The Gene Patent Debate

1. The Gene Patent Debate Angela Foster, PhD, Esq. Law Offices of Angela Foster

2. Where Science, Law & Ethics Meet

3. What is the Debate? • For over 30 years, many scientist opposed the granting of gene patents: • Restricts Research • Restricts Access to Genetic Testing • Biotechnology Industry argues that such patents are needed to encourage investments in genetic research.

4. Ethical Concerns - delays • Delay in Disseminating Information • Researchers waiting for patent approval are less likely to share information until the patent is granted. • Scientists are unlikely to share material or information to ensure they would be entitled to the patent rights as well as gain the financial rewards. • Contrast • Gene patents provide incentive to develop and research new inventions. • Because of patent term expiration, the information is ultimately disseminated to the public

5. Ethical Concerns – hidden • Submarine patents • Researchers waiting for patent approval are less likely to share information until the patent is granted. • Scientists are unlikely to share material or information to ensure they would be entitled to the patent rights as well as gain the financial rewards.

6. Ethical Concerns – hinders • Hinders development of new diagnostic tests and medications • Patent exclusivity rights prevent other organizations from testing for a patented gene. • Experimental Use Exception • limited to research strictly for philosophical inquiry, curiosity or amusement with no commercial use

7. Ethical Concerns – confidentiality • Compromise of autonomy and confidentiality • Patients are potential "treasure troves" for researching lucrative genes. • Struggle with balancing the need for patent protection to encourage the necessary research for advancements in medical technology, while maintaining patient integrity.

8. Patent Law Rights • Patent holders are granted exclusive rights to make, use, and sell their invention to the exclusion of others in exchange for disseminating the information in the public domain.

9. Patent Law Rules • An invention must be a machine, manufacture, process, or composition of matter, or an improvement thereof, in order to be eligible for patenting. • An invention cannot be an abstract idea, physical phenomena, or product of nature. • Mathematical formulas, laws of nature, or natural phenomena such as a mineral or plant organism, even if newly discovered. • However, methods and products utilizing abstract ideas, natural phenomena, and laws of nature to perform a real-world function may be patentable

10. Patent Subject Matter - Chakrabarty • Supreme Court in Diamond v. Chakrabartyheld that a livingorganism—genetically engineeredbacteria capable of breaking down crude oil—is patentable subject matter. • Living organisms were considered to be “products of nature,” specifically excluded from the definition of patentable subject matter under section 101 of the Patent Act. • Because a bacterium such as that described by Chakrabarty is not found anywhere in nature, its creation constitutes a patentable “manufacture” or “composition of matter” under section 101.

11. Patent Subject Matter – Composition of Matter Claims naturally occurring substances • Parke-Davis v. H.K. Mulford Co. – exception • Because the purified adrenaline was extracted from the suprarenal gland and purified in a form that was more stable and concentrated, it could be considered more valuable both therapeutically and commercially.

12. Patent Subject Matter – Composition of Matter Claimsproduct of nature • Funk Brothers Seed Co. v. KaloInoculant Co., - • Each species of bacteria in the mixture could benefit certain specific plant species it might infect by extracting nitrogen from the air and rendering it available for the infected plants to use. • No single species could infect the roots of all types of plants. • Rather, each species could infect only a particular plant group, and different bacteria species could exhibit mutually inhibiting effects when applied to plants in combination. • The patentee had created a mixture of bacteria capable of inoculating the seeds of plants belonging to several groups. • Patents cannot issue for the discovery of the phenomena of nature.

13. Patent Subject Matter – Composition of Matter Claims distinguishable v comparable • Merck & Co. v. Olin Mathieson Chemical Corp – • Isolated a vitamin B12 substance from microorganisms that was identical to the vitamin B12 found in the calf ’s liver. • Because the active substance was unidentified and unknown, no one had produced a “comparable” product to the calf ’s liver. • Compound was far more than simply a purified version of the natural substance.

14. Patent Subject Matter –Composition of Matter Claims purified and isolated DNA sequences • Amgen, Inc. v. Chugai Pharmaceutical – • A purified and isolated DNA sequence encoding the protein, human erythropoietin (EPO), which stimulates the production of red blood cells. • Amgen invention did not claim “DNA sequences encoding the erythropoietin” as previously known, but rather, “a purified and isolated DNA sequence consisting essentially of a DNA sequence encoding the erythropoietin.” • The claimed invention was a “purified and isolated” DNA clone versus actual DNA sequences

15. Patent Office Amended Rules Gene Patents • A patent claim directed to an isolated and purified DNA molecule could cover a gene excised from a natural chromosome or a synthesized DNA molecule. • An “isolated and purified” DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because either: • An excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature or • Synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound.

