Global Perspective on Patentability for Product by Process Claims

INTRODUCTION

Product-by-process claims are best viewed as a subtle and intricate facet of patent law, which allows for creating a patent protection for products that are difficult to capture in definitions by the features of their composition. Unlike other types of patents, these claims address not the physical features of the item but the process of its creation, which makes them crucial for such industries as pharmacology, biotechnology, and materials engineering, where the method of production determines some major properties of the product.

Concerning the patenting of product-by-process claims, approaches across jurisdictions are diverse indicating legal systems, industrial development and the perception of the patent system differently. For instance, Product by Process claims are permitted in India especially where the product cannot in be described adequately but through the method of manufacture, or where through the process of manufacturing the end product acquires new characteristics. As mentioned above, the Indian patent regime, which follows the Patents Act, 1970 along with judicial decisions has laid down that PBP claim per se is allowed only if the product that is obtained has novelty, has an inventive step and is different from what was existing earlier.

On the other hand, the United States and the European Union are of the opinion that the capacity of a product of being patented should not in any way be determined by the methodology used to develop such product. These jurisdictions emphasise that for a product it is necessary to distinguish the standard criteria of novelty and inventive step on the basis of the product itself without reference to the method of production. US courts have upheld the proposition that the manner in which something is made is irrelevant so far as the granting of a patent is concerned particularly if the end-product is no different from that which existed in the prior art.

In the European Union, the question of PBP claims is governed by the European Patent Office which permits them only in circumstances where they cannot be defined in any other manner and the product per se fulfil all the criteria for patentability. What this jeopardizes is not the method of producing the product itself but rather the inherent qualities of the product.

Thus arises the issues related to the definition of the subject matter of patent protection, prior art analysis, and the attempts of courts and patent offices of different jurisdictions to address the issues arising from the application of product-by-process claims. The global view of product by process claims shows that there is a constant development of a fine line between innovation inducement and protection of the interest of the public, which has grown in response to advanced technology and fluidity in law. On the patent offices and courthouses worldwide, nowadays it became quite visible that product-by-process claims pose the problems of defining the extent of the patent coverage, the appraisal of the prior art and the balance between invention and competition. They go a long way to show that although the protection of product-by-process claims is done with the global angle of view with understanding the technology and the needs of the public to a certain degree the global tries to balance on passing high know-how with high protection, and this has not remained constant because of the advanced technologies and the overhauling of legal frameworks.

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 Indian Patents Act, 1970, and the Manual of Patent Office Practice and Procedure (MPPP) 2011[i] are rather silent on determining the patentability of inventions covered by a product-by-process claim. However, the Guidelines issued by the Office of the Controller General of Patents, Designs and Trademark[ii] provide some guidance on the criteria of patentability for examination of a product by process claim, having specific reference to the landmark judgment of IPAB (Intellectual Property Appellate Board) in the case of Research Foundation of State University of New York v. Assistant Controller General of Patents.[iii]

Here, the IPAB observed that the invention which sought the patent does not have any enhanced effect over the mentioned prior art in the claims. It has just used a new process for developing an already known product, and thus it cannot be granted patent on the basis of Product by Process claims as it lacks novelty and inventive step.

In another significant ruling in the case of Umicore AG & Co.KG v. Controller General of Patents,[iv] the court held that the product created cannot be considered novel only for the reason that it was gained through a new and different process and the product in its essence lacked novelty and it was already known. The only difference between the known product and the new product is the process of manufacturing. If the applicant wishes to get the patent, the burden is upon him to show that the new product made is substantially different from the existing product and it has novelty and inventive step, rather than just being made through a new and different process. If the new product crosses the mandate of sufficient modification from the initial product, then it can be granted patent.

UNITED STATES

The U.S. Patent and Trademark Office (USPTO) evaluate 'product-by-process' claims based on the novelty and non-obviousness of the claimed product.[v] The US Court has held in the case of Amgen Inc. v. F. Hoffmann-La Roche Ltd. that if “The method of production has no bearing on a product's patentability. If the product in the product-by-process claim is identical to or obvious from a prior art product, the claim is not patentable, even if the prior product was manufactured using a different process.”[vi] Furthermore, the validity of any patent is determined based on the requirements of the patentability and a patent is termed as invalid if a product made by any specific process which is mentioned in product by process claim is anticipated or is obvious from the prior art, even if those products which are considered as prior art is made by any different process.[vii] However, while analyzing the infringement, the court observed that a product by process claim is infringed if a product is made using the same process described in the claim. It also noted that “a 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”.[viii]

On the question of rejecting the claim of any product which collides with a product with Product by Process claims, the Court, in the case of In re Brown, has opined that “The lack of physical description in a Product by Process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established”.[ix] Thus, it can be said that the US law recognises that the patentability of a product does not depend upon its production method, but rather on the end product, which is view in the light of prior art.

