Gene patenting reform in the US and the knock-on effect in Europe – Health Europa
Posted: November 13, 2019 at 6:48 am
This year there has been quite some talk about patenting the discovery of new genes. The patency eligibility criteria for this is set to undergo major reform in the US, which is likely to have a huge impact on a number of companies offering genetic testing kits, including 23andMe and AncestryDNA. Here, McDowell of EIP, an IP and patent law firm, shares her thoughts on the reform and the potential far-reaching impact it might have in the world of genetics, gene patenting and beyond.
The question of what should and should not qualify as patent eligible subject matter has, for several years, drawn sharp debate in the United States. Since 2012, the US Supreme Court has operated under the Alice/Mayo framework, which has sought to prevent patenting of abstract ideas and naturally occurring phenomena. This has had broad repercussions within the biotechnology sector and beyond; for example, resulting in the widespread proliferation of mail-order spit-kit operations like 23andMe.
Reform of the Alice/May framework has seen strong support from parts of the biotech industry, citing lack of investment as a barrier to greater research into diagnostic methods. However, a more general concern from stakeholders in the United States is that the unpredictability caused by the Alice/Mayo framework puts the US at a disadvantage compared to International competitors; particularly in respect of some of the most cutting-edge technologies, such as AI and molecular diagnostics. A lack of patent availability is allegedly driving investment to other countries, where such inventions are more clearly patent-eligible.
Battle lines have been drawn between the biotechnology and software industries, with calls for less restrictive eligibility criteria coming from the former. The financial input needed to develop new technologies differs substantially between these industries. Lone inventors and small businesses in the software industry, with the ability to develop their products cheaply, felt stifled by overbroad patents granted to others before 2012.
Meanwhile, even small players in the biotech industry rely on high value investment before diagnostic and curative treatments can be brought to patients. Intellectual property protection is key to ensuring that investors in this sector feel secure that the vast sums of money they contribute will be recouped through effective commercialisation.
The Executive Director of Cleveland Clinic Innovations recently explained that: Ability to gain patent protection is the first factor in our assessment of whether a product can reach the market; if an invention cannot get intellectual property protection, usually that is a fatal flaw and the invention is canned at that point.
With this being a widespread stance in the pharmaceutical and diagnostics industries, it is easy to see how the current restrictions to patentability could lead to fewer treatments being developed in the US. What is more, Internationally, the US is no longer top of the list for biopharma companies launching their products; with companies citing inability to protect their ideas as a key reason for not entering the US market.
On the other hand, there are those within the biotechnology sector who side with the software industry in favouring the status quo. Genetic testing companies have reaped the benefits of a restrictive patent eligibility criteria, which has resulted in the invalidation of patents to isolated gene products, and so removed the barriers to developing genetic testing kits.
Since 2013, aided by this provision, the cost of genetic testing kits has decreased significantly leading to a boom in popularity and numerous spit-kit companies have crowded the genetic testing market. This new Bill, if enacted, will likely prove problematic for US companies such as 23andMe, who offer customers the ability to test their DNA to uncover their ancestry or genetic vulnerabilities. Consequently, this might open the door for a widespread change in the industry.
The proposed Bill stuttered when a sticking point emerged during consultations with stakeholders. A last-minute amendment to 35 U.S.C. 112F, which governs how patentees may claim their invention in functional terms (as opposed to reciting specific physical structures), has been criticised by members of the biotech industry for watering down patent protections.
The draft Bill provided that, if any patent claim element is expressed as a specified function without the recital of structure, material, or acts in support thereof, then that claim element will be limited to the corresponding structure, material, or acts described in the specification and their equivalents.
This was offered to assuage concern that overruling the patent-eligible-subject-matter case law would herald a return of nuisance patents directed to business methods and software, which often contain functionally defined terms. However, rather than reassuring stakeholders in the software industry, the proposal seems to have succeeded mainly in frightening the biotechnology sector.
Several witnesses from both sides of the debate raised concerns about the burden that drafters and inventors will face from having to enumerate every way of carrying out a claimed method under the proposed amendment to 112F.
