by Fiona Kellas, Reuben Jacob
16 March 2020
14:20
Reuben Jacob and Fiona Kellas, Maucher Jenkins share their expertise on IP strategies and considerations for gene therapy inventions.
Gene therapy enables the treatment of a disorder or disease through the insertion of a gene into a patients cells instead of using drugs or surgery.This technique involves the introduction of genetic material into cells to compensate for abnormal genes in the patient or to make protein that will be beneficial to the patient.As an example, if a mutated gene causes a protein that is necessary for the correct functioning of cells to be faulty or missing, gene therapy may be able to introduce a normal copy of the gene to restore the function of the protein.Gene therapy is understood to be useful in the treatment of a range of conditions such as cancer, cystic fibrosis, muscular dystrophy and Alzheimers disease.
UK role in gene therapy techR&D
Gene therapy is considered to be very important to the future of medicine and as such, many companies are focussing their research and development into gene therapy technologies.The UK is a growing industry for research into these areas and it is anticipated that by 2035 the UK industry around cell and gene therapy technologies will be worth in the region of 10 billion.Gene therapy research is still at an early stage.Due to this length of time and the associated costs involved in developing an effective gene therapy and taking it through to approval, it will be important for companies working in this area to put into place an effective IP strategy that will provide protection for their inventions and assist them in maintaining their market position.In addition, the competitive nature of the gene therapy industry means that will be important for a company to obtain patent protection for inventions being developed, as well as reviewing the patent landscape to check that the company is free to operate in their chosen area.
What makes something patentable?
In order for an invention to be patentable, it must be new, inventive and capable of industrial application.In addition to the requirement that an invention meets the above requirements of patentability, it is also important that the invention does not contain subject matter that is excluded from patentability.One of the challenges associated with obtaining patent protection for gene therapy inventions is that the European and US patent systems include a number of exceptions to patentability that are relevant to biological material and natural products.In Europe, it is not possible to obtain patent protection for a method of treatment or surgery of the human body.Thus, the removal of cells from a patient would not be considered to be patentable in Europe.In addition, inventions relating to stem cells that are derived from the destruction of human embryos are not patentable in Europe.In the US, recent case law (Molecular Pathology v Myriad Genetics, Inc, 2013) has meant that inventions relating to natural phenomena and natural products must show characteristics that are different to their natural counterpart(s).
However, despite the above challenges, there are a number of aspects of the gene therapy technology that may be eligible for patent protection.Typically, the gene therapy procedure can involve performing the required modification procedure on cells that have been removed from a patient before reintroducing the cells into the subject to produce their modified effect.The process of modifying the cells may be patentable if it fulfils the above requirements of patentability.In addition, it may be possible to obtain protection for the methods that are used to culture, manipulate or modify the cells that are used for gene therapy.
At Maucher Jenkins, we have a team of attorneys who can provide IP advice and assistance in the area of patenting inventions involving gene therapy, molecular biology and biochemistry.
Read the original:
Thinking out loud: IP strategies for gene therapy inventions - Med-Tech Innovation
- Muscular .Dystrophy -Successful-treatment by acupressure , Ayurveda, Yoga - May 10th, 2011 [May 10th, 2011]
- Muscular Dystrophy Treatment - Todd Harrison Improving Balance - May 16th, 2011 [May 16th, 2011]