EUROPEAN UNION

Similar to the patentability requirements in the US, the guidelines of EPO is also of the opinion that the product by process claims can only be allowed if the product in question per se fulfils the patentability requirement under the EU Patent Laws, that is, the product must be novel and inventive, and if there is no other way of defining the product other than those defined in the claims, regardless of the fact that the process for manufacturing the new product is different.[x] It has been held in a landmark case of Kennametal Inc. v. Mitsubishi Materials Corporation,[xi] that a product is not considered as novel only because it is produced by a new process. It must fulfill other criteria such as novelty and invention to be able to get a patent. The claims of Product by Process cover only the Products per se and confer its absolute projection upon the product only. It does not take into account the process undertaken to make the product. Moreover, as required by the Indian laws, the European Courts also casts an obligation upon the applicant to prove that the alleged product lies within the scope of patents and has some distinguishing points from the previous product.[xii]

CHINA

The patent office of China (SIPO) considers the features of the manufacturing process which resulted in certain particular structure or composition of the product. The examiner takes into account that if the person skilled in the art can infer the product having specific structure or composition resulting from the process is different than the product mentioned in the prior art, then the product claimed by the new manufacturing process can be considered as novel.

However, if the prior art product has the same structure or composition as the new manufactured product, then despite of having a new or different manufacturing process, such new product cannot be considered as novel.[xiii]

JAPAN AND KOREA

According to the Japan Patents Office (JPO), when any claim is made as a Product as a feature of its manufacturing process, such statement is considered as the claim of the product itself. If any product can be obtained from a different process than the one mentioned in the claim, such newly claimed invention is not considered as novel if the process of manufacturing is already known to the public. Similarly, in the Korea Patents Office (KPO), it is required by the examiner that the product claim shall be described in such a manner that the technical constituents are directly mentioned in the 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.[xiv]

Thus, it can be concluded by analysing various jurisdictions regarding the Product by Process claim that in every patent laws and judgments of the court, it has been recognised that a claim for Product by Process can be considered only when it fulfils other criteria of Patentability that is Novelty, Inventive Step and Enhanced Efficacy from the already known product.

CHALLENGES OF PRODUCT BY PROCESS CLAIMS

Though the method of defining claims through the product by process method has been proven substantially beneficial for claiming the patent of such products which are difficult to determine and describe within the boundary of Product Patent, there comes a wide range of challenges for the innovators and patent holders with respect to their patentability of Product by Patent Claims.

Some of the Challenges of Product by Process Claims are described here:

Firstly, Extending patent protection to both the product and its manufacturing process may hamper innovation by keeping competitors out of the market, even if they have developed alternative methods of producing the same product. This has the potential to stifle competition and limit consumer options. This can further pose challenge specifically in the pharmaceuticals

industries, where many companies use different process than the patented process to manufacture the generic version of any specific composition of medicine. These productions of generic medicines cater to a large number of people worldwide who might be unable to access the original medicines due to its high price and less availability in the market.

Secondly, it can be difficult to pinpoint the exact limits of patent protection for claims pertaining to a product's manufacturing process. It is frequently difficult to distinguish between a product and its manufacturing process, which makes determining the precise scope of patent rights challenging. The patent holders as well as potential infringers may become uncertain as a result of this ambiguity. Moreover, Assessing the prior art, or the body of knowledge and technologies already in use in the field, is essential to figure out whether or not product-by-process claims can be patentable. Finding pertinent prior art, however, can be difficult, particularly in industries with fast advancing technology like biotechnology and pharmaceuticals.

However, despite of certain challenges in maintaining Product by Process claims, it also presents a variety of opportunities to the innovators by incentivizing research and development in such areas where the traditional product patents may not be sufficient. Such incentivization can lead to the development of more efficient and cost-effective production methods in the near future.

CONCLUSION

A complicated and constantly changing area of patent law, the relationship between product and process patents has significant effects on the public's access to new technologies, competition, and innovation. There are opportunities and challenges associated with the recognition of product-by-process claims, especially in countries such as India, which should be carefully considered. The controversy over product-by-process claims is probably going to stay divisive as patent systems around the globe change to the rapidly evolving technological landscape. The distinction between products and processes is becoming hazier due to the emergence of new technologies like biotechnology and nanotechnology, which makes it harder to apply the conventional division between product and process patents. Product-by-process claims recognition in India is a delicate balancing act between encouraging innovation and protecting consumer interests. As India's patent system evolves, it is critical to strike a balance that promotes both technological progress and fair competition.

Thus, in conclusion, it can be said that in most of the jurisdictions including India, the United States and the European Union, among others, the Product by Process claims are considered novel over prior art which is based on novelty, inventive step and enhanced efficacy of the product. Even though the process used is novel, if the obtained product is same in its technical properties and known efficacy as already known in the prior art, then the obtained product cannot be considered as an invention.

REFERENCES