THE END OF THE BLACK BOX/ MAIL BOX FILING ERA IN PAKISTAN
The year 2005 is continuing to pose multi-dimensional challenges for both the patent practitioners and the Patent Office in Pakistan. January brought the end of the so-called Black Box/Mail Box filing era (hereafter, Black Box filing), which had come into existence after Pakistan signed the World Trade Organization’s agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement. Effective from the first day of January 2005, the old system of UNIFORM filing was restored in Pakistan. The applications kept in Black Box for the last decade have started to be released for examination. They will then be appraised for acceptance or rejection and subsequent patent.
Of special concern are those applications pending on processes, new uses of known compounds, and biological materials intended for use in medicine or agriculture as Black Box applications. The Patent Office have yet to resolve whether such applications will be examined and granted protection, and which provisions of law will justify the issue of such patents. In the succeeding paragraphs, while analyzing these issues, some recommendations have been made for effective implementation of the provisions of Article 70(8) in the Pakistan Patent Law.
Article 70(8) – A cumbersome article
After Pakistan signed the TRIPs agreement, the most significant provision to be accommodated into Patent Law in Pakistan was Article 70(8). It made it incumbent upon the member states to give patent protection to the chemical products in the fields of pharmaceutics and agriculture, if they were not available in the pre-TRlPs regime. Ten years was given to the developing countries to build up their domestic laws to be calibrated with the provisions of the TRlPs.
Pakistan followed the example of other developing countries by only providing process and product-by-process protection in technological fields including pharmaceutics and agriculture in the pre-TRlPs regime. To add product protection to the patentee’s net, the revision of the Patent Law was necessary. In the year 1997, Pakistan amended its Patents and Designs Act of 1911 and in the year 2000 enacted a new Patents Ordinance, introducing a new system of Black Box applications exclusively for product protection in pharmaceutics and agriculture.
With the promulgation of the new Patents Ordinance, the seemingly simple provisions corresponding to Article 70(8) of the TRIPs imposed big changes to patent processes and procedures. The new enactment changed the old system of patenting under the 1911 Act into a two- way procedure that was specifically designed for pharmaceutical and agricultural chemical Products.
In order to complete the procedure correctly, it was critical to know what the term ‘chemical product’ actually applied to. Arguably, a chemical product may be either a product (including a compound or mixture) synthesized in a laboratory or a product (including a biological material) characterized by its method of manufacture, or both. On the other hand, in the pre-TRlPs regime, in addition to the process and product-by-process patent, the Pakistan Patent Office used to grant patents on new products (i.e. compositions/mixtures/combinations) comprising of known compounds to the extent it was stated in the statement of claims that the known active compound is ‘prepared by a process known per se’. Under this provision, it was critical to draw a dividing line between the chemical and a non-chemical product for Black Box filings.
A ‘chemical product’ is a ‘chemical compound’ – Rule 2(b) of the Patents Rules 2003
The definition of a chemical product had remained the most debatable issue in the Patent Office in Pakistan. Under the Patents Rules of 2003, an attempt to resolve the issue was made but this caused more complications. Rule 2(b) of the 2003 Rules defines the chemical product to mean a chemical compound, According to this definition, all other forms of products including compositions/mixtures/combinations are not able to be protected by themselves. On the other hand, until the end of the Black Box filing regime, the Pakistan Patent Office worked with the understanding that the compositions/mixtures/combinations were able to be protected as Black Box applications. With this understanding, they kept on accepting and issuing patents through the insertion of the wording “prepared by a process known per se” as in the past, but now at the choice of the applicant.