- Oculopharyngeal Muscular Dystrophy (OPMD): Exploring Causes and Treatment - May 20th, 2011 [May 20th, 2011]
- Muscular Dystrophy Treatment - Todd Harrison holding body weight - May 21st, 2011 [May 21st, 2011]
- David G VECTTOR Muscular Dystrophy Treatment double arm strength month 6 - May 22nd, 2011 [May 22nd, 2011]
- David Gould Becker Muscular Dystrophy VECTTOR Treatment - June 2nd, 2011 [June 2nd, 2011]
- Muscular Dystrophy Halo - June 3rd, 2011 [June 3rd, 2011]
- Muscular Dystrophy VECTTOR Treatment Documentary - Todd's 6 Month Journey - June 7th, 2011 [June 7th, 2011]
- Muscular Dystrophy Treatment Results - David Gould - New Footage - June 8th, 2011 [June 8th, 2011]
- Muscular Dystrophy - Rewriting History with VECTTOR - June 10th, 2011 [June 10th, 2011]
- Muscular Dystrophy - David Gould 5 month VECTTOR treatment for BMD - June 12th, 2011 [June 12th, 2011]
- Duchenne's Muscular Dystrophy Stem Cell Treatment - Reelabs India - June 14th, 2011 [June 14th, 2011]
- Muscular Dystrophy VECTTOR Treatment - Todd Harrison/Luau Presentation - June 16th, 2011 [June 16th, 2011]
- Dr. William Rader - Muscular Dystrophy Breakthrough - June 16th, 2011 [June 16th, 2011]
- Muscular Dystrophy patient at Xcell-center - Nabeel Mohamed Abdulhusain, 46 years - June 17th, 2011 [June 17th, 2011]
- Charlie's Story: Duchenne Muscular Dystrophy Part 4 - July 18th, 2011 [July 18th, 2011]
- Muscular Dystrophy VECTTOR Treatment - David Gould/Luau Presentation - July 19th, 2011 [July 19th, 2011]
- Testimonial 4 of Muscular Dystrophy after Stem Cell Therapy - August 5th, 2011 [August 5th, 2011]
- Drug Combo Dynamic in Muscular Dystrophy - August 9th, 2011 [August 9th, 2011]
- Testimonial for Fetal Stem Cell Treatment of Duchenne Muscular Dystrophy - August 25th, 2011 [August 25th, 2011]
- Improvement seen in Duchenne Muscular Dystrophy after Stem Cell Therapy - September 11th, 2011 [September 11th, 2011]
- Muscular Dystrophy STS/VECTTOR treatment results - September 24th, 2011 [September 24th, 2011]
- Muscular Dystrophy VECTTOR Treatment Documentary - Todd's One Year Journey - October 2nd, 2011 [October 2nd, 2011]
- Muscular Dystrophy Treatment Day 18 - Todd Harrison's Improvement - October 2nd, 2011 [October 2nd, 2011]
- Wang Yisheng - Muscular Dystrophy Adult Stem Cell Patient - October 9th, 2011 [October 9th, 2011]
- Becker Muscular Dystrophy Miracle TREATMENT - October 11th, 2011 [October 11th, 2011]
- Muscular dystrophy patient_Kleber_Brazil.wmv - October 12th, 2011 [October 12th, 2011]
- Testimonial 1 of Muscular Dystrophy after Stem Cell Therapy - Video - October 18th, 2011 [October 18th, 2011]
- Becker Muscular Dystrophy STS Treatment - Video - October 18th, 2011 [October 18th, 2011]
- Potential Stem Cell treatment of Duchenne Muscular Dystrophy - Video - October 21st, 2011 [October 21st, 2011]
- Muscular Dystrophy treated by Dr Rajesh Shah at Life Force - Video - October 22nd, 2011 [October 22nd, 2011]
- Defying Muscular Dystrophy - I Made It - Video - October 23rd, 2011 [October 23rd, 2011]
- Becker Muscular Dystrophy AMAZING treatment results - Video - October 27th, 2011 [October 27th, 2011]
- First targeted treatment success for Duchenne muscular dystrophy - Video - November 6th, 2011 [November 6th, 2011]
- 125 Days of VECTTOR Treatment Progress - November 18th, 2011 [November 18th, 2011]
- Becker Muscular Dystrophy WALKING ABILITY IMPROVED - Video - November 25th, 2011 [November 25th, 2011]
- PT Muscular Dystrophy Treatment Results - Video - December 5th, 2011 [December 5th, 2011]
- Duchenne Muscular Dystrophy Treated by Cellmedicine - Video - January 8th, 2012 [January 8th, 2012]
- muscular DYSTROPHY treatment IN HOMEOPATH.mp4 - Video - January 28th, 2012 [January 28th, 2012]
- Giulio's strategy is to cure dystrophy with stem cell treatment - Video - January 31st, 2012 [January 31st, 2012]
- Parent Project Muscular Dystrophy is a Featured Nonprofit Selected by Webkinz(TM) Foundation - February 1st, 2012 [February 1st, 2012]
- MDA Awards More Than $12 Million in Grants to Advance Neuromuscular Disease Research - February 1st, 2012 [February 1st, 2012]
- "For treatment we will have in the future" - Video - February 2nd, 2012 [February 2nd, 2012]
