Patentable subject matter and data protection: uncertainties remain

The question of what type of subject matter is eligible for patent protection is often met with confusion and uncertainty, especially when the technology under consideration is complicated.Through the passing of legislation and the increase in judicial precedents examining the doctrine of patent eligibility, patent-eligible subject matter has begun to be defined. Under the Patents Ordinance 2000, subject-matter eligibility is regulated in three ways:

• In order to be patentable, an invention must be capable of industrial application – that is, it must have the potential to be used or made in industry. Showing actual use is not required.
• Section 7(2) of the ordinance provides a list of matters that are regarded as “not an invention”, including abstract ideas (discoveries, scientific theories and mathematical methods), creations of purely aesthetic character, business methods, the presentation of information and naturally occurring substances and substances isolated from nature.
• Section 7(4) provides that a patent shall not be granted for inventions that are contrary to public order or morality, plants, animals and biological processes for their production, methods of treatment of humans or animals, second or subsequent uses of known products or processes, and inventions involving a mere change in physical appearances.

This chapter examines the grey areas between eligible and ineligible subject matter, and considers strategies to overcome practical difficulties when implementing the relevant provisions against pharmaceutical, biotechnology and life sciences innovations. Further, it looks at existing controversies about the direct effect of Article 39(3) of the World Trade Organisation Agreement on Trade-Related Aspects of IP Rights (TRIPs) to clarify the legal position regarding data protection.

Industrial application

The requirement that an invention be capable of industrial application is of particular significance in relation to biotechnology inventions, as the biological function or precise role of many structurally known genes/DNA sequences is still unknown. Unless a substantial, specific and credible function of the claimed gene/DNA sequence or a variation in differing gene sequences (eg, single nucleotide polymorphisms) is disclosed in the specification, it may not be patentable due to a lack of industrial applicability. For instance, if a protein is claimed to have a role in certain immunological and inflammatory events as a receptor, but no antibody substance specifically recognising that protein is disclosed in the specification to materialise this role, a claim drawn to that protein may not succeed. Similarly, utility described “as a probe or research tool” or inferred by a computer program based on homology searches (ie, comparing the claimed gene sequence with gene sequences of known function) is unlikely to confer inventiveness. Therefore, in order to be patentable, the application must disclose concrete and credible utility of the claimed gene/DNA sequence.

Exclusion of ‘non-technical’ inventions

The requirement that an invention have technical character in order to be patentable gains life from the categories of subject matter excluded from patent protection. Interestingly, the common denominator in all excluded categories is either the abstract nature of invention (eg, discoveries, scientific theories and mathematical methods) or non-technical character (eg, aesthetic creations, rules of a game and methods of doing business). Further, the definition of ‘invention’ suggests that a patentable invention must:

• be concrete (in the form of a product or a process resulting in a product); and
• relate to a technical field.

As only abstract or non-technical inventions are excluded from patent protection, technical character is established as a de facto non-statutory requirement for patent eligibility.

Using technical character as a tool for deciding patent eligibility, the Pakistan Patent Office (PK-PO) allowed a claim drawn to a computer-controlled method of operating an apparatus for quick pain suppression on the following grounds:

• The invention made use of a mathematical method or algorithm in the operation of an apparatus, but no claim was directed to that mathematical method or algorithm as such.
• The outcome or result (ie, the quick suppression of pain) was technical in character.
• The method was applied to an apparatus (a sellable product), not to the human or animal body (unsellable items).
• The method did not involve merely administering a known drug to a patient or an activity concerning the mere gathering of data for establishing diagnosis (which would be patent ineligible), but rather a series of technical steps such as modulating the amplitude of signals, analysing oscillations of the comparator and processing feedback signals (which fell outside the scope of patent-ineligible processes).

‘Whole-content’ approach

Under Section 7(3) of the ordinance, an invention cannot be patented if it relates or is directed to a matter falling within one of the excluded categories. For instance, if an invention of a physical machine or apparatus has a computer program as one of its elements, the fact that software cannot be patented does not preclude the machine or apparatus that includes it from patent protection.

Applying the well-recognised ‘whole- content’ approach (ie, when deciding the question of patent eligibility, the invention must be considered as a whole), inventions comprising non-excluded and excluded features receive appropriate patent protection. The deciding factor is the technical contribution, if any, that the invention has made to the art, which is not excluded from patent protection. However, the PK-PO recently rejected Pfizer’s patent application for pregabalin and Otsuka’s application for aripiprazole, which both involved new uses of known techniques in a non-obvious way to achieve a surprising effect, in pre-grant opposition proceedings initiated by local generics. Therefore, the owners of such inventions must be vigilant to avoid losing their valuable patent rights.

