Posts Tagged: "innovation"

On Thursday, October 26, the U.S. International Trade Commission (ITC) issued a limited exclusion order (LEO) and cease and desist order against Apple, potentially barring the technology company from importing Apple Watches into the United States. The ITC found Apple violated section 337 by importing Apple Watches that infringed on two Masimo patents that covered technology related to reading blood-oxygen levels.

Startups often face many competing pressures. Two such pressures that are frequently at odds with each other are the need to adequately protect the intellectual property that will be the basis for future revenue and investment, and the need to bring such revenue and investment into the business to allow for continued technology development and commercialization. Many startups are aware of how the on-sale bar interacts with these pressures and the associated need to file patent applications on any technology prior to offering or placing it on sale. However, fewer startups are aware of the public-use bar and how activities pursued with the goal of growing their businesses may unwittingly invoke it.

On October 23, the U.S. Patent and Trademark Office’s (USPTO) Office of the Chief Economist (OCE) published a report detailing patent application filing trends at the USPTO related to COVID-19 diagnostics technologies. The OCE found that filing activity surged following the arrival of the novel coronavirus in early 2020, with much of that increase driven by small companies and research institutions. The report found further evidence suggesting that federal funding had a significant impact on driving innovation into COVID-19 diagnostics at small R&D entities.

On  April 27, 2023, the European Commission published its proposal for how the licensing of standard essential patents (SEPs) should be governed in the EU. The draft regulation states that the initiative aims to incentivize participation by European firms in the standard development process and the broad implementation of such standardized technologies, particularly in IoT industries. The developments are of interest to any business that develops, implements or markets connective technologies.

I was not even aware of the issue below until a CPA friend of mine happened to mention it during a friendly telephone call. But unless Section 174 of the Internal Revenue Code is restored to its previous state from prior to the 2017 Trump tax cuts, U.S. innovation will be greatly impacted. Section 174 of the Internal Revenue Code has been around since 1954. It was enacted to eliminate uncertainty in the treatment of research and development (R&D) expenditures and to encourage businesses to carry on research and experimentation.

IPWatchdog’s Life Sciences Masters 2023 concluded today, following three days of panels that tackled some of the most pressing issues facing intellectual property professionals in the life sciences space. In the spotlight was the Biden Administration’s recent passage of the Inflation Reduction Act (IRA) and its potential impact on future drug development in the United States. Prescription drug pricing controls are one aspect of the IRA, a landmark piece of legislation passed by Congress last August that also directs funding to be spent on clean energy projects and increased tax enforcement. The IRA authorizes the Health and Human Services (HHS) Secretary to establish a Drug Price Negotiation Program, codified at 42 U.S.C. § 1320f, to establish maximum fair prices of certain drugs that become eligible for the program because they constitute a large portion of expenditures by Medicare Part B and Part D patients. Pharmaceutical companies who do not agree to the price set during negotiations with HHS will have to pay a new excise tax codified at 26 U.S.C. § 5000D calculated based on daily sales and starting at 65%.

The U.S. International Trade Commission (ITC) released a sprawling report on Tuesday analyzing market dynamics surrounding the question of whether to extend the waiver of IP rights for COVID-19 technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to diagnostics and therapeutics. The report stopped short of making any recommendations, but ultimately did not find any definitive evidence that IP rights present a barrier to access in the context of COVID diagnostics and therapeutics. However, it largely amounts to a reiteration of talking points on both sides and seemingly does little to further the debate.

The U.S. Supreme Court on Friday added another case to its docket that challenges the Chevron Doctrine, a decades-old principle instructing lower courts to defer to federal agencies’ interpretations of ambiguous laws. The Court said it will hear Relentless, Inc. v. Dept. of Commerce in tandem with an almost identical appeal brought by Rhode Island herring fishers. Mark your bingo card if you had “Rhode Island herring fishers.”

This week in Washington IP news, Congress returns from its district work period with the House holding several meetings related to IP and innovation. The House Subcommittee on Courts, Intellectual Property, and the Internet holds a hearing on IP competition with China and another subcommittee discusses safeguarding data in the growing AI industry. Elsewhere, IPWatchdog is hosting its Life Sciences Masters™ program in Ashburn, VA, and the U.S. Patent and Trademark Office hosts a panel discussion for its ongoing Women’s Entrepreneurship (WE) program

Last month, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) announced that it had joined with 30 other signatories to publish a framework of intellectual property principles designed to reshape the narrative around intellectual property (IP) rights and maintain America’s global lead in innovation. Broadly speaking, the principles focus on five primary goals to be achieved by American lawmakers and policymakers: 1) national security, 2) technological leadership, 3) fostering creative expression, 4) enforcing the rule of law, and 5) ensuring full access to the innovation ecosystem for all.

Last week, the White House announced that the manufacturers of all ten of the drugs singled out by the Centers for Medicare and Medicaid Services (CMS) and its drug price negotiation program (DPNP) have “agreed” to participate therein. The announcement concerns the manufacturers reluctantly agreeing to subject themselves to the sweeping drug price “negotiation” provisions of the Inflation Reduction Act (IRA), which was passed last year. Those provisions empower CMS to essentially dictate whatever price it pleases for a set of prescription drugs, the first ten of which were announced at the end of August.

In recent months, two U.S. government executive initiatives have reshaped the landscape concerning intellectual property and the domestic production of products resulting from federally funded research. These initiatives are poised to bring substantial changes to the dynamics of academic-industry collaborations as inventions are brought to market.

Judicial rulings have muddied the waters of patent eligibility, with judges themselves expressing uncertainty. In the case, Am. Axle & Mfg., Inc. v. Neapco Holdings LLC, U.S. Court of Appeals for the Federal Circuit judge Kimberly Moore openly shared the challenge of applying Section 101 consistently, explaining that “the majority’s blended 101/112 analysis expands § 101, converts factual issues into legal ones and is certain to cause confusion for future cases.” This haze has driven innovators to tread cautiously, often sidelining potential patents for fear of 101 rejections—stifling the American dream of groundbreaking innovation. Stakeholders craft tactics to dodge these pitfalls while lawmakers propose reforms.

On October 2, the Nobel Assembly at Karolinska Institutet announced that Hungarian-American biochemist Katalin Karikó and American immunologist Drew Weissman were awarded the 2023 Nobel Prize in Physiology or Medicine for their discoveries related to modified messenger ribonucleic acid (mRNA) for use in vaccines. A critical part of the world’s response to the COVID-19 pandemic, mRNA vaccines were not an effective option until the pioneering work of these two scientists, one of whom faced considerable rejection while laying the foundation that answered one of the world’s greatest public health crises.

PERA is no doubt an ambitious bill. In terms of its design, the proposed legislation attempts to deal with each of the Supreme Court’s decisions in Alice, Mayo and Myriad, plus all of their progeny applications thereafter engendered by the Federal Circuit, the Patent Trial and Appeal Board (PTAB), all the way down to the U.S. Patent and Trademark Office (USPTO) examining corp. In a nutshell, the bill, if passed, would return us to a time when Bilski was the law of the land, which will no doubt be welcomed by many innovators.