4. COMPARISON OF THE INDIAN PATENT LAW WITH THE PATENT LAWS IN U.S., EUROPE AND CHINA

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1 4. COMPARISON OF THE INDIAN PATENT LAW WITH THE PATENT LAWS IN U.S., EUROPE AND CHINA Provisions of the Indian patent law were compared with the relevant provisions of the patent laws in U.S., Europe and China. 4.1 Governing laws/ regulations Table 4 provides details about the governing patent laws/ regulations in U.S., Europe, China and India. Table 4: Governing patent laws/ regulations Law Rules/ Regulations U.S. Patent Law (35 U.S.C.); as amended by Leahy-Smith America Invents Act (AIA), 2011 U.S. Patent Rules (37 C.F.R); as updated in November, 2015 European Patent Convention (EPC) - 15 th edition, 2013 Implementing Regulations to the EPC, 2014 Patent Law of the PRC, 1984; as amended in 1992, 2000 and 2008 Implementing Regulations of the Patent Law of the PRC, 2001; as amended in 2002 and 2010 Patents Act, 1970; as amended in 1999, and 2005 Patents Rules, 2003; as amended in 2005, 2006, 2012 and 2014 U.S., Europe, China and India have their respective patent laws and regulations. China and India amended their patent laws to fulfil the obligation of TRIPS agreement. India in 2005 and China in 2008 made their Patent Acts TRIPS compliant. Page 116 of 184

2 4.2 Patentable subject matter and criteria of patentability Subject matter eligible for patent grant and conditions of patentability are compared in Table 5. Table 5: Comparison of patentable subject matter and criteria of patentability Patentable subject matter Criteria of patentability Invention or discovery of a new & useful process/ machine/ manufacture/ composition of matter or improvement thereof Novelty; Nonobviousness; Usefulness Invention which is new, involve an inventive step; & industrially applicable, belonging to any field of technology Novelty; Inventive step; Industrial application Inventions in the form of new technical solution or improvement to a product/ process Novelty; Inventive step; Practical applicability New product or process involving an inventive step and capable of industrial application Newness; Inventive step; Industrial applicability All the countries viz. U.S., Europe, China and India grant patents for inventions which fulfil the three conditions of patentability viz. newness/ novelty, inventive step/ non-obviousness, and industrial applicability/ usefulness. This in compliance with the TRIPS Article 27, which states that patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Page 117 of 184

3 4.3 Patentability of polymorphs/ new forms Comparison in the patentability of polymorphs/ new forms is provided in Table 6. Table 6: Comparison in the patentability of polymorphs/ new forms Specific restrictions on the patentability of polymorphs/ new forms in the governing law/ rules Regulations by case laws/ patent prosecution/ examination guidelines No specific restrictions The new form shall not be a result of routine experimenttation ; it shall not be obvious to try ; and it shall not be inherently disclosed in the prior art; unexpected results can be used to rebut obviousness No specific restrictions The polymorph shall merely not provide only the obvious advantages of a crystalline material over the amorphous form; in the absence of any technical prejudice and unexpected property it cannot be regarded as inventive No specific restrictions An unexpected effect of the claimed polymorph shall be demonstrated; obvious advantages of the polymorph such as better stability is not sufficient to establish the inventive step Under Section 3(d) of the Patents Act, to be patentable a new form of the known substance must show enhanced efficacy as compared to the existing substance Term efficacy in Section 3(d) means therapeutic efficacy Page 118 of 184

4 In India, specific restrictions on the patentability of polymorphs and other new forms of a known drug substances have been put through the Section 3(d). Although, the patent laws in U.S., Europe and China do not explicitly put restrictions on the patentability of polymorphs/ new forms, however limitations in terms of raised standard of inventive step/ obviousness and novelty requirements have been put under the case laws/ patent examination guidelines in these countries. Indian patent law requires that for being patentable, a new form shall be more efficacious than the existing known substance. In the Novartis-Glivec case, the supreme court of India has provided the meaning of the term efficacy in the Section 3(d) as therapeutic efficacy. Some authors however have suggested that the meaning of the term efficacy may be defined in the Patents Act in a broader way to encompass other relevant aspects such as decreased toxicity or side effects, increased bioavailability or improved physicochemical properties. 4.4 Patent filing and prosecution Main differences in the patent filing and prosecution procedure are presented in Table 7. Table 7: Main differences in the patent filing and prosecution procedure Where/ how to file the patent application Provisional specification filing At USPTO office; or through e-filing At EPO in Munich/ Hague/ Berlin; or through e-filing At SIPO, Beijing; or its representative offices; or through e- filing At patent offices in Kolkata, Delhi, Chennai or Mumbai; or through e-filing Allowed Not allowed Not allowed Allowed Page 119 of 184

