By Donald Zuhn --
After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories. For 2014, we identified eighteen 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. On New Year's Eve, we counted down stories #18 to #15, and on New Year's Day, we covered stories #14 to #11. Today, we count down stories #10 to #7 as we work our way towards the top three stories of 2014. As with our other lists (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 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.
10. While FDA Accepts First Biosimilar Application, Some Biosimilar Applicants Try to Bypass BPCIA
In July, Sandoz announced that the U.S. Food and Drug Administration had accepted its application to market a version of the protein filgrastim. The reference product is Amgen's NEUPOGEN®. Sandoz markets a biosimilar filgrastim outside the U.S. under the brand name ZARZIO®. Interestingly, in October, Amgen announced the results of a Phase III clinical trial of its own biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab (sold by AbbVie as Humira®). Amgen and Sandoz were both involved in a BPCIA dispute that was resolved by the Federal Circuit in December. In what some perceived as an attempt to sidestep the requirements of the BPCIA, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. In Sandoz v. Amgen, the Federal Circuit affirmed the District Court's dismissal of Sandoz's suit because "Sandoz did not allege an injury of sufficient immediacy and reality to create subject matter jurisdiction." In other biosimilar developments, the FDA issued a "Guidance for Industry" in August entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." The Guidance provides some grounds for determining the term of market exclusivity under the BPCIA (12 years; Sec. 351(k)(7), codified at 42 U.S.C. 55 262(k)).
For information regarding this and other related topics, please see:
• "Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y. 2014)," December 11, 2014
• "Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)," December 9, 2014
• "Amgen Poised to Enter Biosimilars Market," October 8, 2014
• "FDA Releases Another Prospective Guidance," August 13, 2014
• "Finally, A Biosimilar Application Has Been Accepted By The FDA ," July 28, 2014
• "FDA Releases Draft Guidance on Biosimilars," May 14, 2014
• "Indiana Governor Signs Biosimilar Substitution Bill," April 10, 2014
9. Congress and Tech Sector Wage Battle Against Patent Trolls
Despite having passed patent reform legislation -- the Leahy-Smith America Invents Act -- in September 2011, many in the patent community expected Congress to pass another piece of patent reform legislation in 2014 -- this time addressing patent litigation and the problem of so-called patent trolls. However, after taking up and tabling legislation in March and April, Senator Patrick Leahy (D-VT), Chairman of the Senate Committee on the Judiciary, announced that he was taking the Patent Transparency and Improvements Act of 2013 (S. 1720) off the Committee's agenda because of a lack of "sufficient support behind any comprehensive deal." Meanwhile, the tech sector continued to lobby for patent litigation reform. Congress may take up patent reform again this year.
For information regarding this and other related topics, please see:
• "More Misinformation Regarding the Patent System and Non-Practicing Entities," December 18, 2014
• "Patent Litigation Reform -- Will the Outcome of the Mid-Term Elections Matter, and Is Reform Still Necessary?" October 30, 2014
• "Teva v. Sandoz -- Is Deferential Review a Boon for Patent Trolls?" October 14, 2014
• "House Tries One More Time: Targeting Rogue and Opaque Letters Act of 2014 ("TROL Act")," July 17, 2014
• "Patent Reform Legislation Off The Table -- For Now," May 21, 2014
• "Senate Judiciary Committee Tables Patent Reform, Again," April 3, 2014
• "Stopping Bad Legislation -- The Innovation Alliance Speaks Out," April 2, 2014
• "Stopping Bad Patents -- Senator Schumer Takes on the "Patent Trolls"," April 1, 2014
• "New York Times Op-Ed Argues Law Takes Misguided Approach to Software Patents," March 30, 2014
• "Senate Judiciary Committee Takes Up, Then Tables, Patent Reform," March 27, 2014
• "A Rebuttal to The Economist's "Stalking Trolls"," March 13, 2014
• "Senate Legislation Update -- The Commerce Committee Gets in the Act," March 5, 2014
8. Courts and PTAB Deal with Fallout of Alice Corp. v. CLS Bank
In June, the Supreme Court issued its opinion Alice Corp. v. CLS Bank International, affirming the Federal Circuit's per curiam opinion in CLS Bank International v. Alice Corp. (stay tuned for more on that decision as we move closer to the top three stories of 2014). However, the impact of the Supreme Court's Alice Corp. opinion on Federal Circuit and Patent Trial and Appeal Board decisions made it to #8 on the list. Patent Docs covered nine such decisions during the second half of 2014, and in only one case (DDR Holdings, LLC) did the Federal Circuit conclude that computer-implemented claims survive a § 101 challenge. Readers can look for more discussion of this top story, as well as the Supreme Court's Alice Corp. decision, during our live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015.
