Patent Docs

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
Top Stories of 2013: #11 to #14

December 31, 2013

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. Today, we count down stories #14 to #11, and then over the next few days, we will 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.

14. 23andMe Patent and Diagnostic Test Create Controversy

A patent issued to 23andMe, Inc. in September created some controversy for the Mountain View, California biotech company. The patent, U.S. Patent No. 8,543,339, is directed to a system for identifying a preferred gamete donor from among the plurality of donors based on a phenotype of interest, the genotype of a recipient, and the genotypes of the donors. In the wake of the '339 patent's issuance, 23andMe was criticized for its efforts to secure patent protection on a method of creating "designer babies," and in response, the company posted an article on its blog, stating that it "never pursued the concepts discussed in the patent beyond our Family Traits Inheritance Calculator, nor do we have any plans to do so." In an unrelated matter, the FDA issued a Warning Letter to 23andMe in November, demanding that the company stop selling its Personal Genomic Services (PGS) product without obtaining FDA approval. The FDA's letter was not well received by some healthcare consumers, who posted a petition on the "We the People" portion of the White House website, calling for the Obama Administration to overrule the FDA and permit 23andMe to continue to market the company's PGS product. Other consumers, however, initiated a class action lawsuit against 23andMe on behalf of "tens or hundreds of thousands of women" who may have used the PGS testing service.

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

• "23andMe Patent Creates Controversy," October 8, 2013
• "Bioethicists 'Urge Maximal Transparency' in Response to 23andMe Patent," October 14, 2013
• "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing," November 25, 2013
• "Patients Push Back on FDA Threats to 23andMe Genetic Testing Products," November 26, 2013
• "23andMe Named in Class Action Lawsuit," December 3, 2013

13. Supreme Court Hears Oral Argument in Medtronic v. Boston Scientific

In November, the Supreme Court heard oral argument in the Medtronic Inc. v. Boston Scientific Corp. case, where the sole issue on appeal concerns whether the patent licensee or patent holder/licensor has the burden of proof on the issue of infringement/non-infringement in a declaratory judgment action brought by the licensee under Medlmmune. The Court is expected to issue its opinion before the end of June 2014.

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

• "Oral Argument in Medtronic Inc. v. Boston Scientific Corp.," November 7, 2013
• "Amicus Curiae Briefs in Medtronic v. Boston Scientific – Legal Scholars Support Medtronic; Tessera Supports Vacatur and Remand," November 4, 2013
• "Amicus Curiae Briefs in Support of Federal Circuit Opinion in Medtronic Inc. v. Boston Scientific Corp.," November 3, 2013
• "United States Weighs-In on the Medtronic Case," August 15, 2013
• "Supreme Court Grants Certiorari in Medtronic v. Boston Scientific," May 22, 2013

12. Debate Continues on 12-Year Data Exclusivity Period and Biosimilar Substitution

More than three years after President Obama signed the Patient Protection and Affordable Care Act (PPACA) into law, thereby establishing a biosimilar regulatory pathway in the U.S. via the Biologics Price Competition and Innovation Act (BPCIA), the Administration has continued to press for a reduction of the data exclusivity period from 12 years to 7 years. The debate over the data exclusivity period continued this year, but in the context of negotiations on the Trans-Pacific Partnership Agreement (TPP), a multilateral free trade agreement involving Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States, and Vietnam. In March, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, urged the Acting U.S. Trade Representative in a letter "to seek commitments from our trading partners that reflect the level of protection under U.S. law, for example 12 years of regulatory data protection for biologic pharmaceuticals." While the Biotechnology Industry Organization (BIO) expressed its support for the 12-year data exclusivity period, the AARP asked the U.S. Trade Representative not to sign onto the TPP if the trade agreement includes the 12-year data exclusivity period. While the data exclusivity period of the BPCIA was being debated in the context of the TPP, several states were debating legislation on biosimilar substitution under the BPCIA. In October, California Governor Jerry Brown vetoed a bill in that state that would have authorized a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the prescriber did not personally indicate "Do not substitute." In a letter to the California Senate, Governor Brown noted that he vetoed the bill because the FDA had not yet determined the standards required for biosimilars to meet the higher threshold for interchangeability, and therefore, requiring physician notification would have been "premature."

