Posts Tagged: "USPTO"

In November, the Federal Circuit issued an opinion reversing the Patent Trial and Appeal Board’s (the PTAB or the Board) decision that claim 8 of IPR Licensing Inc.’s (IPRL) wireless communications patent—U.S. Patent No. 8,380,244 (the ‘244 Patent)—was unpatentable as obvious. The Board’s obviousness finding as to claim 8 was erroneous as it relied on a prior art reference that IPRL could neither anticipate nor rebut. Furthermore, its finding was, for the second time, unsupported by substantial evidence. See In re IPR Licensing, Inc. (Fed Cir. Nov. 22, 2019) (Before Newman, O’Malley, and Taranto, Circuit Judges) (Opinion for the Court, O’Malley, Circuit Judge).

Drug innovators are providing much needed focus on rare diseases and, at the same time, leveraging early-stage rare disease results to facilitate down-stream market entry in broad-spectrum diseases. This paper provides a data-based demonstration of how early- and mid-stage pharmaceutical companies are using the Orphan Drug Program—in combination with pursuing patent portfolio protection—to secure investment and de-risk their platforms, thus lowering the financial barrier for expanding their product pipeline. The Orphan Drug Program—which is available for drugs that treat diseases affecting fewer than 200,000 patients annually in the United States—provides a number of incentives that can lower the barrier for successfully getting a drug to market. For instance, due in part to the reduced size of clinical trials associated with rare diseases, gaining regulatory approval for treating rare diseases is widely perceived to be simpler and more cost-effective than gaining approval for broad-spectrum diseases. Indeed, the Food and Drug Administration (FDA) allows a number of alternative clinical trial designs to meet approval standards, and orphan drugs are also more likely to qualify for expedited review and approval procedures. On top of this, orphan drugs are eligible for a 25% tax credit for clinical trial expenses (which can be claimed up to 20 years after receipt of the designation, and can in some instances be applied to offset payroll taxes), eligibility for research grants, waiver of FDA user fees, and a seven-year post-approval market exclusivity.

Since the passing of the America Invents Act (AIA) and the implementation of the inter partes review (IPR) process, IPR has become a popular and important avenue for companies and individuals to challenge the validity of a patent in an administrative proceeding through the U.S. Patent and Trademark Office (USPTO). In the past five years, patent owners and challengers alike have presented new and sometimes novel challenges to the way the Patent Trial and Appeal Board (PTAB), comprised of a panel of administrative law judges that review and decide cases, conduct trial proceedings, causing the PTAB to reevaluate and tweak the process along the way. Building on the scores of changes and interpretations the PTAB has made since the first AIA trial, the USPTO provided guidance in August 2018 and more recently in July 2019 summarizing and clarifying how the PTAB handles the IPR process.  On November 20, 2019, the Patent Office issued a consolidated Office Patent Trial Practice Guide (“Practice Guide”) incorporating the updates from August 2018 and July 2019, providing practitioners with a single streamlined blueprint for the overall review process.

The Supreme Court ruled in Peter v. NantKwest today that the U.S. Patent and Trademark Office (USPTO) cannot recover the salaries of USPTO attorneys and paralegals who work on civil actions against the USPTO Director in the Eastern District of Virginia. The Court held that the language of Section 145 of the Patent Act, which says that applicants must pay all the expenses of the proceedings for a civil action, “does not overcome the American Rule’s presumption against fee shifting.” The USPTO argued that the Federal Circuit’s en banc 2018 decision holding “all expenses” does not include “expenses that the USPTO incurs when its employees, including attorneys, defend the agency in Section 145 litigation,” is inconsistent with the ordinary meaning of  “expenses” and Section 145’s “history and purpose.”

The Supreme Court heard oral arguments on Monday in Thryv, Inc. v. Click-to-Call Technologies. The case asks the nation’s highest court whether 35 U.S.C. § 314(d)—which states that decisions to institute inter partes review (IPR) proceedings shall not be appealable—permits appeals of PTAB institution decisions based upon 35 U.S.C. § 315(b)— which states that IPRs won’t be instituted if the patent owner served the petitioner with a complaint for patent infringement more than one year prior to the petition. The U.S. Court of Appeals for the Federal Circuit ruled in August 2018 in a panel rehearing that the Patent Trial and Appeal Board (PTAB) had “committed legal error” in rendering its determination that an IPR petition challenging claims of Click-to-Call’s patent was not time-barred under Section 315(b). All 12 judges joined a footnote finding that the Section 315(b) time bar applies even when the earlier infringement action had been voluntarily dismissed without prejudice. Here is what those who have reviewed the transcript of Monday’s oral arguments had to say

