Posts Tagged: "patents"

On Monday, April 1, the Court of Appeals for the Federal Circuit issued a decision in Cleveland Clinic Foundation v. True Health Diagnostics affirming the invalidity of patents covering medical diagnostic tests for determining a patient’s risk for cardiovascular disease. The decision, which is nonprecedential and was decided along similar lines to another 2017 decision between the two parties, is yet another depressing sign that U.S. patent law is woefully inadequate when it comes to supporting important innovations in the biotech fields. Of particular note is the Federal Circuit’s finding against Cleveland Clinic’s argument that the district court didn’t give appropriate deference to subject matter eligibility guidance published by the U.S. Patent and Trademark Office (USPTO) as required by the U.S. Supreme Court’s 1944 decision in Skidmore v. Swift & Co. Although this argument related to USPTO guidelines published in 2016, it would seem to call into question the USPTO’s more recent revised subject matter eligibility guidance issued earlier this year by USPTO Director Andrei Iancu. This gives voice to fears that the “Iancu Effect” on subject matter eligibility won’t matter much if the Federal Circuit and other courts don’t adhere to the USPTO’s views on patent eligibility under Section 101.

This week in Other Barks & Bites: a trio of U.S. Senators introduce a bill for countries and municipal governments that want to register trademarks; Williams-Sonoma and Amazon go to court in trademark case over rights to resell merchandise; Apple wins a ruling that ends a seven-year long dispute over the iPad trademark; Prenda Law attorney at the center of a copyright settlement mill scheme could receive a prison term of 12.5 years; the Kardashians avoid an adverse ruling in a trademark case over the Khroma cosmetic line; the World Intellectual Property Organization unveils new AI-powered tools for trademark searches; and Poland’s ruling conservative party indicates freedom of speech concerns over the new EU copyright reforms.

During a break at IPWatchdog’s recent Patent Masters™ Symposium, former Federal Circuit Chief Judge Paul Michel went on record to express his grave concerns about the U.S. patent system and where he believes it’s headed. Like many of the Patent Masters, Michel’s view was decidedly grim, but he did express optimism about the new IP leadership in Congress. Following are Judge Michel’s remarks in full.

The Federal Circuit recently vacated a district court decision which found a patent for the antipsychotic drug “Saphris,” belonging to Forest Laboratories (Forest), valid as nonobvious, but not infringed by ANDA filers Alembic Pharmaceuticals Ltd. (Alembic) and Breckenridge Pharmaceuticals, Inc. (Breckenridge). See Forest Labs., LLC v. Sigmapharm Labs., LLC, Nos. 2017-2369, 2017-2370, 2017-2372, 2017-2373, 2017-2374, 2017-2375, 2017-2376, 2017-2389, 2017-2412, 2017-2436, 2017-2438, 2017-2440, 2017-2441, 2019 U.S. App. LEXIS 7485 (Fed. Cir. Mar. 14, 2019) (Before Prost, Dyk, and Moore, J.) (Opinion for the court, Moore, J.). The Court highlighted an unanswered question that the district court skimmed over at trial and took issue with a claim construction. The Court vacated and remanded for further proceedings on this basis. Alembic and Breckenridge were among a number of drug manufacturers that filed Abbreviated New Drug Applications (ANDA) to market generic versions of Saphris. Saphris is an antipsychotic containing asenapine maleate. Saphris is administered sublingually, meaning under the tongue. Forest sued the ANDA filers for patent infringement. At trial, the district court held that the relevant claims of asserted Patent No. 5,763,476 (“the ’476 patent”) were not invalid as obvious, and that Forest had not established infringement by Alembic or Breckenridge. Alembic and Breckenridge appealed the invalidity determination, and Forest cross-appealed the non-infringement decision as clearly erroneous. On appeal, the Federal Circuit vacated and remanded both the validity and infringement determinations for reconsideration under a correct claim construction of the term “excitation.”

