Posts in Patents

Just as the drug pricing debate on Capitol Hill is heating up, an important new study, “The Bayh-Dole Act’s Vital Importance to the U.S. Life-Sciences Innovation System,” published by the Information Technology & Innovation Foundation (ITIF), underscores the law’s contribution to the United States’ lead in the life sciences. The report warns that attempts to misuse the march-in rights provision of the law to control drug prices would have serious consequences to our competitiveness and our health. Predictably, the critics condemned the report as “A lot of myth and propaganda.” Despite being repeatedly rebuffed, they continue to argue the law authorizes the government to license competitors if a resulting product isn’t “reasonably priced.” That debate spilled over to the Capitol Hill unveiling of the study, in which I participated. What happened there sheds a lot of light on the nature of the argument.

The Electronic Frontier Foundation (EFF) is at it again, this time with what they refer to as a Save Alice campaign. The EFF does not like the Revised Patent Eligibility Guidance published by the United States Patent and Trademark Office (USPTO) in January 2019 and is charging USPTO Director Andrei Iancu with attempting to subvert the United States Supreme Court and essentially ignore Alice v. CLS Bank. These assertions are bogus, and truthfully, they are hardly worth the consideration of thoughtful individuals interested in a meaningful dialogue about the state of the U.S. patent system. Director Iancu has issued guidance that strictly follows exactly what the Supreme Court ruled in Alice, period. Over the years patent examiners, Administrative Patent Judges, district courts, and the Federal Circuit have dramatically expanded Alice. It was admitted in Alice that the “invention” could be coded over a weekend by a second-year college student, which means it was extremely trivial and not innovative.

This week on Capitol Hill, both houses of Congress are abuzz with a full schedule of hearings related to science, technology and innovation topics. In the House of Representatives, various committees explore a proposed net neutrality bill, innovation in the aviation industry, and ways to improve competition in the pharmaceutical industry—a hot topic of debate in recent weeks. Both the House and the Senate will hold hearings on the future of America’s space program. The Senate will also consider consumer data privacy regulations, rural broadband investments, and military applications of artificial intelligence. On Tuesday, a pair of events at the Brookings Institution will look at the impact of technological advances on public policy, as well as the artificial intelligence race between the U.S. and China.

In a previous essay, I discussed a U.S. Supreme Court case that had nothing to do with patent law, but that patent practitioners may wish to note. That discussion pertained to a decision indicating that constitutional arguments ought to be preserved before an administrative agency?such as the United States Patent and Trademark Office?even if the agency lacks the jurisdiction to decide constitutional questions on their merits. In this essay, I turn to one of the most humorous Supreme Court decisions in recent years. Even though this case seems far removed from patent law, it may hold a serious lesson for patent practitioners.

The U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics changed the landscape of what is considered patentable material in the context of genetic inventions. In the five years since Myriad, companies have pushed the boundaries of patenting certain types of genetic materials. Despite Myriad’s express statement that it was not considering “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” the courts have not yet established the contours of how much nucleotide sequences need to be altered in order to “create something new” in order to be patentable. However, as we discuss in the next section, we expect the Court to address these questions as biotechnology companies increasingly invest resources into emerging, expensive technologies involving genes and seek to protect their investments through patents.

Preparation of the background section of a specification that complies with the requirements of both U.S. Patent and Trademark Office (USPTO) and European Patent Office (EPO) requirements is a classic conundrum for patent drafters seeking to file an application in both jurisdictions via the Patent Cooperation Treaty (PCT) or direct filings. In U.S. patent applications, statements made in the background section can be considered an admission of prior art, regardless of whether the admitted prior art would otherwise qualify under 35 U.S.C. 102 and regardless of any disclaimer made. Additionally, statements made in the background section of an issued U.S. patent can not only be used against expert testimony that describes the prior art differently and during claim construction, but also can have a limiting effect on claim interpretation. As a consequence, discussion of deficiencies in the prior art can be interpreted as a disclaimer of the related features and therefore can severely (and often inadvertently) limit the interpretation of the claims. In contrast, statements made in the background section of EPO applications that discuss deficiencies and technical problems present in the prior art are expected to be included in order to enable the reader to understand the technical contribution to the art made by the invention as claimed. In particular, according to EPO practice, the applicant is expected to discuss the technical problem solved not just in view of the closest prior art at filing (subjective technical problem), but also, more importantly, in view of the prior art cited during prosecution in the context of the problem-and-solution approach (objective technical problem). Accordingly, applicants drafting applications to be filed at the EPO tend to provide a heavy background section with discussions of cited documents, related deficiencies and problem solved and later adjust it in view of the objective technical problem in view of the objective technical problem arising during prosecution. What constitutes best practice in this scenario and how the two practices can be harmonized is controversial.

