After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories.  For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants.  Last week, we counted down stories #20 to #16, and today we count down stories #15 to #11 as we work our way towards the top five stories of 2015.  As with our other lists (2014, 2013, 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 2015" on January 21, 2016 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories, can be found here.

15. Federal Circuit Decides Biosig v. Nautilus on Remand

In April, the Federal Circuit considered the question of indefiniteness on remand from the Supreme Court's reversal in Nautilus v. Biosig and found again that the Biosig's claims were not indefinite.  In the earlier proceedings in the case, the District Court found the term "in spaced relationship" indefinite as a matter of law, and the Federal Circuit reversed, using its "insolubly ambiguous" test to hold that the claim was amenable to construction and thus not indefinite.  The Supreme Court rejected the Federal Circuit's standard, holding that "a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty those skilled in the art about the scope of the invention," and reversed and remanded for reconsideration by the Federal Circuit under this standard.  On remand, the Federal Circuit again reversed the District Court's indefiniteness determination, noting that that "an ordinarily skilled artisan would be able to determine this language requires the spaced relationship to be neither infinitesimally small nor greater than the width of a user's hands," and concluding that "[t]he term 'spaced relationship' does not run afoul of 'the innovation-discouraging 'zone of uncertainty' against which [the Supreme Court] has warned,' and to the contrary, informs a skilled artisan with reasonable certainty of the scope of the claim."

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

• "Biosig Instruments, Inc. v. Nautilus, Inc. (Fed. Cir. 2015)," April 27, 2015

14.  Supreme Court Decides Kimble v. Marvel

In August, the Supreme Court let stand its fifty-year ban on royalties post patent expiry (Brulotte v. Thys Co., 1964).  The case involved U.S. Patent No. 5,072,856 to Kimble, directed to a toy that simulated the web-shooting devices used by the fictional Spiderman, which Kimble attempted to license to Marvel (which owns the rights to the Spiderman character, comic books, movies, and ancillary merchandise).  Marvel instead chose to copy the invention, bringing their own version of the toy to market, and the parties subsequently settled the resulting patent infringement lawsuit on terms wherein Marvel purchased the patent for a lump sum (~$500,000) plus a 3% royalty; the settlement containing no limit on this royalty obligation with regard to patent expiry.  Marvel brought a declaratory judgment action against paying post-expiry royalties in which it prevailed, and the Supreme Court majority refused to overrule the Brulotte rule.  Although the majority recognized that royalty plans like the one at issue here can have advantages including "draw[ing] out payments over time and t[ying] those payments, in each month or year covered, to a product's commercial success," the majority believed that the principle of limiting the exclusive right to the statutory term is sufficiently important to require patentees and their licensees to "find ways around Brulotte" using other means.

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

• "Kimble v. Marvel Entertainment, LLC (2015)," August 20, 2015

13.  FDA Approves First Biosimilar

In January, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN^® biologic drug, making Sandoz's application the first to be accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA), which was part of the healthcare reform package passed in 2010 and commonly referred to as "Obamacare."  Two months later, the FDA approved the biosimilar version of Neupogen® for sale in the U.S. -- thus becoming the first biosimilar to be approved under the BPCIA (a mere ten months after Sandoz filed its biosimilar application).  Sandoz (a division of Novartis) began selling its biosimilar product in September under the brand name Zarxio™.  Sandoz also avoided the disclosure provisions of the BPCIA in 2015, successfully arguing that those provisions were optional before the District Court and the Federal Circuit (but that's a "top story" for another day).

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

• "Sandoz' NEUPOGEN® Biosimilar Now on the Market," September 7, 2015
• "The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?" March 12, 2015
• "FDA Approves Sandoz Filgrastim Biosimilar," March 8, 2015
• ""No Clinically Meaningful Differences": The First Accepted Biosimilar Application Has Been Recommend for FDA Approval," January 14, 2015

