Patent Docs

USPTO Releases Performance and Accountability Report for FY 2011

By Donald Zuhn --

The U.S. Patent and Trademark Office recently released its Performance and Accountability Report for Fiscal Year (FY) 2011.  With respect to the Office's performance goals, the report indicates that four of five patent-related performance targets were met in FY 2011.  Among the patent-related performance targets that the Office met were patent average total pendency (33.7 months actual versus 34.5 months target) and patent applications filed electronically (93.1% actual versus 90% target).  The lone performance target that went unmet was patent average first action pendency (28 months actual versus 23 months target).

The FY 2011 report, like the FY 2010 report, identifies three strategic goals, each comprising several objectives:

1.  Optimize patent quality and timeliness
2.  Optimize trademark quality and timeliness
3.  Provide domestic and global leadership to improve intellectual property policy, protection and enforcement worldwide

With regard to the first strategic goal, the report indicates that the Office met four of five objectives (see table below), up from a 40% success rate in FY 2010 (click on any table to expand).

In particular, the report states that the Office:

[M]ade significant progress in FY 2011 in meeting our goal of providing timely and quality patents.  While less-than-planned spending authority has greatly impacted the USPTO's ability to decrease patent pendency and the backlog, the Patent organization continued to respond to these challenges and obstacles by launching new and innovative initiatives to achieve its strategic goals.  Despite budget constraints suspending routine programs such as examiner hiring, overtime, and training, the Patent organization succeeded in making progress by focusing on new methods and processes to increase efficiencies and strengthen effectiveness through collaboration, communication, and transparency.

The report notes that patent filings increased 5.2% for FY 2011, jumping from 510,060 in FY 2010 to 536,604 in FY 2011 (according to preliminary data).  This follows a 4.8% increase in patent filings for FY 2010.

Despite accepting more than 500,000 patent applications for the second straight year, the number of applications awaiting action dropped from 726,331 in FY 2010 to 690,967 in FY 2011 (the first time the Office has been below 700,000 applications awaiting action since 2005).  The total number of pending applications, however, was up slightly from 1,163,751 in FY 2010 to 1,168,928 in FY 2011.

Utility patent issuances were up significantly in FY 2011 (according to preliminary data), rising from 207,915 in FY 2010 to 221,350 in FY 2011.  It was the second straight year that the Office set a record for utility patent issuances, and marked the fourth straight increase.

With respect to first action and total pendency, the report shows that the Office will have to be satisfied with a split.  After dropping 0.1 months between FY 2009 and FY 2010, patent average first action pendency jumped 2.1 months to 28 months.  Patent average total pendency, however, was down 1.6 months to 33.7 months, the lowest this measure has been since FY 2008.

The report states that the increase in patent average first action pendency "was expected due to the efforts focused on clearing up the oldest patent applications from the backlog through the COPA [Clearing the Oldest Patent Applications] initiative," and that "with sufficient funding and the ability to hire and utilize overtime, the USPTO is confident that it will not only meet but exceed its target goals for next year."

Participation in electronic filing continued to rise in FY 2011, with electronically-filed patent applications jumping from 89.5% in FY 2010 to 93.1% in FY 2011.  Only five years ago, less than half of all patent applications were filed electronically.

For biotechnology and organic chemistry applicants, average first action pendency rose from 22.8 months in FY 2010 to 23.8 months in FY 2011, and total average pendency dropped from 36 months in FY 2010 to 33.6 months in FY 2011.  Both pendency measures were below the Office's overall averages of 33.7 months and 28 months, respectively.  No other Technology Center posted a better first action pendency than TC 1600, and only TC 2800 (semiconductor, electrical, optical systems & components) and TC 3600 (transportation, construction, agriculture & electronic commerce) posted better final action pendencies (as they did in FY 2010).

For additional information regarding this and other related topics, please see:
• "USPTO Releases 2010 Performance and Accountability Report," November 17, 2010
• "USPTO Announces 'Highest Performance Levels in Agency's History' in 2008," November 18, 2008
• "USPTO Announces 'Record Breaking' 2007 Performance," November 15, 2007
• "Patent Office Announces Record-Breaking Year," December 27, 2006

In re Stepan Co. (Fed. Cir. 2011)

By Kevin E. Noonan --

It is widely appreciated that the Supreme Court has spent the better part of the last ten years exercising its supervisory role over the Federal Circuit, something the Court generally refrained from doing for the first 15-20 years of the appellate court's existence (see "Is It Time for the Supreme Court to Stop Flogging the Federal Circuit?").  One of the first cases serving as a bell-weather for the High Court's new thinking about the Federal Circuit was Dickinson v. Zurko, 527 U.S. 150 (1999), where the Supreme Court found that the Federal Circuit, like all appellate courts, was constrained by the provisions of the Administrative Procedures Act of 1948 in the exercise of its supervisory authority over the U.S. Patent and Trademark Office.  This standard required the Federal Circuit to defer to factual determinations made by the Patent Office, imposing a "substantial evidence" standard for reversing decisions by the Office.  This was a much more deferential standard than the one the Federal Circuit was used to, albeit not rising to the "arbitrary and capricious" standard espoused by the PTO Commissioner (Q. Todd Dickinson).  But in rejecting the argument that the Federal Circuit was special and entitled to satisfy its own standards (due inter alia to its unique position among the regional Circuit Courts of Appeal), the Supreme Court clearly mandated that the Federal Circuit comply with legal standards the Court had established rather than ones the Federal Circuit felt appropriate for the fulfillment of its peculiar purpose of interpreting U.S. patent law.

It is both ironic and perhaps fitting, then, that the Federal Circuit had the opportunity to turn the provisions of the APA on the Patent Office in reversing the Board's decision in In re Stepan Co.  Stepan Co. ("Stepan") appealed the Board's decision affirming an Examiner's obviousness rejection in reexamination proceedings.  The Examiner based his rejection on a prior art reference to Singh (WO 97/21764) applied under 35 U.S.C. § 102(b).  The Board affirmed the rejection that the claims were obvious, but considered the reference to be prior art under 35 U.S.C. § 102(a).  In making its determination, the Board determined that a Declaration submitted by Stepan during the reexamination pursuant to 37 C.F.R. § 1.131 was "ineffective to remove Singh as a reference qualifying under 35 U.S.C. § 102(a)"; this determination was relevant because, unlike the absolute statutory bar of § 102(b), the requirement of § 102(a) that the invention was known or used in this country "before the invention thereof" by the patent applicant permits an inventor to "swear behind" the asserted reference.