- Renowned Pediatric Cardiology Physician-Scientist Linda Cripe Joins Nationwide Children's Hospital - February 3rd, 2012 [February 3rd, 2012]
- JumpStart Invests $250,000 in Milo Biotechnology - February 14th, 2012 [February 14th, 2012]
- When nerve meets muscle, biglycan seals the deal - February 14th, 2012 [February 14th, 2012]
- Medical clinics offer help for Big Island children - February 16th, 2012 [February 16th, 2012]
- Dateline Long Beach: The Aquatic Center brings swim therapy to disabled - February 19th, 2012 [February 19th, 2012]
- Parent Project Muscular Dystrophy Awards $500,000 to Tivorsan Pharmaceuticals - February 21st, 2012 [February 21st, 2012]
- Cure Duchenne Announces Three New Funded Research Projects to Help Develop Treatments and Find a Cure for Duchenne ... - February 21st, 2012 [February 21st, 2012]
- Ligand Licenses DARA Program to Retrophin - February 21st, 2012 [February 21st, 2012]
- AVI BioPharma Regains NASDAQ Compliance - February 23rd, 2012 [February 23rd, 2012]
- Scientists create potent molecules aimed at treating muscular dystrophy - February 23rd, 2012 [February 23rd, 2012]
- AVI BioPharma Announces Fourth Quarter and Full Year 2011 Financial Results and Corporate Update Conference Call - February 23rd, 2012 [February 23rd, 2012]
- Pembroke's Christine McSherry is an 'Inspirational Woman' - February 25th, 2012 [February 25th, 2012]
- The Rare Clinical Diseases Research Network - February 25th, 2012 [February 25th, 2012]
- A Solution for Duchenne Muscular Dystrophy? - Research Summary - February 28th, 2012 [February 28th, 2012]
- A Solution for Duchenne Muscular Dystrophy? -- In Depth Doctor's Interview - February 28th, 2012 [February 28th, 2012]
- Antisense oligonucleotides make sense in myotonic dystrophy - February 28th, 2012 [February 28th, 2012]
- A life of dependence - February 29th, 2012 [February 29th, 2012]
- Nationwide Children's Hospital neuromuscular disorder podcasts now available on iTunes - March 2nd, 2012 [March 2nd, 2012]
- Next-generation DNA sequencing to improve diagnosis for muscular dystrophy - March 6th, 2012 [March 6th, 2012]
- The Dire Limits of Health Care - March 7th, 2012 [March 7th, 2012]
- AVI BioPharma Announces Late-Breaker Oral Presentation of Phase IIb DMD Study at 2012 AAN Annual Meeting in April - March 12th, 2012 [March 12th, 2012]
- Cataracts affect millions of people around the globe, and for many of us they will be a normal part of our aging ... - March 14th, 2012 [March 14th, 2012]
- Your Health: Duchenne's Muscular Dystrophy - March 16th, 2012 [March 16th, 2012]
- Newborn Screening for Duchenne Muscular Dystrophy Shows Promise as an International Model - March 20th, 2012 [March 20th, 2012]
- Newborn screening for DMD shows promise as an international model - March 20th, 2012 [March 20th, 2012]
- Rhenovia launches drug discovery for Huntington's disease - March 20th, 2012 [March 20th, 2012]
- Halo Therapeutics Reports Favorable Independent Review of Lead Drug Candidate HT-100 - March 21st, 2012 [March 21st, 2012]
- Invasive treatment strategy may increase survival for patients with certain neuromuscular disorder - March 28th, 2012 [March 28th, 2012]
- Parent Project Muscular Dystrophy Endorses FAST Act Legislation to Expedite FDA Review of Life-Saving Therapies - March 29th, 2012 [March 29th, 2012]
- AVI BioPharma Announces Conference Call and Webcast on Monday, April 2, 2012, to Discuss Top-Line Data Results From ... - March 31st, 2012 [March 31st, 2012]
- Drug for rare disease may lift AVI BioPharma shares: Barron's - April 2nd, 2012 [April 2nd, 2012]
- AVI BioPharma Announces Eteplirsen Meets Primary Endpoint, Demonstrating a Significant Increase in Dystrophin at 24 ... - April 2nd, 2012 [April 2nd, 2012]
- U.S. Stock Futures Little Changed Before Factory Report - April 2nd, 2012 [April 2nd, 2012]
- Leading experts on congenital muscular dystrophy convene at University of Nevada, Reno - April 20th, 2012 [April 20th, 2012]
- Nature Publishes Work Utilizing N-Gene's Core Technology to Advance the Treatment of Duchenne Muscular Dystrophy - April 20th, 2012 [April 20th, 2012]
- Getting the boots filled - April 29th, 2012 [April 29th, 2012]
- Local business, civic leaders 'arrested' for MDA fundraiser - May 3rd, 2012 [May 3rd, 2012]