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Product by Process Claims (Indian Scenario vis-a-vis other Countries)

Introduction

Patent claims are the most integral part of a patent application, claiming various aspects of process, product, technology which inventor claims to be novel. Claims provide the basis of protection offered to the scope of invention in patent examination/prosecution and litigation. Claims of a patent application are indicative of defining the scope of protection sought to an invention, thus highest caution should be regarded while drafting patent application claims.

Drafting of claims can be done in various ways and for various types of claims to protect the widest scope of an invention. The types of claims are mainly “product claim” and “process claim”. Generally, a product patent consists of claims defining a structure, apparatus, or a composition. A process patents on the other hand has claims directed towards a method/process of manufacture of a product. Another type of drafting claims is product-by-process claims. The claims directed to product-by-process claims define the process of product by which the product is made.

Objective and protection sought by “product-by process” claim

According to JPO, The product-by process claims are construed mainly by two approaches the “product identity theory” where the claim is analyzed as being directed to the product irrespective of the recited manufacturing process, and “process limitation theory” by which the claim is constructed as being directed to the product limited by the recited process of manufacturing. The same approach can be considered while understanding interpretation of product-by-process claims in India and other Jurisdictions.

The invention is defined by product-by-process claim specifically, when the invention could not otherwise be defined. A claim defining a product in terms of its process can only be read as product per se. The technical content of invention lies not in process as such, but rather in technical properties imparted to the product by the process.

In other words, only the product and not the process is protected when product-by-process claims are drafted.

Patentability of Product by Process claims in India

Product-by-process claims are patentable in India, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps of the product would be expected to impose distinctive structural characteristics to the product. A patent application can use a product-by-process claim for a new product. The process does not play any role in determination of patentability of product-by-process claims.

The validity of product-by-process claim is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process is anticipated by or obvious from prior art products, even if those products are made by different process.             

Examination Guidelines of IPO

The Indian patent office has drafted the guidelines regarding product-by-process claims as represented below:

The product-by-process claims are mainly used in case of chemical or pharmaceutical compositions. The patent office in their guidelines directs that a claim to a product obtained by a process is anticipated by any disclosure of the particular product, regardless of its method of production. The Applicant can only seek right to a product even in case of product-by-process claim. The product by process claim must define a novel and un-obvious product and the patentability in such claim cannot depend on the novelty and un-obviousness of the process limitation alone.

Therefore, the care should be taken regarding the product defined in process terms, is not anticipated or rendered obvious by any prior art product.

In other words, the product must qualify for novelty and inventive step irrespective of the novelty or inventive step of the process.

[Source: http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_37_1_3-guidelines-for-examination-of-patent-applications-pharmaceutical.pdf]

Comparison of patentability of product by process claims with other jurisdictions

The patent office of China (SIPO) along with Korea (KIPO) and Japan (JPO) has carried out comparative studies of examination guidelines for patentability of claims.  In case of a claim defining a product by its manufacturing process all SIPO, KIPO and JPO adapt similar examination procedure and grounds.

In some jurisdictions, the “product identity theory” is adopted for examination of pending actions and infringement analysis. While in the others, the “product identity theory” is adapted for the purpose of examination and “process limitation theory” is adopted in infringement actions.

In SIPO, the feature of manufacturing process resulting in certain particular structure and/or composition of the product is considered by the examiner. If the person skilled in the art can infer that the process will result in product having specific structure/ composition which is necessarily different than the product cited in prior art, then the product claimed by its manufacturing process is considered as novel. However, if the cited references has the same product with same structure/ composition, in spite of different manufacturing processes the claim does not stand as novel.

[Source: http://english.sipo.gov.cn/docs/2018-01/20180131104418783958.pdf]

In JPO, when the claim is recited as a product as a feature of its manufacturing process of the product,  such a statement is considered as claim of the product itself. If the same product can be obtained a different process from the one stated in claim, such claimed invention is not novel if the process of manufacturing is publicly known in the art. The examiners differ or relate the cited references with the product-by process claims based on examples of reasonable doubts as below:

  • The cited patents are found to have same starting materials and are manufactured by same manufacturing process;
  • The cited arts are found to be identical or similar to the working examples in the specification of the claimed invention;
  • if the product made by the process meets patentability criteria and the requirement that the product was “impossible” otherwise to define by its structure or properties on the filing date, then a product-by-process claim is patentable; and
  • regardless of the process by which the product was made, a product-by-process claim covers any product identical to the claimed product.

[Source: https://www.jpo.go.jp/e/system/laws/rule/guideline/patent/tukujitu_kijun/product_process/index.html ]

In KIPO, the examination department directs that the product-by-process claim shall be described in such a way that technical constitutions should be directly stated in a claim, even though the process of manufacturing of product is stated in claim. If the identical product can be obtained by a different process from the one stated in the claim, the claimed invention is not novel where the product is publicly known prior to the time of filing.

[Source: https://www.kipo.go.kr/upload/en/download/JP-CN-Comparative_Table_of_Novelty.pdf ]

In case of EPO, the product-by-process claim is examined and addressed in similar way. The technical invention of product-by-process claim lies in in the technical properties imposed by the product and not the process per se. Claims of product-by-process claim covers the “product per se” and confers absolute projection upon the product only. The burden of proof of alleged distinguishing points lies with the applicant and the invention claimed by product-by-process claims can be differentiated based on distinct differences existing in properties of products.

