DRAFTING PATENT CLAIMS IN PAKISTAN - AN ANALYSIS OF THE CONVENTIONAL AN CURRENT PRACTICES
In patent process patent claims hold significance analogous to a nucleus in an atom. May it be the question of novelty or infringement analysis work, or of invalidity, every step of patent process revolves around claims. Therefore, drafting of claims and interpretation has always been a matter of great importance for patent practitioners. Especially, under the rapidly changing face of intellectual property and multitude of international treaties and conventions, as well as regional agreements, claims drafting and interpretation has become even more sensitive and technical. While drafting claims, besides language, form and contents, the jurisdiction for which patent protection is sought also requires special attention. A carefully drafted claim may reduce the prosecution costs enormously, which often compel small entities to drop an important and commercially feasible patent, before it gets mature for grant.
During the last one decade, patent laws in Pakistan have undergone substantial amendments. For instance, the availability of product per se protection corresponding to Article 70(8) of the TRIPs in the patentee’s net has brought about considerable changes in the forms on which, the claims had been drafted in the past. The succeeding paragraphs shall depict the substantive provisions of law viz-a-viz the conventional and current practices followed by the Pakistan Patent Office (PPO) with regard to the pattern of the claims. The readers interested to get their patents protected in Pakistan would find the same of information and interest.
Statutory provisions regarding claims
Similar to the laws of other countries, provisions regarding claims in the Pakistan Patents Ordinance, 2000 are few. These are: i) Section 15(3)(c) and 15(4) which require that: Claims shall- a) concisely define the scope of the invention for which protection is claimed; b) relate to a single invention; c) be clear and succinct; and d) be fairly based on the matter disclosed in the specification. ii) Section 15(8) which stipulates that claims- a) In respect of pharmaceutical or agriculture chemical product shall be structurally defined; and relate to a single chemical product only excluding its derivatives and salts; b) In respect of a product for which structural description is not possible (e.g. biological products) be made for product-by-process; c) In respect of mere admixture resulting only in aggregation of the properties of the component substances, or a processing of producing of such substances shall not be allowed.
Patent claims are determinant of the scope of protection:
According to Section 15(3) ibid, scope of protection provided by a patent is to be determined by the claims. According to the third limb of Section 15(4), claims should be fairly based on the matter disclosed in the specification. Per said provisions of law, patent claims and the invention disclosed in the specification are the main deciding factors in establishing the scope of protection. There are, however, other factors like the prior art at the time of the priority date, contents of the patent specification and the priority documents published in Pakistan, general public knowledge, etc, which may require due consideration. Per said provisions, a clear claim widen to embrace which is not fairly based on the matter disclosed in the specification or which the inventor did not actually work may not be construed as broadly than the description justifies.
Clarity and succinctness:
Section 15(4) of the Ordinance stipulates that claims must be clear and succinct, besides being fairly based on the matter disclosed in the specification. The PPO does not generally allow claims with long-winded statements, vague and ill-defined terms, inappropriate references to published patents, and references to trade marks etc. A claim to a process of manufacture of a chemical product is generally considered unclear if the intermediatery steps of the process and the specific reaction conditions are not defined. A claim to an apparatus is considered as lacking clarity if a working inter-relationship amongst various integers is not defined. In the same vein, a claim to a composition is not clear if besides the active ingredient, the inactive or auxiliary ingredients of the composition are not defined.
The “fair basis” requirement of claims is contained in Section 15(4)(d) of the Ordinance. Read with its Section 15(3)(c), “fair basis” generally connotes that claims shall be accepted as defining the scope of the invention if there is a disclosure in the specification coterminous with the invention defined in the body of claims. Disproportionately wide claims, covering details of what the inventor has not actually contributed to, may amount to unfairness and are not generally allowed by the PPO. However, unfair basis has not been recognized as one of the grounds for opposition and revocation enumerated under Section 23 of the ibid Ordinance, which appears to be an omission. Almost same is the position under 1977 Act of UK and laws of other EU countries. Thus, PPO is required to exercise great care and vigilance while examining an application and deciding to disallow claims with unduly wide scope or which are lacking fair basis.