Stepan contended that the difference in the grounds of the rejection constituted a "new ground of rejection" that should have triggered the provisions of the APA (and the Office's own procedural rules) to provide (of right) an opportunity for further examination by the examiner, i.e., that the Board should have remanded the case back to the Group for further consideration.

In a opinion by Judge Prost, joined by Judge Dyk, the Federal Circuit[1] agreed.  Citing "a series of [prior] opinions," the panel found that:

[B]oth this court and our predecessor court, the United States Court of Customs & Patent Appeals ("Patent Court"), have recognized that if the appellant has not had a full and fair opportunity to litigate the Board's actual basis of rejection, the administrative validity proceedings before the United States Patent and Trademark Office ("PTO") should be allowed to continue.

In re Kumar, 418 F.3d 1361, 1367–68 (Fed. Cir. 2005) (collecting cases).  This right to a "full and fair hearing" is embodied in Patent Office regulations, inter alia, 37 C.F.R. § 41.50(b), which the Court says is required to satisfy the statutory notice requirement embodied in 35 U.S.C. § 6.  In addition, as a procedural matter, Stepan argued that it had been denied the opportunity to address whatever deficiencies the Board found existed in its Rule 131 Declaration.  At root, this constituted a claim that Stepan's administrative due process rights had been violated.

The Court agreed with Stepan that changing the statutory basis for deciding that the Singh reference was prior art (specifically, what kind of prior art) was a new ground of rejection.  The Federal Circuit rejected the Office's contention that since the basis for the rejection was the same -- obviousness -- there was no "new ground of rejection" asserted by the Board and thus due process was not implicated in its decision.  The panel also found insufficient the government's argument that, since Stepan had had the opportunity to present evidence and argument (and in fact had done so) during proceedings before the Board on the issue, it had been afforded with the required opportunity to be heard.  Finally, and equally unavailingly, the government argued that Stepan was under an obligation to petition for rehearing and by having failed to do so had squandered the right to "allege that it was deprived of its administrative due process rights."  Not so, according to the panel:

It is crucial that the examiner issue a rejection (even if that rejection is subsequently withdrawn) so the applicant is on notice that it is obligated to respond.  Mere reliance by the Board on the same type of rejection or the same prior art references relied upon by the examiner, alone, is insufficient to avoid a new ground of rejection where it propounds new facts and rationales to advance a rejection -- none of which were previously raised by the examiner.

It was "mere fortuity" that Stepan had argued the validity of its Rule 131 Declaration during reexamination (its validity vel non not having been raised by the Examiner).  Further, the Court found that the phraseology of § 41.50(b), that "[s]hould the Board have knowledge of any grounds not involved in the appeal for rejecting any pending claim, it may . . . [issue] a new ground of rejection" (emphasis added) did not make discretionary notice of a new ground of rejection and remand to the examiner.

It is this part of the argument that raises the sweet irony of the Zurko case.  In rejecting the government's arguments, the Court reminded the Office that "the PTO's regulatory interpretation is due no deference in view of the agency's statutory obligation under the Administrative Procedure Act ("APA") to provide prior notice to the applicant of all 'matters of fact and law asserted' prior to an appeal hearing before the Board.  5 U.S.C. § 554(b)(3)."  Granting the Office such discretion (i.e, to designate whether there was a new ground of rejection) would "frustrate the notice requirements of the APA," said the Court, citing the Zurko decision.  And the Court noted that the Office's own regulation predicated an applicant's obligation to request rehearing on the Board having designated its decision as a "new ground of rejection," recognizing that the Board's failure to do so here not only absolved Stepan of the obligation to request hearing but actually had prevented it from doing so.  Accordingly, the Court vacated the Board's decision and remanded to the Office "with instructions to designate its rejection as a new ground of rejection," leaving Stepan "free to pursue its patent application according to the requirements of 37 C.F.R. § 41.50(b)."

In re Stepan Co. (Fed. Cir. 2011)
Panel:  Circuit Judges Dyk, Friedman[1], and Prost
Opinion by Circuit Judge Prost

---

[1] Judge Friedman was on the panel that heard oral argument and was involved in the panel’s deliberations, but his death this past July prevented him from contributing to the opinion.

Rep. Burgess Introduces Genetic Diagnostic Testing Bill

By Kevin E. Noonan --

A decade after completion of the Human Genome Project, and after more than a decade of hyperbole regarding the promise and benefits of "personalized medicine," genetic diagnostic testing has come to the attention of Congress.  For example, Representative Debbie Wasserman Schultz (D-FL) introduced a provision of the Leahy-Smith America Invents Act (LSAIA) that would have "guaranteed" availability of "second opinion" testing for any patented genetic diagnostic test (see "Manager's Amendment (and Others) to H.R. 1249 -- Second Opinions in Genetic Diagnostic Testing").  She withdrew this amendment in the face of strong opposition from the American Civil Liberties Union and other groups, who pursue a complete ban on such testing as well as other aspects of biotechnology; she later introduced a standalone bill (H.R. 2276) that would "require the Director of the United States Patent and Trademark Office to conduct a study on effective ways to provide confirming genetic diagnostic test activity where gene patents and exclusive licensing exist" (see "Bio/Pharm Legislation Watch"); these provisions were added to the LSAIA enacted into law as a mandate that the U.S. Patent and Trademark Office perform a study directed to such a determination.  And Congressman Xavier Becerra continues to introduce a bill that would ban all gene patenting, at least prospectively (see "He's Baaack!").

The latest Congressional foray into genetic diagnostic testing comes from Rep. Michael Burgess (R-TX) (at left), who introduced legislation that would prohibit the Food and Drug Administration from regulating genetic diagnostic testing, based on the apprehension that such regulation would cripple innovation and that such testing would be "subsumed" by the bureaucracy.  Such testing is already regulated (as is all other laboratory testing) by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).  Rep. Burgess discussed his bill on November 17th at a "bi-partisan policy forum" sponsored by The Hill and the American Clinical Laboratory Association.  The bill was prompted, in part, by FDA announcements that it intends to regulate "direct-to-consumer" genetic diagnostic tests.  Rather than cast the legislation as a ban, his bill (the "Modernizing Laboratory Test Standards for Patients Act of 2011," H.R. 3207) provides for regulation of such genetic diagnostic tests under the current CLIA regime, but with new guidelines and regulations directed towards greater clinical validity of such tests.  The bill also provides for the establishment of a Laboratory Developed Test (LDT) Test Registry Data Bank (for promoting "transparency") and a reporting requirement for clinical laboratories regarding death or serious injury that occurred as the result of a LDT.

