Patent Docs

FDA Approved 27 New Drugs in 2013

January 8, 2014

By Donald Zuhn —

Last month, the U.S. Food and Drug Administration (FDA) announced that the agency approved 27 new drugs and biological products in 2013. According to the FDA release, the 27 new molecular entities (NMEs) that were approved last year include:

The number of new drugs approved in 2013 fell by almost a third from the 39 new drugs approved in 2012 ("New Molecular Entity Approvals for 2012"), and was three less than the 30 new drugs approved in 2011 ("New Molecular Entity Approvals for 2011").

According to a Reuters report, the FDA attributed the drop in approvals to a drop in the number of applications filed, while noting that the 27 approvals were just under the 5-year average of 28.
NAI & IPO Release List of Top 100 Universities Receiving Patents in 2012

January 7, 2014

By Donald Zuhn —

Last month, the National Academy of Inventors (NAI) and the Intellectual Property Owners Association (IPO) published a list of the top 100 worldwide universities that received the most U.S. utility patents in 2012. The groups did not provide a detailed discussion regarding the compilation of the list, stating only that the list was based on data obtained from the U.S. Patent & Trademark Office. A comparison of the top spots on the list, however, indicates that the data is identical to that found in the IPO's annual list of the top 300 organizations receiving U.S. patents (see "IPO Releases List of Top 300 Patent Holders for 2012"). The top 20 universities on the NAI/IPO listing are as follows:

The complete list of 100 universities can be found here.

As we reported last month, the Center for Technology Innovation at the Brookings Institution asserted in a paper that by relying on a technology transfer model based on patent licensing, only a few universities have been able to generate significant revenues, and in fact, most university technology transfer offices do not generate enough income to even cover their operating expenses (see "Brookings Paper Calls for Technology Transfer Model Based on University Start-ups"). That paper suggested that the highest earners among universities had become a select club with a stable membership, with only 37 universities having reached the top 20 of licensing revenue in any given year over the last decade. A comparison of the Brookings Institution's "select club" of 37 universities with the NAI/IPO list indicates that the following universities made both lists:

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

• "Brookings Paper Calls for Technology Transfer Model Based on University Start-ups," December 12, 2013
• "IPO Releases List of Top 300 Patent Holders for 2012," June 24, 2013
• "Another Look at IPO Top 300 and Life Sciences Top 53," June 11, 2012
• "IPO Releases List of Top 300 Patent Holders for 2011," June 7, 2012
• "IPO Releases List of Top 300 Patent Holders for 2010," June 30, 2011
• "IPO Releases List of Top 300 Patent Holders for 2009," May 26, 2010
• "IPO Releases List of Top 300 Patent Holders for 2008," May 14, 2009
• "IPO Releases List of Top 300 Patent Holders," May 22, 2008
• "IPO Posts List of Top 300 Patent Holders," April 20, 2007
Court Report

January 6, 2014

By Sherri Oslick —

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

Cephalon Inc. v. Sandoz Inc.
1:13-cv-02104; filed December 31, 2013 in the District Court of Delaware

Cephalon Inc. v. Hospira Inc.
1:13-cv-02094; filed December 26, 2013 in the District Court of Delaware

Cephalon Inc. v. Accord Healthcare Inc. et al.
1:13-cv-02095; filed December 26, 2013 in the District Court of Delaware

• Plaintiff: Cephalon Inc.
• Defendants: Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

Cephalon Inc. v. Sun Pharma Global FZE et al.
1:13-cv-02096; filed December 26, 2013 in the District Court of Delaware

• Plaintiff: Cephalon Inc.
• Defendants: Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.

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) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013) 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 Hospira complaint here.

Helsinn Healthcare S.A. et al. v. Accord Healthcare Inc. et al.
1:13-cv-02101; filed December 27, 2013 in the District Court of Delaware

• Plaintiffs: Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants: Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

Infringement of U.S. Patent Nos. 8,598,218 ("Liquid Pharmaceutical Formulations of Palonosetron," issued December 3, 2013) and 8,598,219 (same title, issued December 3, 2013) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting). View the complaint here.

Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
2:13-cv-07884; filed December 27, 2013 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued December 14, 2010 ("Sensitive Drug Distribution System and Method" issued February 22, 2011), 8,263,650 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued September 11, 2012), 8,324,275 (same title, issued December 4, 2012), 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), 7,765,106 (same title, issued July 27, 2010), 7,765,107 (same title, issued July 27, 2010), 7,895,059 (same title, issued February 22, 2011), 8,457,988 (same title, issued June 4, 0213), and 8,589,182 (same title, issued November 19, 2013) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.

