Posts Tagged: "Section 112"

Amicus Filings in Biogen v. Mylan Urge SCOTUS to Eliminate Uncertainty in Drafting Patents to Satisfy Written Description Requirement

Last week, the U.S. Supreme Court received several amicus briefs filed in support of the petition for writ of certiorari filed in Biogen International GmbH v. Mylan Pharmaceuticals Inc. If cert is granted, this case will ask the nation’s highest court to clarify the written description requirement under 35 U.S.C. § 112. The appeal follows a contentious decision this March from the U.S. Court of Appeals for the Federal Circuit to deny panel rehearing and rehearing en banc of an earlier ruling affirming the Northern District of West Virginia’s invalidation of Biogen’s patent claims covering a method of treating multiple sclerosis (MS) under Section 112.

Petitioner Distances Eligibility Case from American Axle, Imploring SCOTUS to Weigh in on ‘Quasi-Enablement’ Analysis

Interactive Wearables, the petitioner in yet another patent eligibility case that the U.S. Supreme Court is being asked to review, filed a reply brief on July 11 distancing its petition from that of American Axle & Manufacturing, Inc.’s, which was denied certiorari on June 30, 2022. The brief characterizes U.S. patent eligibility doctrine as being “perilously fractured” and narrows its arguments to focus on the third question presented in its petition, since the first two were addressed, and have now been rejected by the Court, in the American Axle case.

CAFC Vacates Section 112 Indefiniteness Ruling, Sending St. Jude Medical Back to Court

On April 11, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Niazi Licensing Corp. v. St. Jude Medical S.C., Inc. in which the court affirmed most of a ruling from the District of Minnesota, including sanctions against Niazi for improper use of expert testimony, as well as a finding of no induced infringement by St. Jude on one of Niazi’s asserted patent claims. However, the Federal Circuit’s decision reversed the Minnesota district court’s ruling invalidating most patent claims asserted by Niazi for indefiniteness under Section 112. The CAFC found that Niazi’s asserted claims were not invalid simply for including descriptive words or terms of degree, as long as the intrinsic record and extrinsic evidence enable a skilled artisan to identify the boundaries of a claim’s scope.

O’Malley Dissents from ‘Concerning’ CAFC Ruling that Biogen’s MS Drug Patent is Invalid

The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.

IPWatchdog LIVE ‘Jurassic Patents’ Panel Explores Patenting Challenges for Life Sciences Innovation

On the final day of IPWatchdog LIVE last week, a panel titled “Jurassic Patents: Genetic Engineering and the Future of Life Science Innovation,” moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, examined the challenges of patenting discoveries in the life sciences in light of recent legal developments. The panel included patent litigator and partner at Akin Gump, Dr. Rachel Elsby, patent prosecutor and shareholder with Volpe Koenig, Dr. Douglas Bucklin, and food and drug lawyer and counsel at McGuire Woods, Kae Gruner.

Tillis and Cotton Urge Hirshfeld to Adopt Pilot Program to Address ‘Inherently Vague and Subjective’ Eligibility Analyses

Senators Thom Tillis (R-NC) and Tom Cotton (R-AR) sent a letter on Monday to the acting Director of the United States Patent and Trademark Office (USPTO), Drew Hirshfeld, asking him to “initiate a pilot program directing examiners to apply a sequenced approach to patent examination,” rather than the traditional “compact approach.” This proposed pilot program would require a select group of examiners and applicants who elected to participate in the program “to engage in a full examination of the grounds of patentability and then, once that process is complete, a full examination of the grounds of eligibility.”

CAFC Affirms Section 112 Invalidation/ Non-Infringement in Synchronoss v. Dropbox Dispute

On February 12, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court’s conclusion of invalidity under Section 112 and/or non-infringement in Synchronoss v. Dropbox. Synchronoss had appealed the district court’s decision that the asserted claims, which were “drawn to technology for synchronizing data across multiple devices” are either invalid under 35 U.S.C. Section 112 for indefiniteness, or not infringed.” Meanwhile, Dropbox cross-appealed, arguing that the claims are patent ineligible subject matter under Section 101. The patents at issue are U.S. Patent Nos. 6,671,757; 6,757,696; and 7,587,446.

