal Co. v. Acella Pharmaceuticals, L.L.C.
5:14-cv-00771; filed September 2, 2014 in the Western District of Texas

Infringement of U.S. Patent No. 6,521,247 ("Dual Iron Containing Nutritional Supplement," issued February 18, 2003) based on Acella's manufacture and sale of its Prenaissance Promise, Prenaissance DHA, and Prenaissance 90 DHA prenatal supplements. View the complaint here.

Hospira, Inc. v. Janssen Biotech, Inc. et al.
1:14-cv-07049; filed August 29, 2014 in the Southern District of New York

• Plaintiff: Hospira, Inc.
• Defendants: Janssen Biotech, Inc.; New York University; NYU Langone Medical Center; Kennedy Trust for Rheumatology Research

Declaratory judgment of non-infringement and invalidity U.S. Patent Nos. 6,284,471 ("Anti‐TNFa Antibodies And Assays Employing Anti‐TNFa Antibodies," issued September 4, 2001), 7,223,396 ("Methods of Treatment of Fistulas in Crohn's Disease with Anti‐TNF Antibodies," issued May 29, 2007), 7,846,442 ("Methods of Treating Rheumatoid Arthritis with an Anti-TNF-alpha Antibodies and Methotrexate," issued December 7, 2010), 8,298,537 ("Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-α Antibodies and Methotrexate," issued October 30, 2012), and 8,383,120 ("Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-alpha Antibodies and Methotrexate," issued February 26, 2013) based on Hospira's anticipated manufacture and sale of its Inflectra® product, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis). View the complaint here.

Boehringer Ingelheim Pharma Gmbh & Co. KG et al. v. Mylan Pharmaceuticals Inc.
1:14-cv-00146; filed August 29, 2014 in the Northern District of West Virginia

• Plaintiffs: Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendant: Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent No. 6,015,577 ("Pharmaceutical Compositions Containing Dipyridamole or Mopidamol and Acetylsalicylic Acid or the Physiologically Acceptable Salts Thereof, Processes for Preparing Them and Their Use in Treating Clot Formation," issued January 18, 2000) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Boehringer's Aggrenox® (extended-release dipyridamole/acetylsalicylic acid, used to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis). View the complaint here.
U.S. Bancorp v. Solutran, Inc. (PTAB 2014)

September 10, 2014

By Michael Borella —

In the weeks since the Alice Corp. v. CLS Bank Supreme Court decision, we have been watching patents and applications fall left and right due to use of that case's more stringent test regarding patent-eligibility. This test requires that, for purposes of determining whether claims involve statutory subject matter under 35 U.S.C. § 101, one must apply a two prong analysis. The first prong is to determine whether the claims are directed to a patent-ineligible law of nature, natural phenomenon, or abstract idea. If so, the second prong is to determine whether any additional claim elements transform the nature of the claim into a patent-eligible application that amounts to significantly more than the ineligible concept itself.

While not explicitly targeting software and business methods, in reality the Court has made these types of patents more difficult to obtain. The U.S. district courts, the Federal Circuit, and the U.S. Patent and Trademark Office have been applying the CLS Bank test aggressively. In the vast majority of cases, the claims under consideration are found to be patent-ineligible.

Consequently, one of the difficulties we have when trying to draft or amend claims so that they withstand scrutiny is that there are very few examples of claims that are patent-eligible under CLS Bank. All Federal Circuit case law interpreting § 101 prior to June 19 of this year (the date of the CLS Bank decision), is suspect. Thus, when a post-CLS Bank case that applies the CLS Bank test finds claims patent-eligible, that case is worthy of attention.

U.S. Bancorp v. Solutran, Inc. was a covered business method review before the Office's Patent Trial and Appeal Board. While this case does not carry the weight of precedent, it does provide a glimpse at what some of the Office's administrative patent judges may be thinking regarding § 101.

U.S. Bancorp petitioned for the review in order to challenge the patentability of claims 1-6 of U.S. Patent No. 8,311,945, owned by Solutran. As an example, claim 1 of the '945 patent recites:

1. 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 Board first verified that this patent is ripe for covered business method review, in that the petitioner had been sued for infringement of the patent, the claims for which review had been requested were directed to a financial product or service, and that the challenged patent was not technical in nature. The last part of this test as applied by the Board is notable. The Board sought to determine "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 answering this question in the negative, the Board wrote that the claimed features of "checks, digital image scanners, and computers were known technologies in the prior art before the effective filing date of the '945 patent in 2006," and that "no limitation of claim 1 . . . represents a technological feature that is novel or unobvious over the prior art." With that threshold test out of the way, the Board initiated the review.

Among other points, U.S. Bancorp contended that "[o]ther than the claimed idea of a non-merchant entity performing check scanning, claim 1 includes nothing but mental process steps, insignificant extra-solution activity, and conventional computer hardware components for performing basic computer functions." The Board responded by indicating that "[i]n determining whether a method or process claim recites an abstract idea, we must examine the claim as a whole." Thus, the Board found U.S. Bancorp's arguments unpersuasive because "they are directed to each method step individually without accounting sufficiently for the claims as a whole."