Unity of invention:
What constitutes unity of invention is a matter of practical consideration and is commonly decided by the PPO. A PPO examiner may not allow more than one independent claims in a single application on the ground of non-unity. Claims directed to different novel aspects of the same invention may, however, be presented and allowed in one application provided there is a “technical relationship” amongst various features of the invention and each independent feature is dependent on the preceding claims. Thus, as provided in the Ordinance, a claim to an intermediate product may be included in a single application together with a claim to the final product and a process of its manufacture etc., if the claims specifically highlight that the intermediate product or process is for use in the preparation of the final product.
Forms of claims:
Forms on which the claims are drafted play a pivotal role in determination of the scope of protection intended for a patent. A claim reading on a ‘combination’ will protect the combination as a whole and not its individual components per se. In contrast to the former Patent Act of 1911, a claim to a compound is per se allowable under the 2000 Ordinance. However, one application may not cover the compound in its free form and in the form of its salts or derivatives. Therefore, it is imperative and safe that separate applications are filed to protect each of the compound and its derivatives. What is the pattern of claims generally acceptable or otherwise to the PPO may further be brought to limelight in the following text.
Medical use claims:
As had been the practice in the past, PPO is not sympathetic to allow claims reading on new uses of known compounds drafted in the Swiss form or the American Method of treatment style. As always, the PPO is, however, generous in allowing a claim reading on a composition of a known active component for a new purpose of certain specific dosage range with suitable excipients. The rationale for such generosity is not entirely clear, yet the practice is standing since years after years and has never been questioned.
Claims to diagnostics, testing, and screening methods:
Per Section 7(4)(c), claims to diagnostics, therapeutic and surgical methods for the treatment of humans or animals are statutorily disallowed. Though method of testing and screening do not fall within the prohibition of Section 7(4)(c) ibid, yet these are not allowed on other counts; such as, the same do not satisfy the definition of process as laid down in Section 2(8) of the Ordinance.
Claims to compounds per se (Markush practice)
A claim reading on a compound defined by a generic structural formula (e.g., A compound represented by formula I – wherein X is Cl, Br, I; R is alkyl, aryl —- n is 0, 1, 2, —— ) etc., covering alternatives of invention having common property or activity, sharing a common structural element, so-called “Markush grouping” commonly in the chemical field, well-works in Pakistan. Though Section 15(8) explicitly states that claim shall relate to a single chemical product only (i.e., specie claims) yet it does not put any restrictions/checks on the applicant’s freedom to draft claims which may give the broadest legitimate cover for his invention.
Claims to intermediates:
If the intermediate and the final product share the same essential structural elements or are technically interrelated as well as the intended use of the intermediate product is the preparation of the final product, it may be allowed protection. Independent claims to intermediates which themselves are chemically active for other uses may invite a PPO examiner to non-unity attack.
Claims to products defined by physical parameters (Fingerprint claims):
One of the statutory requirements for claims to pharmaceutical or agricultural chemical compound per se is its structural description. According to Section 15(8), compound with unknown structure is not per se protectable. Protection in such cases is limited to the product obtained from the claimed process only. The dominant practice of the PPO, however, is that compounds (e.g. antibiotics) defined in terms of their physical, chemical, physiochemical, biochemical, biological properties etc. are allowed per se protection.
Since claims to products with the exception of biological products not definable by their structure, per se are protectable in Pakistan, claims to product-by-process are not of much significance, especially where such claims may result in a considerable increase in the official fee. Whether or not claims to processes are made, it is a statutory requirement to disclose the method of production of the product in the body of specification. Failure to disclose the method may subject the application to an insufficiency attack.