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

• "AARP Seeks Reduced Data Exclusivity Period in TPP," October 31, 2013
• "Governor Brown Vetoes California Biosimilar Bill," October 16, 2013
• "California Biosimilar Bill Aligns with BIO Principles on Biologic Substitution," October 3, 2013
• "GPhA Opposes California Biosimilar Bill; Points to Report on Savings from Biosimilars," October 2, 2013
• "White Paper Asserts That Existing Trade Agreements Provide No Data Exclusivity for Biologics," August 26, 2013
• "BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics," August 20, 2013
• "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not," May 9, 2013
• "WLF Submits Comments on Abbott's Citizen Petition on Biosimilars," March 6, 2013

11. EU Council Signs Unified Patent Court Agreement, Taking Step Towards Unitary Patent System

In February, the Council of the European Union announced that twenty-four member states had signed the international agreement that would establish a Unified Patent Court (UPC), a specialized court having exclusive jurisdiction over infringement and validity questions related to unitary patents. The signing initiated the process of ratification by national parliaments, with ratification requiring at least thirteen member states (including France, Germany and the United Kingdom). Ratification of the UPC agreement will result in implementation of two EU regulations on the unitary patent. According to some reports, ratification may not take place until at least 2015 or 2016, or perhaps even 2017 or 2018. Spain, which did not sign the agreement, continued to challenge the regulations underpinning the Unitary Patent System in 2013.

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

• "News from Abroad: Spain's Further Challenges to the Unitary Patent Regulations," June 6, 2013
• "Member States Sign Agreement to Establish Unified Patent Court," February 21, 2013
AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)

December 30, 2013

By Kevin E. Noonan —

A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the S-omeprazole enantiomer) as "the little purple pill." One reason this strategy deserves admiration is that it is not the type of evergreening that some commentators and politicians have objected to (such as using formulation or other types of patents to continue protection after the composition patent has expired; for the record, there is nothing improper about that type of evergreening, either). But no strategy is perfect, as AstraZeneca found when the Federal Circuit affirmed a District Court judgment of non-infringement in AstraZeneca v. Hanmi.

The claimed invention was directed to the magnesium salts of the esomeprazole isomer sold as Nexium®. AstraZeneca filed suit under 35 U.S.C. § 271(e)(2) after receiving notice that Hanmi had submitted an ANDA for a generic version of the drug comprising the strontium salt of esomeprazole. The claims of the Orange Book listed patents in suit (U.S. Patent Nos. 5,714,504 and 5,877,192) as filed and the specification recited six specific cations as components of the enantiomeric salts of the invention: Na⁺, Mg²⁺, Li⁺, K⁺, Ca²⁺, or N⁺(R)₄, where R is an alkyl with one to four carbons (the latter cation is also called generically an ammonium ion). However, the issued claims recited the esomeprazole isomer more generically as an "alkaline" salt, as in Claim 1 of the '504 patent:

A pharmaceutical formulation for oral administration comprising a pure solid state alkaline salt of the (-)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole and a pharmaceutically acceptable carrier.

The District Court construed this and all the claims at issue to be limited to esomeprazole salts of the six specific cations recited in the specification, and the parties conceded that under this construction Hanmi's strontium salt formulation did not infringe. AstraZeneca appealed, on the basis that these cations were exemplary and that the skilled worker would recognize that the patents were entitled to the broader scope of "alkaline salts" that would encompass Hanmi's strontium salt of esomeprazole.

The Federal Circuit disagreed with AstraZeneca's arguments, in an opinion by Judge Taranto joined by Judges Dyk and Moore. The Court found that while the plain meaning of the term "alkaline salt" would encompass Hanmi's strontium salt, "[b]y conspicuously choosing only certain members of the class, and using the language [in the patent specifications that] it did, AstraZeneca conveyed a clear and definitive meaning that it was disclaiming other members of the class" including Hanmi's strontium salts. The Court cited portions of the specification in support of this construction, for example, "[t]he first sentence of the Detailed Description":

The present invention refers to the new Na⁺, Mg²⁺, Li⁺, K⁺, Ca²+ or N⁺(R)₄ salts of the single enantiomers of omeprazole, where R is an alkyl with 1-4 carbon atoms, i.e. Na⁺, Mg²⁺, Li⁺, K⁺, Ca²+ or N⁺(R)₄ salts of (+)-[omeprazole] and (-)-[omeprazole], where R is an alkyl with 1-4 carbon atoms.

