Top Stories of 2013: #7 to #10

by McDonnell Boehnen Hulbert & Berghoff LLP

FireworksReflecting 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


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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