In this regard, the bill requires disclosure for LDTs of the following information to the Data Bank:

• The location of the laboratory.
• The certification and licensure information of the laboratory.
• The purpose of the test.
• The claimed use or uses of the test.
• A description of the test methodology.
• Information regarding the analytical validity of the test.
• Information regarding the clinical validity of the test for each of its claimed uses.
• Information describing the status of the test as an existing test (as described under paragraph (4)), a new test pending review (under subsection (c)), or an authorized new test (under subsection (c)(4)(B)).

For so-called "direct-to-consumer" (DTC) DNA testing, the information required to be submitted includes all the aforementioned and in addition:

(i)  The identity, location, and registration information of the test-offering entity.
(ii)  The identity of the certified laboratory that will perform the test, and the certification and licensure information for such laboratory.
(iii)  information to demonstrate that the consumer will be provided with access to pre-test and post-test counseling by a physician or qualified genetic counselor.

Rep. Burgess has garnered the support of 4 co-sponsors (Rep. Marsha Blackburn, R-TN; Rep. Howard Coble, R-NC; Rep. Robert Latta, R-OH, and Rep. Erik Paulsen, R-MN).  The bill was referred to the House Committee on Energy and Commerce, and specifically the Subcommittee on Health, on October 14, 2011.

Court Report

By Sherri Oslick --

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

Medicines Co. v. Sun Pharma Global FZE et al.
2:11-cv-15175; filed November 23, 2011 in the Eastern District of Michigan

• Plaintiff:  Medicines Co.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.; Caraco Pharmaceutical Laboratories, Ltd.

Medicines Co. v. Sun Pharma Global FZE et al.
3:11-cv-06819; filed November 19, 2011 in the District Court of New Jersey

• Plaintiff:  Medicines Co.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.; Caraco Pharmaceutical Laboratories, Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the New Jersey complaint here.

Warner Chilcott Co. LLC v. Mylan Inc. et al.
3:11-cv-06844; filed November 22, 2011 in the District Court of New Jersey

• Plaintiff:  Warner Chilcott Co.
• Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Famy Care Ltd.

Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive, " issued December 23, 2003) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Generess^TM Fe (norethindrone and ethinyl estradiol, used for oral contraception).  View the complaint here.

Cephalon Inc. et al. v. Impax Laboratories Inc.
1:11-cv-01152; filed November 18, 2011 in the District Court of Delaware

• Plaintiffs:  Cephalon Inc.; CIMA Labs Inc.
• Defendant:  Impax Laboratories Inc.

Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001), 6,974,590 (same title, issued December 13, 2005), 7,862,832 ("Generally Linear Effervescent Oral Fentanyl Dosage Form and Methods of Administering," issued January 4, 2011) and 7,862,833 ("Effervescent Oral Opiate Dosage Forms and Methods of Administering Opioids," issued January 4, 2011) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer).  View the complaint here.

Yeda Research and Development Co., Ltd. v. Kappos
1:11-cv-01272; filed November 18, 2011 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,947,672 ("Water-Soluble Anionic Bacteriochlorophyll Derivatives and Their Uses," issued May 24, 2011).  View the complaint here.

Takeda Pharmaceutical Co. et al. v. Hetero Drugs Ltd. et al.
1:11-cv-08302; filed November 16, 2011 in the Southern District of New York

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.
• Defendants:  Hetero Drugs Ltd.; Hetero Labs Ltd. Unit V; Hetero USA Inc.; Camber Pharmaceuticals Inc.; Invagen Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,329,404 (same title, issued December 11, 2001), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,211,205 (same title, issued April 3, 2001), 6,271,243 (same title, issued August 7, 2001), and 6,303,640 (same title, issued October 16, 2001) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Takeda's Actos® (pioglitazone hydrochloride, used to treat type II diabetes).  View the complaint here.

Aventis Pharma S.A. et al. v. Strides Inc. et al.
1:11-cv-01121; filed November 14, 2011 in the District Court of Delaware

• Plaintiffs:  Aventis Pharma S.A.; Sanofi-Aventis US LLC
• Defendants:  Strides Inc.; Onco Therapies Ltd.

Infringement of U.S. Patent Nos. 5,714,512 ("Compositions Containing Taxane Derivatives," issued February 3, 1998) and 5,750,561 (same title, issued May 12, 1998) following a Paragraph IV certification as part of Strides' filing of an ANDA to manufacture a generic version of Aventis' Taxotere® (docetaxel, used to treat breast, lung, prostate, gastric, and head and neck cancers).  View the complaint here.

Alkermes Pharma Ireland Ltd. v. Par Pharmaceutical Inc.
1:11-cv-01119; filed November 11, 2011 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Allergan, Inc. v. Lupin Ltd. et al.
6:11-cv-00611; filed November 11, 2011 in the Eastern District of Texas

• Plaintiff:  Allergan, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 7,851,504 ("Enhanced Bimatoprost Ophthalmic Solution," issued December 14, 2010) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Allergan's Lumigan® (0.03% bimatoprost ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension).  View the complaint here.

Celgene Corp. et al. v. Par Pharmaceutical, Inc.
2:11-cv-06640; filed November 10, 2011 in the District Court of New Jersey

• Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendant:  Par Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Watson Laboratories, Inc. et al.
1:11-cv-08130; filed November 10, 2011 in the Southern District of New York

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG
• Defendants:  Watson Laboratories, Inc.; Watson Pharma, Inc.; Watson Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,602,176 ("Phenyl Carbamate," issued February 11, 1997), 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 Waton's 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.

Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals, LLC
1:11-cv-08153; filed November 10, 2011 in the Southern District of New York

• Plaintiffs:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies; Grunenthal GMBH
• Defendant:  Amneal Pharmaceuticals, LLC

Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), 7,683,072 (same title, issued March 23, 2010), and 7,776,314 ("Abuse-Proofed Dosage System," issued August 17, 2010) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Conference & CLE Calendar

November 30 to December 1, 2011 - Advanced Forum on Biotech Patents*** (American Conference Institute) - Boston, MA

December 1, 2011 - Biotechnology/Chemical/ Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) - 9:00 am - 5:15 pm (ET)

December 1, 2011 - Strategic Implications of the Patent Reform Act of 2011 (American Bar Association Section of Litigation & Navigant) - Chicago, IL (check here for information regarding other roundtable locations and dates)

December 5, 2011 - 22nd Annual Conference on USPTO Law and Practice -- PTO Day (Intellectual Property Owners Association and U.S. Patent and Trademark Office) - Washington, D.C

December 5-7, 2011 - Drug and Medical Device Litigation*** (American Conference Institute) - New York, NY

December 6, 2011 - Biosimilars: Emerging Legal Challenges (Strafford) - 1:00 - 2:30 pm (EST)

December 6-7, 2011 - Paragraph IV Disputes*** (American Conference Institute) - San Francisco, CA

December 16, 2011 - A Review of the America Invents Act and Its Impact on the USPTO (Birch, Stewart, Kolasch & Birch, LLP and CONNECT) - San Diego, CA

January 4-8, 2012 - 29th Annual National CLE Conference (Law Education Institute) - Snowmass, CO

January 31 - February 1, 2012 - Patent Reform for Life Sciences Companies (American Conference Institute) - New York, NY

January 31 - February 1, 2012 - Pharma & Biotech Patent Litigation (C5) - Amsterdam, The Netherlands

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

ACI Conference on Patent Reform for Life Sciences Companies

American Conference Institute (ACI) a conference on Patent Reform for Life Sciences Companies from January 31 to February 1, 2012 in New York, NY.  Topics of discussion at the conference will include:

• Scrutinizing the specific provisions of patent reform in The America Invents Act (S. 23 & H.R. 1249);
• Analyzing the impact of a change to the first to file system from a first to invent system;
• Strategic tools for taking advantage of or defending against expanded opposition procedures including inter partes reviews, supplemental examinations, post-grant reviews and multiple oppositions;
• Accounting for changes to PTO fees including the reduction of fees for small and micro-entities;
• Determining what constitutes prior art under the new requirements;
• Navigating changes to PTO practices and procedures; and
• Revamping strategic IP planning in light of new requirements under patent reform.

In particular, ACI's faculty will offer presentations on the following topics:

• Keynote address: USPTO Commissioner Robert L. Stoll;
• The timeline of enactment: Identifying what needs to be done now and planning for future changes;
• First to file: Developing an updated and comprehensive intellectual property strategy in the new race to the Patent Office regime;
• Audience Q&A open forum for discussion on the impact of first to file;
• Examining the consequences of changes to inventorship provisions;
• Prior art and public disclosure: Identifying what constitutes prior art under the revised §102;
• Expediting the examination process by strategically using the different examination tracks, including the new prioritized examination option;
• Balancing the seemingly contradictory best mode provisions to maximize IP protection;
• Preparing for emerging patent challenges under the new post grant review system;
• Accounting for changing evidentiary requirements and procedures for inter partes review;
• Examining the potential ramifications of patent reform on Hatch Waxman litigation and the brand/generic wars;
• Audience Q&A open forum for discussion on the new litigation provisions and the impact on life sciences companies;
• Specific considerations for universities, non-profit institutions and micro-entities; and
• Analyzing the potential impact of the "miscellaneous provisions" on life sciences companies.

In addition, a pre-conference workshop entitled "Patent Reform 101: Overview of the Fundamental Provisions in the America Invents Act" will be offered from 1:00 to 4:00 pm on January 30, 2012.

A program for this conference, including an agenda and detailed descriptions of conference sessions can be obtained here.  The registration fee for the conference is $2,195.  Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering.  Those interested in registering for the conference can do so here, 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 Patent Reform for Life Sciences Companies conference.

Legal Roundtable on Strategic Implications of AIA

The American Bar Association Section of Litigation and Navigant will be holding a IP legal roundtable on the "Strategic Implications of the Patent Reform Act of 2011" on December 1, 2011 from 12:00 to 1:30 pm at Navigant's offices in Chicago, IL.  The roundtable will be moderated by Benjamin Bradford of Jenner & Block LLP.  There is no registration fee for the roundtable, but those interested in registering for the roundtable can do so here.  A program discussion outline for the roundtable can be downloaded here.  Roundtables will also be held in Atlanta (on December 1), Dallas (12/8), Las Vegas (12/7), Memphis (12/7), Minneapolis (12/7), Nashville (12/7), Philadelphia (12/8), and Washington, DC (11/29).  Additional information regarding other roundtable locations can be found here.

Happy Thanksgiving from Patent Docs

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 25th.

Biotech/Pharma Docket

By James DeGiulio --

Pfizer Settles Lipitor Patent Suits with Aurobindo, Kremers

Pfizer has settled separate cases with Aurobindo and Kremers, ending its patent infringement actions over the generic companies' efforts to enter the market for the cholesterol drug Lipitor.  On June 27, 2011, Pfizer sued Aurobindo in response to the generic's filing of an ANDA for atorvastatin calcium, claiming infringement of U.S. Patent No. 5,969,156, issued in 1999, and its reexamination certificate, issued in 2006 (see "Court Report," July 4, 2011).  Aurobindo's May 17 letter informed Pfizer of its intent to seek FDA approval to sell 10 mg, 20 mg, and 80 mg dosages of generic Lipitor.  The '156 patent's expiration date is July 8, 2016, but the patent has been granted a further period of pediatric exclusivity running through January 8, 2017.

On November 7, Judge Leonard P. Stark signed off on a joint motion to dismiss filed by the parties under Federal Rule 41(a)(2).  The joint motion indicated that Pfizer and Aurobindo had entered into a settlement agreement on November 2, thus prompting their request for dismissal of all claims and counterclaims.  The dismissal is without prejudice and shall not act as an adjudication on the merits.

On November 18, in another Lipitor case pending since December 2009 (see "Court Report," December 7, 2009), Kremers Urban Pharmaceuticals Inc. also entered into a settlement agreement with Pfizer over 10 mg, 20 mg, 40 mg, and 80 mg dosages, known generically as atorvastatin calcium tablets.  The terms of this agreement are confidential, and the agreement remains subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Mylan and Novartis Settle Patent Suit over Vivelle-Dot

Mylan has settled both of its patent litigations with Novartis related to the estrogen therapy drug Vivelle-Dot, opening the door to begin manufacturing a generic version of the estrogen replacement patch.  In February, Novartis filed two lawsuits against Mylan, one in the U.S. District Court for the District of Vermont and one in the U.S. District Court for the Southern District of New York.  The suits allege that Mylan's ANDA covering a generic Vivelle-Dot infringes U.S. Patent Nos. 5,656,286 and 6,024,976.  Mylan asserted that these patents were invalid or unenforceable, and would not be infringed by the generic estradiol transdermal system the company proposed.  Novartis requested a permanent injunction barring Mylan from manufacturing the drug and damages if the company produced its proposed generic before the two patents expired.