This disclosure is specific, not generic according to the Court, and amounts to an express disclaimer of the scope of the claims AstraZeneca sought in litigation against Hanmi.

The Court further held that this disclaimer was not overcome by more generic language in the specification, when taken in context, because there was no evidence that AstraZeneca used the more generic terms in any sense other than joined by express recitation of the six exemplary cations. Neither the prosecution history nor the doctrine of claim differentiation was persuasive to the Court; with regard to the latter of AstraZeneca's asserted grounds of error, the Court stated that "the doctrine of claim differentiation does not . . . override clear statements of scope in the specification" citing Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1302 (Fed. Cir. 1999).

Regarding AstraZeneca's prosecution history arguments, at least a part of the Court's reasoning for its decision is that it perceived from the prosecution history that the focus of what AstraZeneca was trying to protect changed during prosecution. Specifically, the Court noted that AstraZeneca "conducted experiments that led it to conclude that one of the two enantiomers gave particularly good results," i.e., that which of the separated enantiomers (if either) was preferable was only known after the patent application was filed. As a result, AstraZeneca "filed amended claims to focus on that enantiomer" in response to a rejection:

When AstraZeneca filed the application that issued as the '504 patent, the language of the claims aligned perfectly with the written description's clear language about the scope of the "present invention": the broadest of the claims were limited in terms to salts using the six identified cations, combined with either one of the two omeprazole enantiomers. . . . After the Examiner rejected those claims for anticipation and obviousness, . . . AstraZeneca shifted the focus to unexpected benefits achieved by using the (-)-enantiomer rather than the (+)-enantiomer. Whereas the original claims and written description treated the two enantiomers with parity, AstraZeneca now distinguished the prior art by amending the claims to cover only esomeprazole, which it argued "unexpectedly exhibits a different and more advantageous pharmacokinetic profile than the racemic mixture or the (+)-enantiomer of omeprazole. To support that assertion, AstraZeneca submitted clinical studies that, it explained to the Examiner, "involved both the monovalent sodium salt and the divalent magnesium salt of the (-)-enantiomer of omeprazole, thus supporting the full scope of the genus of alkaline salts disclosed in the application and as claimed herein."

(record citations omitted, emphasis in opinion).

The Court did not find the italicized language in the patents' prosecution history to be sufficient to overcome the intrinsic limitations in the language of the specification and broaden the scope to alkaline salts to be greater than the six expressly recited cations (the Court characterizing this as a "substantial expansion" of claim scope).

AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)
Nonprecedential disposition
Panel: Circuit Judges Dyk, Moore, and Taranto
Opinion by Circuit Judge Taranto
Court Report

December 29, 2013

By Sherri Oslick —

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

Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited
1:13-cv-09227; filed December 26, 2013 in the Northern District of Illinois

• Plaintiffs: Janssen Pharmaceuticals Inc.; Grünenthal GmbH
• Defendant: Alkem Laboratories Ltd.

Janssen Pharmaceuticals, Inc. et al. v. Alkem Laboratories Ltd.
2:13-cv-07803; filed December 23, 2013 in the District Court of New Jersey

• Plaintiffs: Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
• Defendant: Alkem Laboratories Ltd.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,536,130 (""Use of 1 Phenyl-3-Dimethylamino-Propane Compounds for Treating Neuropathic Pain," issued September 17, 2013), licensed to Janssen, following a Paragraph IV certification as part of Alkem's filing of an ANDA to manufacture a generic version of Janssen's Nucynta® ER (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults). View the New Jersey complaint here.

Merck Sharp & Dohme B.V. v. Warner Chilcott Co. LLC et al.
1:13-cv-02088; filed December 24, 2013 in the District Court of Delaware

• Plaintiff: Merck Sharp & Dohme B.V.
• Defendants: Warner Chilcott Co. LLC; Warner Chilcott (US) LLC

Infringement of U.S. Patent No. 5,989,581 ("Drug Delivery System for Two or More Active Substances," issued November 23, 1999) following a Paragraph IV certification as part of Warner Chilcott's filing of an ANDA to manufacture a generic version of MSD's NuvaRing® drug product (ethinyl estradiol and etonogestrel vaginal ring, used for contraception). View the complaint here.

