IMPORTANT ISSUES RELATING TO PAKISTAN
Multinational companies (MNCs) engaged in the development of pharmaceutical and agricultural chemical products are a substantial source of Intellectual Property (lP) related activities in Pakistan. The said companies roughly account for more than 60% of the lP assets in the country. Since the enactment of the Patents Ordinance 2000 and availability of provisional protection in the form of exclusive marketing rights (EMR), the annual counts of applications filed at the Pakistan Patent Office (PPO) for pharmaceutical and agricultural chemical products protection have increased exponentially.
The Ordinance has brought the Pakistan Patent Law in line with the agreement on the Trade Related Aspects of Intellectual Property (TRlPs), specifically with its Articles 70 (8) and (9), which provide for product patent protection in the areas of pharmaceutics and agriculture. Consequently, the graph of patent infringement cases and revocation petitions, especially, in pharmaceutical patents on commercially significant products, has also raised. The principal reason for increase in litigation may partially be linked up with the availability of product protection as contrary to the pre-TRlPs regime, a pharmaceutical or agricultural chemical product now stands infringed if manufactured by any novel and/or improved process.
However, till now the litigation is generally common in two areas:
i) where the patent on the basic molecule had expired but the patentee de facto got the monopoly rights extended. e.g., by obtaining patents on new or subsequent uses of known compounds/products; and
ii) when the patentee with intent to enter the market once the patent expires, starts conducting experiment so as to avoid an artificial extension of patented rights for delays in getting registration of drug (i.e., the so-called anticipated or threatened infringement).
It may not be out of context to highlight that the patent officials have evolved some practices and notions which are neither in line with the manifest tenors of the patents laws nor permissible by the rules of statutory interpretations, as may be visualized in the succeeding paragraphs.
The Patents Ordinance 2000
Lawmakers and the judiciary have laid down certain guidelines for interpretation of statutes, which are to be adhered to so as to give effect to the manifest intent of the legislature, instead of making a mockery of law. Yet there are certain instances where the patents law is not being followed in its true letter and spirit, as delineated below:-
Legal protection for new or subsequent medical uses
Section 7(4)(d) of the Patents Ordinance, 2000 directs that a patent shall not be granted, inter alia, “for a new or subsequent use of a known product or process”. It may be appreciated that a new or subsequent use does imply the use of a known product or process in its existing known form for another purpose; e.g., the use of a known chemical in paints as a pesticide in agriculture while the form, chemical or structural formula, and process of manufacture remains the same. However, an invention modifying the characteristics of a known compound or a process for producing a known compound in better yield or with enhanced activity but reduced toxicity is not a mere use or change in mere physical form; thus shall stand outside the scope of exceptions created by section 7(4)(d).
Contrary to a clear wording of the ibid section, practice of the patent officials has been to allow patent applications relating to new or subsequent uses of known compounds if the claims of the Swiss-form (i.e. use of a compound X for the manufacture of a medicament for the treatment of a disease Y) or the method of treatment form of USA (i.e. a method of treatment of a disease Y comprising administering of a therapeutically effective amount of a compound ‘X’) are amended in the form of product claims (i.e. a composition comprising a compound X for the treatment of a disease Y in combination with pharmaceutically acceptable carrier). This practice of protecting new or subsequent uses of known compounds under the disguise of product claims is in derogation with the substantive provisions of law. Whether or not new uses of known compounds are inventive and deserve protection, it is unfair to give product protection unless the law is amended to this effect. This irregular protection to “off patent” not only have negative and adverse impact on the local industry but is also contrary to the quid pro quo of the patent laws (i.e. to enrich art and industry in return of monopolization of patented rights for a limited period of time).
On the one hand, the generic competitors are threatened by legal action for infringement of patented rights while the patent right holders remain under the risk of pre-grant or belated opposition as section 20(3) of the Ordinance enlists, amongst others, “invention not patentable” as a ground of opposition and/or revocation.
One-year reduction in the term of patent
Another instance of misinterpretation of law may be seen in the description of the term of patent. Section 31 of the Ordinance stipulates that “The term of a patent shall be 20 years from the filing date”. This is in consonance with Article 33 of the TRIPs agreement, which provides that:
“The term of protection available shall not end before the expiration of a period of 20 years counted from the filing date”,
The impact of section 31 has been weakened by reading it in conjunction with section 29 of the Ordinance which reads: “Subject to the other provisions of this Ordinance, every patent shall be dated as of the filing of the application and in case of a convention application the date of such earliest application filed in the convention country from which priority has been claimed”.
Thus for a convention patent the term of 20 years is calculated from the date of priority. Section 29 is an independent section and provides a date of patent for the purposes of establishing right of priority and novelty; whereas the term of patent under section 31 is an independent matter and must be respected in its independent status. Obviously, this one year reduction in term of patent on the one hand is a hurdle in enjoying the benefits of patented rights to their fullest extent and on the other hand may benefit the generic competitors known to be active in pharmaceutical field. Hence, the MNCs may have a real concern in this regard.
Exaggeration of section 15(8)
Misreading of section 15(8) is another example of malpractice on the substantial provision of the patent law. Section 15(8) of the Patents Ordinance, 2000 stipulates: Claim or claims 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 derivates and salts, each of which, with a material or a novel improvements in its claim from the main product, shall be filed as a separate invention or, where applicable, as a divisional application. Where structural description is not possible, as in the case of biological product, the “product by process” claim shall be made and protection shall be limited to the product obtained with the claimed process only: Provided that a claim which is based on a mere admixture resulting only in aggregation of the properties of the component substances thereof or a processing or producing such admixture, shall not be allowed”.