On November 23, New York District Judge Katherine B. Forrest issued a stipulation and order staying the case pending approval of the settlement by the U.S. Department of Justice and the Federal Trade Commission.  According to the agreement, Mylan will receive a patent license to begin selling generic versions of the product on December 16, 2013, or earlier under certain circumstances.  Additional details of the settlement are confidential.  The agreement allows Mylan to begin manufacturing a generic version of the estrogen replacement patch, and Mylan can enter the market first as the first ANDA filer.  Vivelle-Dot generated $240 million in U.S. sales over the past year.

Teva and Bayer Settle Dispute over Levitra Patents

Bayer reached a settlement with Teva over two patents directed to Levitra, and Teva agreed not to produce the generic drug until a settled date following a consent judgment for the plaintiffs.  Teva notified Bayer in May 2009 that it had filed an ANDA seeking to market generic vardenafil hydrochloride.  In response, Bayer filed five related but separate cases in 2009 and 2010, alleging infringement of U.S. Patent Nos. 6,362,178 and 7,696,206 based on Teva's ANDA (see "Court Report," April 19, 2010 and July 25, 2010).  Teva asserted that Bayer's patents were invalid and would not be infringed.  Bayer argued that Teva's Paragraph IV notice letter provided no valid basis for these assertions regarding the patents-in-suit.

On November 17, Judge Sleet signed off on a consent judgment and order, entering judgment in favor of Bayer and against Teva on Bayer's claims of infringement of the '178 and '206 patents.  Under the judgment, claims 1-5, 7, and 8 of the '178 patent and claims 1-6 of the '206 were deemed valid, the patents were declared enforceable, and Teva's ANDA was found to infringe the same claims.  Teva agreed not to make, offer for sale, or sell the products that are described in its ANDA prior to the date set forth in the Settlement Agreement.  The parties waived any right to appeal the judgment.

Like Two Ships Passing in the Night: U.S. and Europe Consider Patent Eligibility of Biological Materials

By Kevin E. Noonan --

Sometimes the U.S. and Europe seem to be on diametrically opposed trajectories when it comes to patent policy.  One such moment was in the 1980's, when the U.S. Patent and Trademark Office responded to the Supreme Court's Diamond v. Chakrabarty decision by permitting broad patenting of biotechnological inventions while Europeans debated the wisdom of such a course and suffered the resulting lag in development of a native biotechnology industry.  A similar outcome may result from the recent European Court of Justice decision to ban patenting of any invention that involves the destruction of a human embryo; while U.S. efforts in this industry were retarded by the Bush Administration's wrongheaded stem cell ban, European stem cell science prospered (and American efforts devolved at least in theory to states like Massachusetts and California, which funded their own stem cell research initiatives).

Conversely, the U.S. patent system is in the throes of judicial review over subject matter eligibility of isolated genes (something settled in Europe in the affirmative by the Biotechnology Directive 99/44EC issued in 1998) as well as questions over the patent-eligibility of diagnostic method claims.  A recent decision by the U.K. Supreme Court (a bench comprising a subset of the House of Lords called the "Law Lords" although the Court is institutionally separate from Parliament; see "Biographies of the Justices") overturned a decision by Judge Kitchen denying a patent to Human Genome Sciences on the human Neurokine-alpha gene, and in doing so seems to have expanded the scope of patent eligibility to be greater than exists under current U.S. law (even before the challenge to the Myriad patents by the American Civil Liberties Union and the Public Patent Foudation).

The case involved a nullity action brought by Eli Lilly and Co. over the U.K. national phase counterpart (U.K. 0,939,804) of HGS's European Patent for the human Neurokine-alpha gene and protein encoded thereby (EP 0939804).  Claim 1 is representative:

An isolated nucleic acid molecule comprising a polynucleotide sequence encoding a Neutrokine-α polypeptide wherein said polynucleotide sequence is selected from the group consisting of: 
(a) a polynucleotide sequence encoding the full length Neutrokine-α polypeptide having the amino acid sequence of residues [as defined]; and 
(b) a polynucleotide sequence encoding the extracellular domain of the Neutrokine-α polypeptide having the amino acid sequence of residues [as defined].

The patent was granted by the EPO and invalidated by the Opposition Division, only to be reinstated (in modified form) by a decision of the EPO Technical Boards of Appeal (whose decisions have significantly less precedential value, in the EPO and the EP member nations, than does the Federal Circuit in the U.S.).  The patent, filed on October 25, 1996, contained the nucleotide and amino acid sequences of the isolated nucleic acid and predicted protein product, respectively.  The patent disclosed the structural relationship between the human Neutrokine-alpha (hNα) gene and other memebrs of the tumor necrosis factor (TNF) "superfamily" of related cytokine proteins.  The specification further noted that "all known members" of the superfamily "are involved in regulation of cell proliferation, activation and differentiation, including control of cell survival or death by apoptosis or cytotoxicity" but failed to disclose any particular biological function for the hNα protein.  The in vivo expression pattern of the hNα gene was disclosed as being expressed in "neutrophils . . . in kidney, lung, peripheral leukocyte, bone marrow, T-cell lymphoma, B-cell lymphoma, activated T-cells, stomach cancer, smooth muscle, macrophages and cord blood tissue."  Although the patent discloses the use of the hNα protein for "the diagnosis, prevention, or treatment of an extraordinarily large and disparate number of, sometimes widely expressed, categories of disorders of the immune system," "nowhere in the Patent is there any data or any suggestion of in vitro or in vivo studies" and "there is no experimental evidence to support any of those suggestions."

