Showing posts with label attack on patents. Show all posts
Showing posts with label attack on patents. Show all posts

Sunday, 9 May 2021

It is simplistic and short-sighted to undermine Covid-19 patent rights

President Biden’s administration is making a major mistake by its top trade advisor, Katherine Tai, advocating a waiver of patent rights for Covid-19 vaccines.

While all who are involved, or would like to be, should move heaven and earth to increase Covid-19 vaccine supply until everybody worldwide who wants to be vaccinated has been vaccinated, undermining patent rights will not help but only hinder achieving that objective.

Patents are not recipes and do not provide the knowledge and expertise needed for production

All evidence is that the limiting factor is in vaccine supply—not in patent-licensing costs. The pressing need is to remove constraints—such as export bans that block ingredient supply chains— and to increase manufacturing capacity. Production supervision and training from those with the expert knowledge in operating such facilities who can ensure high-quality output reliably and on a massive scale are also required.

Instead of stripping Covid-19 patent owners of their core assets and rights, incentives to license patents and owners’ wider range of intellectual property—also including vital trade secrets such as how to make the vaccines with manufacturing process know-how—should be retained.

Vaccine demand remains immense. Many highly populated nations still have very low vaccination rates in the single digit percentages, for example, in India where the pandemic is currently raging with hospital facilities being overwhelmed. Satisfying demand will benefit us all when most of the world’s entire population is vaccinated because none of us will be safe from the virus and the threat of new variants until then. This is also a major incentive to vaccine patent owners—for example, BioNTech whose business model is in technology transfer, licensing and collaboration with downstream partners—to scale up that further. Fair reward for such efforts will enable licensors to justify up-front commitments and investments required in providing that support.

Patents encourage R&D investment and licensing-based horizontal business models

While the debate about whether patents stimulate or impede R&D investment and innovation continues among those with strong vested interests on either side, research including empirical data over many decades indicates that strong patent rights are particularly important to small, non-vertically integrated firms like BioNTech. A recently recorded LeadershIP seminar publicly available online illustrates this by featuring academic Jonathan Barnett’s new book on the subject entitled Innovators, Firms and Markets: The Organizational Logic of Intellectual Property. The session also includes remarks from others including entrepreneur and venture capitalist Greg Raleigh on the importance of patents to small companies such as BioNTech in biotechnology being able to raise investment capital to fund R&D.

The first-to-market and highly efficacious BioNTech/Pfizer vaccine is a stellar example of how the patent system works. In absence of strong patent protection companies like BioNTech would not exist. Not only did patents incentivise venture capitalists to make large and risky investments ahead of BioNTech’s technology commercialisation prospects, patents also enabled the firm to partner Pfizer, with its wide gamut of complementary resources required to collaboratively complete R&D and bring the vaccine through clinical trials to production and distribution. The partnership’s rapid delivery of Covid-19 vaccine is a huge technical, commercial and humanitarian success story.

Vaccine costs including patent fees are small versus economic costs of pandemics

The Covid-19 epidemic has cost several trillion dollars in the $88 trillion global economy—given a projected economic decline of 5.2 percent in 2020 versus growth of 2.3 percent in 2019. Patent licensing fees pale in comparison to this given that the entire cost of doses has averaged approximately $20 each. In comparison, I recently spent more than $100 on a Covid-19 PCR test and anticipate having to do that several more times in coming months. With competition among many different clinically approved vaccine technologies and suppliers including the highly effective, safe and easy to distribute Oxford/AstraZeneca vaccine priced at around $5 per dose already, existing free market commercial pressures on licensing charges—including patent royalties and for transfers of other intellectual property—are substantial.  With around 1.3 billion total doses of Covid-19 vaccines administered worldwide so far, at that price, vaccinating the rest of the world’s entire 7.8 million population with two doses would cost around $70 billion.

Other people’s money and redistribution of wealth

While, as Tai said recently, "This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures", this is not the first and it will not be the last global health crisis. President Biden plans to spend $3 trillion in government borrowings and tax receipts with various programmes including construction in response to the economic harm from the pandemic. An opportunistic raid on patent owners would also redistribute wealth to intermediaries such as manufacturers, but the world needs ongoing technical developments from large and small, young and old companies in the biotechnology and pharmaceutical industry to deal with new variants of Covid-19 and other new pathogens that will surely emerge. There is abundant economic justification not to undermine the valuable long-term gains the patenting and licensing system is providing. As well as rewarding existing patent holders, availability of such potential returns in “a global health crisis” will reassure and attract others to invest in additional R&D. While this pandemic is terrible with around 3.3 million deaths worldwide already, the next one could be even worse given that the 1918 Spanish flu epidemic killed 50 million people. We need to be as well prepared as we possibly can for whatever might ensue.

Wednesday, 20 January 2016

10 Patent Considerations for Startups in the Age of the Assault on Patents

Today, Oxfirst sponsored a talk by the distinguished Rt. Honorable Professor Robin Jacob defending patents.  Another commentator has also stepped forward to defend patents.  Recently, attorney John R. Harris authored an article titled, “The Patent System is Under Assault:Startups, Should You Care? Ten Things About Patents that Startups Need to Consider,” published in the 44 American Intellectual Property Law Association Quarterly Journal 27 (Winter 2015).  Mr. Harris outlines the current assault by describing one of the attacks coming from the Patent Trial and Appeal Board (affectionately known as the so-called “Death Squad” for patents) and its rate of 80% in finding patents invalid in Inter Partes Review Proceedings.  Notably, the U.S. Supreme Court has recently granted certiorari in Cuozzo Speed Techs., LLC v. Lee to determine whether the Patent Trial and Appeal Board is applying the correct standard in reviewing patents for invalidity.  The outcome of that case will be closely watched—particularly, I think, given the current gaming going on concerning shorting the stock of companies whose patents are then challenged through IPRs.

In defending patents, particularly in the context of startups, Mr. Harris states:

But most significantly for startups, that property right can represent enhanced value for investors and improve the prospects for obtaining early stage financing.  A well-crafted patent—or even better, a collection of patents in a portfolio that forms a patent “thicket”—reveals and represents the fruits of product or service development, helping form a protective barrier against theft. If that product or service requires capital to come to market, investors draw some comfort from the patents’ protection of the investment while the product is commercialized. This early protection is vital because, in this author’s experience, it often takes companies years to go from “maybe a good idea,” to a prototype, to a testing environment, to a sold product, to market acceptance, to profitability, and finally, to investment realization.

My own personal experience mirrors Mr. Harris’: it can be difficult to draw attention from venture capitalists without solid patent rights.  I haven’t practiced in a while, but my understanding is that venture capitalists still value patents in determining whether to invest in a startup.  [Interestingly, I’ve never seen the use of term “patent thicket” in a positive light.]

Moreover, in spite of the assault on patents (and their cost), Mr. Harris notes that startups should take into account these ten considerations concerning patents: 1. Enterprise Value Enhancement; 2. Signaling Quality to Investors and the Investment Community; 3. Establishing Ownership of Technology and Inventions; 4. Assertion Against Competitors; 5. Avoiding the IP of Competitors and Others; 6. Revenue Generation/Licensing/Monetization of IP; 7. Facilitating Collaborative Research; 8. If You Get the Patent, You Block the Competitors; 9. The Laws Will Change . . . Again; and 10. Although Trade Secrecy and Copyright Offer Some Protection, There Is No Viable Alternative to Patents.
Do you have any other considerations to add?  Also, what is on the cost side?