Worldwide: World Wide Legal Status Of Medical Method Patents: An Overview

Therapeutic, surgical and diagnostic methods (collectively, "medical methods") produce effects on human (or animal) body, and they don't have an industrial effect. Therefore, they may be deemed not patentable because of non-compliance with the industrial applicability requirement provided for in most patent laws, even in the absence of a specific exception. The norms of medical profession as expressed in Hippocratic Oath and medical codes of ethics mandate that physician share medical knowledge for benefit of their patients and not for personal gain. The medical profession finds itself in a unique position because it forms part of the scientific community where innovation is encouraged but it also specifically imposes a code of ethics on its members prohibiting them from patenting medical procedures.

More than 80 countries, including most Trans-Pacific Partnership (TPP) negotiating parties, exclude medical procedures from patentability. Medical methods are expressly excluded from patentability in Brunei Darussalam (Section 16 of the new Patents Act (2011)), Chile (Article 37 of Chilean Law No. 19.039 on Industrial Property), Malaysia (Section 13 of the Malaysia Patents Act (291 of 1983)), Mexico (Article 19 (VII) of the Industrial Property Law), Peru, (Article 20 of Andean Community Decision 486 "Common Intellectual Property Regime" , as authorized by Article 16.9.2 of the US-Peru TPA), Singapore, (Section 16(2) of the Patents Act (No. 24 of 2001, as amended by Act No. 2 of 2007), as authorized by Article 16.7.1 of the US-Singapore FTA), and Vietnam (Vietnamese Law on Intellectual Property (50/2005)). In Canada, Section 2(d) of the Canadian Patent Act does not exclude medical procedures from patentability, but case law prohibits patents on surgical and therapeutic methods, while allowing patents on diagnostic methods. In New Zealand, while medical procedures are not statutorily excluded from patentability, case law has generally rejected such patents. Only Australia—even though it maintained the flexibility to do so in the AUSFTA (Article 17.9.2)— the Patents Act of 1990 doesn't specifically exclude medical procedures from patentability, and case law suggests that they are in fact patentable.1

TRIPS AGREEMENT:

The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)2 under Paragraph 3 of Article 27 allows members to exclude diagnostic, therapeutic and surgical methods for the treatment of humans or animals from the scope of patentable subject matter.

INDIAN STATUS:

Section 3 (i) of India's Patent Act, 1970 excludes from patentability "any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products".

This provision rules out the patentability of methods used for the treatment of not only human beings, but also animals and plants. Although with the advent of The Patents (Amendment) Act, 2002, any process for treatment of plants has now become patentable, still the diagnostic or therapeutic processes are not considered to be patentable.3 .In Lalit Mahajan's patent application,4the issue was whether 'a device for detection of antibodies to HIV and p24 antigen of HIV in human serum or plasma' was excluded under Section 3(i). The opponents argued that the Applicant had hidden the diagnostic aspect of the device. The Patent Examiner observed that the invention in question was a device and not a diagnostic or therapeutic process/ method. As a result, the ground raised by the opponent was not sustainable and Section 3(i) was found to be inapplicable. This view was consistent with a previous decision finding the exclusion inapplicable in case of a device for the rapid detection of presence of IgG and IgM antibodies against dengue viral antigens in a sample (human serum) for a diagnostic purpose.5 In a patent application dealing with 'a method of discovering compounds suitable for the treatment and or prophylaxis of obesity...', the Patent Examiner concluded that it is a method of diagnosis and treatment and hence not patentable under Section 3(i).6

Similarly, in M/s. Applied Research Systems Ars Holding, Netherland's patent application7 the issue was whether the claim relating to a 'kit for the treatment of infertility in women comprising multiple doses of FSH ...' could be excluded under Section 3(i). The Patent Examiner concluded that the said invention was merely a method of medical treatment in the guise of the claimed kit (a product), and was not patentable under Section 3(i).