Instead, when conducting the first prong of the CLS Bank test, the Board found that the claim 1 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."

Noting that "application of the Supreme Court's test cannot disembody such recitations from the claim viewed as a whole," the Board held that claim 1 was directed to processing paper checks rather than an abstract idea. Thus, the Board concluded that U.S. Bancorp "has not demonstrated that it is more likely than not that challenged claims 1-6 are unpatentable under 35 U.S.C. § 101." (Ultimately, the Board ordered a covered business method review of the claims because it also concluded that the claims were more likely than not obvious over applicant admitted prior art and a secondary reference.)

The procedural stance of this case is unusual. It was before the Patent Trial and Appeal Board rather than a federal court. Also, this opinion only considered whether it is more likely than not that the claims would eventually be found to be unpatentable. Nonetheless, the Board's application of the first prong from CLS Bank is informative, and provides patent holders with a tool than can be used to rebut contentions of patent-ineligibility — namely, an example of a business method patent that is not directed to an abstract idea.

Since the Board decided that the claims were not directed to an abstract idea, it never reached the issue of whether the claims recite "significantly more." A case that illustrates how to apply the second prong would be welcome.

U.S. Bancorp v. Solutran, Inc., Case No. CBM2014-00076, 2014 WL 3943913 (PTAB Aug. 7, 2014)
Federal Trade Commission “Meets the Press”

September 9, 2014

By Kevin E. Noonan —

Federal Trade Commission Chairwoman Edith Ramirez and Debbie Feinstein, Director of the Commission's Bureau of Competition, held a thirty-minute press conference on Monday to discuss the latest foray in the Commission's crusade against the pharmaceutical industry (branded and generic). Seemingly emboldened by its partial victory at the Supreme Court in FTC v. Actavis, in this action the Commission has expanded its allegations of anticompetitive behavior beyond cash payments from branded to generic drug companies (provocatively termed "pay-for-delay" agreements) to other forms of agreements (and not for the first time).

The drug at issue is Androgel, "a topical pharmaceutical gel product approved for testosterone replacement therapy in men with low testosterone", which has been the subject of other FTC actions, (including FTC v. Actavis); the Commission stated that the branded drugmakers, AbbVie and Besin Helathcare, had annual sales of over one billion dollars for this drug. The e-mail announcing the press conference (as well as statements made during the conference) was awash with the scarlet rhetoric (and self-congratulatory hagiography) that has characterized the Commission's anti-reverse settlement campaign. This is "the latest action to ensure competition in the nation's healthcare markets" according to the Commission, its aim to stop "several major pharmaceutical companies [from] illegally blocking American consumers' access to lower-cost versions of the blockbuster drug AndroGel." The Commission describes the goal of its efforts as "stop[ping] anticompetitive conduct by AbbVie, Besins Healthcare and Teva which has forced consumers to overpay hundreds of millions for the drug AndroGel," and by filing the lawsuit to "reinforce[] the Commission's longstanding commitment to protect American consumers from collusive arrangements between branded and generic pharmaceutical companies that inflate the prices of prescription drugs and harm competition." The Commission also wants to force the parties to "disgorge their ill-gotten gains" (a remark the brings to mind Humphrey Bogart's comment in The Maltese Falcon that "the cheaper the gunsel, the gaudier the patter") in addition to having a court issue a permanent injunction against the parties regarding this settlement.

The Commission describes its complaint as alleging that "AbbVie Inc. and its partner Besins Healthcare Inc. filed baseless patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of the testosterone replacement drug AndroGel," a charge also asserted by Ms. Feinstein during the press conference. The specific ground for the complaint is a settlement between the parties that the Commission characterizes as "an anticompetitive pay-for-delay settlement agreement." But as further explained by Chairwoman Ramirez and Director Feinstein, the complained-of agreement was in fact not a "pay-for-delay" agreement. On the contrary, what the Commission wants to ban in this case is an agreement wherein AbbVie agreed to permit Teva to market an authorized generic for a cholesterol drug called TriCor. The Commission makes much of the fact that annual U.S. sales of this drug were more than $1 billion in 2011, and thus "highly profitable for Teva" (of course, this can also be characterized as "consideration"; as noted in In re Lamictal Direct Purchaser Antitrust Litig., 2014 U.S. Dist. LEXIS 9257, at *24, "[a] law student learns in the first semester that consideration is an essential element of any enforceable contract. In this sense, there is 'payment' in every settlement.") Also, the Commission contends that this arrangement "made no independent business sense for AbbVie." Thus the agreement constituted anticompetitive behavior. Such contentions are a far cry from the Supreme Court's holding in the Actavis case.