The section implies that the compounds along with their derivatives and salts may not be retained in a single application, regardless of the fact that the derivatives and/or salts may or may not have any material or novel improvement in their claims from the main product. However, in order to justify a separate or divisional application, the derivative or salt must possess some material or novel improvements in its characteristic from the main product such as better safety and/or efficacy. It may be appreciated that scope of the section in the law is explicitly confined to derivatives and salts.
In view thereof different esters, isomers, racemates, hydrates, tautomers, diastereoisomers and complexes, which are neither derivatives nor salts, should be considered the same active substance; thus may withstand alongwith the active compound in the same application, unless they differ significantly with regard to their characteristics such as safety and/or efficacy. The exclusion of derivatives and salts residing within the same inventive concept as the claimed compound from the single invention concept is overtly narrowing the scope of the section. Therefore, it may swallow the single invention concept, besides putting the inventor(s) in trouble as they would be required to file a separate application to protect each equivalent of the claimed compound.
Nevertheless, such an interpretation may not obviate the applicant’s legitimate right to prevent others from seeking protection of the salts and derivatives of the claimed compounds on the ground of obviousness.
Double patenting – a financial burden on MNCs
Although there is no provision in the Patents Ordinance which explicitly prohibits the grant of two patents for one invention (e.g., one for the product and other on the process for preparing the product) for the purpose of obtaining better scope of protection, yet “breadth in scope” is not a ground for filing another patent for the same invention – a practice which has cropped up in Pakistan. However, section 13(3) of the Ordinance promotes the concept of single invention. It provides that “Each application shall relate to one invention only”; meaning thereby that there shall not be two applications for one invention” or “one application shall be for one invention only” or “two inventions may not be protected under one application”.
In the last possible interpretation, once an application is granted, non-unity is not a ground for invalidation under the patent laws of Pakistan. Independent of the above, after the enactment of Patents Ordinance, 2000 providing product patent to all technological innovations including pharmaceutics and agriculture, there appears to be no utility, except incurring additional expenses, for maintaining two patent applications, one for product and the second for its process of preparation.
Lack of “Bolar” exemption
Contrary to the position in USA, and now in UK and Europe as well, there is no provision corresponding to a “Bolar” style regulatory trial exemption in the Pakistan Patents Laws. On the other hand, the experimental use exemption to patent infringements provided in section 30(5)(c) of the Patents Ordinance, 2000 is limited in scope and may be invoked only if the purpose is “experimentation”. Section 30(5)(c) stipulates: “The rights under the patent shall not extend to … acts done only for experimental purposes relating to a patented invention”.
It may, for example, be noted that experimentation or testing done with a view to collect data for applying to the Ministry of Health (MoH) for the registration of the drug is considered as having a “commercial purpose”, thus is infringement under the notion of “threatened infringement” provided in section 30(3) of the Ordinance, whereby rights granted under the patent extend “to acts which make it likely that infringement will occur”.
It may also be worthwhile to mention that until the amendment of the ordinance providing a “Bolar” style regulatory trial exemption, the generic competitors had to wait until the expiration of the patent to conduct experiments or tests to collect data for drug regulatory approval. Such a prohibition may increase life of patent and raise barrier to market entry, as a generic competitor could not enter the market unless he had obtained the drug registration from the drug registration authorities.
Getting patents on unpatentable inventions
As indicated above, it has been the practice of officials in Pakistan to grant patent on any technological innovation if language of the claim is amended either to read on a product or to a process of its preparation and/or improvement of a product. On this principle, the patent officials did not hesitate to allow method-of-treatment, business method, method for the production of plants and animals, in spite of the fact that the subject matter remained intrinsically un-patentable in the law.
However, since 2005, the generic competitors have expressed concerns over this unlawful practice of extension of patented rights in Pakistan. Resultantly, the number of pre-grant oppositions and petitions for revocation of patents is on the increase. Getting patents on new or subsequent uses of known compounds under the disguise of product (i.e. composition) claims is no more a safe and successful strategy. Conversely, this is causing financial losses owing to costly litigations.
On the other hand, if one succeeds in obtaining an interim injunction or a final verdict closer to the end of the term of patent, enforcement of the verdict in its true letter and spirit shall remain a doubtful proposition, as a generic competitor may come up with a new name and get-up in the market to feel its presence and receive its share. Thus, strategies will have to be evolved to trap or unarm the infringers, besides establishment of lP courts, which is sine quo non, as in Japan, USA and UK. This will not only minimize the chances of infringement but also ensure speedy disposal of infringements/litigations through professional judiciary trained in lP law. This will also help the litigants/lP law practitioners to benefit from the verdicts of specialized courts, as we find hardly any case law or interpretation of lP laws by superior judiciary. A parallel strategy for the time being is to apply for cancellation of drugs registration by the potential infringers on the ground of public health and safety.
The upshot of above discussion is that there is a dire need to interpret substantive provisions of the Patents Ordinance and laws related thereto in a legal and professional manner and to develop a practice which neither deviate nor alleviate the boundaries defined by the law. Misreading of law to gain some targets is immoral and against the norms and philosophy of the patent laws which stress on a balance between the rights of patent owners and those of the public. It is the legal as well as moral duty of the patent owners to accept the entry of generic competitors to the market, once a patent has expired and that of the generic competitors not to disturb the right-holders by infringing their patented products or processes during the life of patents. Disrespect of others’ rights may bring disrespect to yours.