Novartis Pharmaceuticals Corp. v. Fresenius USA, LLC
2:13-cv-07914; filed December 27, 2013 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer). View the complaint here.

Cephalon Inc. v. Glenmark Pharmaceuticals Ltd. et al.
1:13-cv-02093; filed December 26, 2013 in the District Court of Delaware

• Plaintiff: Cephalon Inc.
• Defendants: Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics S.A.; Glenmark Generics Inc. USA

Infringement of U.S. Patent No. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) following a Paragraph IV certification as part of Glenmark's 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 complaint here.
IPO Webinar on FTC v. Actavis

January 6, 2014

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "After Actavis: FTC Update" on January 9, 2014 beginning at 2:00 pm (ET). A panel consisting of Steven Lee of Kenyon & Kenyon LLP, Michael Perry of the Health Care Division of the Bureau of Competition at the Federal Trade Commission, and Bruce Wexler of Paul Hastings LLP will discuss the valuation of reverse payments in general, the role of ancillary agreements such as joint marketing agreements, and whether a branded company's promise not to launch an authorized generic during the generic’s exclusivity period amounts to a reverse payment.

The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Top Three Stories of 2013

January 5, 2014

By Donald Zuhn —

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. On Tuesday, Wednesday, and Thursday, we counted down stories #14 to #4, and today we count down the top three stories of 2013. As with our other lists (2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.

3. Supreme Court Decides Monsanto v. Bowman — Exhaustion Doctrine Does Not Allow Purchaser to Make New Copies of Patented Invention

In May, the Supreme Court issued its opinion in Bowman v. Monsanto Co., determining that the doctrine of patent exhaustion did not permit a farmer who buys patented seeds to reproduce them through planting and harvesting without the patent holder's permission, affirming the Federal Circuit's decision that such activities amount to the creation of a newly infringing article. Writing for a unanimous Court, Justice Kagan began a concise 10-page opinion by noting that "[u]nder the doctrine of patent exhaustion, the authorized sale of a patented article gives the purchaser, or any subsequent owner, a right to use or resell that article," but that such sale "does not allow the purchaser to make new copies of the patented invention." Although the Bowman opinion provided a (rare) favorable outcome for the life sciences sector in 2013, Justice Kagan concluded the opinion by noting that the Court's holding "is limited — addressing the situation before us, rather than every one involving a self-replicating product."

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

• "Organic Seed Growers & Trade Ass'n v. Monsanto Co. (Fed. Cir. 2013)," July 4, 2013
• "Bowman v. Monsanto Co. (2013)," May 13, 2013
• "Bowman v. Monsanto: Oral Argument," February 19, 2013
• "Parties Reiterate Arguments from Certiorari Petitions in Briefs to Supreme Court," February 18, 2013
• "Universities Urge Supreme Court to Affirm in Bowman v. Monsanto," February 18, 2013
• "WLF Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," February 7, 2013
• "U.S. Government Requests Argument Time in Bowman v. Monsanto — at Monsanto's Expense," February 5, 2013
• "It Ain't Necessarily So Down on the Farm: Not All Farmers Agree with Farmer Bowman in Bowman v. Monsanto," January 31, 2013
• "BayhDol25 Files Amicus Brief in Bowman v. Monsanto," January 30, 2013
• "Government Sticks to Its Guns in Bowman v. Monsanto Amicus Brief," January 28, 2013
• "IPO Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," January 24, 2013
• "House Considers Alternative Patent Royalty Scheme for Genetically Engineered Seed," January 14, 2013

2. First-Inventor-to-File Provisions of Leahy-Smith America Invents Act Take Effect

On March 16, 2013, the final provisions of the Leahy-Smith America Invents Act took effect, subjecting some (but not all) applications filed on or after that date to the first-inventor-to-file rules of the AIA. As part of the process of implementing the AIA, the U.S. Patent and Trademark Office began the year by publishing a final rule in the Federal Register setting and adjusting certain patent fees pursuant to the Office's fee-setting authority under § 10 of the AIA. While most of the fees changes took effect last March, the remaining changes took effect only days ago on January 1. The fees changes final rule was followed by a February 14 final rule to implement the first-inventor-to-file (FITF) provisions of the AIA. In the lengthy final rule, which numbered 160 pages in a pre-publication version released on February 13, the Office provided some interesting replies to comments submitted in response to the proposed rule. The impact of the Office's comments on post-AIA filing strategies is quite complex (readers are advised to review our February 13, 2013 report on the final rule), and we find that the subject continues to foster significant discussion. Interestingly, the change in the filing date requirements for a patent application brought about by the ratification of the Patent Law Treaty (PLT) and enactment of the Patent Law Treaties Implementation Act of 2012 (PLTIA) (see Top Story #6) have further impacted and altered post-AIA filing strategy. Finally, in April, the USPTO published two Federal Register notices to implement technical corrections to the AIA. An interim final rule revised the rules of practice to implement changes to the patent term adjustment (PTA) provisions, and a second final rule implemented changes with respect to the new (and thus far, quite popular) inter partes review proceedings.