Conflicting views on the draft proposal has meant that the initial momentum for reform has been lost for the time being. This will frustrate those in the biotech industry who are keen to see a return the ability to obtain patent protection for their products and processes, which they hope will boost research, and drive investment back into the United States.
Read the rest here:
Gene patenting reform in the US and the knock-on effect in Europe - Health Europa
- A New Price Tag for Breast Cancer Genetic Testing - Video [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Genetic testing technologies - Video [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Prostate Cancer Genetic testing - Video [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Genetic Testing - Video [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Genetic Testing - One of the Best Things to Happen to Me - littlemamauk - Video [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- BowelGene - genetic testing - Video [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Genetic Testing Fact Sheet - National Cancer Institute [Last Updated On: May 22nd, 2015] [Originally Added On: May 22nd, 2015]
- Genetic Testing - Genetics Home Reference [Last Updated On: May 22nd, 2015] [Originally Added On: May 22nd, 2015]
- FAQ About Genetic Testing - Genome.gov [Last Updated On: May 31st, 2015] [Originally Added On: May 31st, 2015]
- Regulation of Genetic Tests [Last Updated On: June 9th, 2015] [Originally Added On: June 9th, 2015]
- Types of Genetic Testing - Genetics Home Reference [Last Updated On: June 29th, 2015] [Originally Added On: June 29th, 2015]
- Genetic Testing: What You Should Know - FamilyDoctor.org [Last Updated On: July 3rd, 2015] [Originally Added On: July 3rd, 2015]
- Genetic Testing - BRCA1 & BRCA2 Mutations | Susan G. Komen [Last Updated On: July 6th, 2015] [Originally Added On: July 6th, 2015]
- What is genetic testing? - Genetics Home Reference [Last Updated On: July 6th, 2015] [Originally Added On: July 6th, 2015]
- Genomics |Genetic Testing [Last Updated On: August 24th, 2015] [Originally Added On: August 24th, 2015]
- What is genetic testing? - American Cancer Society [Last Updated On: August 24th, 2015] [Originally Added On: August 24th, 2015]
- Genetic testing - WebMD [Last Updated On: September 2nd, 2015] [Originally Added On: September 2nd, 2015]
- Genetic Testing and Screening | Florida Hospital [Last Updated On: September 2nd, 2015] [Originally Added On: September 2nd, 2015]
- Genetic Testing Toledo OH - DNA Diagnostics Center [Last Updated On: September 29th, 2015] [Originally Added On: September 29th, 2015]
- Genetics - Genetic testing and counselling - NHS Choices [Last Updated On: October 25th, 2015] [Originally Added On: October 25th, 2015]
- Genetic Testing Germantown MD - DNA Diagnostics Center [Last Updated On: February 18th, 2016] [Originally Added On: February 18th, 2016]
- GeneDx | Genetic Testing Company | The DNA Diagnostic Experts [Last Updated On: February 18th, 2016] [Originally Added On: February 18th, 2016]
- Genetic Testing - kidshealth.org [Last Updated On: February 24th, 2016] [Originally Added On: February 24th, 2016]
- BRCA1 and BRCA2: Cancer Risk and Genetic Testing [Last Updated On: February 29th, 2016] [Originally Added On: February 29th, 2016]
- Genetic Testing - Breastcancer.org - Breast Cancer ... [Last Updated On: April 4th, 2016] [Originally Added On: April 4th, 2016]
- Frequently Asked Questions About Genetic Testing - Genome.gov [Last Updated On: April 10th, 2016] [Originally Added On: April 10th, 2016]
- Pregnancy & Prenatal Testing: Genetic Testing for Inherited ... [Last Updated On: April 19th, 2016] [Originally Added On: April 19th, 2016]