The Commission's complaint also asserts as one ground that the branded drug makers' lawsuit was a sham (an allegation also made by Teva in the underlying ANDA litigation in support of an antitrust counterclaim but one that comes close to finding anticompetitive behavior by way of statutory compliance). The litigation is asserted to be a sham because the Orange Book listed patent, U.S. Patent No. 6,503,894, claimed a testosterone formulation containing a specific (skin) penetration enhancer, isopropyl myristate (IPM), and the generic formulations comprised other penetration enhancers (specifically, isostearic acid or isopropyl palmitate). The complaint alleges that the Besin's plaintiff and patentee Unimed (a predecessor-in-interest to AbbVie) had narrowed broad claims as filed to any penetration enhancer to encompass only formulations comprising IPM, and had distinguished over formulations comprising other enhancers. Thus, the Commission contended in its complaint that the generic formulations did not literally infringe the '894 claims and could not infringe under the doctrine of equivalents because prosecution history estoppel barred the claims from having this scope. (Ironically, the Commission should be in exactly the position foretold by Chief Justice Roberts in his Actavis dissent, of having to prove the patenting issues as a predicate to considering the antitrust issues.) Moreover, the Commission alleged in its complaint that plaintiffs had successfully used a Citizens' Petition to convince the FDA to require generic defendants to file NDA's on their formulations, based on differences between IPM and the other penetration enhancers. The Commission also alleged that the incentive for filing ANDA litigation was to trigger improperly the 30-month stay in FDA approval mandated by the statute.

It is possible that this attempt to expand the factual grounds for putting ANDA settlement agreements under the Commission's antitrust microscope may be going too far for some of the Commissioners; as Chairwoman Ramirez and Director Feinstein admitted, for the first time the vote to bring the complaint was not unanimous, and indeed was 3-2, with Commissioners Maureen K. Ohlhausen and Joshua D. Wright dissenting (there is no public record of either the deliberations or the dissents). The complaint was also filed in light of rejection of the FTC's theory that actions other than cash payments can trigger application of the Supreme Court's Actavis precedent, in a decision in the District Court of Rhode Island regarding the drug Loestrin. In that case, District Court Judge William E. Smith (on September 4, 2014, four days before the FTC filed its complaint in this case) granted defendants' motion to dismiss an antitrust claim based on an agreement over an authorized generic rather than a cash payment (while recognizing that how district courts are deciding the question of whether non-cash arrangements fall within the scope of the Actavis decision has been inconsistent, an outcome also anticipated by Chief Justice Roberts in his Actavis dissent).

The complaint, alleging violations of the FTC Act for monopolization and restraint of trade, was filed under seal in the U.S. District Court for the Eastern District of Pennsylvania on September 8, 2014 and only a redacted version has been made public.
Court Report — Part II

September 8, 2014

By Sherri Oslick —

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

Roxane Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc.
2:14-cv-05423; filed August 28, 2014 in the District Court of New Jersey

Roxane Laboratories, Inc. v. Amneal Pharmaceuticals, LLC
2:14-cv-05420; filed August 28, 2014 in the District Court of New Jersey

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,563,032 ("Formulation and Manufacturing Process for Calcium Acetate Capsules," issued October 22, 2013) based on defendants' anticipated manufacture and sale of a generic calcium acetate capsule, having filed an ANDA to manufacture a generic version of Fresenius' PhosLo® Gelcaps (calcium acetate, used for the reduction of serum phosphorous in patients with end stage renal disease). View the Zydus complaint here.

Novartis Pharmaceuticals Corp. et al. v. Zydus Noveltech Inc. et al.
2:14-cv-05405; filed August 28, 2014 in the District Court of New Jersey

• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
• Defendants: Zydus Noveltech Inc.; Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

Novartis Pharmaceuticals Corp. et al. v. Zydus Noveltech Inc. et al.
1:14-cv-01104; filed August 27, 2014 in the District Court of Delaware

• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
• Defendants: Zydus Noveltech Inc.; Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Zydus' 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 Delaware complaint here.

Senju Pharmaceutical Co. Ltd. et al. v. Micro Labs Ltd. et al.
1:14-cv-01105; filed August 27, 2014 in the District Court of Delaware

• Plaintiffs: Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
• Defendants: Micro Labs Ltd.; Micro Labs USA Inc.

Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued December 25, 2001) following a Paragraph IV certification as part of Micro Labs' filing of an ANDA to manufacture a generic version of Allergan's Zymaxid® (0.5 w/v % gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis). View the complaint here.

Bristol-Myers Squibb Co. v. Amneal Pharmaceuticals LLC
1:14-cv-01086; filed August 22, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 5,206,244 ("Hydroxymethyl (Methylenecyclopentyl) Purines and Pyrimidines," issued April 27, 1993) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of BMS's Baraclude® (entecavir, used to treat chronic hepatitis B virus infectrion). View the complaint here.

Janssen Pharmaceuticals Inc. v. VIVUS Inc.
1:14-cv-01088; filed August 22, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 6,071,537 ("Anticonvulsant Derivatives Useful in Treating Obesity," issued June 6, 2000) based on Vivus' manufacture and sale of its Qsymia product (phentermine and topiramate, used to for chronic weight management in adults with a high initial body mass index (BMI)). View the complaint here. [NB: The case was voluntarily dismissed two days after filing.]

Acorda Therapeutics, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:14-cv-00139; filed August 22, 2014 in the Northern District of West Virginia

• Plaintiffs: Acorda Therapeutics, Inc.; Alkermes Pharma Ireland Ltd.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.

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 Mylan's 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.

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