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

• " The First IPR Decision — A Win for the Patent Challenger," November 18, 2013
• "Coalition Opposes Expansion of AIA § 18," September 13, 2013
• "Op-Eds in The Scientist Debate Impact of the AIA," September 5, 2013
• "USPTO Issues Rules to Implement AIA Technical Corrections," April 3, 2013
• "USPTO Issues First-Inventor-to-File Examination Guidelines and Final Rule," February 13, 2013
• "USPTO Publishes Final Rule Setting Patent Fees," January 21, 2013

1. Supreme Court Decides AMP v. Myriad — Naturally-Occurring, Isolated DNA Excluded from Patent Eligibility

In June, the Supreme Court issued its much anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc., holding that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but determining that cDNA is patent eligible because it is not naturally occurring. In writing for the Court, Justice Thomas provided one caveat with respect to cDNA, noting that "insofar as very short series of DNA may have no intervening introns to remove when creating cDNA," under such circumstance, "a short strand of cDNA may be indistinguishable from natural DNA," and therefore, would likely be patent ineligible. While the biotechnology industry avoided a categorical ban on patenting DNA (which was the goal of the ACLU) or, worse, on "products of nature" no matter how altered, the Court's carefully focused opinion contained enough worrisome dicta to permit plaintiffs to declare victory even though the Court expressly disclaimed any decision on genetic diagnostic methods (which, after all, was the purported basis for the litigation in the first place). While the case did not establish a categorical "product of nature" preclusion and thus should not be interpreted as mandating that other products of nature are categorically unpatentable, we warned in one of our posts that those cases are to come. In July, Consumer Watchdog attempted to pull the Myriad decision into the appeal of an inter partes reexamination involving a Wisconsin Alumni Research Foundation (WARF) stem cell patent. Reaction to the decision also led Myriad to file patent infringement suits against a number of diagnostic companies, as well as be pulled into declaratory judgment actions by some of these same companies (see Top Story #10). The Myriad decision also led Sen. Patrick Leahy (D-VT) to send a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), to urge the Director to consider using march-in rights under the Bayh-Dole Act to ensure greater access to genetic testing for breast and ovarian cancer. While the Myriad case has finally reached a conclusion, and has reclaimed the top spot on our Tops Stories list (the case was #2 in 2012, #2 in 2011, #1 in 2010, and #4 in 2009), the full impact of this case has yet to play out.