On November 27, briefing concluded at the Supreme Court with the filing of Fossil’s respondent’s brief in Romag Fasteners, Inc., v. Fossil, Inc., et al. The final briefing sets the stage for the Court to hear the case on January 14, 2020. The Court will hopefully resolve a current Circuit split on the availability of disgorgement of profits as damages for trademark infringement. Currently, the First, Second, Eighth, Ninth, Tenth and D.C. Circuits all require willful infringement before allowing disgorgement of an infringer’s profits (the First Circuit requires willfulness if the parties are not direct competitors and there is also some disagreement on where the Eighth Circuit falls on the issue). The Third, Fourth, Fifth, Sixth, Seventh and Eleventh Circuits all allow for disgorgement of profits without willful infringement. There has been a Circuit split for some time on this issue and the Supreme Court previously denied certiorari on similar cases but the Court is now set to resolve the split.

On Monday, December 9, the U.S. Supreme Court will hear oral arguments in Thryv, Inc. v. Click-to-Call Technologies, LP. The case, which has gone through multiple name changes since its original appeal from the Patent Trial and Appeal Board (PTAB), will ask the nation’s highest court whether 35 U.S.C. § 314(d), which states that decisions to institute inter partes review (IPR) proceedings shall not be appealable, permits appeals of PTAB institution decisions based upon 35 U.S.C. § 315(b). Section 315(b) states that IPRs won’t be instituted if the patent owner served the petitioner with a complaint for patent infringement more than one year prior to the petition. To summarize the lower court proceedings in this case, the patent-at-issue was first asserted against Keen Inc. by Inforocket.com in 2001 in a case that was voluntarily dismissed. Click-to-Call acquired the patent and asserted it in 2012 against Ingenio, a company formed through a merger of Keen and Inforocket.com. Ingenio filed for an IPR petition and Click-to-Call challenged it based on the Section 315(b) time-bar and the former suit against Ingenio’s predecessor. The appeal reached the Supreme Court, where it was remanded in June 2016 in light of Cuozzo Speed Technologies v. Lee. Most recently, the U.S. Court of Appeals for the Federal Circuit rendered a decision last August where all 12 Federal Circuit judges joined a footnote finding that the Section 315(b) time bar applies even when the earlier infringement action had been voluntarily dismissed without prejudice.

This week in Other Barks & Bites: the U.S. Supreme Court hears oral arguments over copyright status of the Official Code of Georgia Annotated; the Federal Circuit remands Ericsson appeal to calculate release payment in patent license; Apple, Ford and others urge the USPTO to retain policy against injunctions on companies practicing SEPs; Huawei asks the Fifth Circuit to undo the FCC’s ban preventing it from supplying U.S. networks; Sergey Brin and Larry Page relinquish executive duties at Google; U.S. antitrust regulators explore Amazon’s cloud business; Washington politicians send letter to ALI over Copyright Restatement Effort concerns; and Qualcomm challenges Judge Koh’s class action certification at the Ninth Circuit.

Senator Thom Tillis (R-NC) yesterday led a hearing of the Senate Committee on the Judiciary’s Subcommittee on Intellectual Property titled “Fraudulent Trademarks: How They Undermine the Trademark System and Harm American Consumers and Businesses.” The hearing included five witnesses from academia, private practice and the business community who testified on ways to declutter the U.S. trademark register, curb fraudulent trademark filings from China, and improve current mechanisms for enforcing trademarks in U.S. courts, among other topics. All agreed that the U.S. Patent and Trademark Office’s (USPTO’s) August rule change requiring that foreign trademark applicants use U.S. counsel has likely only temporarily helped to ebb the flow of fraudulent filings from China, as bad actors are already adjusting their strategies.

Earlier this month, Mallinckrodt succeeded in its inter partes review (IPR) challenge against patent owner Biovie, Inc. (Biovie). The Patent Trial and Appeal Board’s (PTAB’s) final determination held that all claims of Biovie’s U.S. Patent No. 9,655,945 (the ‘945 patent) were unpatentable. The claims of Biovie’s ‘945 patent, directed to administering terlipressin to ascites (abnormal buildup of fluid in the abdomen) patients, were deemed anticipated and/or obvious over the prior art. During the IPR, Biovie attempted to use the recent Federal Circuit decision from OSI Pharmaceuticals v. Apotex (OSI) as a shield to patentability, but the shield was unsuccessful. As such, OSI is unlikely to be a cure-all for pharmaceutical method of treatment claims, in IPR proceedings or otherwise.