Claims to “Mere admixtures”:
The proviso to Section 15(8) ibid stipulates that a claim is not allowable, if it is based on a mere admixture resulting only in aggregation of the properties of the component substances or a processing of producing such substance. This implies that there is no bar on the patentability of a claim to a mixture, where the components mutually support each other (so-called synergism) regardless of their being fully or partly known, and produce a new technical result.
Claim to crystal forms:
Section 7(4)(c) of the Ordinance provides that a patent may not be granted for a mere change in physical appearance of a chemical product where the chemical formula or process of manufacture remains the same. However, proviso to the said section stipulates that any such invention fulfilling the criteria of patentability may be granted patent. Hence, a claim to a crystal form which is novel, non-obvious and/or better in characteristic, e.g. physiochemical and pharmacokinetics, than the compound in its known form may be per se acceptable. A typical claim to a crystal form may read: “A crystal of compound represented by formula X which yield a powder X-ray diffraction pattern having characteristics peaks at reflection angle —-”.
Such claims are allowed without any additional costs for the applicant. However, multiple dependency on multiple features of the invention is objectionable. For example, a process claim may dependent on all preceding claims to processes. Multiple dependency on various aspects of same invention e.g., process, compounds and compositions claimed in the preceding claims is objectionable.
Claims to improvements made after the first application made in a convention country:
Under the repealed Patent Act of 1911, a convention application was required to include claims of exactly the same scope as in the priority document, “the so-called (Thornhill claims of UK)”. In relaxation to the ibid Act, an applicant, under the 2000 Ordinance, is entitled to include claims in respect of developments of or addition to the invention made in a convention country in his Pakistani counterpart. Notwithstanding this relaxation, in order to be entitled to a claim of priority, a claim of precisely the same scope as in the priority document is still desirable.
Two-part form of claims (so-called Germanic Form)
The general rule for a claim is, it should concisely define the scope of invention for which protection is claimed. Where, however, the invention relates to an improvement in the prior art, a two-part Germanic form of claims (often Jepson claims) in which the first part “the pre-characterizing clause” gives an indication of what is novel and/or improved over the prior art may also be used well in Pakistan.
Claims referring back to the invention disclosed in the specification with reference to the drawings and/or specific examples are permitted in Pakistan. The typical form of omnibus claims for a product patent is “A product substantially as hereinbefore described with reference to examples”.
Claims to Micro-organism per se
Protection to micro-organism per se is an important development in the Pakistan Patent Laws. Until the enactment of the Patents Ordinance 2000, patentability of micro-organisms such as bacteria, viruses etc. per se in Pakistan was beyond question. There is no specific requirement as to the form of claims for microorganisms, however, a microorganism may not be considered as patentable per se unless it is given a form, quality, characteristics/properties not present in the form it exists in nature.
Claims to processes for the production of animals and plants:
As a matter of principles, plants and animals are generally excluded from the scope of patentable inventions, yet Section 7(a)(b) ibid creates some exceptions; whereby non-biological and microbiological processes for the production of animals and plants have been placed out of the pale of general exclusion, thus may be allowed.
Claims to genetically modified organisms:
The Patents Ordinance 2000 in its amended and updated form is a well-drafted piece of legislation which equally meets the needs of biotechnological industry, as for the chemical and pharmaceutical industry. Compared to the repealed Patents Act of 1911, under the Ordinance ibid, claims for the products obtained by genetic engineering techniques (i.e. recombinant DNA technology), for example, DNA sequences, amino acid sequences, proteins, material used in the production of such products such as vector, host cells etc. have been per se allowed by the PPO.
The foregoing is an attempt to provide the readers with an insight into the pattern of claims currently acceptable to the PPO. The present form of claims is not a deviation from the previously acceptable claims, but an improvement within the legal parameters provided by the 2000 Ordinance. Generally, clarity, succinctness, fair basis and adherence to the forms are key for the scope of protection desired under a patent. Complexity, ambiguity, repetition, and irrelevant details may be detrimental to the success of the claims regardless of the nature and importance of the technology disclosed in the specification, in Pakistan.