Both the U.K. High Court and the U.K. Court of Appeals found the patent to be invalid, based on a failure to describe any specific uses for the hNα protein or the gene that encodes it.  As characterized by the U.K. Supreme Court opinion (by Lord Neuberger, joined by Lords Hope, Walker, Clarke, and Collins), the "central issue" considered by the lower U.K. courts and the Opposition Division of the EPO was "whether, in the light of the common general knowledge at October 1996, by disclosing the facts summarised in para 10 above (namely the existence and structure of Neutrokine-α, the sequence of its encoding DNA, its tissue distribution, its expression, and its membership of the TNF ligand superfamily), the Patent satisfied Articles 52 and 57 of the EPC so as to enable HGS to claim the encoding gene for Neutrokine-α."  Articles 52 and 57 read as follows:

Article 52:

European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.

Article 57:

An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture.

The U.K. courts decided in the negative, finding (as did the EPO Opposition Division) that the disclosed function of the hNα protein or the gene that encodes it were speculative and lacked a "concrete basis for anything other than a research project."  HGS's argument, as frankly put by the Supreme Court's opinion, was that these lower U.K. courts were wrong and had "set too high a standard for industrial applicability in the context of a patent for biological material."

This being a case of first impression before the U.K. courts regarding the patent-eligibility of human gene patents, the parties and the courts relied upon decisions of the EPO Technical Boards of Appeal, "decisions of courts in the United States" and some earlier U.K. decisions on patent-eligibility of biological material.  Citing U.K. Appellate Court Judge Jacob, the standard enunciated in the High Court's opinion is that "[h]owever clever and inventive you may have been in discovering a gene sequence, you cannot have a patent for it or for the protein for which it encodes if you do not disclose how it can be used."  The question thus became whether the HGS patent specification satisfied that standard.  The opinion finds little help in deciding this question in the prior U.K. precedent, and while the legal analyses in the U.S. cases "deserve great respect," they entail "obvious risks" relating to the differences between European and U.S. patent law (citing as "notorious examples" the "first to file" rule in Europe and the existence of prosecution history estoppel in the U.S.).

The Supreme Court thus turned to decisions from the EPO Technical Boards of Appeal (TBA) for guidance, noting the parallel considerations that the countries of the EPC interpret the Articles consistently while permitting individual member states to make their own determinations on sovereignty grounds.  As may be expected, the opinion notes several diverse opinions of the TBA (including T 0870/04 BDP1 Phosphatase/ Max-Planck; 0898/05 Hematopoietic receptor/ZymoGenetics; T 1329/04 Factor- 9/John Hopkins; T 0604/04 PF4A receptors/Genentech; T 1452/06 Serine protease/Bayer; and T 1165/06 IL-17 related polypeptide/Schering) that support both parties here, and ultimately decides that the lesson of this jurisprudential review is that each situation requires specific application of the Article 52 and 57 requirements to its own unique facts.

Considering the U.K. High Court decision, the Supreme Court noted that Judge Kitchin accepted HGS's contention that its claims were "significant" because of the "importance of the identification of the tissues where [it] is expressed, the tissues where it acts, the nature of its biological activity and how that profile varies in any particular disease state" while noting that there was "no data is provided to support these claims" and that "the variety of conditions for which the described method is said to be useful [is] puzzlingly wide and . . . the method itself impossible to operate in the absence of any information as to the standard level of Neutrokine-α expressed in each of these tissues in normal conditions."  Under these conditions, the High Court characterized "the idea that Neutrokine-α and [its antagonists] could be used to treat the extraordinary range of diseases identified was fanciful" and that "the skilled person would come to the conclusion that the inventors had no idea as to the activity of Neutrokine-α when drafting the Patent."  "[S]imply identifying a protein is not necessarily sufficient to confer industrial utility upon it," according to Judge Kitchin, contrasting the situation with "insulin, human growth hormone and erythropoietin" (where the utility was "immediately suggest[ed]") with cases, as here in the High Court's opinion, where "the function of the protein is not known or is incompletely understood and if no disease has been attributed to a deficiency or excess of it."

In rendering its decision that the lower U.K. courts had erred in finding the HGS claims to be patent ineligible, the Supreme Court noted that "it is plainly appropriate in principle, and highly desirable in practice, that all [national] tribunals interpret the provisions of the EPC in the same way" (here, to find the claims patent eligible), a sentiment supported by several earlier court cases both in the U.K. (Generics (UK) Ltd v H Lundbeck A/S [2009] UKHL 12; [2009] RPC 13) and Germany (Case Xa ZR 130/07 (10 September 2009)).  This principle is limited by instances where courts "form different judgments in view of the same expert and factual evidence" in the application of the same "relevant principles" -- i.e., reasonable minds may differ while agreeing with the underlying legal rationale behind patent eligibility.  And the Court adds instances where a national court believes that a TBA decision "may take the law in an inappropriate direction, misapplies previous EPO jurisprudence, or fails to take a relevant argument into account."  But such instances should require "very unusual facts" where the EPO Board "has adopted a consistent approach to an issue in a number of decisions."  And the opinion asserts that it considered a letter from the BioIndustry Association (BIA) informing it of its members' opinion that "clarity and certainty" were required to support an industry "with an aggregate turnover in 2010 of about £ 5.5 billion and a workforce of 36,000 in the U.K., in view of the "large amount of research and development [] required before there can be any therapeutic benefit" from a newly discovered biological molecule like hNα:

If the application is filed early, . . . [t]he company will be left with no patent protection, but would have disclosed its invention in the published patent application to competitors.  If the application is filed late, there is a risk in such a competitive environment where several companies may be working on the same type of research projects, that a third party will already have filed a patent application covering the same or a similar invention, in which case the company may not be able to gain any patent protection for its work and by continuing their programme they may risk infringing that third party's patents.  In both cases, the company will have lost much of the benefit of its costly research and development.