Prepared by a process known per se
What does the phrase “prepared by a process known per se” signify? What are the boundaries of its scope? These are some of the questions which have never been tested on the touchstone of judicially acceptable principles in the history of the Pakistan Patent Law. The phrase was previously used to solve almost any problem that arose during patenting. In the pre- and the post-TRlPs regime, a patentee may be awarded a patent for its novel product other than compounds through insertion of ‘prepared by a process known per se’ phrase. It may be appreciated that, in the pre- TRIPs regime, this practice was introduced to protect the rights of the inventor who had not invented a novel process in the preparation and production of a product but had brought significant modification to the form, characteristics, and/or use of the product. This, in essence, was a form of product protection but was arguably weak due to ‘prepared by a process known per se’ limitation.
While Pakistan has followed the product per se regime, the Pakistan Patent Office has forthwith obviated the decades old requirement of the process known per se limitation for inventions concerning non-compound products (i.e., compositions/mixtures/combinations) involving uses of known compounds. This practice further strengthens the view that non-compound products were also able to be protected before December 31, 2004 or at least until the issuance of the 2003 Rules.
One patent for one chemical product
Another issue is the interpretation of the provisions requiring that the inventions relating to a chemical product shall be specific to a single product only. From the provisions of the Patents Ordinance 2000, a single product may be defined as a compound either in free form or in the form of its derivatives and salts definable by a structural formula. A compound in free form is one product while its derivatives and salts is another product, for which a separate or divisional application may be filed.
In my opinion, in the case of compositions/mixtures/combinations, a claim to a composition comprising both the known compound and/or its pharmaceutically acceptable salts, falls squarely within the ambit of Section 15(8) of the Patents Ordinance 2000, which explicitly covers the chemical compounds or its pharmaceutically acceptable salts. Section 15(8) reads that a claim in respect of a complete specification of a chemical product intended for use in agriculture or medicine shall be structurally defined and shall relate to a single chemical product only, excluding its derivatives or salts. The manifest provision of the section suggests no other interpretation, except that which I have concluded. Thus, the practice of the Patent Office acting against the established principles of interpretation may cause trouble for future patents.
Can Black Box/Mail Box applications digest process claims?
Another point of theoretical difficulty arises from the Pakistan Patents Ordinance 2000 is that the inventions relating to processes lying outside the definition of a chemical product in Article 70(8) must be refused patent protection. In my opinion, there is no such problem as section 15(3) of the Patents Ordinance, 2000 clearly provides that every complete specification shall-
fully and particularly describe the invention and the method by which it is to be performed.
The expression ‘every complete specification’ refers to a complete specification whether relating to a product or a process patent. So to satisfy the full disclosure requirement the disclosure of a method of manufacturing by which the invention is to be performed or carried out in the specification is a statutory requirement. Thus in cases where different aspects of the same invention including a novel method of preparing a novel compound disclosed in the specification, the applicant may present a set of different claims. For instance, claims of a novel compound, its manufacturing process and composition comprising it in one application.
The upshot of above discussion is that there is a dire need to strike a balance in the statutory provisions and their application in practice. A practice deviating from the manifest tenures of the statute commits malpractice. The Patents Ordinance 2000 does not place any restriction on the forms of products (including compounds/ compositions/ mixtures/ combinations) meeting the statutory criteria of patentability for protection. Therefore, any interpretation creating a division between compositions/mixtures/combinations and compounds for per se protection is theoretically far away from reality. On the other hand, one patent for one product is the statutory requirement but to demand that one product should be defined by a definite structural formula is misinterpretation of law.
Similarly refusal to grant protection to compounds and their derivatives as well as salts in one application is in line with the statutory provisions but such refusal for compositions/mixtures/combinations comprising known compounds and their derivatives as well as salts appear to be non-statutory and therefore create a mockery of the law. Nevertheless a balance may be struck and equilibrium maintained between Article 70 (8) and corresponding provisions of the Pakistan Patent Law if the term ‘chemical product’ under rule 2(b) of 2003 Rules is defined to include chemical compounds rather than to refer exclusively to those chemical compounds. This will ensure that besides compounds products including compositions/mixtures/combinations are able to be protected in Pakistan, as required under the TRIPs agreement, and the law is applied to its true letter and spirit.