This week in Other Barks & Bites: The United Nations highlights the importance of women in innovation on International Women’s Day; Comments due today on USPTO Section 101 Guidance; FDA Commissioner Scott Gottlieb resigns; a Senate bill with six bipartisan co-sponsors would increase requirements on patent disclosures for biologics; USPTO Director Iancu speaks out on Alice; Apple announces its intention to increase its presence in San Diego while its patent battle with Qualcomm heats up; Chinese copyright registrations increased by double digit percentage points in 2018; Stanley Black & Decker faces off against Sears in a trademark infringement battle over branding for Craftsman tools; Amazon announces that it will close dozens of pop-up stores in the U.S.; and Democrats from both houses of Congress introduce a new net neutrality bill.

I hold nine U.S. computer security device recovery and communication patents relating to Findmyphone technology, which helps owners display return or recovery information before or with the lock screen to help get their smartphone, tablet, computer or laptop back. In February, I was notified that my latest U.S. application overcame a 35 USC 101 objection following an amendment that explicitly referenced Director Andrei Iancu’s Section 101 Guidance. My story should provide some hope that the guidance can provide a clearer path for inventors on how to adjust their claims to meet the USPTO’s new high standards to achieve success and satisfy the requirements that Iancu is looking for to ensure stronger U.S. software patents.

The state of patent eligibility in America is shocking. Between the passage of the 1952 Patent Act and 2012, when the U.S. Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012), the patent eligibility threshold was an exceptionally low hurdle. A group of Senators and Representatives are currently considering a legislative fix to this patent eligibility debacle created by the Supreme Court and perpetuated by a Federal Circuit unwilling to define the contours of a sensible patent eligibility test. These talks, which are being held in closed-door roundtable format, will seek legislative language to introduce soon. It is anticipated that bills will be introduced in both the House and Senate sometime this summer. What those bills will look like seems to be genuinely up in the air—or perhaps it’s better to say open for discussion. If the discussion should turn to the one thing Congress could do that would have the most impact, the answer would be clear. In order to have the most immediate, positive impact Congress must expressly overrule Mayo. The root of all the patent eligibility evil lies with that single Supreme Court decision.

What happens when technology convergence fundamentally changes your patent risk profile? What do you do when your customer demands broad intellectual property (IP) indemnification and your supplier provides almost none? Industries that clear patents as a standard practice are integrating technology from industries that specifically do not clear patents. If this sounds like a potential train wreck, well, it is. We recently completed a survey of 16 companies’ activities with respect to freedom to operate. In that study, we found substantially divergent patent risk mitigation strategies. For example, as you would expect in the chemical industry, companies did full patent clearance searches of their new molecules and processes—they wanted freedom to operate. That means they searched in all their major markets for any patents they might infringe prior to releasing new products. In contrast, high technology companies did no clearance search prior to product launch, but they adopted other techniques for reducing their overall risk—they wanted freedom of action. For professionals in each Industry, their respective risk mitigation strategy makes sense. But how can it be that in one industry people review and clear patents and in another they do not? The answer lies in the specific patent risks faced in each industry, and we will explore some of those risks.