Time to Wake Up: Stakeholders Must Compromise to Save the U.S. Patent System

Things are bad for many innovators and there is little hope for improvement on the foreseeable horizon. Despite the best efforts of Senator Thom Tillis (R-NC) and Senator Chris Coons (D-DE), efforts to reform America’s patent system for the better have stalled to the point that the Senate IP Subcommittee is moving on from patent matters and will focus on copyright reform throughout 2020. “Given the reasonable concerns that have been expressed about the draft as well as the practical realities of the difficulty of passing legislation, absent stakeholder consensus I don’t see a path forward for producing a bill—much less steering it to passage—in this Congress,” Senator Tillis told the Intellectual Property Owners Association in an interview published earlier today. Sources tell IPWatchdog that it is not inconceivable that the Subcommittee will steer back toward patent issues – namely patent eligibility reform – but disagreement among the interested constituencies has shelved any hope for patent eligibility reform. Shockingly, the disagreement that has shelved the long-awaited legislative fix for 35 U.S.C. 101 is among those who support reform. It seems the various constituencies that want 101 reform have their own demands and – if you can believe it – would prefer no change to a change that doesn’t give them 100% of what they are seeking.

The Most Common Design Patent Application Rejections (and How to Avoid Them) – Part I

As one of about 46,000 registered practitioners in the United States, most of us are unfortunately too well acquainted with Section 101, 102, and 103 rejections from the U.S. Patent and Trademark Office (USPTO). But it may be surprising that most rejected design patent applications are not rejected under these sections. Instead, the least favorite number of the design patent practitioner is 112. While Section 112 rejections on utility applications are generally easily overcome, that is often not always the case with such rejections on design applications. Since there are only about 30,000 design applications issued each year, each of the 46,000 registered practitioners handle on average less than one design application per year! So, for those unfamiliar with the quirks of design patent practice, which is most of us, and since design patent applications have a relatively high allowance rate of 84% (see the USPTO Data Visualization Center/Design Data page, it might be tempting to rely on your patent draftsperson to prepare what they think are adequate drawings, copy the mostly boiler-plate specification language, and just file the application. But that can be a costly mistake.

Federal Circuit Invalidity Determination for Idenix Underscores Continuing Intra-Circuit Split

One day before the now-famous Arthrex decision was issued, the U.S. Court of Appeals for the Federal Circuit (CAFC) decided an appeal by Idenix Pharmaceuticals LLC and Universita Degli Studi Di Cagliari (collectively “Idenix”) against Gilead Sciences, Inc. (Gilead) that reiterates the extent to which the Court is split in its approach to so many issues. The precedential opinion was authored by Chief Judge Prost, with Judge Newman dissenting. In 2013, Idenix sued Gilead for infringement of U.S. Pat. No. 7,608,597 (the ‘597 patent), which claims a drug directed to the treatment of the hepatitis C virus (HCV). In response, Gilead argued that the ‘597 patent was invalid for failure to meet the written description and enablement requirements. At trial, the jury found for Idenix and upheld the validity of the patent. Gilead filed a renewed motion for Judgment as a Matter of Law (JMOL) on the written description and enablement requirements, and the court granted the motion only on enablement grounds, thus holding the patent invalid. The decision overturned the jury’s award to Idenix of $2.5 billion.

Examining the Unforeseen Effects of the USPTO’s New Section 112 Guidelines

When the USPTO issued its 2019 Revised Patent Subject Matter Eligibility Guidance in January of this year, it seemed as if the patentability tides had finally shifted in favor of software applicants. Far less attention and fanfare, however, was afforded to the concurrently issued and unassuming Section 112 Guidelines on examination practice for computer-related and software claims. In particular, potential pitfalls awaiting software applicants may lie unforeseen in the requirement that “[f]or a computer-implemented 112(f) claim, the specification must disclose an algorithm for performing the claimed computer function, or else the claim is indefinite.” 