Inequitable conduct remains the most powerful defense to patent infringement. In contrast to other defenses to patent infringement that require a claim-by-claim analysis, the defense of inequitable conduct is global. A finding of inequitable conduct renders the entire patent unenforceable. For this reason, the U.S. Court of Appeals for the Federal Circuit has referred to the defense of inequitable conduct as the “atom bomb of patent law” Aventis Pharma S.A. v. Amphastar Pharmaceutical, Inc., 525 F.3d 1334, 1349 (Fed.Cir.2008). Given the tremendous impact of the inequitable conduct defense, the Federal Circuit, in Therasense, Inc. v. Becton, Dickinson and Co., 649 F. 3d 1276 (Fed. Cir., 2011), has significantly increased the burden on patent infringers who assert this defense. Rather than needing to prove materiality in the context of 37 C.F.R. § 1.56 and intent to deceive, Therasense now requires an infringer prove “but for” materiality and a specific intent to deceive—a much higher burden than before. To the disappointment of those who believed that Therasense would spell the demise of inequitable conduct, this defense to patent infringement remains alive and well, although less prevalent than before. See Energy Heating, LLC v. Heat On-The-Fly LLC, 889. F.3d 1291 (Fed. Cir. 2018). Moreover, the Federal Circuit, in Gilead Sciences, Inc. v. Merck & Co. 890 F.3d 1231(Fed. Cir 2018), now seems to recognize an equitable defense (“business misconduct”) separate from inequitable conduct to penalize patentees for unethical behavior committed outside of the confines of patent prosecution before the United States Patent and Trademark Office (USPTO).

In ChargePoint Inc. v. SemaConnect, Inc., (2018-1739) the Federal Circuit inexplicably stated in its opinion that “[i]t is clear from the language of claim 1 that the claim involves an abstract idea—namely, the abstract idea of communicating requests to a remote server and receiving communications from that server, i.e., communication over a network.”  The Court further stated, “[w]e therefore continue our analysis to determine whether the focus of claim 1, as a whole, is the abstract idea. As explained below, we conclude that it is.” In reaching this conclusion, the panel rationalized that “the broad claim language would cover any mechanism for implementing network communication on a charging station, thus preempting the entire industry’s ability to use networked charging stations. This confirms that claim 1 is indeed “directed to” the abstract idea of communication over a network to interact with network-attached devices.” As an electrical engineer and patent attorney, I am truly perplexed by this statement. Claim 1 recites numerous physical electrical components, a control device (on/off switch), transceiver to communicate with a remote server and a controller to activate the on/off switch based on communications from the server. The configuration of the components may be anticipated or obvious under the patent statute based on prior art, but they are anything but abstract and do not preempt all ways of charging a vehicle using a network. Congress specifically stated in 35 U.S.C. 101 that there are four statutory categories of patentable subject matter: process, machine, manufacture, or composition of matter. If claim 1 is not a machine, I don’t know what is.

On March 8, Foster Pepper filed a petition for certiorari with the Supreme Court, case number 18-1199, challenging the Federal Circuit’s emerging “physical realm” test as part of its Alice/Section 101 analysis. Amicus briefs in support of our cert petition are most welcome to assist the Court’s understanding of why it is important to grant cert and clarify the correct patent eligibility test for computer-implemented inventions. We are also seeking amicus brief writers for the many amici we have already secured. These efforts will help clear up the uncertainty innovators and patent holders face in cutting-edge fields of our modern economy and, as a result, help drive innovation forward. 

It is safe to say that Artificial intelligence (AI) and Machine Learning (ML) are hot topics and, as with any rapidly growing technological area on the industry side, there is also a rapidly growing number of patent applications being filed.In view of this, the European Patent Office (EPO) issued new guidance for examination for AI and ML patent applications in November 2018. Meanwhile, in January 2019, the U.S. Patent and Trademark Office (USPTO) also issued revised guidance directed to what constitutes patent eligible subject matter under 35 U.S.C. §101. Although the USPTO’s revised guidance is more generally directed to software applications, at least one of the accompanying hypothetical examples (Example 39) is directed to the AI and ML space. Therefore, while there may be lingering concerns that AI and ML inventions will face extra scrutiny toward patentability due to their software-centric nature, the extra attention that the EPO and USPTO are paying toward AI and ML will likely help swing the pendulum of patentable subject matter toward a place that is in harmony with the current state of technology. The below analysis reviews the recent developments by the EPO and the USPTO to provide specific guidance on the topic of AI and ML.

This week on Capitol Hill will include a series of hearings related to tech and innovation topics on Tuesday at the House of Representatives, where debate will focus on the 2020 budget for NASA and the National Institutes of Health, as well as on technology issues at Veterans Affairs. Senate hearings will take a look at Alzheimer’s research and funding for the Department of Energy. On Wednesday, the Senate IP Subcommittee will hold a hearing to look at gender diversity issues in the U.S. patent system. Elsewhere in D.C., the Cato Institute will look at Medicare drug pricing issues, a topic which has increasingly included discussion of patents, and the American Enterprise Institute will consider consumer data privacy issues in a two-hour event featuring officials from the Federal Trade Commission and Department of Justice.