Based on all the above, it would appear that the Indian Patent Office interprets the method of medical treatment exclusion in a wider manner than the EPO and UK patent office/courts, consequently excluding a larger number of such inventions from patentability.

U.S. LAW:

US law does not prohibit the patenting of medical methods, it provides an exception for medical professionals in cases where medical method patents are infringed, thereby limiting the enforcement of patent rights on medical methods.

The United States Patent Office allows medical use claims as long as the steps are recited. For example, a claim for use of a known compound in the manufacture of a medicament will be rejected unless the steps involved are recited.

US patent law allows patenting of medical treatment methods but denies a remedy for its infringement, thus nullifying the right in so far as there is no enforceability. The nullification provision was hastily enacted in 1996 after wide dissatisfaction was provoked in the medical community by Pallin case8 where a surgeon sued other surgeons for patent infringement , caused amendment in 1996 such that in principle patent rights do not apply to medical activity by physicians etc (35 USC 287 (c)(1)). Patent application for method inventions related to medical activity are judged by whether they meet the patent requirements such as novelty, and patents may be granted unless grounds for objections are found. Although current law does not prohibit the patenting of medical methods, it provides an exception for medical professionals in cases where medical method patents are infringed, thereby limiting the enforcement of patent rights on medical methods.9

In US, case law is swinging the pendulum even further away from broad medical procedure patents. Supreme Court reiterated the importance of limiting the adverse effects of diagnostic method patents, which remain among the most contentious of the medical procedure trio. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. — (2012), the Court invalidated Prometheus's patent on a diagnostic method that involved administering thiopurines and observing chemical reactions in the body as a basis for dosing advice, stating that the patent improperly claimed a natural law.10

EUROPEAN PATENT CONVENTION (EPC):

European Patent Convention11 under Article 52 Clause 4 excludes surgical, therapeutic and diagnostic methods because these medical methods do not fulfill the statutory requirement of industrial applicability; hence they are not eligible for patent protection. The issue has been litigated to a considerable extent in the European courts. Instead of excluding medical methods completely, the judges have found In vitro diagnostic methods and cosmetic surgeries or therapies to be patentable.

JAPAN (JPO):

The patent law of Japan also excludes methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on humans" from the scope of granting a patent. Part II of the Examination Guidelines for Patent and Utility Models provides extensive guidelines for patenting methods of medical treatment similar to European law. The Examination Guidelines permit patenting of In vitro diagnostic methods and cosmetic methods. "On the other hand Methods of medical treatment have long been excluded from patenting in the UK. The exclusion can be traced back to the 1914 case of In the Matter of C & W's Application for a patent12.

In this case, the solicitor general refused an application for patent protection for a process of extracting toxic lead from living human beings upon the ground that the alleged invention related simply to a medical treatment process did not employ any form of manufacture or of trade, thus lacking commercial value13. Since that decision, for many years it was accepted as univocal that there could be no patents for medical treatment, because they do not results in, or in the improvement of, a "vendible product"14, a product that can be sold.

AUSTRALIA:

Contrary to world trend, Australian patent law does not exclude methods of medical treatment from patentability. In Bristol-Myers Squibb Co v F H Faulding & Co Ltd, the Federal Court of Australia in a case involving the validity of petty patents that claimed a method of administering the anti-cancer drug Taxol opined in dictum that a method of medical treatment is patentable. This court has validated the statute by positively allowing methods of medical treatment to be patentable. On 4 December 2013 the High Court confirmed that methods of medical treatment involving the administration of therapeutic drugs are patentable subject matter in Australia15. This decision of the High Court confirms the eligibility of medical treatment methods for patent protection in Australia, particularly those methods which require the administration of therapeutic drugs. The patentability of purely medical procedures such as surgery was not however specifically confirmed by High Court and hence may be subject to further consideration.

OTHERS:

In China, Article 25 provides the list of subjects excluded from patentability. Clause (3)16 states that no patent right shall be granted for a method of diagnosis or for the treatment of diseases. Thus Chinese patent law provides a broad ban on patentability of such methods. In Canada, Section 2(d) of the Canadian Patent Act does not exclude medical procedures from patentability, but case law prohibits patents on surgical and therapeutic methods, while allowing patents on diagnostic methods.

