Posts Tagged: "biotech"

Recently published research conducted by Vital Transformation shows legislative provisions similar to those found in the Inflation Reduction Act of 2022, which allows the U.S. Government to “negotiate” drug prices under a set framework based upon the amount of time a drug has spent on the market, would have significant, negative effects on patient access to new therapies because funding would be severely curtailed for research and development. According to Vital Transformation, the reduction of net earnings due to government price fixing would substantially reduce the amount of research and development of small biotech firms, which would negatively impact future drug discovery and development. The model used in the study estimates that with government price fixing “only 6 of 110 previously approved therapies would be considered ‘not at risk’ of being cancelled, or at very least divested.”

As we enter the second month of 2022, the old saying, “If at first you don’t succeed, try, try again” and the famous line, “I’m not dead,” from Monty Python and the Holy Grail, come to mind to describe two issues we’ll be watching closely this year relating to litigation involving small and large molecule therapies. In the first instance, Amgen recently petitioned the Supreme Court to review the Federal Circuit’s affirmance invalidating several patent claims based on the lack of enablement for genus claims. This case comes on the heels of the Supreme Court’s denial of cert. in Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019) on similar issues. Amgen now hopes for a better result.

On June 21, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing and rehearing en banc filed by Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (Amgen) in their case against Sanofi, Aventisub LLC, FKA Aventis Pharmaceuticals Inc., Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S. LLC (Sanofi). Judge Lourie was joined by Judges Prost and Hughes in a separate opinion on the denial of the petition for panel rehearing. A group of intellectual property professors; GlaxoSmithKline plc; and Biogen Inc., Bristol-Myers Squibb Company, Corning Incorporated, and Merck Sharp & Dohme Corp. filed amicus briefs.

While the discussions around waiving intellectual property (IP) rights set forth in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are currently (and somewhat amorphously) limited to COVID-19 related drug and medical products, it is probably shortsighted to ignore the implications for other technologies critical to sustaining our environment and advancing a more healthful world. In fact, if we want to ensure continued investment in these technologies, we should be very concerned about the message conveyed by the international political tide: if you overcome a challenging scientific problem and your solution has the potential to save lives, be prepared to be subjected to intense political pressure and to potentially hand over your technology without compensation and regardless of the consequences.

As discussed in Part I of this article, the European Patent Office (EPO) recently published its Guidelines for Examination 2021, which came into force on March 1. In the previous article, we detailed changes affecting computer-implemented inventions and with respect to procedural matters. Here, we will address the Guidelines’ changes for biotech. In addition to some specifications regarding the interpretation of terms relating to amino and nucleic acid sequences and the definition of the concept of “therapy” and of the products that can be claimed in view of their new medical use, the main additions that have been made to the part of the Guidelines relating to biotechnological inventions concern the exclusions from patentability, and in particular the ineligibility of inventions relating to plants or animals and human embryos. A full section has also been added relating to the patentability of antibodies.

If the objective is to beat this virus as fast as possible it simply isn’t helpful to talk about the compulsory licensing of drugs that don’t yet exist and the patents that can’t possibly be issued by the United States Patent and Trademark Office for at least the next two to three years. The COVID-19 crisis will be long since over by the time the first patent issues relating to anything specifically related to COVID-19. Yet somehow it is viewed as productive to demand compulsory licensing of vaccines, treatments and cures for COVID-19 that do not exist?

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.

The opening salvo in what promises to be one of the hottest debates in the new Congress was fired January 29 during a day-long hearing in the House Committee on Oversight and Reform—how to lower the price of prescription drugs. And it didn’t take long to make it clear that patents are right in the middle of the scrum. The role of patents was a prominent part of the House hearing. While cursory nods were made to the importance of encouraging innovation, the witnesses discussed how patent exclusivity, thickets, and evergreening drove up prices while promoting the greater use of Patent Trial and Appeal Board (PTAB) reviews against drug patents. The Committee was assured that curtailing patents wouldn’t harm innovation because the National Institutes of Health (NIH) is such an important funder of life science R&D.