- Genetic Testing | Family Caregiver Alliance [Last Updated On: April 19th, 2016] [Originally Added On: April 19th, 2016]
- Genetic Testing - American Medical Association [Last Updated On: April 19th, 2016] [Originally Added On: April 19th, 2016]
- Genetic Testing - Cancer Treatment | CTCA [Last Updated On: April 19th, 2016] [Originally Added On: April 19th, 2016]
- genome.gov - FAQ About Genetic Testing [Last Updated On: April 27th, 2016] [Originally Added On: April 27th, 2016]
- Family Cancer Genetics Program at UC San Diego Moores ... [Last Updated On: May 2nd, 2016] [Originally Added On: May 2nd, 2016]
- Genetic Testing - Benefits, costs, and risks of genetic testing [Last Updated On: May 13th, 2016] [Originally Added On: May 13th, 2016]
- Myriad Genetics | Healthcare Professionals | About Genetic ... [Last Updated On: May 13th, 2016] [Originally Added On: May 13th, 2016]
- Genetic Testing | Gluten-Free Society [Last Updated On: May 13th, 2016] [Originally Added On: May 13th, 2016]
- Genetic testing - Canadian Cancer Society [Last Updated On: May 13th, 2016] [Originally Added On: May 13th, 2016]
- Genetic Testing and Molecular Biomarkers [Last Updated On: May 13th, 2016] [Originally Added On: May 13th, 2016]
- genetic testing | Britannica.com [Last Updated On: May 13th, 2016] [Originally Added On: May 13th, 2016]
- Genetic Testing: Best Defense Against Breast Cancer? [Last Updated On: May 13th, 2016] [Originally Added On: May 13th, 2016]
- Genetic Testing | Issue List [Last Updated On: May 13th, 2016] [Originally Added On: May 13th, 2016]
- Jewish Genetics, Part 1: Jewish Populations (Ashkenazim ... [Last Updated On: June 19th, 2016] [Originally Added On: June 19th, 2016]
- What Is Genetic Testing -- Information About Genetic Testing [Last Updated On: June 23rd, 2016] [Originally Added On: June 23rd, 2016]
- Genetic Testing Report - genome.gov [Last Updated On: June 23rd, 2016] [Originally Added On: June 23rd, 2016]
- Good Laboratory Practices for Molecular Genetic Testing ... [Last Updated On: June 26th, 2016] [Originally Added On: June 26th, 2016]
- Genetics and Cancer | American Cancer Society [Last Updated On: July 18th, 2016] [Originally Added On: July 18th, 2016]
- Genetic testing - FSH Society [Last Updated On: September 22nd, 2016] [Originally Added On: September 22nd, 2016]
- Myriad Genetics | Patients & Families | Genetic Testing 101 [Last Updated On: September 22nd, 2016] [Originally Added On: September 22nd, 2016]
- BRCA1 and BRCA2: Cancer Risk and Genetic Testing Fact Sheet ... [Last Updated On: September 22nd, 2016] [Originally Added On: September 22nd, 2016]
- FAQ About Genetic Testing - National Human Genome Research ... [Last Updated On: September 22nd, 2016] [Originally Added On: September 22nd, 2016]
- Genetic testing - Wikipedia [Last Updated On: November 1st, 2016] [Originally Added On: November 1st, 2016]
- Genetic Testing for Cancer Risk | Cancer.Net [Last Updated On: November 25th, 2016] [Originally Added On: November 25th, 2016]
- Cancer Genetics Risk Assessment and Counseling (PDQ ... [Last Updated On: December 20th, 2016] [Originally Added On: December 20th, 2016]
- Patients Who Tested Positive For Genetic Mutations Fear Bias ... - NPR - NPR [Last Updated On: July 1st, 2017] [Originally Added On: July 1st, 2017]
- Genetic Testing for the Healthy - Harvard Medical School (registration) [Last Updated On: July 1st, 2017] [Originally Added On: July 1st, 2017]
- Genetic testing Overview - Mayo Clinic [Last Updated On: July 1st, 2017] [Originally Added On: July 1st, 2017]
- The real reason why all women should get their DNA tested - Quartz [Last Updated On: July 4th, 2017] [Originally Added On: July 4th, 2017]