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

• " In Defense of Patenting," December 19, 2013
• "Genes and Information: The Problem of Disease-specific Databases," October 15, 2013
• "Authors of Genome Medicine Article Form Genetic Testing Company," August 12, 2013
• "NCI Researchers Generate Largest Database of Cancer-specific Genetic Variations," August 6, 2013
• "Consumer Watchdog Argues That WARF Stem Cell Patent Is Invalid under § 101," August 1, 2013
• "Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test," July 17, 2013
• "After Myriad: A Herd of Elephants in the Room," July 3, 2013
• "Consortium Launches Public Database of BRCA Data," July 2, 2013
• "Reaction to Supreme Court's Decision in AMP v. Myriad," July 1, 2013
• "Does the Myriad Decision Presage a Golden Age of Patent-Free Personalized Medicine?" June 19, 2013
• "AMP v. Myriad: A Bad Day At Black Rock," June 16, 2013
• "The Supreme Court's Myriad Decision: Where Does It Leave the 'Inventive Concept' Test?" June 16, 2013
• "Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)," June 13, 2013
• "USPTO Issues Memo on AMP v. Myriad to Examining Corps," June 13, 2013
• "Supreme Court Issues Decision in AMP v. Myriad," June 13, 2013
• "The Myriad Case and "Gene" Patents: Much Ado about Nothing?" May 14, 2013
• "A Perspective on the Cost of the Myriad BRCA Gene Test," May 2, 2013
• "What We May Learn from the Myriad Oral Argument," April 18, 2013
• "PBS NewsHour Examines Oral Argument in AMP v. Myriad — Patent Docs Author Kevin Noonan Appears on Program," April 16, 2013
• "Myriad Genetic Database Under Siege," April 15, 2013
• "A Response to Dr. Mason's "Rebuttal" to Criticisms of His Genomics Medicine Article," April 11, 2013
• "A Primer on Claim Construction — Comments on Dr. Mason's Response," April 11, 2013
• "Dr. Chris Mason Responds to Blog Posts on Genome Medicine Article — Updated," April 10, 2013
• "Revisiting Genome Medicine Article on 'Pervasive Sequence Patents' That 'Cover the Entire Human Genome'," April 8, 2013
• "Genome Medicine Article Calls for Limits on Patenting of Existing Nucleotide Sequences," April 2, 2013
• "Is Lack of Preemption the Key for the Supreme Court to Decide in Myriad's Favor?" March 26, 2013
• "IPO Files Amicus Brief in Support of Respondents in AMP v. Myriad Genetics," March 19, 2013
• "AIPLA Submits Amicus Brief to Supreme Court in AMP v. Myriad Genetics," March 13, 2013
• "Myriad Sets Forth Its Case to the Supreme Court," March 11, 2013
• "News from Abroad: Federal Court of Australia Affirms Patentability of Isolated Nucleic Acids," February 17, 2013
• "News from Abroad: Australian Federal Court Upholds Myriad's BRCA1 Gene Patents," February 17, 2013
• "United States Asks Supreme Court to Affirm on cDNA, Reverse on Isolated, Unmodified DNA," February 12, 2013
• "Is It Time for Myriad to Concede in AMP v. Myriad for the Good of the Biotechnology Industry?" January 23, 2013
Conference & CLE Calendar

January 5, 2014

January 8-12, 2014 – National CLE Conference (Law Education Institute, Inc.) – Vail, CO

January 16, 2014 – "Provisional Patent Applications: Preserving IP Rights in First-to-File System — Assessing Whether to Use — and Strategies for Leveraging — Provisional Applications Under the New Patent Regime" (Strafford) – 1:00 to 2:30 pm (EST)

January 21, 2014 – "Top Patent Law Stories of 2013" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

January 22, 2014 – European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (EST)

January 22-23, 2014 – Patent Reform*** (American Conference Institute) – New York, NY

January 23, 2014 – "Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications — Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy" (Strafford) – 1:00 to 2:30 pm (EST)

January 23-24, 2014 – IP Counsel Exchange for Biosimilar Applicants & Sponsors*** (Momentum) – New York, NY.

January 30, 2014 -"Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Litigation and Post-Grant Proceedings — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" (Strafford) – 1:00 to 2:30 pm (EST)

February 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

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

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

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

***Patent Docs is a media partner of this conference or CLE
IP Counsel Exchange for Biosimilar Applicants & Sponsors

January 3, 2014

Momentum will be holding an IP Counsel Exchange for Biosimilar Applicants & Sponsors January 23-24, 2014 in New York, NY. Developed to provide a forum for IP counsel within the pharmaceutical, biopharmaceutical and biotechnology space, the IP Counsel Biosimilars Exchange will focus on providing participants with best practices and proven strategies for best positioning biosimilar/biobetter products to obtain market exclusivity.

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

• Patent Caselaw Year in Review
• Orange Book Withdrawal
• So You Think You Can Patent Dance?
• Dissecting the Divergent Litigation Pathways of Small vs. Large Molecule Products and What Steps Your Company Should Take Now to Prepare Your Future Litigation Strategy
• The Evolving Biosimilar Landscape
• Addressing the Potential Use of Trade Secrets (Or Not) in Connection with the FDA's Review of Biosimilar Applications Citing a Reference Product and BLA That Predates the BPCIA
• Understanding the Biosimilar Landscape: Addressing Emerging Regulatory and Legal Issues
• To Collaborate or Not to Collaborate?
• Global IP Considerations, Challenges, Risks and Opportunities for Biosimilar Applicants and Sponsors When Filing Patent Applications Abroad
• Interactive Roundtable Discussions

In addition, attendees can pick from one of two workshops to be held on January 23, 2014. The workshops are entitled "Dissecting the European Biosimilars Experience" (Workshop A) and "Navigating the Patent Application Process" (Workshop B).

An agenda for the conference and workshops can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be downloaded here.

The registration fee for the conference is $1,395. Those interested in registering for the conference can do so here.