12.  Patent Reform Stalls in Congress

The year began with Rep. Bob Goodlatte (R-VA), the Chairman of the House Judiciary Committee, introducing his "Innovation Act" bill (H.R. 9), which sets forth several "reforms" of U.S. patent law, in substantially the same form as in the last Congress.  In July, Rep. Goodlatte released a 200-page Report on H.R. 9.  While many considered eventual passage of H.R. 9 to be a near certainty, the bill did not come to the House floor for a vote before the August recess and the year concluded with the bill sitting on the House calendar.  Although the Innovation Act is primarily directed to addressing the "problem" of so-called "patent trolls," over the course of 2015 a different patent reform issue (especially in the biopharm sector) started to gain traction.  In an article published last fall on Medium, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood highlighted this issue, urging Congress to modify the inter partes review (IPR) system, which he argued had "turn[ed] the serious business of medical innovation and entrepreneurial risk-taking into a casino."  In a letter sent to the Senate and House Committees on the Judiciary, 101 patient organizations also expressed "concern[] that, as currently written, H.R. 9 falls short of preserving important patent protections for the biopharmaceutical innovation our communities rely on to achieve a better quality of life."  The group of patient organizations contended that "IPR[s] opened the door to abuses that threaten the unique and specialized mechanisms under the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act) and the Biologics Price Competition and Innovation Act (BPCIA)."  Whether the Innovation Act moves to a House vote, and whether that bill (or an alternative) proposes any reforms to the IPR system, will begin to play out as Congress reconvenes this week.

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

• "BIO CEO: IPR System Threatens Medical Innovation," December 6, 2015
• "Pigs Fly, Hell Has Frozen Over, and the New York Times Supports Small Inventor and University Patenting," October 28, 2015
• "101 Patient Organizations Ask Congress to Curb IPR Abuse," October 11, 2015
• "PTAB Denies Inter Partes Review Petitions Against Two Acorda Patents," August 24, 2015
• "Ferrum Ferro Capital Files Motion to Strike Allergan's Complaint Alleging Misuse of IPR Process," August 12, 2015
• "Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act," August 6, 2015
• "Rep. Goodlatte Releases Report on H.R. 9," August 4, 2015
• "CBO Provides Cost Estimate to Government to Implement Innovation Act," July 27, 2015
• "Allergan Fights Back, Files Complaint Against Venture Fund That Filed IPR Petition," July 13, 2015
• "A Sea Change for IPRs? -- Part II," June 10, 2015
• "A Sea Change for IPRs?" June 9, 2015
• "Senate Judiciary Committee Passes PATENT Act," June 4, 2015
• "Group of National and State Organizations Asks Congress to Enact Legislative Reforms to Maintain Strong Patent System," June 1, 2015
• "A Modest Proposal (or Two)," April 22, 2015
• "Legislation Introduced in House to Eliminate Uncertainty Regarding AIA Grace Period," April 20, 2015
• "STRONG Patents Act of 2015 -- An Alternative Patent Reform Bill," March 4, 2015
• "Rep. Goodlatte Introduces His Patent Reform Bill (Again) -- Part II," February 9, 2015
• "Rep. Goodlatte Introduces His Patent Reform Bill (Again)," February 5, 2015
• "Pro-Patent Coalition Writes Letter to the House and Senate Judiciary Committees," January 29, 2015
• "Big Ten Lobbies Congress to Tread Lightly on "Patent Reform"," January 29, 2015

11.  Australia Follows U.S. Lead on DNA Claims

In June, the High Court of Australia heard the long anticipated appeal from the unanimous decision of a 5-judge bench of the Full Federal Court to allow Myriad's claims to isolated nucleic acids.  In October, the High Court of Australia handed down its decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35, unanimously striking down the validity of the first three claims of Myriad's patent, which related to isolated nucleic acid sequences of the BRAC1 gene.  In reaching that decision, the majority judgment characterized the claimed invention as "information" rather than a chemical product, because it was defined as a code for the BRAC1 gene, which can be stored in various products, such as the isolated DNA of a person or cDNA where the introns in the sequence have been excised.  The product was merely the medium in which that information resides.  The High Court's decision marked a dramatic departure from the Australian Parliament's position on "gene patents" in recent years.  Australia Patent Law only expressly excluded from patentability "human beings and biological processes for their generation", and in 2010 the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which sought to exclude not only DNA and RNA, but all biological entities from patentability, failed to pass after the Senate Legal and Constitutional Affairs Legislation Committee (SLCALC) recommended against the Bill.  As one of Patent Docs correspondents noted, the High Court's decision in D'Arcy v Myriad Genetics Inc brought Australia's position on isolated DNA and RNA in line with that of the United States, while representing a marked deviation from major trading partners such as Europe and the U.S. on the issue of patentability of cDNA.

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

• "Australian High Court Has Ruled in Myriad Gene Patent Case," October 8, 2015
• "High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia," October 8, 2015
• "Isolated Nucleic Acids Not Patentable in Australia," October 7, 2015
• "Isolated Gene Sequences Suffer A Cruel Fate in the Hands of the High Court of Australia," October 7, 2015
• "High Court of Australia Hears Myriad Appeal," June 16, 2015