Patent law of New Zealand does not contain any statutory exclusion from patentability of medical methods like those prevalent in Canada and Australia17. Further the Courts in New Zealand have historically conformed with English decisions and held that a method of treatment of human illness or disease does not qualify for the grant of a patent, since it does not meet the requirement of 'manner of manufacture' under the definition of 'invention' in Section 2. 18

CONCLUSION

Even in countries where the patentability of such methods is allowed, patents granted are relatively rare. One possible reason for this is that enforcing such patents is very problematic. The patent owner would need to monitor the activities by a more or less large number of doctors and surgeons, who generally provide their services subject to strict privacy rules. Enforcement may be more feasible when new and complex methods are applied by a small group of easily identifiable professionals. The law around the world permits the granting of patents for drugs and medical devices, at the same time, patentability for a method of treatment of the same body is denied in some countries on various public policy grounds.

The various forms of legal systems that exclude medical methods from patent protection are based on ethical reasons. As such ethical reasons are appearing in the patent laws of various legal systems, and are acting as obstacles to the patent protection of medical methods. With the exception of Australia and US , most nations of the world exclude methods of medical treatment from the scope of patentable subject matter and in doing so they have taken away the incentives offered by the patent system. Such a policy has been adopted in light of the ethics inherent in the practice of medicine.

Footnotes

1. http://www.stemcellpioneers.com/showthread.php?7759-Allowing-Medical-Procedures-to-be-Patented-World-wide

2. Agreement on Trade Related aspects of Intellectual Property Rights("TRIPS"), Apr.15,1994,Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, THE LEGAL TEXTS:THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 320(1999),1869U.N.T.S. 299, 33 I.L.M. 1197(1994)

3. http://www.patentoffice.nic.in/ipr/patent/salient_f.htm

4. Patent Application No. 693/KOL/2007 decided on 11.01.2010

5. Patent Application No. 2484/DEL/2007 decided on 24.07.2009.

6. Patent Application No. 195/MUMNP/2003 decided on 18.05.2006.

7. Patent Application No. 404/MUMNP/2005 decided on 28.09.2007.

8. Pallin v. Singer, 36 U.S.P.Q. 2d 1050(D.Vt. 1995)

9. Cynthia M.Ho, Patents, Patients, and Public Policy: An Incomplete Intersection at 35 U.S.C. $ 287(c), 33 U.C. DAVIS L. REV. 601, 641-44(2000).

10. https://blogs.law.harvard.edu/billofhealth/2012/09/08/is-the-ustr-trading-away-doctors-rights-to-freely-performmedical-procedures/

11. convention on the Grant of European Patents, Oct. 5, 1973, 1065 U.N.T.S. 255

12. In the Matter of C & W's Application for a Patent:31 RPC 235. (1914)

13. In the Matter of C & W's Application for a Patent:31 RPC 235. (1914)

14. Re GEC's Application (1942)60 RPC 1, per Morton j at 4.

15. Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50

16. Article 25 (China): For any of the following, no patent right shall be granted :...( 3) Methods for the diagnosis or treatment of diseases.

17. "Invention" means any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies and any new method or process of testing applicable to the improvement or control of manufacture. See Section 2 of the Patents Act 1953 (New Zealand).

18. Swift & Company's Application, [1960] NZLR 775, [1961] RPC 129, [[[1962] RPC 37 (D.C.) (N.Z. H.C. (formally S.Ct.); Wellcome Foundation v. Commissioner of Patents 1983 NZLR 385. Courts placed reliance on Schering A.G.'s Application [1971] RPC 337; Upjohn Co. (Robert's) Application [1977] RPC 185. Tom Syddall, 'Method of Treatment Claims and Patent Law Reform in New Zealand', CIPA Journal, June, 423(1996).

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