PATENTING LIFE SCIENCES
While biotechnology and life sciences inventions have been so long within the patent fold, and from their inception the industry has been sustained by such patents, patenting in this field still today poses considerable problems often provoking a rash of litigation. Although in Pakistan there has never been a general embargo on patents which involve living matter, yet for a long time, until the US Supreme Court in the well-known case of Diamond v Chakrabarty permitted a patent for a genetically engineered micro-organism, biological materials (such as novel genes, DNA sequences and the like) were not considered to be proper subject matter for patenting. This chapter is intended to provide what is patentable and non-patentable in biotech and life sciences in Pakistan. In so doing, we look at the ownership of patent rights; other forms of protection available; the boundaries of protection; activities exceeding the safe harbor for use of patented products; right of enforcement and/or the legal remedies for infringement.
As a general rule, the ownership of IP rests with the actual devisor of the IP. If, however, the inventor is employed to invent or to solve a problem then entitlement to the invention automatically goes to the employer. On the other hand, if the employee invents something outside the scope of his employment using the employers resources, the employer has a shop right (i.e. a royalty free, non-exclusive, non-transferable, implied-in- law license) to use the employees patented invention. In case where two or more persons are named as co-inventors, in the absence of an assignment, each of them is the owner of the patent and may exploit, use, exercise and sell the patented invention for his own benefit without accounting to the other joint-owner.
Patentability of biotech and life sciences inventions
Beyond the limits that are inherent in the nature of many of the biotech and life sciences products, limits on what can and can’t be patented in this sector is set out by the express exclusions in the patent law which provides that-
– “substances that exist in nature or if isolated therefrom” shall not be regarded as invention ;
– “A patent shall not be granted for plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes”.
In stark contrast to the position in UK and EP, the Pakistan Patent Law provides no distinction between something that is “natural” (non-patentable) and something which results from human efforts in isolating those substances from their natural environment (patentable invention). It places “naturally-occurring substances” and “substances isolated from those naturally occurring” under the head of “NOT AN INVENTION”. However, looking beyond the apparent suggestions of the provisions, below conclusions may be drawn:
i) First, as the exclusion applies to “substances that exist in nature” and to those “isolated” therefrom, it has no application to novel process claims that enables a substance existing in nature to be isolated from its surroundings.
ii) Second, as the exclusion applies to substances that “exist” in nature (previously recognized, and/or identified) or if isolated from those “existing” in nature, it does apply to substances as found in nature as such. Put it otherwise, exclusion may not apply to a substance which- i) has had no previously recognized existence; and ii) can be shown to have or produce a technical effect (say a medicinal/therapeutic effect).
iii) Third, as the exclusion applies to substances that “exist” in nature or if isolated therefrom as such, it may not apply to “modified and/or improved” naturally occurring substances.
Patents not available (for plants, animals, and essentially biological processes)
Exclusion of animals and plants as laid down under section 7(4)(b) of the 2000 Ordinance is to the extent where claims are directed to plants and animals per se or to processes for the production of animals and plants that consist entirely of natural phenomena such as crossing or selection. Processes for the production of plants and animals either non-biological or microbiological are, however, patentable. There is, however, no suggestion whether products of such non-biological and microbiological processes, or the processes which are mixture of microbiological and non-biological steps, are also patentable. The second part of section 15(8), however, provides that “where structural description is not possible as in the case of “biological products”, the “product-by-process” claim shall be made and protection shall be limited to the product with the claimed process only:
In the light of this provision, if the product of a microbiological or non-biological process or mixture of non-biological and microbiological process step is novel per se, then protection may extend at least to the product obtained with the claimed process.
Types of claims
Below are some of the types of claims applicable or inapplicable to biotechnology and life sciences:
Claims directed to micro-organisms per se:
Claims directed to micro-organisms per se (whether or not naturally occurring but which has had no previously recognized existence) are allowable. An exemplary claim of the sort may read:
“Micro-organism of species X, or a mutant or variant thereof having the activity Y”
Claims directed to plants and animals per se:
Plants and animals (including transgenic plants and animals) are not patentable per se. Plants and animals produced by processes that are “essentially biological” also fall within the scope of statutory exclusion.
Claims directed to process of “isolation” of naturally occurring substances:
Novel processes for the isolation of substances that exist, or not known to exist in nature, are patentable. However, mere reproduction of the known substance synthetically is considered to lack inventive step, hence may not be patentable.
Claims directed to “substances” isolated from the nature:
Claims directed to a substance “X” when free of “Y” is not allowable, if the substance is already known. If, however, the known naturally occurring substance “X” is “modified”, the “modified substance” may be patentable per se. On the other hand, if substance “X” (though found in nature but has had no previously recognized existence), is identified and characterized by its structure, as well as can be shown to have a technical effect, the substance per se may be patentable.
Claims directed to genes/DNA sequences:
It is generally accepted that being “embodiments of information” and “product of nature” genes and DNA sequences, coding for known products are not patentable per se. Same may be the position with regard to recombinant “DNA sequences” coding for a known protein on the ground of “obvious to try” subject matter. However, novel gene/ DNA sequences and/or their modified versions that can be shown to produce a technical effect, may be patentable per se. On the other hand, a gene sequence (or its fragments or “expressed” sequence tags (ESTs) whose utility is either unknown or merely as “use as a probe” (i.e. self-obvious utility); or whose likely utility is assigned/predicted by known computer programs may not be patentable.
