Posts Tagged: "life sciences"

Our current experiences with COVID-19 in the United States, together with headlines warning of major efforts by the Chinese and Russian governments to hack corporate, academic and federal laboratories to steal information on pending therapies, underline the importance of maintaining the U.S. lead in the life sciences. It’s not just our health at risk—it’s also our security. We’ve just had a taste of what it’s like depending on China for medicines and protective gear. We also face an internal threat posed by “drug populists” calling for arbitrary government price controls while blaming patents for costs and blocking innovation. Ironically, a perfect example of this school of thought appeared in the  New York Daily News the same day as an important new report issued from the Information Technology & Innovation Foundation (ITIF). Titled “Ensuring U.S. Biomedical Competitiveness”,  the report is a treasure trove of critically needed information.

The recently published Global Startup Ecosystem Report 2020 ranks the top global startup ecosystems by metrics including performance, funding, connectedness, talent, and knowledge to highlight the winning startup cities worldwide. In a league of their own, this year’s top five global startup ecosystems have a combined value of $1.5 trillion, 1.7 times the remaining top ecosystems. Silicon Valley maintains the #1 ranking, a position it has held since 2012, when rankings were first released. Meanwhile, New York remains at #2, although now tied with London. And finally, Beijing is at #4, and Boston is at #5. Tel-Aviv and Los Angeles rounded out the top seven. The 2020 analysis includes almost 300 ecosystems, up from 60 in 2018 and 150 in 2019. It ranks the top 40 global startup ecosystems and 100 emerging startup ecosystems.

With two-thirds of the world in lockdown and no clear way out of the novel coronavirus crisis, it’s increasingly obvious that biopharmaceutical innovation will play a pivotal role. A new treatment that can mitigate the worst effects of COVID-19, and ultimately a preventative vaccine, could, literally, save the world. Such life-saving technology is less likely to be forthcoming if, in their panic, governments sacrifice intellectual property (IP) rights for new COVID-19 therapeutics and vaccines. The signs are not promising. IP-skeptic governments in Chile and Ecuador have taken preemptive measures by permitting compulsory licensing of any new COVID-19-related technology. Otherwise innovation-friendly Canada and Germany have passed legislation to issue compulsory licenses more easily. Even in the United States—the center of modern biopharmaceutical innovation and a major player in ongoing COVID-19 research and development (R&D) efforts—there is pressure to break patents.

Underscoring the seriousness of the threat posed by the Chinese government’s campaign to obtain results of U.S. publicly funded research, the Board of Directors at the Moffitt Cancer Center in Tampa, Florida announced that its President and CEO, Dr. Alan List, along with center director, Timothy Sellers, suddenly resigned after an internal review found they had violated conflict of interest rules regarding their relationships with China. Four researchers also abruptly left.  The actions came after the Moffitt Center conducted an internal review of collaborations between its employees and Chinese institutions as a result of warnings from the National Institutes of Health (NIH) to its grant recipients about foreign attempts to influence or compromise their research. 

In 2002, India’s Patent Act 1970 [“the Act”] was amended to include Section 107A. This provision says that any act of making, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law in India, or in a country other than India, shall not be considered as infringement of patent rights.  This provision also outlines India’s Bolar exemption. As per the “Bolar doctrine,” which arose out of the U.S. case of Roche Products v. Bolar Pharmaceuticals (1984), it is permissible for third parties to carry out research and development on patented products (especially drugs) for the purposes of submitting information as required by regulatory authorities. The purpose of this provision is to ensure that third parties can conduct research and development and obtain prior regulatory approvals, enabling them to launch the patented products on the market as soon as the patent term expires. This ensures that patent holders do not get a de facto monopoly on their inventions after expiration of their patent term. Further, it ensures that the public has access to cheaper generic versions of the drugs immediately after expiration of the patent term. In India, the scope of this provision has been controversial for some time now, leading to a slew of litigation between major international pharmaceutical companies and Indian generic manufacturers claiming the Bolar exemption. In the recent combined decision in the matters of Bayer Corporation v. Union of India & Ors. LPA No. 359/2017 and Bayer Intellectual Property GMBH & Anr. v. Alembic Pharmaceuticals Ltd. RFA(OS)(COMM) 6/2017 (March 22, 2019), the Division Bench of the Delhi High Court laid these controversies to rest by deciding the question of whether export is permissible under this provision.

For life sciences industries and research organizations that utilize any biological resource from India for research, commercial or other purposes, awareness and regulatory compliance with India’s Biological Diversity (BD) Act, 2002 could mean the difference between success and failure. India became a party to the Convention on Biological Diversity (CBD), a multilateral treaty, in 1994. In order to comply with the CBD’s provisions on conservation and sustainable use of biological diversity with fair and equitable benefit sharing arising from utilization of genetic resources, the country enacted the BD Act in 2002, and the corresponding Rules in 2004. In 2012, India ratified the Nagoya Protocol, a supplementary agreement to the CBD that mainly focused on strengthening the implementation of benefit sharing, and subsequently issued the Guidelines on Access and Benefit Sharing (ABS) in 2014.Under the Ministry of Environment and Forests (MoEF), the implementing system of the BD Act is three-tiered. The National Biodiversity Authority (NBA) is at the central level, the State Biodiversity Boards (SBBs) are at the state level, and the Biodiversity Management Committees (BMCs) are at the local level, with each authority performing specified functions.