Patent Docs is a media partner of the IP Counsel Exchange for Biosimilar Applicants & Sponsors.
Conference on Pharmaceutical and Biotechnology Patent Life Cycles

January 3, 2014

American Conference Institute (ACI) will be holding a conference on Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies on February 26-27, 2014 in New York, NY. ACI faculty will help attendees:

• Apply second generation small molecule patent portfolio management strategies to large molecule patents;
• Understand how safe harbor and 272(e)(1) controversies under Classen and Momenta are impacting pharmaceutical and biotechnology patent portfolio and life cycle management;
• Assess the future of innovation within the confines of new Supreme Court jurisprudence concerning 101 patentability and its implications for diagnostics and other life sciences-related patented inventions;
• Explore new exclusivity concerns over combination products and related Orange Book listing controversies;
• Decipher the implications of the Watson/Activis on long term life cycle planning strategies;
• Weigh the pros and cons of BLA filings vs. biosimilars filings;
• Appreciate how the dichotomy in the Federal Courts and PTO in obvious determinations is influencing patenting strategies for pharmaceutical and biotechnology inventions;
• Examine the relationship between inducement / divided infringement theories and methods of treatment claims in pharmaceutical and biotechnology patents;
• Devise tactics to develop, protect, and enhance antibodies and related technologies;
• Comprehend how new PTO proceedings such as PGR and IPR are influencing prosecution strategies for large and small molecules; and
• Analyze the PTO's new proposed Rules of Professional Conduct.

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

• Commentary on Developing New Patent Life Cycle and Portfolio Planning Strategies for Small and Large Molecules and Ancillary Technologies in An Evolving IP Landscape
• PTO Keynote: AIA implementation and Its Impact on Pharmaceutical and Biotechnology Patents — to be presented by Janet Gongola, Associate Commissioner for Patent Examination Policy, U.S. Patent & Trademark Office
• Second Life Molecule Patent Planning Strategies and Tactics: What Large Molecules Can Learn From Small Molecules in Patent Life Cycle Management
• Prometheus and Myriad: Questions of Natural Law and 101 Patentability and Their Implications for Life Sciences Innovation and the Future of Personalized Medicine
• Circumventing the Tempest Which Has Entered the Safe Harbor: IP and R&D Strategies for Pharmaceutical and Biotechnology Patents in the Wake of New 271(e)(1) Controversies
• Biosimilars or BLA: Choosing the Path the Makes the Most IP and Economic Sense for Your Company
• Antitrust Update: The Actavis Fallout and Other New Antitrust Hot Buttons Impacting Patent Life Cycle Strategies in the Biopharmaceutical Industry
• Obviousness In Review: New Developments in the Courts and PTO That May Affect Life Cycle and Patent Portfolio Management in the Pharmaceutical, Biopharmaceutical and Biotechnology Industries
• Strategies for Antibody Patenting in the Wake of Myriad
• Evolving Theories of Inducement and Divided Infringement Concerning Method Treatment Claims and Their Implications for Pharmaceutical and Biotechnology Patents
• Impact of PGR, IPR and Other PTO Proceedings on Life Cycle Planning Strategies for Large and Small Molecules
• Exclusivities: New Developments, Controversies and Concerns for Small Molecules, Large Molecules and Combination Products
• Ethics and Biopharmaceutical IP: An Update on The PTO’s Recent Activity Concerning Ethics and Conduct and Related Matters

Two pre-conference workshops will be offered on February 25, 2014. The first workshop, entitled "'First Inventor to File' Master Class: Successful Strategies for Pharmaceutical, Biopharmaceutical, and Biotechnology Patent Practitioners," will be offered from 8:30 am to 12:00 pm, and the second workshop, entitled "PTA-PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Pharmaceutical, Biopharmaceutical, and Biotechnology Industries," will be offered from 2:00 pm until 5:30 pm.

An agenda for the conference can be found here, and additional information regardfing the wrokshops can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee is $2,295 (conference alone), $2,895 (conference and workshop), or $3,495 (conference and both workshops). Those registering by January 6, 2014 will receive a $300 discount and those registering by February 3, 2014 will receive a $200 discount. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies conference.
Top Stories of 2013: #4 to #6

January 2, 2014

By Donald Zuhn —

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. On Tuesday and Wednesday, we counted down stories #14 to #7, and today we count down stories #6 to #4 as we work our way towards the top three stories of 2013. As with our other lists (2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.