Claims directed to proteins, antibodies etc.:
Claims directed to novel proteins, antibodies etc. defined in terms of their sequences and specific activity may be allowed per se
Claims directed to functional directives/equivalents of patented genes, DNA sequences, etc.
Claims directed to novel genes; DNA sequences etc. defined in terms of their sequences are considered to encompass their functional derivatives (i.e. molecules having biological activity in common with the patented gene; DNA sequences, etc. but different/ modified nucleic acid, amino acid sequences etc.). Hence, a protein or antibody, even with a different nucleic acid sequence, by performing exactly the same function may infringe the gene, DNA sequence etc. patent so long as it shall remain in force.
Trade secret (collateral know-how and data) as a tool for protecting plant innovations
Trade secret protection in Pakistan can be used for inventions that at one hand do not qualify for patent protection (such as plants) while on the other hand no other form of protection (such as PVP certificates, utility patents) is available. Though trade secrets have limited applicability to plants because the sale of the plant or seed effectively discloses any secret yet for the owner of hybrid plant varieties, protecting the identity and seed of inbred parent to a hybrid is easy. Since the exact characteristic of the parental lines of a hybrid cross is difficult to ascertain, the company can maintain secrecy by selling only the seed resulting from the cross of the parental lines while keeping the “genetic message” of parental lines as a trade secret.
Pharmaceutical patent term extension
Irrespective of the technology involved, under the provisions of the 2000 Ordinance, a patent is granted for a term of 20 years. Put it otherwise, no extension beyond 20 years is possible. However, for patents granted under the old Act of 1911, the 2000 Ordinance provides that despite the repeal of the Act of 1911, provisions corresponding to the term of old existing patents which does include patent term extension shall remain in force. Given this, for old existing patents, the normal term of 16 years may be extended upto a further term of 5 years (or 10 years in exceptional cases) on the ground of “inadequate remuneration”.
Data protection and data exclusivity in pharmaceuticals and agricultural products
So far, there is no specific legislation available in Pakistan in the form of a time-limited IP right (i.e. “data exclusivity” regime) as was created and adopted in USA and European Union prior to TRIPs agreement, for providing “exclusivity” for test or data created by the research-based companies as a pre-condition of obtaining marketing approval for a pharmaceutical or of agricultural chemical product. However, being a member of the WTO’s agreement on TRIPs, the drug registration authority ((MOH) in Pakistan is under obligation to provide automatic “data protection” as envisaged in article 39(3), for both medicine and agriculture to the extent of avoiding unfair commercial practices or use.
Enforcement of IP rights and reliefs
Given the complex, expensive and long-winded nature of patent litigation, fewer patents are being litigated in Pakistan. Although inducement to parties to settle out-of-court, attorney’s fees and use of expert evidence increasing the cost of litigation, are important factors in the way for a case to reach at trial but stretching litigation in most of the cases until closer to the expiry of patent due to procedural reasons adds to the reduced number of reported cases in patents. However to the extent of legislation, the Government of Pakistan, through enactment of Patents Ordinance, 2000 has fulfilled its obligations in response to the TRIPs call for enforcement procedures which permit effective action against any act of infringement of intellectual property rights, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements. Below remedies are available to the holder of a patent:
I. Pre-trial reliefs
Prevention of importation (or action before customs):
II – Remedies at full trial
Final or perpetual injunction
Delivery up or destruction of infringing goods
Damages or costs
Accounts of profits
Declaration of validity
Experimental use exception
For some acts relating to the use of patented invention, the 2000 Ordinance provides certain exceptions from infringement. Some of the particular acts include-
acts done only for experimental purposes relating to a patented invention;
acts, including tests, necessary for the approval of a product for its commercialization after the expiration of the patent.
A research scientist may thus claim a right to free use of patented invention where the use is related solely to see or satisfy whether he or she can produce the product according to the method disclosed in the specification.
Exception of testing by a generic producer of the patented invention to collect safety and efficacy data or to do such acts that are ultimately necessary to obtain drugs marketing approval from regulatory authorities is line with the US Hatch-Waxman Act but out-of-line with the European approach which does not allow such testing in advance of the expiry of patent. However, testing to discover new uses of the patented product or to conduct pre-clinical experiments to identify and develop the potential drug candidates exceeds the safe harbor for free use of the patented process or product. Thus any testing which is other than collecting data or providing information necessary for drug approval is infringing.
Exclusive right to sell the patented product or at least the direct product of a patented process is one of the important rights given to the holder of a patent (product or process) in Pakistan To define the boundaries of such rights section 30(5)(a) of the 2000 Ordinance provides that where the patented product is first put on the market anywhere in the world- i) by the owner of the patent itself; or ii) someone else with his consent; or iii) by an authorized person; or iv) in any other legitimate manner such as compulsory licenses, he has no control over the subsequent sale, import and/or export of the product (second sale). This is the so-called principle of the “International Exhaustion of Patent Rights (IEPRs)” which was set forth in place of the national exhaustion in 2000 in Pakistan. According to the principle of national exhaustion of rights, exclusive right to sell the patented product ends upon first sale, within the country. A patentee thus may not enforce the patent against Parallel Imports (PI) whereas under the principle of IEPRs upon first sale, anywhere in the world, of the patented product, the exclusive right to sale ends and the patentee may not place further reliance on the patent to prevent PI.
As can be seen that plants and animals are the subject of statutory exclusion from patent protection, protection to plant cells and other genetic materials isolated therefrom suggests that nearly any affirmative manipulative step can make a natural product patentable in Pakistan provided the resulting product meets the other criteria for patentability.