16. Patent Subject Matter – Method Claims Mayo v. Prometheus • Prometheus Labs., Inc. v. Mayo Collaborative Services • A method for determiningthe most effective dosage of a drug,thiopurine, intended to treat Crohn’sdisease, an immune mediated gastrointestinaldisorder. • Determine metabolitelevels of thiopurine in clinical samplestaken from patients. • District Court held unpatentable because correlating drug metabolite levels with therapeutic efficacy and toxicitywas a natural body process and merelyinvolved necessary data-gathering steps. • Federal Circuit disagreed: • determining metabolite levels” was “transformative” because the “levels cannot be determined by mere inspection. • The step included growing cells.

17. Patent Subject Matter – AMP v. MyriadBreast Cancer Gene • Myriad patent covered mutations to the BRCA1 and BRCA2 genes; use of these mutations for diagnosis and prognosis for breast and ovarian cancer; screening for cancer predisposition; and development of therapeutic cancer treatments. • The plaintiffs argued that the isolated DNA and sequence for BRCA1 and BRCA2are “products of nature” and unpatentablesubject matter. • District Court agreed: • In order to be patentable under section 101, “isolated” DNA must be “markedly different” from naturally occurring DNA.

18. Patent Subject Matter – Myriad District Court Decision – DNA claims • District Court agreed: • In order to be patentable under section 101, “isolated” DNA must be “markedly different” from naturally occurring DNA. • Because isolated DNA containing naturally occurring sequences is not “markedly different” from the native DNA, it fell within the “product of nature” exception to patentable subject matter under section 101. • Because the “fundamental quality” of DNA consists of the physical embodiment of biological information, the isolated DNA and naturally occurring DNA possess the same “fundamental quality” and therefore are not markedly different.

19. Patent Subject Matter – Myriad District Court Decision – Method Claims • Myriad method claim: • comparing or analyzing gene sequences to identify the presence of mutations corresponding to a predisposition to breast or ovarian cancer. • District Court rejected method claims based on “machine or transformation” test. • A claimed process or method must be tied to a particular machine or apparatus, or it transforms a particular article into a different state or thing. • Myriad method claims also did not qualify for patentability subject matter under section 101 because claims comprising comparisons of the BRCA sequences to determine whether a mutation is present refer only to an “abstract mental process.”

20. Patent Subject Matter – Myriad Federal Circuit Decision • Federal Circuit reverses District Court: • Claims covering isolated breast cancer DNA sequences are patentable because the isolated DNA molecules are chemically cleaved from the native DNA – markedly different characteristic. • Claims covering involving comparing or analyzing gene sequences were unpatentable because they were abstract mental processes without any transformation steps. • Court held Myriad’s for screening potential cancer therapeutics via changes in cell growth rates of transformed cells is patentable.

21. Patent Subject Matter – Prometheus Revisit • Supreme Court reverses the Federal Circuit • Method for comparing the relationship between the concentration of blood metabolites and optimal dosages of a therapeutic drug: • Unpatentable – mere recitation of laws of nature • Supreme issues 3-step Inquiry: • Is the claim drawn to a process? If yes: • Does the claim focus on a natural principle? If yes: • Is the claim more than a recitation of the natural principle and instructions to “apply it”?

22. Myriad Standing Attack • On appeal, Myriad challenged the grant of standing to the 20 plaintiffs in the case: • Public interest groups • Patients • Health insurance plaintiffs • Declaratory Judgment • Alleged or potential infringer ask the court to rule they are not liable for patent infringement because: • Do not infringe • Patent is invalid or unenforceable.

23. Declaratory Judgment Standard • A court has jurisdiction to hear an action for declaratory judgment only if at the time the action is filed there is an actual controversy. • Historically, this meant that a plaintiff must have a reasonable belief that it would be sued by a patent owner for infringement based on actions of the plaintiff. • When multiple plaintiffs are present, the court must find at least one plaintiff-defendant relationship that meets this standard.

24. Significance of Standing Issue • No standing • Vacation of Southern District of New York’s decision that Myriad BRCA genes are not patentable. • Standing • Courts could face a significantly higher risk of declaratory judgment actions by plaintiffs who have had little or no contact with the patentee but who claim a right to invalidate the patent.

25. Federal Circuit Standing Decision • Federal Circuit ruled that only the research of one scientist was hampered by Myriad's patent. • Other organizations lacked standing • Simply disagreeing with the existence of a patent on isolated DNA sequences or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the declaratory judgment standard • Other parties had made no preparation to undertake potentially infringing activities.

26. Appeal to Supreme Court • The question of whether human genes and the information they convey are patentable is of paramount importance to the future of patent law, the advancement of medical science and the health of patients. • Patents on “isolated” DNA are invalid under section 101. • The method claim upheld is inconsistent with the decision in Mayo. • Holding that petitioners lacked standing unless they were personally threatened by Myriad imposed a rigid standing requirement contrary to the Supreme Court

27. QUESTIONS

28. THANK YOU! Angela Foster, PhD, Esq. Law Offices of Angela Foster 2906 Birchwood Court North Brunswick, New Jersey 08902 Telephone: 732-821-9363 Fax: 732-821-4692 fosteratlaw@aol.com