Teijin Ltd. et al. v. Zydus Pharmaceuticals USA Inc. et al.
1:13-cv-02086; filed December 23, 2013 in the District Court of Delaware

• Plaintiffs: Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals U.S.A., Inc.
• Defendants: Zydus Pharmaceuticals USA Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent No. 7,361,676 ("Solid Preparation Containing Single Crystal Form," issued April 22, 2008) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout). View the complaint here.

Genetic Veterinary Sciences Inc. v. Canine EIC Genetics LLC
2:13-cv-00422; filed December 20, 2013 in the Eastern District of Washington

Declaratory judgment of non-infringement of U.S Patent No. 8,178,297 ("Method of Detecting Canine Exercise-Induced Collapse," issued May 15, 2012) based on PPG's genetic screening service for Exercise-Induced Collapse ("EIC") in dogs. Also, various claims sounding in state law, including unfair competition, etc. View the complaint here.

Cephalon Inc. v. Agila Specialties Inc. et al.
1:13-cv-02080; filed December 20, 2013 in the District Court of Delaware

• Plaintiff: Cephalon Inc.
• Defendants: Agila Specialties Inc.; Onco Therapies Ltd.

Cephalon Inc. v. InnoPharma Inc.
1:13-cv-02081; filed December 20, 2013 in the District Court of Delaware

Cephalon Inc. v. Dr. Reddy's Laboratories Ltd. et al.
1:13-cv-02082; filed December 20, 2013 in the District Court of Delaware

• Plaintiff: Cephalon Inc.
• Defendants: Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,445,524 ("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 Agila complaint here.

Cephalon Inc. v. Hetero Labs Ltd. et al.
1:13-cv-02046; filed December 19, 2013 in the District Court of Delaware

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

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 Hetero'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.

IGI Laboratories Inc. v. Mallinckrodt LLC et al.
1:13-cv-02044; filed December 19, 2013 in the District Court of Delaware

• Plaintiff: IGI Laboratories Inc.
• Defendants: Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.

Declaratory judgment of non-infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012) and 8,546,450 ("Treatment of Pain with Topical Diclofenac Compounds," issued October 1, 2013) based on IGI's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)). View the complaint here.
Conference & CLE Calendar

December 29, 2013

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 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)

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
Webinar on Maximizing Patent Prosecution Opportunities in Europe

December 27, 2013

Strafford will be offering a webinar/teleconference entitled "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" on January 23, 2014 from 1:00 to 2:30 pm (EST). Rebecca M. McNeill of VIVICAR Law and Jens Viktor Nørgaard of HØIBERG will provide guidance for patent counsel in drafting U.S.-origin patent applications to maximize prosecution opportunities in both the U.S. and Europe, and offer best practices for U.S. patent application drafters to protect inventions in Europe without sacrificing U.S. strategy. The webinar will review the following questions:

• What are the key considerations for patent counsel drafting U.S. applications when global patent protection is anticipated or desired?
• What are the significant differences between the U.S. and European approaches to patent applications?
• What steps should counsel take when drafting U.S. patent applications to maximize protection in Europe?

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

December 27, 2013

D Young & Co will be offering its next European biotech patent law update on January 22, 2014. The 45-minute webinar will be offered at three times: 4:00 am, 7:00 am, and 12:00 pm (EST). D Young & Co European Patent Attorneys Simon O'Brien and Robert Dempster will provide an essential update and live Q&A on EPO biotechnology case law.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here.
Webinar on Use of Provisional Applications under First-to-File Regime

December 27, 2013

Strafford will be offering a webinar/teleconference entitled "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" on January 16, 2014 from 1:00 to 2:30 pm (EST). Dale S. Lazar and Timothy W. Lohse of DLA Piper, and Craig Opperman, Chief Intellectual Property Officer of Naspers will discuss provisional patent applications, their benefits and limitations, and best practices for leveraging such applications. The panel will also examine when and why provisional applications should be used and the issue of tying non-provisional patent applications to provisional applications. The webinar will review the following questions:

• Under what circumstances will a patent claimant get the most out of a provisional patent application?
• What are the benefits and limitations of using a provisional patent application?
• What are the important considerations when determining whether and when to use a provisional application?

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

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