In May of 2017, the United States Supreme Court delivered a unanimous decision in TC Heartland LLC v. Kraft Food Group Brands LLC that reversed the Federal Circuit and said that 28 U.S.C. 1400(b) remains the only applicable patent venue statute, that 28 U.S.C. 1391(c) did not modify or amend 1400(b) or the Court’s 1957 ruling in Fourco Glass Co. v. Transmirra Products Corp., and that the term “residence” in 28 U.S.C. 1400(b) means only the state in which a company is incorporated. Since TC Heartland, courts and plaintiffs have struggled to understand the real world application of this decision; most recently, the Federal Circuit in In re Google allowed a case to remain in the Eastern District of Texas because Google had servers there. Thus, while the decision has undoubtedly resulted in a shift away from the heyday of the Eastern District of Texas, the precise parameters of a “physical presence” sufficient to satisfy venue remain murky. To examine the effect TC Heartland has had so far, I recently sat down with Mike Oropallo of Barclay Damon, who has been out there litigating patent cases around the country. Among other observations, Oropallo says that—as usual—it all comes down to the Federal Circuit. Read on for more.

The Federal Circuit recently vacated a district court’s decision dismissing a complaint under Federal Rule of Civil Procedure 12(b)(6). Coda Development S.R.O. v. Goodyear Tire & Rubber Co., No. 2018-1028, 2019 U.S. App. LEXIS 5144 (Fed. Cir. Feb. 22, 2019) (Before Prost, C.J., Wallach, Hughes, J.) (Opinion for the Court, Prost, C.J.) Coda Development and Frantisek Hrabal (collectively “Coda”) sued Goodyear Tire & Rubber Company for trade secret misappropriation and correction of inventorship of 12 Goodyear patents directed to self-inflating tire (SIT) technology. Coda alleged that, during several confidential meetings held between the parties, Goodyear copied Coda’s inventions and filed patent applications based on those inventions without naming Coda as an inventor or co-inventor. The district court dismissed the complaint under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief can be granted and denied the Plaintiff’s motion for leave to amend the complaint.

I am sure that the justices of the Supreme Court did not anticipate the confusion they created when they issued their controversial decision in Alice Corporation v. CLS Bank in 2014. That case effectively upended well-established precedence when the Court unanimously held that a computer-implemented scheme for mitigating settlement risk was not patent eligible subject matter because the claims were drawn to an abstract idea, and that merely requiring generic computer implementation fails to transform the claims to eligible subject matter. The Court itself said their holding was to be narrowly construed, but in providing a vague, two-step test to determine whether something is patent eligible, they unleashed a world of hurt on some of our domestic industries seeking patents in cutting-edge technologies. The application of the Alice test to some of our health-related industries is having disastrous effects. On February 6, 2019, in a split decision, the United States Court of Appeals for the Federal Circuit (CAFC) found in Athena Diagnostics v. Mayo Collaborative Services that diagnostic methods are not patent subject matter eligible unless they embody a separate technical improvement beyond the correlation of certain antibodies in bodily fluids to particular diseases. In a footnote, the majority lamented that they felt compelled by Supreme Court precedence to render their decision, but recognized that protection of diagnostic methods would be for good for society. The Athena case does not portend well for the CAFC adoption of the recent USPTO guidance on Section 101. The courts will eventually be able to either put their imprimatur on those guidelines or discard them. The sooner that is done, the better.

USPTO Director Andrei Iancu’s 2019 Revised Patent Subject Matter Eligibility Guidance promises to virtually eliminate the greatest patent problem of our time. If implemented properly by the examiners and Patent Trial and Appeal Board (PTAB) judges, the guidance could solve the 101 mayhem and the incredible harm that it has done to inventors of computer implemented inventions. The guidance will also increase the value of patents, since strategic infringers will not be able to use the PTAB as the killing ground for patents using subject matter eligibility. Director Iancu needs us to support him with positive public comments as justification for his guidance and, very importantly, to suggest improvements to his guidance for its final/future version(s) and its implementation. Please send the following text with any of your edits to Eligibility2019@uspto.gov by the March 8, 2019 deadline.

The Licensing Executives Society (LES) 2017 High Tech Deal Term & Royalty Rate Survey is a milestone event for at least three reasons. First, it was the third survey since the inaugural survey in 2011, and the three surveys fully covered the time period of a decade—from 2008 to 2017. Second, the 2017 Survey marked the fifth anniversary of Inter Partes Review (IPR) procedure and the third anniversary of the Supreme Court’s ruling in Alice v. CLS Bank. Third, at the time of the Survey, a new USPTO Director was nominated by the Trump Administration, bringing a fresh glut of uncertainties, anxieties, and hopes to the already jittery IP market.