Since its inception, the Patent Trial and Appeal Board (PTAB) has been a frequent venue for patent challenges in the pharmaceutical and biotechnology industries. By the end of the U.S. Patent and Trademark Office’s (USPTO’s) 2018 fiscal year, patents in those fields were targeted in nearly 10% of all petitions for inter partes review (IPR), totaling approximately 900 individual petitions. Of these 900 petitions, roughly 5% challenged patents listed in the FDA’s Orange Book for approved drug products. The remaining petitions challenged biologic drugs (1.3%) and other biologic-, biotechnology-, or pharmaceutical-related patents (3.5%). Many of these petitions have ultimately resulted in the cancellation of all challenged claims, including those of a significant number of Orange Book patents. Based on the PTAB’s initial high rate of claim cancellation in pharma and other areas, critics of the PTAB were quick to deem it a patent “death squad.” Does the PTAB still deserve the “death squad” label when it comes to Orange Book patents? In this article, we examine the rates of challenge, institution, and final written decision outcomes for patents listed in the Orange Book, from the PTAB’s inception through the end of its 2018 fiscal year.

A well-devised intellectual property (IP) portfolio can go a long way to ensure a startup biotech company’s business success in the marketplace. Patents allow a patent holder to exclude others from making, using, offering to sell, selling or importing a similar product based on what is claimed in the patent while the patent is in force (35 U.S.C. 154). Biotech startups generally invest in utility patents to protect core inventions and serve as barriers to entry against competitors. When faced with budget constraints, biotech startups can tap into less expensive IP protection options to boost market position, drive up value, attract venture capital funds and generate revenue, including cross-licensing and/or settlement agreements.

Rep. Lloyd Doggett (D-TX) recently introduced the Medicare Negotiation and Competitive Licensing Act of 2018. Lest the title confuse you, by “competitive licensing” Rep. Doggett means compulsory licensing anytime a company declines to sell their drug for whatever price the Secretary of Health and Human Services  cares to offer during “Medicare negotiations” where the government holds all the cards. Past attempts to impose artificial “reasonable pricing” requirements on developers of government supported inventions did not result in cheaper drugs. A study titled Compulsory Licensing Often Did Not Produce Lower Prices For Antiretrovirals Compared to International Procurement found that resulting drug prices were often higher than they would have been under a more cooperative approach.

Technology and intellectual property (IP) have become vital components to virtually every business in all industries as they often drive the value and efficiencies of a business and enable companies to monetize their products and services. In order to capitalize on this trend, private equity (PE) investors are making significant investments in companies focused on developing and commercializing IP. In 2017, a record number of PE deals were IP and technology focused, ranging from consumer-facing companies with valuations driven by trademark portfolios and brand awareness, to cloud platform and biotech companies with significant patent portfolios and research and development efforts. According to analysts of PE deal-trends, this wave of IP-centric PE transactions has continued and will continue to grow during 2018.

A jury verdict awarded more than $26 million to a group of plaintiffs including San Diego, CA-based gene analysis firm Illumina, Inc. The jury found that Ariosa Diagnostics infringed upon two patents, awarding $15.7 million in lost profits to Illumina and nearly $11 million in lost profits to Verinata Health… In the recent jury verdict, both Illumina and Verinata lost on willful infringement arguments made against Ariosa during the trial. However, the validity of both patents was confirmed after being challenged by Ariosa during the case.

For the first time since the inception of the Bloomberg Innovation Index, the U.S. ranked outside the top 10, ranking 11th out of the 50 economies. This latest dip in standing for the U.S. innovation economy is simply the most recent sign that significant issues exist relative to innovation and intellectual property… Another trend pointed out by the recent Bloomberg Innovation Index is the slow rise of the innovation economy in China which has shown signs of improving just as the United States continues to be unable to address key IP issues. China climbed two rank positions in the most recent version of the Bloomberg index, up to 19th from 21st the previous year.