Urge Congress to Keep the Established and Efficiently Working Sections 100 and 112 of the U.S. Patent Act

Now that the Senate Subcommittee on Intellectual Property has concluded its hearings on patent eligibility reform, it appears that the draft changes to Sections 100 and 112 are the last great danger in the overall patent eligibility debate and we must not let our guard down. A new version of the bill is due out sometime after the July 4 holiday; please send the following text with any of your edits to IntellectualProperty@tillis.senate.gov.

Perspective: Weakening Alice Will Weaken the U.S. Patent System’s Second Engine of Innovation

Today is Alice’s fifth birthday; some may not be celebrating, but as a birthday gift, John Vandenberg argues the decision was not new law and should not be abrogated. – On the third day of the U.S. Senate Judiciary Committee – IP Subcommittee’s hearings this month on whether to radically revise the standards for patent eligibility, I testified on behalf of our patent system’s under-appreciated second engine of innovation. Below are some of the key arguments I made in my oral and written testimony and my thoughts on why the Alice Corp. v. CLS Bank decision was good law that should not be abrogated. Much of the anti-Alice commentary touts our patent system’s first engine of innovation, which uses the lure of monopoly profits or royalties to incentivize innovation and the public disclosure of those innovations. Today’s Sec. 101 jurisprudence is said to harm that first engine of innovation, particularly in life sciences where it is easier to get a patent in Europe and China than in the U.S., causing investment in personalized therapy and medicine R&D in the U.S. to suffer. While some question those factual premises, the “101 status quo” camp primarily responds that Alice (along with IPRs) has curtailed abusive patent troll litigation, cutting patent litigation costs by 40% or more. But, another important point has received little attention: expanding what can be patented, and how claimed, risks harming our patent system’s second engine of innovation.

Congress’ Section 101 Fix Would Create a 112(f) Problem

Senators Coons and Tillis and a group of Representatives recently proposed an admirable piece of legislation to amend the Patent Act to abrogate Supreme Court Section 101 cases on patent eligible subject matter. I like that they propose a fix to Section 101. So far, so good. Alice was an interpretation of Mayo, which was an interpretation of Flook, which was an interpretation of Benson, which was supposed to be an interpretation of what Congress meant by the short and crisp statement of Section 101 of the Patent Act. But just as a photocopy of a photocopy of a photocopy gets more distorted with each generation, so did Supreme Court rulings. The judicially-invented residue left behind not only errs by failing to capture the plain and unambiguous scope of Section 101 and patent-eligible subject matter, but also catastrophically undermines and invalidates important patents that, until then, protected breakthrough inventions. Congress is right to step in. Inventors of breakthroughs need protections to form companies and create new jobs. What the senators propose is not perfect, but at least as far as Section 101 is concerned, will restore fairness to many future outcomes.But there’s an extra bit. To call it alarming would be an understatement. That extra bit would sharply and sweepingly limit the property rights of all technology patents. The proposal (as currently drafted) amends Section 112 to require any patent claim limitation that names any function “without the recital of a structure, material or act in support thereof” to be interpreted as limited to the structural embodiment in the patent specification that practices that function (plus equivalents).

Pinning False Blame of Lack of Enablement In Issued Patents On the USPTO

Last week, the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, held an oversight hearing on the U.S. Patent and Trademark Office (USPTO) with Director Andre Iancu as the sole witness. A particular inquiry from Rep. Zoe Lofgren (D-CA) regarding the USPTO’s allegedly lax examination quality under 35 U.S.C. § 112 caught my attention. She remarked [at 1:33:30]:  “Theranos, the blood testing company whose founder is being investigated for fraud, was granted nearly 100 patents based on an invention that didn’t work; and it concerns me that a patent application for an invention that doesn’t work gets approved.”  She generally questioned examiners’ attention to Section 112 requirements. Rep. Lofgren’s statement was no doubt primed by information from the Electronic Frontier Foundation (EFF) in the Ars Technica blog post titled “Theranos: How a broken patent system sustained its decade-long deception.” In this article, the author, who was introduced as holding the “Mark Cuban Chair to Eliminate Stupid Patents” at EFF, declares with no evidence or proof, that the “USPTO generally does a terrible job of ensuring that applications meet the utility and enablement standards.” The article cited no study, identified no patent, nor any claim to any “invention that didn’t work.” This outrageous, baseless allegation is outright reckless and irresponsible.