For information regarding this and other related topics, please see:
• "DDR Holdings, LLC v. Hotels.com, L.P. (Fed. Cir. 2014)," December 8, 2014
• "Ultramercial Inc. v. Hulu LLC (Fed. Cir. 2014)," November 16, 2014
• "Ultramercial Inc. v. Hulu LLC -- Party Briefs," November 6, 2014
• "Cambridge Assoc., LLC v. Capital Dynamics (PTAB 2014); PNC Bank v. Secure Axcess, LLC (PTAB 2014)," October 16, 2014
• "U.S. Bancorp v. Solutran, Inc. (PTAB 2014)," September 10, 2014
• "Planet Bingo, LLC v. VKGS LLC (Fed. Cir. 2014)," August 27, 2014
• "I/P Engine, Inc. v. AOL Inc. (Fed. Cir. 2014)," August 18, 2014
• "Stewart Title Guaranty Co. v. Segin Software, LLC (PTAB 2014)," July 23, 2014
• "Digitech Image Technologies, LLC v. Electronics For Imaging, Inc. (Fed. Cir. 2014)," July 14, 2014
• "Cyberfone Systems, LLC v. CNN Interactive Group, Inc. (Fed. Cir. 2014)," March 3, 2014
• "SmartGene, Inc. v. Advanced Biological Laboratories, SA (Fed. Cir. 2014)," January 29, 2014
7. Supreme Court Addresses Fee Shifting Determinations in Exceptional Cases
In April, the Supreme Court issued opinions in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc. The issue in both cases centered on the attorney fee-shifting provision of 35 U.S.C. § 285. In Octane Fitness, a mostly unanimous court held that "an 'exceptional' case is simply one that stands out from others with respect to the substantive strength of a party's litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated," the Court leaving the determination of whether a case is "exceptional" to the discretion of the District Court judge. In Highmark, the Supreme Court determined that "an appellate court should apply an abuse-of-discretion standard in reviewing all aspects of a district court's §285 determination," even though "questions of law may in some cases be relevant to the §285 inquiry." The Supreme Court's decisions make it easier for a trial court to shift fees to the non-prevailing party if it believes that the litigation was brought or conducted in an abusive manner, and also make it more difficult for an appellate court to overturn such a determination.
For information regarding this and other related topics, please see:
• ""Standing Out" -- A Closer Look at the "Exceptional Case" Standard Articulated in Octane Fitness," April 29, 2014
• "Patent Trolls Beware -- Supreme Court Issues Decisions in Octane Fitness and Highmark," April 29, 2014
• "Oral Arguments in the Supreme Court Octane Fitness, LLC v. ICON Health & Fitness, Inc. Case," February 27, 2014
• "Supreme Court to Hear Oral Arguments in Attorney Fee Shifting Cases," February 25, 2014
• "Supreme Court Preview -- Highmark Inc. v. Allcare Health Mgmt. Sys., Inc.," February 19, 2014
• "Supreme Court Preview -- Octane Fitness, LLC v. ICON Health & Fitness, Inc.," February 13, 2014
Pigs Fly, Hell Has Frozen Over, and the New York Times Supports Small Inventor and University Patenting
By Kevin E. Noonan --
The column was prompted by the paradox that for some, like the Electronic Frontier Foundation, anyone who is a non-practicing entity (or NPE) and asserts a patent is a patent troll. Mr. Nocera clearly understands the received wisdom about patent trolls: they are NPEs that "use [their patents] not to further innovation or manufacture a product but to conduct a kind of legal extortion racket," based on patents that are "sometimes absurdly vague." He cites as an example the Lemelson bar code patents (which of course were never accused of being vague but this is journalism so, close enough). Patent trolls, Mr. Nocera writes, are "sand in the engine of commerce."
But it is clear that Mr. Nocera has been taken aback by the rhetoric that patent trolls should include universities because "[w]henever the university's scientists come up with innovations -- which they rarely intend to use to manufacture a product -- WARF [who licenses patents from the University of Wisconsin] applies for a patent and then seeks to license it, just as trolls do." Naively, he then states that "of course, nobody thinks a university is a patent troll" based on his (correct) understanding that "[u]niversities are supposed to come up with new ideas, not manufacture new products. That's what companies do." And he further understands that even anti-troll champions like Hastings College of Law Professor Robin Feldman recognizes the social utility of encouraging universities to license their patented technology, because it will "encourage the commercialization of new products."
The social utility could be hampered, Mr. Nocera realizes, if the bills in Congress aimed at curtailing the type of "trolling" he disparages ends up "having huge negative consequences for legitimate inventors." Or if "a series of Supreme Court rulings make matters worse, putting onerous burdens on inventors while making it easier for big companies to steal unlicensed innovations." (The latter has, of course, already happened; see "The ACLU, Working for the Man").
According to Mr. Nocera, those decisions and the AIA have created a situation where "big companies can now largely ignore legitimate patent holders." And the companies doing it "don't call it stealing"; instead, they call it "efficient infringing" according to Robert Taylor, a patent lawyer for the National Venture Capital Association. The result: the big company expropriates patented technology and then has "top-notch" patent lawyers working for it to invalidate any patent asserted against it. And "[b]ecause the courts have largely robbed small inventors of their ability to seek an injunction [] the worst that can happen is that the infringer will have to pay some money. Which, for a rich company like, say, Apple, [is] no big deal," according to Mr. Nocera. In Apple's case, the piece states that Apple has a policy, expressly stated on its website, that "the company can lay claim to any unsolicited [note, not unpatented] idea." He then describes the lawsuit between Wisconsin and Apple and the $234 million judgment the WARF obtained against Apple for patent infringement. But he mentions that this doesn't make Wisconsin whole, due to lost opportunity costs, stating that WARF didn't have the chance to license the technology exclusively to an Apple competitor, and in addition had to risk infringement litigation to obtain any recovery at all.
The piece ends with a reminder that bills remain pending in both the House and Senate that "will [] effectively tilt the playing field even further toward big companies with large lobbying budgets" and states:
For the sake of real innovation, and in the name of the small inventor, who holds a special place in America's mythology, the pendulum needs to start swinging in the other direction.
Perhaps a measure of sanity will return to the patent law debate, if the Times Op-Ed editors saw fit to publish Mr. Nocera's column. Patentees would do well to send a copy to their Senators and Representatives in Congress, and perhaps take the opportunity to engage legislators in a discussion of these issues.
Because we can be sure that those "large lobbying budgets" are not going unspent by companies engaging in "efficient infringement."
Posted at 11:34 PM in Media Commentary | Permalink | Comments (3)