- DNA insurance: Why genetic testing could revolutionise the industry - Verdict [Last Updated On: July 4th, 2017] [Originally Added On: July 4th, 2017]
- Everything you need to know about the Government plan for genetic testing to treat cancer patients - BreakingNews.ie [Last Updated On: July 4th, 2017] [Originally Added On: July 4th, 2017]
- Greater access to genetic testing needed for cancer diagnosis and treatment - Cancer Research UK [Last Updated On: July 5th, 2017] [Originally Added On: July 5th, 2017]
- Chief medical officer calls for gene testing revolution - BBC News - BBC News [Last Updated On: July 5th, 2017] [Originally Added On: July 5th, 2017]
- Genetic Testing Facilities and Cost - Breastcancer.org [Last Updated On: July 5th, 2017] [Originally Added On: July 5th, 2017]
- Greater access to genetic testing needed for cancer diagnosis and ... - Medical Xpress [Last Updated On: July 7th, 2017] [Originally Added On: July 7th, 2017]
- Global Breast Cancer Predictive Genetic Testing Market Outlook 2022 - PR Newswire (press release) [Last Updated On: July 7th, 2017] [Originally Added On: July 7th, 2017]
- Invitae: Growth in Genetic Testing - Moneyshow.com (registration) [Last Updated On: July 7th, 2017] [Originally Added On: July 7th, 2017]
- Cystic Fibrosis Among Asians: Why Ethnicity-Based Genetic Testing is Obsolete - PLoS Blogs (blog) [Last Updated On: July 7th, 2017] [Originally Added On: July 7th, 2017]
- Hospital gets cardiac genetic test service created in memory of broadcaster's son - Belfast Telegraph [Last Updated On: July 8th, 2017] [Originally Added On: July 8th, 2017]
- David Frost cardiac genetic testing service opens - BBC News - BBC News [Last Updated On: July 8th, 2017] [Originally Added On: July 8th, 2017]
- UK's chief medical officer calls for gene testing revolution in cancer treatment - Daily Nation [Last Updated On: July 8th, 2017] [Originally Added On: July 8th, 2017]
- Konica Minolta buys US genetic test maker in $1B deal - BioPharma Dive [Last Updated On: July 10th, 2017] [Originally Added On: July 10th, 2017]
- Checking the cost of a genetic test - Chicago Tribune - Chicago Tribune [Last Updated On: July 11th, 2017] [Originally Added On: July 11th, 2017]
- Genomic Testing in Oncology: From Single Genes to Whole Genomes - Labiotech.eu (blog) [Last Updated On: July 12th, 2017] [Originally Added On: July 12th, 2017]
- Direct-To-Consumer Genetic Testing Can Be a Trip Down the Rabbit Hole - Newswise (press release) [Last Updated On: July 12th, 2017] [Originally Added On: July 12th, 2017]
- DNA Diagnostics Center brings four genetic testing options to retail - Drug Store News [Last Updated On: July 12th, 2017] [Originally Added On: July 12th, 2017]
- Jeans for Genes Day stall at Taree City Centre - Gloucester Advocate [Last Updated On: July 31st, 2017] [Originally Added On: July 31st, 2017]
- She thought she was Irish until a DNA test opened a 100-year-old mystery - Chicago Tribune [Last Updated On: July 31st, 2017] [Originally Added On: July 31st, 2017]
- Genetic testing: The new way to identify and train elite athletes? - USA TODAY High School Sports [Last Updated On: July 31st, 2017] [Originally Added On: July 31st, 2017]
- Mail order genetic tests for health risks. How much do you want to ... - KOMO News [Last Updated On: July 31st, 2017] [Originally Added On: July 31st, 2017]
- Genetic Testing: Finding the cause of your infertility ... [Last Updated On: July 31st, 2017] [Originally Added On: July 31st, 2017]
- SF's Invitae to acquire two prenatal genetic screening firms - SFGate [Last Updated On: August 1st, 2017] [Originally Added On: August 1st, 2017]
- For Indian doctors, it's written in the genes not stars - Economic Times [Last Updated On: August 1st, 2017] [Originally Added On: August 1st, 2017]