6. Rules of Practice Revised to Implement Patent Law Treaty

Setting aside the significant rules changes that were introduced to implement the final provisions of the Leahy-Smith America Invents Act, there were other important changes to the rules of practice that did not have their basis in the AIA. For example, in April, the U.S. Patent and Trademark Office issued new USPTO Rules of Professional Conduct, which conform the ethical obligations for representing others before the USPTO to the ABA Model Rules of Professional Conduct, which have been adopted in some form by every state (except California) and the District of Columbia. Also, in October, the USPTO issued a final rule revising the rules of practice pursuant to title II of the Patent Law Treaties Implementation Act of 2012 (PLTIA), which amends U.S. Patent Law to implement the provisions of the Patent Law Treaty (PLT). Those rules took effect on December 18. As a result of U.S. ratification of the PLT and enactment of the PLTIA, the rules of practice were revised to (1) change the filing date requirements for a patent application, (2) allow for the restoration of patent rights via the revival of abandoned applications and acceptance of delayed maintenance fee payments, and (3) permit the restoration of the right of priority to a foreign application or the benefit of a provisional application in a subsequent application filed within two months of the expiration of the twelve-month period for filing the subsequent application. In response to the changes resulting from the PLT and PLTIA, the Office also revised the patent term adjustment provisions to provide for a reduction of any patent term adjustment if an application is not in condition for examination within eight months of its filing date or date of commencement of national stage in an international application.

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

• " USPTO Issues Memo on Changes Pertaining to Patent Law Treaty," December 26, 2013
• " USPTO Issues Final Rule to Implement Patent Law Treaty — Changes Take Effect December 18," December 16, 2013
• "IPO White Paper Calls for Update to Patent Examination System," September 25, 2013
• "USPTO Proposes Rules Changes to Implement Patent Law Treaty," June 5, 2013
• "USPTO Publishes Final Rule Adopting New Rules of Professional Conduct," April 4, 2013
• "USPTO Extends Comments Deadline, Will Hold Roundtables on RCE Practice," February 11, 2013
• "USPTO News Briefs," February 6, 2013

5. Supreme Court Decides FTC v. Actavis — Rule of Reason Analysis Should Be Applied in Reverse Payment Settlement Cases

In June, the Supreme Court ruled in favor of the Federal Trade Commission in FTC v. Actavis, reversing the decision of the Eleventh Circuit Court of Appeals dismissing the FTC's complaint that a "reverse payment" settlement agreement between an innovator drug maker and generic challengers in ANDA litigation was anticompetitive and violated the antitrust laws. The Court, however, refused to accept the FTC's position that such agreements are presumptively unlawful, holding instead that lower courts should apply an antitrust "rule of reason" analysis when evaluating such agreements. Shortly after the Supreme Court's decision, the Generic Pharmaceutical Association (GPhA) released a study on the effects of reverse payment settlement agreements in ANDA litigation. The study indicated that settlements of ANDA litigation for 33 different drug molecules resulted in a savings to consumers of $25.5 billion from 2005-2012, and were projected to provide an additional $61.7 billion through patent expiry for patents listed in the Orange Book for these drugs. Not satisfied with its victory in Actavis, the FTC filed an amicus curiae brief in August in In re Effexot XR Antitrust Litigation, where the agreement the FTC objected to involves Wyeth committing not to launch a so-called "authorized generic" form of its branded Effexor XR extended-release product and Teva not entering the market with its generic product for two years (but nevertheless entering the market several years before it would otherwise be able to do so).

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

• "The FTC Is at It Again," August 22, 2013
• "IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation," July 18, 2013
• "Federal Trade Commission v. Actavis, Inc. (2013)," June 17, 2013
• "Supreme Court Oral Argument in FTC v. Actavis," April 1, 2013
• "Academic White Paper Rebuts FTC and S. 214," March 28, 2013
• "Case Brief: Federal Trade Commission v. Watson Pharmaceuticals," March 25, 2013
• "Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements," March 14, 2013
• "Par/Paddock Answers FTC Before Supreme Court," February 27, 2013
• "FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation," January 17, 2013

4. Federal Circuit Confronts Patent Eligibility of Computer-Implemented Inventions

We stretched a little on our criteria with respect to story #4, which is obviously not a biotech/pharma patent story. However, the Federal Circuit's difficulty in dealing with the Supreme Court's § 101 jurisprudence in CLS Bank Int'l v. Alice Corp., Ultramercial, Inc. v. Hulu, LLC, and Accenture Global Services, GmbH v. Guidewire Software, Inc. could impact how the Federal Circuit decides future § 101 cases on the biotech/pharma side of the fence. As we noted in May, the per curiam opinion issued in CLS Bank Int'l may be the most important § 101 jurisprudence since the Supreme Court's Bilski v. Kappos and Mayo v. Prometheus decisions, with a plurality of judges setting forth procedures for determining whether claims that recite an abstract idea or a law of nature meet the requirements of this section. In December, the Supreme Court granted certiorari in Alice Corp. v. CLS Bank Intl., opening the door once again for the Justices to further carve out the landscape of patent-eligible software and business method claims, and making this a story to watch in 2014.