Ultimately, while acknowledging the legal and logical force behind the High Court opinion by Judge Kitchin (and his better position to hear and evaluate the evidence), Lord Neuberger decided that the claims at issue were patent eligible, as that decision being most consistent with what the opinion calls the "general principles" enunciated by the EPO Board for the satisfaction of Article 57 by claims to biological materials:

• (i)  The patent must disclose "a practical application" and "some 
profitable use" for the claimed substance, so that the ensuing monopoly "can be expected [to lead to] some . . . commercial benefit" (T 0870/04, para 4, T 0898/05, paras 2 and 4);

• (ii)  A "concrete benefit", namely the invention's "use . . . in industrial practice" must be "derivable directly from the description," coupled with common general knowledge (T 0898/05, para 6, T 0604/04, para 15);

• (iii)  A merely "speculative" use will not suffice, so "a vague and speculative indication of possible objectives that might or might not be achievable" will not do (T 0870/04, para 21 and T 0898/05, paras 6 and 21);

• (iv)  The patent and common general knowledge must enable the skilled person "to reproduce" or "exploit" the claimed invention without "undue burden," or having to carry out "a research programme" (T 0604/04, para 22, T 0898/05, para 6);

Where a patent discloses a new protein and its encoding gene:

• (v)  The patent, when taken with common general knowledge, must demonstrate "a real as opposed to a purely theoretical possibility of exploitation" (T 0604/04, para 15, T 0898/05, paras 6, 22 and 
31);

• (vi)  Merely identifying the structure of a protein, without attributing 
to it a "clear role," or "suggest[ing]" any "practical use" for it, or suggesting "a vague and speculative indication of possible objectives that might be achieved," is not enough (T 0870/04, paras 6-7, 11, and 21; T 0898/05, paras 7, 10 and 31);

• (vii)  The absence of any experimental or wet lab evidence of activity of the claimed protein is not fatal (T 0898/05, paras 21 and 31, T 1452/06, para 5);

• (viii)  A "plausible" or "reasonably credible" claimed use, or an "educated guess," can suffice (T 1329/04, paras 6 and 11, T 0640/04, para 6, T 0898/05, paras 8, 21, 27 and 31, T 1452/06, para 6, T 1165/06 para 25);

• (ix)  Such plausibility can be assisted by being confirmed by "later evidence," although later evidence on its own will not do (T 1329/04, para 12, T 0898/05, para 24, T 1452/06, para 6, T 1165/06, para 25);

• (x)  The requirements of a plausible and specific possibility of exploitation can be at the biochemical, the cellular or the biological level (T 0898/05, paras 29-30);

Where the protein is said to be a family or superfamily member:

• (xi)  If all known members have a "role in the proliferation, differentiation and/or activation of immune cells" or "function in controlling physiology, development and differentiation of mammalian cells," assigning a similar role to the protein may suffice (T 1329/04, para 13, T 0898/05, para 21, T 1165/06, paras 14 and 16, and T 0870/04, para 12);

• (xii)  So "the problem to be solved" in such a case can be "isolating a 
further member of the [family]" (T 1329/04, para 4, T 0604/04, 
para 22, T 1165/06, paras 14 and 16);

• (xiii)  If the disclosure is "important to the pharmaceutical industry," 
the disclosure of the sequences of the protein and its gene may suffice, even though its role has not "been clearly defined" (T 0604/04, para 18);

• (xiv)  The position may be different if there is evidence, either in the patent or elsewhere, which calls the claimed role or membership of the family into question (T 0898/05 para 24, T 1452/06, para 5);

• (xv)  The position may also be different if the known members have different activities, although they need not always be "precisely interchangeable in terms of their biological action," and it may be acceptable if "most" of them have a common role (T 0870/04, para 12, T 0604/04, para 16, T 0898/05, para 27).

The Supreme Court based its decision on satisfaction of points viii through xiii based on the relationship between the disclosed hNα gene and the properties of the other TNF superfamily members.

The issue before the U.K. Supreme Court as "first impression" will be readily apparent to participants in the U.S. patent system; in the wake of an avalanche of gene patent filings at the end of the last century the U.S. Patent and Trademark Office promulgated examination guidelines that required isolated gene sequences to encode a protein for which a specific, substantial and credible utility was disclosed or would be apparent to the skilled worker.  This standard is much narrower than the standard adopted by the U.K. Supreme Court.  Indeed, the U.K. Supreme Court in its opinion seems to adopt a standard requiring an alleged use to be merely "indeed plausible" to give rise prima facie to satisfying Article 57 EPC; this is far less than the "specific, substantial and credible" standard adopted by the USPTO.  Whether these differences, and the course U.S. patent law will take after it has traversed the seas of judicial consideration on patent eligibility of biological materials and methods, lead to a continued strength of U.S. biotechnology or an eclipse by a resurgent Europe cannot be predicted.  But it can be, and rightly should be, feared by those interested in continued prosperity and contributions to human health and well-being by American inventors.

Senate Bill Creates New Incentive Structure to End Pay-for-Delay Deals

By Donald Zuhn --

Last week, Sen. Jeff Bingaman (D-NM) introduced a bill in the Senate (S. 1882) that would eliminate the 180-day exclusivity period for a generic applicant that enters into a disqualifying agreement as defined by the legislation.  In introducing the bill, also known as the "Fair And Immediate Release of Generic Drugs Act" or "FAIR Generics Act," Sen. Bingaman (at right) asserted that the legislation was "an important step in addressing the root cause of the growing cost of healthcare--the delay of generic drugs entering the market."  Noting that "[p]ay-for-delay patent settlements [between] brand and generic pharmaceutical manufacturers . . . are delaying timely public access to generic drugs, which costs consumers and taxpayers billions of dollars annually," and that "[m]any experts and consumer advocates have called for legislation to address this problem and ensure access to affordable medicines for all Americans," the Senator stated that S. 1882 "addresses the root cause of anti-competitive pay-for-delay settlements between brand and generic  pharmaceutical manufacturers -- the unintended, structural flaw in the Hatch-Waxman Act that allows 'parked'' exclusivities to block generic competition."  According to the Senator:

The legislation would prevent "parked exclusivities'" from delaying full, fair, and early generic competition by modifying three key elements of existing law.  First, the legislation would grant the right to share exclusivity to any generic filer who wins a patent challenge in the district court or is not sued for patent infringement by the brand company.  The legislation also maximizes the incentive for all generic challengers to fight to bring products to market at the earliest possible time by holding generic settlers to the deferred entry date agreed to in their settlements.  Finally, in order to create more clarity regarding litigation risk for pioneer drug companies and generic companies, the legislation requires pioneer companies to make a litigation decision within the 45 day window provided for in the Hatch-Waxman Act.

In a statement posted on Sen. Bingaman's website, the Senator indicated that the legislation would, if enacted, "save American consumers and the federal government hundreds of millions of dollars and level the playing field among generic manufacturers."  He explains that:

Unfortunately, in many instances, the "first-filer" [i.e., first generic filer] is paid by or settles with the name brand company to delay selling their generic drug.  This leaves only the expensive brand name drug on the market, while both the name-brand company and the generic company financially benefit.  During this delay, the brand name company enjoys market exclusivity, reaping 100 percent of profits from drug sales.  The generic company may enjoy a settlement payment, and blocks other generics from coming to market.  In the meantime, American consumers and the federal government (through Medicaid, Medicare, and other federal healthcare programs) are forced to purchase more expensive medications for longer periods of time.