[Source: https://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_iv_4_12.htm ]

In case of USPTO, the law regarding product-by-process claims is slightly different. It includes requirements of patentability and infringement of product-by-process claims. U.S patent law does not have any requirement regarding the product, like the product must be difficult or impossible to define by reference to its properties or structure, unlike EP or JP patent law. In contrast, to Japanese and European law the product-by-process claim is construed to cover only the product made by the steps recited in the claim. The process terms of a product-by-process claim served as claim limitation so that similar products made by a different process did not infringe on the claim in US examination. Claims for products defined in terms of process of manufacture are allowable only if the products as such fulfil the requirements for patentability, i.e. inter alia that they are new and inventive, and if it is impossible to defined the claimed product other than in terms of process of manufacture.

According to USPTO product by process claims are not limited to manipulation of recited steps. If the product in the product-by process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even through the prior product was made by the different process.

In India, with respect to product-by-process claims a novel and unobvious product must be defined, and that its patentability cannot depend on the novelty and non-obviousness of the process limitations alone. Thus, the product must qualify for novelty and inventive step irrespective of the novelty or inventive step of the process.

The approach of various countries about determination of novelty and inventive step and as to the determination of patent infringement, respectively, may be summarized as follows:

Jurisdiction US EP CN JP KR IN
Determination of novelty and inventive step (ground for invalidation of the patent) Product identity theory (EPO) Product identity theory Product identity theory Product identity theory Product identity theory Product identity theory
Determination of patent infringement (finding of infringement) Process limitation theory (Germany) Product identity theory Process limitation theory Product identity theory Product identity theory Product identity theory

http://www.epo.org/law-practice/legaltexts/html/guidelines/e/f_iv_4_12.html;
http://www.ipindia.nic.in/writereaddata
http://www.wipo.int/wipolex/en/details

https://www.gov.uk/guidance/manualof-patent-practice-mopp/section-14-the-applica tion/

Product by process claim from infringement perspective

Earlier a product claimed in product-by process claim was considered as infringement to the prior art even if obtained from different process. If, the product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim. The product-by-process claim is only infringed by a product made by the process recited in claim.

Amendments to product-by-process claims

The amendments in product-by process claims may regard to amending the manufacturing process of the product. The process of manufacturing or obtaining the product should be amended in such a way that, the process should recite the steps responsible for enhancing the efficacy or property of product or for incorporating novel and inventive features to the product.

Example of Product-by-process claim

The following example claim relates to a paint product prepared by a ball milling process.

A paint composition for production of durable paint obtained by a process comprising steps of:

(a) preparing a Y prepaint;

(b) Adding a color pigment;

(c) introducing extender of particle size B;

(d) adding of dispersing agent, stabilizer and defoamer to  the Y prepaint to form a pre-mix; and

(e) ball-milling the pre-mix of the pre-paint.

The product-by-process claim may include words/connecting phrases such as, “according to the process of “, “obtainable by”, “produced by”, purified from”, “the product of the process comprising the steps of”, prepared in advance with the method of”, “prepared by a”, “by a process which comprises the steps of” and similar other connectors.

Cases:

The Research Foundation of State University of New York Vs. the Assistant Controller of Patents

In this case, the applicant, the Research Foundation of State University of New York filled a patent application 3219/DELNP/2005. The application was related to a ceramic based nanoparticles for entrapping therapeutic agents for photodynamic therapy and method of using the same. The invention was based on novel and inventive product-by-process claims. The Controller has refused the patent application on the ground of lack of inventive step in light of cited prior art.  The Applicant has approached to Intellectual Property Appellate Board in an appeal against Assistant Controller of Patents.

IPAB Decision

IPAB observed that the instant invention does not have any enhanced effect over that of the cited prior art. Thus, in the absence of any comparative advantages IPAB maintained the decision of refusal of the claims.

Umicore AG & Co.KG v. Controller General of Patents

In another case the Applicant Umicore AG & Co.KG filled a patent application based on “vanadium free catalyst obtained by process of impregnating Ce-Zr mixed oxide with aqueous solution of compound of Cr, Mo, W or mixture of them thereof”. The claimed invention was in form of product-by-process form where the catalytic properties of vanadium free catalyst were obtained by a novel and better process. Primarily, the Examiner stated that there is lack of novelty as in prior art vanadium free catalyst is known and the only difference is in process of preparation. Therefore, as a result the court held that product created will not be considered as novel only because it is obtained by a different process.

Applicant has argued that the claim comprises of different process leading to novel product of catalyst having W inside pore of Ce-Zr mixed oxide which was not there in the prior art. Also, the Applicant has compared catalytic properties and showed that the claimed product by its process consisted of enhanced catalytic activities which ultimately was resulted as different product with different production process. Applicant has to give evidence to show modifications of process parameters led to a new product. As a result, finally Controller grated the Patent.

Conclusion

In Conclusion, it can be inferred that the product-by-process claims are mainly used in inventions of pharmaceutical, chemical and materials field. The product-by-process claims in most of the jurisdictions including India are considered novel over prior art based on the novelty and enhanced properties of product. Even if the process is novel, however the product with same technical properties and efficacies is known in the prior art then the invention is not considered novel.

References:

  1. https://www.legalcrystal.com/cases/search/name:product-by-process-claims
  2. http://www.asiaiplaw.com/article/41/353/
  3. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2272997
  4. http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_37_1_3-guidelines-for-examination-of-patent-applications-pharmaceutical.pdf
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5084995/
  6. https://www.soei.com/en/wp-content/uploads/sites/2/2017/04/Product-by-Process-Claims-AIPPI-Journal-March-2017.pdf
  7. https://www.intepat.com/blog/patent/product-process-claims/
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