This week in Other Barks & Bites: Karyn Temple is appointed Register of Copyrights; the International Trade Commission recommends excluding certain iPhone models for infringing Qualcomm patent claims; the EU approves new copyright rules which will affect online media platforms; Senators Tillis and Coons move forward with stakeholder discussions on a legislative fix to Section 101 of patent law; Peloton responds to copyright infringement suit by dropping online cycling classes; Amazon adds nearly 1,000 jobs in Austin, TX; the District of Delaware tosses out willful infringement claims against Intel; and Oracle files opposition asking Supreme Court to deny a petition for writ filed by Google.

There is little doubt that the way intellectual property is viewed and protected has transformed over the last 12 years, at least in the eyes of those who strategically appreciate both the importance and limitations of rights available today. Once upon a time, corporations would seek to patent as much innovation as possible, working to obtain gargantuan patent portfolios. These gargantuan patent portfolios often provided protection in numbers, and not necessarily in quality. But with the Supreme Court becoming more interested in patents since 2007, and with decisions in KSR, Bilski, Myriad, Mayo and Alice, many of these gigantic portfolios were reduced to rubble. There were several very large technology companies that led the charge both in the courts and on Capitol Hill to change U.S. patent laws in a way that many believed would weaken patent rights and ultimately the patent grant itself. These companies enjoyed tremendous success, and today, U.S. patent laws simply do not look anything like they did a mere 12 years ago. This became indisputably clear last year when the U.S. Supreme Court decided Oil States and said that a patent is merely a government franchise, which shocked many observers.

IPWatchdog’s most recent Patent Masters™ Symposium, held Monday and Tuesday March 25-26 in Washington, D.C., examined the state of the U.S. patent system and how we arrived here. Some concluded that Congress, rather than the courts, must take action to resolve the many conflicts that presently exist in the muddled judicial approach to patents that has been developed over the last two decades or the U.S. patent system will become irrelevant. While the mainstream narrative traditionally has held that patents impede innovation by making access to technology too difficult or expensive, the narrative that unfolded over the two days of discussions with some of the leading legal experts in the field told quite an opposite tale. Institutions such as the Cleveland Clinic are closing up their diagnostics shops due to uncertainty around Section 101 law in that area, and small businesses are unable to secure funding due to the many risks and expenses surrounding patent enforcement in a post-America Invents Act environment. These developments demonstrate that patents are vital to economic prosperity and that weak patents result in medical and other technologies simply not being made here. Many of the Masters lamented the fact that China and Europe currently have more reliable patent systems than the United States, precisely because those countries have begun to copy the previous U.S. approach, while we stray farther away from it. Alden Abbott, General Counsel of the U.S. Federal Trade Commission, delivered a keynote speech in which he emphasized that uncertainty around the ability to obtain patents is also harming the U.S. competitive process.

Artificial Intelligence (AI) patents have made a strong comeback under the new 2019 Revised Patent Subject Matter Eligibility Guidance. As the first graph above shows, allowances per office action have gone from an average of 15% before the guidance to 38% after the guidance. The increase occurred almost immediately after examiners were trained on the new guidance in January. For AI inventors concerned about the impact of the old Alice guidelines on the examination of AI-related applications, it looks like more hopeful times are ahead. The situation is grimmer for finance patents. The new guidance has not had any significant effect on allowances per office action. I reviewed a number of recent office actions under the new guidelines to see where the problem might be. It appears that most examiners in the finance art units 3691 to 3697 consider any improvement to a computer implemented financial process to be nothing more than an abstract idea. It doesn’t matter how novel or sophisticated the algorithms might be. The Patent Trial and Appeal Board has been backing up this examiner perspective, with the affirmance rate for related appeals being more than 90%.

In Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, the Federal Circuit reversed the decision of the United States District Court for the Southern District of California, which had held that a series of patents owned by Natural Alternatives International, Inc. (“Natural Alternatives”) were directed to laws of nature and lacked an inventive concept sufficient to render them patent eligible under 35 U.S.C. § 101. Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, No. 18-1295, 2019 U.S. App. LEXIS 7647 (Fed Cir. March 15, 2019) (Before Moore, Reyna, and Wallach, Circuit Judges) (Opinion for the Court, Moore, Circuit Judge) (Concurring-in-part and dissenting in part, Reyna, Circuit Judge). The patents at issue were directed to the use of beta-alanine in dietary supplements to “increas[e] the anaerobic working capacity of muscle and other tissue.” After Natural Alternatives asserted the patents in multiple lawsuits in California, Creative Compounds, LLC (“Creative Compounds”) moved for judgment on the pleadings. The district court granted the motion. In performing its eligibility analysis, the district court accepted Natural Alternatives’ proposed claim construction and held that the asserted claims were patent ineligible. Natural Alternatives appealed, and the Federal Circuit reversed and remanded.