5 Stages in patent examination Request for early publication Option to optout of the publication Issue of search report & opinion on patentability Expedited patent examination Member of PPH program Supplemental examination Continued examination/ reexamination One stage Two stages viz. Formalities examination and Substantive examination Two stages viz. Preliminary examination and Substantive examination One stage Possible Possible Possible Possible Available Not available Not available Not available No Yes No No Available Available Available Currently Not available; proposed in the new draft rules Yes Yes Yes No Yes No No No Yes No Yes No All the countries provide option of e-filing and filing of patent application in print copy at the respective patent office or its branches. To felicitate patent filing, China has additionally established representative offices of SIPO at all state capitals and district headquarters, where a Chinese citizen can file his/ her patent application. Page 120 of 184

6 The major steps during patent prosecution viz. patent filing, publication, examination, opposition and patent grant/ rejection are followed universally. Still few differences exist in the patent prosecution in the U.S., Europe, China and India. In the U.S. and India, the patent prosecution consists of only one stage comprising of several steps. However, in Europe and China patent prosecution is divided into two distinct stages viz. formalities/ preliminary examination stage and substantive examination stage, wherein a patent application can enter in the substantive examination stage only when it first passes the formalities/ preliminary examination stage. In U.S. it is possible to opt-out of the publication of the patent application, through which applicants can avoid publication of their applications in certain cases. This option allows the applicants to keep their patent application confidential and out of the sight of their competitors till the patent is granted. This provision is not available in Europe, China and India. EPO issues a search report & opinion on patentability on the claimed invention. The search report helps the applicant to make decision on whether to get the application further examined and in which member countries to pursue the application. Based on the results of the search report the applicant may also amend the application before it is substantially examined. The provisions related to search report & opinion are not available in the U.S., China and India. Patent laws in U.S., Europe and China provide various procedures to expedite the patent examination, whereas, no such options are currently available in India. India is also currently not a member of Patent Prosecution Highway (PPH), to which U.S., Europe and China are the members. The Draft Patent (Amendment) Rules, 2015 has proposed to add the provision for expedited patent examination in India. The proposed rules for expedited examination Page 121 of 184

7 have however been criticized on various grounds (See Expedited patent examination (2.1.8) in the Chapter 2: Patent Laws in India, U.S., Europe and China). The new AIA provides the option for supplemental examination after the grant of a patent in U.S. Supplemental examination is not available in Europe, China and India. In U.S. and China, in the case of patent rejection the applicant can still resume prosecution with the patent office through continued examination/ re-examination, and avoid losing the priority date of the application. EPC and India do not provide such option. 4.5 Duty to disclose information regarding foreign applications Comparison of the provision regarding duty to disclose information regarding foreign applications is presented in Table 8. Table 8: Comparison of the provision regarding duty to disclose information regarding foreign applications Provision under the law Case laws All information material to the patentability of the invention shall be disclosed to USPTO Information is material to the patentability if it establishes a Copy of the results of prior art search/ patent examinations (priority search reports) shall be provided to EPO Copy of the results of prior art search/ patent examinations (priority search reports) shall be provided to SIPO Detailed particulars of the corresponding foreign patent application(s) must be submitted to the Indian Patent office from time to time Conflicting decisions; IPAB held that failure to comply due to Page 122 of 184

8 Consequence/ penalty on failure to comply prima facie case of unpatentability; or based upon which unpatentability could not be opposed; or patentability of the claim could not be established Failure to comply is an inequitable conduct; during a counter claim of infringement, patent can be invalidated Application deems to be withdrawn if priority search reports are not provided by the applicant to EPO upon request by the office; not a ground of patent revocation after patent grant Application deems to be withdrawn if priority search reports are not provided by the applicant to SIPO upon request by the office; not a ground of patent revocation after patent grant any reason whatsoever is a violation; whereas as per High Court decision omission of information due to unintentional/ clerical/ bonafide error is exempted Ground of patent opposition u/s 25(1) and 25(2); Patent can be revoked after the grant u/s 64(1)(m); All the countries viz. U.S., Europe, China and India require the applicants to disclose information regarding corresponding foreign patent applications. However, regulations in India in this context seem to be much more strict and difficult to comply with. In the U.S., the applicant s duty is limited to submit any information that is material to the patentability of the claimed invention. Similarly SIPO and EPO require only the copies of priority search/ Page 123 of 184