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

• " Supreme Court Grants Cert. in Alice Corp. v. CLS Bank Intl.," December 6, 2013
• "Accenture Global Services, GmbH v. Guidewire Software, Inc. (Fed. Cir. 2013)," September 6, 2013
• "Ultramercial, Inc. v. Hulu, LLC (Fed. Cir. 2013)," June 27, 2013
• "SAP America, Inc. v. Versata Development Group, Inc. (PTAB 2013)," June 18, 2013
• "The Broader Meanings of the CLS Bank Decision," May 27, 2013
• "CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) — Opinions by Judge Moore, Judge Newman, and Judges Linn and O'Malley," May 21, 2013
• "CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) — Chief Judge Rader's Concurrence-in-part and Dissent-in-part," May 20, 2013
• "CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) — Judge Lourie's Concurrence," May 15, 2013
Top Stories of 2013: #7 to #10

January 1, 2014

By Donald Zuhn —

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. Yesterday, we counted down stories #14 to #11, and today we count down stories #10 to #7 as we work our way towards the top three stories of 2013. As with our other lists (2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.

10. Myriad Asserts Patents Against Diagnostics Companies

Less than one month after the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., holding that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, Myriad filed suit against Ambry Genetics, Corp. for infringement of ten patents relating to genetic diagnostic testing. Ambry Genetics had been one of the first companies to announce that it would provide genetic diagnostic testing for the BRCA 1 and BRCA 2 genes following the Supreme Court's decision. Since Myriad filed suit against Ambry, it has followed with suits against Gene-by-Gene, Quest, GeneDx, Invitae, and LabCorp. The accused infringers have not sat idly by, with both Quest and Invitae filing declaratory judgment actions against Myriad (Counsyl has also filed a declaratory judgment action against Myriad). Myriad has also expanded its suit against certain defendants to encompass claims directed to colon cancer predictive genetic diagnostic testing. The lawsuits show that Myriad is serious about protecting its intellectual property, including more than its BRCA tests, and may have decided it has much more to lose than the company's patents scheduled to expire over the next few years. Sixteen years of patent exclusivity have certainly provided Myriad with the motivation and the economic means to protect its franchise, but this story will have to wait until at least 2014 for an ending.

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

• " Invitae Files Motion to Dismiss for Lack of Personal Jurisdiction in Myriad Genetics v. Invitae Corp.," December 11, 2013
• " Myriad Genetics Sues LabCorp over BRCA Gene Testing," December 4, 2013
• " Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back," November 27, 2013
• "Where Do We Stand?" October 31, 2013
• "Defendants' Oppose Myriad's Motions to Dismiss Antitrust Counterclaims," October 28, 2013
• "Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing," October 23, 2013
• "Myriad Genetics Sues Quest for Patent Infringement," October 22, 2013
• "Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents," October 21, 2013
• "Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics," October 13, 2013
• "Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics," October 10, 2013
• "Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies," October 9, 2013
• "Defendants' Response to Myriad's Preliminary Injunction Motions," September 19, 2013
• "Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine," August 28, 2013
• "Amici Submit Brief in Support of Ambry Genetics and Gene by Gene," August 27, 2013
• "Ambry Responds to Myriad Lawsuit," August 7, 2013
• "Why Does Myriad Think It Can Win BRCA Gene Lawsuits?" July 30, 2013
• "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes," July 10, 2013
• "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes," July 9, 2013

9. District Court Finds Prenatal Diagnostic Method Not Patent Eligible; Alternatives to Method Not "Commercially Viable"

On October 30, Judge Susan Illston of the Northern District of California granted summary judgment to declaratory judgment plaintiff Ariosa Diagnostics Inc. in Ariosa Diagnostics v. Sequenom. In a case on remand from the federal Circuit, and involving claims directed to non-invasive prenatal diagnosis of sex determination, blood typing, other genetic disorders, and detection of pre-eclampsia, using a simple blood test that reduces or eliminates the need for amniocentesis and chorionic villus sampling (which incur risks to both mother and child), the District Court determined that the asserted claims were not drawn to patent eligible subject matter because paternally inherited cffDNA is a natural phenomenon and the asserted claims merely add well-understood, routine, conventional activity in the field to that natural phenomenon. With respect to the issue of preemption, the District Court noted that "[b]ecause generally one must be able to find a natural phenomenon to use it and apply it, claims covering the only commercially viable way of detecting that phenomenon do carry a substantial risk of preempting all practical uses of it." The District Court therefore agreed with Ariosa's argument that the alternative methods for detecting cffDNA that Sequenom presented were not practical and commercially viable. Life sciences patent practitioners will be following this case closely in 2014.