While part one of this two-part series on intellectual property (IP) due diligence focused on a life science company’s own IP portfolio, part two will address a company’s understanding of how it fits into the market by considering its freedom to operate, as well as its competitors’, and the interplay of patent and regulatory exclusivity as it relates to the company’s product. Patent and regulatory exclusivity—two areas that can provide the most value and protection to a life science product—are very interrelated. Simply identifying when a key patent naturally expires is not sufficient, because regulatory exclusivity could possibly extend the company’s ability to keep competitors off the market or allow competitors to speed up entry in certain situations.

The success of a life science product, and thereby the company, rests heavily upon a combination of patent protection, regulatory exclusivity and product life cycle management. A company’s ability to formulate and articulate an integrated strategy is critical to obtaining investments, strategic partnerships and market success. In this two-part series, we will discuss recent judicial developments that affect life science companies’ IP strategies and also outline the four basic principles of an integrated IP strategy on which a company’s intellectual property audit and preparation for third-party diligence should focus. These are: (1) patent prosecution and strategy, (2) rights and ownership, (3) interplay of patent and regulatory exclusivity, and (4) freedom to operate and competitors. Part one will focus on patent prosecution and strategy, as well as rights and ownership.

Patents covering an antibody are often claimed by the antibody’s function (the residues where it binds to the antigen) rather than its structure (amino-acid sequence). This tactic can successfully cast a very wide net of patent protection over potentially millions of different antibodies. In doing so, even if the patent holder’s own antibodies never make it out of the laboratory, the patents can nevertheless corner the market on intellectual property covering a new class of inhibitors. The risk of this strategy, however, is that extremely broad patent scope can simultaneously doom a patent’s validity for not being sufficiently enabled or lacking written description. As an example, a recent decision from the District of Delaware, MorphoSys AG v. Janssen Biotech, Inc., No. 16-221 (LPS) (Dkt. 471) (Jan. 25, 2019), invalidated broad antibody patents for not being sufficiently enabled, as well as coming near to invalidating the same patents for lacking written description. The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.

As the pharmaceutical industry continues to shift toward biologic-based drugs, including monoclonal antibodies, protecting the underlying technology has been and continues to be a priority for companies. As with any drug, patenting therapeutic monoclonal antibodies as early as possible in the drug development process is crucial to protect the underlying invention. In the early days of antibody discovery for therapeutic development, protection could be obtained with minimal disclosure of the actual antibody. But as the art and case law have evolved, companies now need far more data to obtain the broadest scope of protection. For that reason, it has become more of a challenge to determine the best time to file with the U.S. Patent and Trademark Office (USPTO). After the America Invents Act (AIA), it is a race to the USPTO to be the first to claim your invention, but you may lack the requisite data to enable you to obtain patent protection in the end.

This article examines Supreme Court and Federal Circuit analyses of patent eligibility under 35 U.S.C. § 101 where the patent claims at issue were directed to Life Sciences-related technologies. I first examine this topic in the context of composition of matter patent claims and then in the context of method claims. As reflected in the below discussion, while the § 101 case law is fairly straightforward with respect to composition claims, the case law is murkier when it comes to method claims.

“If companies were to lobby to allow for more polluting most people would think that is unethical,” Lauder explained. But there are people lobbying to make it more difficult for companies to come up with cures that allow for the creation of cures that save lives, which Lauder says he finds “equally unethical.” Lauder hopes that others start to look at the problem in the same way. That would indeed be a big step forward.

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.

Immunotherapy has emerged as one of the most promising mechanisms to combat diseases like cancer and microbial infections. Since 2000, multiple antibody drugs have reached blockbuster status, including the anti-TNF antibodies adalimumab and infliximab, the anti-CD20 antibody rituximab, the anti-VEGF-A antibody bevacizumab, and the anti-HER-2 antibody Trastuzumab. In 2016, five of the top 10 pharmaceuticals were antibody drugs, with combined sales exceeding $45.8 billion. The cancer immunotherapy market is expected to reach nearly $120 billion… The promise of immunotherapy as a treatment option has opened up the intellectual property landscape of the field. Many companies and institutions have filed patent applications related to the various drugs and targets… The claim language in a patent is crucial to the effective protection of the invention, and the balance between breadth of the claims and validity is a difficult one to achieve.

Those who believe that patents aren’t important or that companies would undertake the rigors of commercial development with only non-exclusive licenses don’t understand the realities facing innovators like Inovio… Unfortunately, there’s good reason for anxiety. If they are successful their patents could be subjected to years of post-grant reviews by competitors and those who believe life science patents harm the public interest. Even if their IP holds up, they may face howls from critics and politicians demanding that the government step in to issue compulsory licenses so others here and abroad can copy the vaccine. For the 35 million living with HIV, the scientific barriers aren’t the only ones standing in the way of effective treatments.