9 examination reports to be submitted. Whereas, in India as per the Section 8, the applicant is required to submit detailed particulars related to corresponding foreign application at the Indian Patent Office, irrespective of whether such information is material to patentability or not. Further, meaning of the term detailed particulars has not been provided under the Act, which makes this provision ambiguous and thus difficult to comply with. In Europe and China failure to comply with this provision is not a ground of patent revocation after the patent grant. Whereas, in India it is a ground of patent revocation under Section 64 of the Patents Act. In U.S. failure to comply this provision can be a ground of patent invalidation only in the cases of counterclaim of infringement. High Court of India has provided an important clarification that any unintentional omission of the information by the applicant shall not be treated as violation of this provision. 4.6 Patent opposition Provisions relating to patent opposition are compared in the Table 9. Table 9: Comparison of patent opposition in U.S., Europe, China and India Pre-grant opposition Proceeding Ex-parte Ex-parte Ex-parte Inter-partes preissuance observations observations pre-grant submissions by third parties by third opposition by third parties parties Fee No No No No Estoppel No No No No Provision Threshold to institute the proceeding Not applicable Not applicable Not applicable No threshold prescribed Page 124 of 184

10 Post-grant opposition Proceeding - Inter partes 1 post-grant Threshold to institute the proceeding review Inter partes post-grant opposition Inter partes post-grant invalidation Inter partes post-grant opposition Yes No No No Estoppel Provision Proceeding - 2 Proceeding - 3 Yes No Yes Yes (as per the Supreme Court decision) Inter partes No similar No similar No similar review Ex parte reexamination provision No similar provision provision No similar provision provision No similar provision U.S., Europe and China fallows Ex-parte preissuance submissions at the pregrant stage, whereas, India has adopted an Inter-partes pre-grant opposition procedure. No fee, estoppel provision and threshold to institute the proceeding are applicable at pre-grant stage in all the four countries. At post-grant stage all the four countries follow Inter partes post-grant opposition. Threshold to institute the post-grant opposition proceeding is applicable only in U.S. Estoppel provision during post-grant opposition is applicable in U.S. and China. U.S. additionally also has two other post-grant opposition mechanisms viz. Inter partes review and Ex parte re-examination. 4.7 Compulsory licensing Comparison of compulsory licensing provisions is provided in Table 10. Page 125 of 184

11 Table 10: Comparison of compulsory licensing provisions in the U.S. and India Ground for compulsory license (CL) Use of patented invention by or for the government Anti- competitive/ anti-trust practice by the patentee Non-working of the patent by the patentee Non-working of patents acquired under government funded projects Provision in the U.S. law Provision in Indian Patents Act 28 U.S.C. 1498(a) (1) Sec. 92: CL on notifications by central government (2) Sec : Use of invention for purposes of government Sherman Antitrust Act Denial of injunctive relief as per the Supreme Court s decision in ebay Inc. vs. MercExchange Bayh-Dole Act Sect. 83(f): Anticompetitive practice is a ground for the issue of CL Sec. 84(1)(c): Nonworking of the patent is a ground for the issue of CL No similar Act Although TRIPS flexibilities for compulsory license have not been adopted in the U.S. patent law, still provisions similar to compulsory licensing are provided in other domestic laws in the U.S. Both U.S and India may grant compulsory license on the grounds of government use, anti- competitive practice and non-working of the patent. Further, in the U.S. compulsory license may also be granted under Bayh-Dole Act, whereas this type of provision is currently not available in India. Comparison of compulsory licensing provisions in Europe and India is provided in Table 11. Page 126 of 184

12 Table 11: Comparison of compulsory licensing provisions in Europe and India Ground for compulsory license (CL) Export of patented pharmaceutical products under paragraph 6 decision of the Doha Declaration Mandatory crosslicensing between the owners of patented biotechnology inventions and registered plant variety Provision in European Regulation Regulation (EC) No 816/2006 Directive 98/44/EC Provision in Indian Patents Act Section 92A No similar provision Provisions for the export of patented pharmaceutical products as per the Doha Declaration have been adopted both under European and Indian regulations. Provisions for the mandatory cross-licensing between the owners of biotechnology patents and registered plant varieties are currently not available in India, as provided in the European regulations. Comparison of compulsory licensing provisions in China and India is provided in Table 12. Table 12: Comparison of compulsory licensing provisions in China and India Ground/ parameter for compulsory license (CL) Provision in Chinese Patent Law Provision in Indian Patents Act Non-working of the patent Article 48 Sec. 84(1)(c) by the patentee Anti- competitive practice Article 48 Sect. 83(f) by the patentee Circumstances of national Article 49 Sec. 92 emergency or extreme urgency Public health crises Article 50 Sec. 92 Page 127 of 184