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

• " Patent Eligible Subject Matter in the District Courts: Ariosa Genetics v. Sequenom (N.D. Cal. 2013)," November 5, 2013

8. Media and Congress Combat Patent Trolls

Only months after the final provisions of the Leahy-Smith America Invents Act were implemented, Congress deemed it necessary to propose further reforms to U.S. patent law. The outcries last year stemmed from the apparent proliferation of "Patent Trolls," also known by the less derogatory term Patent Assertion Entities (or PAEs), and their alleged penchant of engaging in abusive patent litigation. The mainstream media, as exemplified by National Public radio (NPR), focused on the Patent Troll problem, and Congress, perhaps swayed by the media's focus, started introducing a number of bills intended to remedy the problem. The bill at the forefront of the discussion has been H.R. 3309, which was introduced by Rep. Bob Goodlatte (R-VA), and which the House passed in early December. The Senate is now working on its own bills to curb PAE abuse, and given the speed with which the House passed H.R. 3309, there is a possibility that legislation may be presented to the President sometime in 2014.

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

• "Senate Judiciary Committee Holds Hearing on 'Protecting Small Businesses and Promoting Innovation by Limiting Patent Troll Abuse'," December 23, 2013
• "Reaction to the Passage of the Innovation Act (H.R. 3309)," December 9, 2013
• "Innovation Act Passed By House — A Closer Examination," December 5, 2013
• "House Passes H.R. 3309 (Innovation Act)," December 5, 2013
• "'Non-Practicing Lawmakers' — The Mark-up of H.R. 3309 (Innovation Act)," November 27, 2013
• "The Futility of Petitioning Congress (After the Fix Is In): Stakeholders Tell Judiciary Committee What's Wrong with Goodlatte Bill (H.R. 3309)," November 21, 2013
• "Yet Another 'Patent-Troll' Bill – Senator Leahy Introduces Patent Transparency and Improvements Act," November 20, 2013
• "When NPR Podcasters Hit the Patent System – An Update," November 12, 2013
• "Trolls Better Watch Out This Halloween — Senator Hatch Introduces Patent Litigation Integrity Act," October 30, 2013
• "House Judiciary Committee Holds Hearing on Innovation Act," October 29, 2013
• "Rep. Goodlatte Introduces 'Innovation Act" to Combat Patent Trolls," October 23, 2013
• "Rep. Goodlatte Introduces Second "Discussion Draft" of Legislation Aimed at Curbing "Abusive Patent Litigation"," September 24, 2013
• "The War on Patent Trolls — Congress Prepares for Battle," September 18, 2013
• "The GAO Issues a Report on Patent Litigation Trends — It Turns Out that the Sky Is Not Falling," August 29, 2013
• "In Defense of the Patent System: How the Mainstream Media's Representation of it is "Broken"," July 31, 2013
• "New Patent Litigation Bill Introduced in House," July 16, 2013
• "When NPR Podcasters Hit the Patent System," June 12, 2013
• "Congress Continues Efforts to 'Reform' U.S. Patent Law," June 10, 2013
• "'When the Patent System is Attacked!' — The White House Task Force on High-Tech Patent Issues," June 4, 2013

7. EPO Removes Time Limit for Filing Divisional Applications

In August, word started to leak out that the European Patent Office (EPO) would be removing the current two-year time limit for filing divisional applications. By October, reports indicated that the administrative council of the EPO had voted to amend Rule 36 EPC to remove the controversial 24-month time limit within which European divisional applications may be filed, with the sole criterion set forth in amended Rule 36(1) EPC being that the application to be divided still be pending. In practice this means that any case that is not granted or finally refused can be divided once the new rule comes into force. The amended rule is set to come into force on April 1, 2014. While rules changes are frequently met with trepidation, this rule change will no doubt be welcomed by patent practitioners and applicants prosecuting applications before the EPO.

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

• " News from Abroad: EPO to Rescind Deadline for Filing Divisional Patent Applications," October 17, 2013
• " News from Abroad: EPO Proposal Would Remove Time Limit for Divisional Filing," September 13, 2013

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