Sen. Bingaman notes that his bill would remedy this situation by "allow[ing] any generic company that wins a patent challenge in district court or is not sued by the brand name company to share most of the 180 day market exclusivity that was originally reserved for first filers only."

Among other changes, S. 1882 would amend § 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act to delete section (bb) in clause (iv)(II), and re-designate sections (cc) and (dd) as (bb) and (cc), respectively.  The current version of § 505(j)(5)(B)(iv) reads as follows:

(iv) 180-day exclusivity period.
    (I) Effectiveness of application. Subject to subparagraph (D), if the application contains a certification described in paragraph (2)(A)(vii)(IV) and is for a drug for which a first applicant has submitted an application containing such a certification, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant.
    (II) Definitions. In this paragraph:
        (aa) 180-day exclusivity period. The term "180-day exclusivity period" means the 180-day period ending on the day before the date on which an application submitted by an applicant other than a first applicant could become effective under this clause.
        (bb) First applicant. As used in this subsection, the term "first applicant" means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug.
        (cc) Substantially complete application. As used in this subsection, the term "substantially complete application" means an application under this subsection that on its face is sufficiently complete to permit a substantive review and contains all the information required by paragraph (2)(A).
        (dd) Tentative approval.
            (AA) In general. The term "tentative approval" means notification to an applicant by the Secretary that an application under this subsection meets the requirements of paragraph (2)(A), but cannot receive effective approval because the application does not meet the requirements of this subparagraph, there is a period of exclusivity for the listed drug under subparagraph (F) or section 505A, or there is a 7-year period of exclusivity for the listed drug under section 527.
            (BB) Limitation. A drug that is granted tentative approval by the Secretary is not an approved drug and shall not have an effective approval until the Secretary issues an approval after any necessary additional review of the application.

The bill would add an additional clause to § 505(j)(5)(B) that would essentially move section (bb) to the end of § 505(j)(5)(B), and additionally require that the first applicant "has not entered into a disqualifying agreement under clause (vii)(II)."  Clause (vii)(II) states:

(II) AGREEMENT THAT DISQUALIFIES APPLICANT FROM FIRST APPLICANT STATUS.—An agreement described in this subclause is an agreement between an applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the 180-day exclusivity period whereby that applicant agrees, directly or indirectly, not to seek an approval of its application or not to begin the commercial marketing of its drug until a date that is after the expiration of the 180-day exclusivity period awarded to another applicant with respect to such drug (without regard to whether such 180-day exclusivity period is awarded before or after the date of the agreement).

The legislation, which was supported by co-sponsors Sen. Sherrod Brown (D-OH), Jeff Merkley (D-OR), Bernard Sanders (I-VT), and David Vitter (R-LA), has been referred to the Senate Health, Education, Labor, and Pensions (HELP) committee.

FDA Approves 35 New Drugs in FY 2011

By Donald Zuhn --

Earlier this month, the U.S. Food and Drug Administration announced that the agency has approved 35 new drugs over the past twelve months.  With the exception of 2009, when 37 new drugs were approved, more drugs were approved in fiscal year (FY) 2011, which ended September 30, than in any other year over the past decade.  The largest number of drug approvals occurred in 1996, when the FDA approved 53 new drugs; the number of annual approvals declining since then.

The new drugs approved this year include two new drugs for hepatitis C and drugs for late-stage prostate cancer, Hodgkin's lymphoma, and lupus.  The last two drugs are the first new drugs approved for treating Hodgkin's lymphoma and lupus in 30 and 50 years, respectively.  In addition, two other drugs (for treating melanoma and lung cancer) were approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits.

In a report entitled "FY 2011 Innovative Drug Approvals," the FDA outlined how the agency boosted the number of drug approvals to 35 while maintaining drug safety standards.  The report notes that that the FDA achieved faster approval times than its counterparts around the globe.  In fact, 24 of the 35 drugs were approved in the U.S. before being approved by any other country.  The quick approvals were made possible in part by priority review and accelerated review procedures.  FDA Commissioner of Food and Drugs Dr. Margaret Hamburg said that the FDA is "committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century."

Conference & CLE Calendar

November 30 to December 1, 2011 - Advanced Forum on Biotech Patents*** (American Conference Institute) - Boston, MA

December 1, 2011 - Biotechnology/Chemical/ Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) - 9:00 am - 5:15 pm (ET)

December 5, 2011 - 22nd Annual Conference on USPTO Law and Practice -- PTO Day (Intellectual Property Owners Association and U.S. Patent and Trademark Office) - Washington, D.C

December 5-7, 2011 - Drug and Medical Device Litigation*** (American Conference Institute) - New York, NY

December 6, 2011 - Biosimilars: Emerging Legal Challenges (Strafford) - 1:00 - 2:30 pm (EST)

December 6-7, 2011 - Paragraph IV Disputes*** (American Conference Institute) - San Francisco, CA

December 16, 2011 - A Review of the America Invents Act and Its Impact on the USPTO (Birch, Stewart, Kolasch & Birch, LLP and CONNECT) - San Diego, CA

January 4-8, 2012 - 29th Annual National CLE Conference (Law Education Institute) - Snowmass, CO

January 31 - February 1, 2012 - Pharma & Biotech Patent Litigation (C5) - Amsterdam, The Netherlands

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

Public Policy Forum on the Impact of the AIA on the USPTO

Birch, Stewart, Kolasch & Birch, LLP and CONNECT, a regional program that catalyzes the creation of innovative technology and life sciences products in San Diego County and has assisted in the formation and development of more than 3,000 companies, will be holding a public policy forum entitled "A Review of the America Invents Act and Its Impact on the USPTO" with U.S. Patent and Trademark Office Director David Kappos on December 16, 2011 from 8:30 to 10:00 am at the Joan Kroc School of Peace and Justice Theater at the University of San Diego.  Joining Director Kappos will be Leonard Svensson of Birch Stewart, Kolasch & Birch, LLP and moderator Donald Rosenberg, Executive Vice President, General Counsel and Corporate Secretary of Qualcomm Inc.  The registration fee for the forum is $25 (students), $45 (pre-registered members), $60 (pre-registered non-members), or $90 (at the door).  Those interested in registering for the lecture can do so here.