13 Ground/ parameter for compulsory license (CL) Provision in Chinese Patent Law Provision in Indian Patents Act Export of patented drugs Article 50 Section 92A Licensing of related patents Article 51 Section 91 Predominant use for the Article 53 Section 90(1)(vii) domestic market Prior efforts of the applicant Article 54 Section 84(6)(iv) to obtain a voluntary license is necessary Termination of the Article 55 Section 94 compulsory licence Non-exclusive basis Article 56 Section 90(1)(iv) Adequate remuneration to Article 57 Section 90(1)(i) the patentee Decision on compulsory Article 58 Section 117A license subject to judicial review Detailed guidelines on CL Measures for Compulsory Licensing of Patent Implementation,2012 No similar guidelines Both China and India have adopted compulsory license provisions based on the grounds specified under TRIPS agreement. China has prescribed detailed guidelines on compulsory license. No similar guidelines are available currently in India. 4.8 Reporting of working of patents Requirement relating to reporting of working of patents are compared Table 13. Page 128 of 184

14 Table 13: Comparison of the requirement for reporting of working of patents Is reporting mandatory? Penalty on failure to comply No No No Yes (in Form-27) Not applicable Not applicable Not applicable Failure to furnish the information is punishable with fine up to ten lakh rupees; knowingly furnishing false information is punishable with imprisonment up to six months, or with fine, or with both Indian patent law mandates each patentee and licensee of the patent to submit each year, information about the extent to which the patented invention has been worked on a commercial scale in India. This information is to be submitted in Form-27. Many defects however, have been observed in the format of the Form-27. Patentee who fails to comply with this requirement is liable for penalty. Requirement for reporting of working of patents is not prescribed under the EPC and the patent laws of U.S. and China. 4.9 Extension of patent term Provisions related to extension of patent term are compared in Table 14. Page 129 of 184

15 Table 14: Comparison of the provisions for patent term extension Patent term adjustment Patent term restoration Available Available Not available Available (SPC) Not available Not available Not available Not available U.S. law provides for both the patent term adjustment (to compensate loss in patent term due to delay in patent grant), and patent term restoration (to compensate loss in patent term due to delay in drug product approval by US FDA). EC regulations in Europe provide for patent term restoration in the form of Supplementary Protection Certificates (SPC). Patent term adjustment is not available in Europe. China and India don not provide either patent term adjustment or patent term restoration Patent linkage Provisions for patent linkage are compared in Table 15. Table 15: Comparison of patent linkage Relevant provision Hatch- Waxman Act, 1984 Not available Basic frame work under the Drug Registration Rules Not available U.S. law provides an extensive frame work for patent linkage, which aims to prevent patent infringement dispute between the innovator and generic drug companies after the marketing approval of the generic drugs. China follows only a basis structure of patent linkage, which requires from the generic drug Page 130 of 184

16 company a certificate that the generic drug will not infringe the innovator s patent. However, Chinese law does not have full mechanism for the adjudication of patent validity and infringement before the marketing of generic drugs, as it is present in the U.S Specialized IP/ patent courts Provisions relating to IP/ patent specialized courts are compared in Table 16. Table 16: Comparison of the provisions relating to IP/ patent specialized courts IP/ patent specialized courts The Federal Circuit court is specialized to deal with appeals related with patent disputes IP specialized courts are constituted at national level in some countries e.g. U.K.; Unified Patent Court (UPC) is going to be constituted under forthcoming unitary patent system. Three IP courts have been established in Beijing, Shanghai and Guangzhou No IP/ patent specialized courts; IP cases worth > Rs 1 crores shall be adjudicated in the newly created Commercial Courts IP/ patent specialized courts have been set up in U.S., Europe and China. In India currently there are no such types of courts are established for specifically adjudicating matter related with IP rights. Newly created Commercial Courts in India will handle IP disputes worth > Rs 1 crores. Page 131 of 184

17 4.12 Regulations for service/ employee inventions Regulations for service/ employee inventions are compared in Table 17. Table 17: Comparison of the regulations for service/ employee inventions Regulation No specific regulation EPC distinguishes between the rights of employers and the employeeinventors; the comparative right of employer/ employee on the service inventions to be determined according to the laws of the individual member State Under Article 16 of the Chinese patent law specific mechanism to ensure adequate rewards/ remunerations for the inventors of service inventions No specific regulation Regulations for service/ employee inventions are prescribed under EPC and Chinese patent law. No specific regulations for the same are provided in the U.S. and Indian laws. Page 132 of 184