During this turbulent era in the history of the U.S. patent system, many enterprises have pursued new models for IP strategy and execution. Others have taken a wait-and-see, business-as-usual tack. Change certainly is no stranger to patent systems around the world. Yet, some principles remain timeless and unassailable no matter how winds may shift. For example, we all can agree that patent filing and maintenance decisions should be sound, protecting the right technologies in the right places for the right reasons. Technology companies face patent-related decision points around seemingly every corner. The consequences of suboptimal decision-making are troubling, including wasteful expenditures, missed strategic opportunities, and diminished shareholder value. Therefore, enterprises should not hesitate to continually reflect on the quality of their patent filing and maintenance decisions, and on the framework that supports them. Cognitive bias—defined as “the collection of faulty ways of thinking … hardwired into the human brain”—can hijack patent decision processes just as it does every other area of human endeavor. As such, it can lead to suboptimal outcomes despite IP stakeholders’ sincere, dedicated participation.

On November 13, the United States Patent and Trademark Office (USPTO) requested the U.S. Court of Appeals for the Federal Circuit suspend all consideration of an appeal from the Patent Trial and Appeal Board (PTAB) that would raise the same issues addressed in Arthrex, Inc. v. Smith and Nephew, Inc., because the Office will seek rehearing en banc in Arthrex. See Stuben Foods, Inc. v. Nestle USA, Inc., No. 20-1082, -1083. As a reminder, on October 31, the Federal Circuit issued an important constitutional decision in Arthrex, which found that the hiring of Administrative Patent Judges (APJs) violated the Appointments Clause of the U.S. Constitution. The Federal Circuit did, however, attempt to provide a gift to the Office by rewriting the section of the statute they found to create the problem, which created the PTAB and the appointment of APJs, and by so doing turned APJs into inferior officers. The solution: APJs were judicially decreed to be employees-at-will in order to save the statute. So, why hasn’t Director Iancu cleaned house at the PTAB? It would seem to be because the USPTO believes Arthrex was wrongly decided.  

My company, Chestnut Hill Sound Inc. (ChillSound), has been victimized by a U.S. patent system that for nearly a decade has been in a sorry state. Changes wrought by the America Invents Act (AIA) in 2011 and other recent developments cost my company, its investors and inventors millions of dollars. These changes have allowed a large company to reap great profits at our expense. Even more unfortunately, our story is too typical of many other inventors and small companies. Small businesses are the backbone of our economy and need to be cultivated, as they are the most dynamic source of new jobs and competitive products and technologies. There have always been reports of large corporations stealing inventions from small businesses, but it used to be possible via the courts to vindicate the patent rights of owners and obtain ultimate redress.  The AIA—sold by the “efficient infringers” lobby as a measure to protect big business from the expense and nuisance of so-called “patent trolls”—has turned into a weapon of deep-pocketed big businesses that enables them to steal with impunity inventions from small businesses and independent inventors. The AIA brought with it the Patent Trial and Appeal Board (PTAB) and Inter Partes Review (IPRs), a post-grant adversarial proceeding at the United States Patent and Trademark Office (USPTO). As has been amply discussed here on IPWatchdog, the Court of Appeals for the Federal Circuit (CAFC) recently opined that the so-called Administrative Patent Judges (APJs) were unconstitutionally appointed from the beginning. Yet these unconstitutionally appointed APJs continue to kill patents, especially when the patent owner is a small company that has sued a large company for infringement, as was the case with ChillSound.

It is not unusual for there to be unintended consequences in the law or life. A loved one gives you something you don’t really like, but you do such a good job of feigning happiness that it becomes a regular gift. Who knew you could ever have too many “lovely” ties or too much single malt Scotch? Congress is in the process of giving the patent bar some welcome relief on some important issues, but may be throwing in that unwanted gift along with it. The STRONGER Patents Act intends to address the potential for inconsistent rulings between district court cases and inter partes reviews (IPRs). The Act achieves this by expressing a preference for district court rulings and by requiring IPRs to apply the same standards for validity determinations that are used in the district court. This is already the case by USPTO regulation with respect to claim construction, but the Act would make it statutory for both claim construction and validity, and thus not subject to change by the USPTO. While the use of the same standard for validity in both forums will make the rulings more consistent, the statutory preference for the district court over the IPR may have an unintended consequence.

Since inventors are rarely allowed to participate in patent discussions in Congress, I would like to submit my testimony here. In Arthrex, the Federal Circuit in effect decided that our rights are subordinate to the government, so the government has the authority to giveth them to us or taketh them away. I would like to remind the Federal Circuit, the Supreme Court, and Congress that you are tasked with the honor, privilege and duty to defend our rights. That is the very basis on which you are employed, and you have no function other than that. Our rights preexist you, supersede you, and come from sources that are above your pay grade. They exist as a matter of our birth. You have no legitimate authority to take those rights just because it is inconvenient for the huge multinational corporations that have to now deal with the illegitimate position of owning our rights because so-called judges unconstitutionally took them from us and gave them to those huge corporations.