Overriding form of claims

It is an established rule of claims interpretation that “a valid claim cannot read on a prior art product”. However, in practice, in order to secure some form of patent protection, claims drafters often try to give non-patentable inventions an inventive gloss. In Pakistan, the two excluded categories where such attempts are frequently made are:

• diagnostic, therapeutic and surgical methods for the treatment of humans or animals; and
• new or subsequent uses of known products or processes.

Claims drawn to the US-style method of treatment or Swiss-style use claims are often re-worded as purpose-bound product claims of the format “A pharmaceutical composition A (known) comprising a compound X (known) in association with a pharmaceutically acceptable carrier for the treatment of a disease Y (known)” in order to appear to fall outside the excluded categories. Contrary to past practice, in such situations the PK-PO now responds by focusing on the substance of the invention rather than the forms of the claims. Until recently, attempts to secure more patents covering new uses of known drugs under the guise of purpose-bound-product claims failed. Therefore, under the existing examination policy, in order to secure further patents on new medical indications, something more is needed – for example, in terms of material improvement in the physical, chemical, pharmacological or pharmacokinetic properties of a known product, supported by experimental data or test results. A mere claim with dummy examples that a known medicinal compound has been improved in efficacy may not be enforceable in the courts, even if the patent is granted.

In regard to inventions relating to new or subsequent uses, the PK-PO is at odds with the US, EU and UK patent offices. However, until the law is amended to give protection to second or further uses of known substances, patents covering claims that extend beyond the scope of original disclosure or lack fair basis shall remain threatened by revocation proceedings.

An alternative approach to attempting to protect new use-related innovations is to draft the original specification on patent-eligible subject matter such as new dosage forms, fixed-dose compositions, new selected concentration ranges or pharmaceutical packs, provided that in each case the new form or selection has the potential for enhanced therapeutic efficacy or pharmacological effect.If they satisfy the statutory criteria of novelty and inventive step, in many respects such alternatives are advantageous over the old claim redressing approach, solely because they are supported by the law.

Impact of Bilski

Whether an invention is technical is easy to decide in pharmaceutical, chemical and mechanical fields; but when the invention relates to financial systems, information technology or computer-related inventions, playing with signals, images, numbers and differential markings, the courts often find it hard to rule. The Pakistani courts have taken inspiration from Justice Morton in GEC’s Application ([1943] 60 RPC 1) and the US Supreme Court in Bilski v Kappos and CLS Bank v Alice, and the patent eligibility of inventions relating to business or financial methods involving the use of fundamental principles of law or algorithms is now tested against the manner of manufacture rule,which is equivalent in meaning and scope to the machine or transformation set out in Bilski.

Under the manner of manufacture rule, a method or process is patentable if it:

• results in the production of a substance, article, apparatus or machine; or
• brings a new and useful improvement.

In line with Bilski, the claimed method requires something beyond what is a mere ‘extra solution’ activity. Mere outright or forthright variations imposing no meaningful limitation on the claims scope in terms of the use of specific techniques or means for carrying out the process may not transform a patent-ineligible process claim into an eligible one.

Patenting of transgenic plant cells

Under Section 7(4)(b), plants and biological processes for their production are ineligible for patent protection. The PK-PO considers the term ‘plants’ to cover both naturally occurring and genetically modified plants.

Based on this approach, claims for transgenic plants and their parts, including plant cells and DNA, have been disallowed until recently, when a leading biotechnology company took a strong stance against this overly narrow interpretation of the law. Consequently, the PK-PO has now allowed per se claims to transgenic plant cells and DNA that impart in the resulting plants increased insect resistance, in light of:

• the principal distinction drawn by Article 27(3)(b) of TRIPs between a claim reading on a “plant” and a “plant variety”;
• the reasoning that the language of Section 7(4)(b) excludes plants, but does not declare plant varieties to be unpatentable; and
• the Canadian Court of Appeal’s ruling in Monsanto v Schmeiser (2004), in which the court held that “grant of a patent to plant cells ultimately extends to plant and their parts”.

Although the PK-PO is still cautious in allowing claims to transgenic plants per se, the allowance of plant cells and isolated DNA has been hailed as a great victory in the relevant industries. If the PK-PO is consistently presented with reasonable and convincing arguments, further cracks may appear in its strong wall of conventionalism.

Does Article 39(3) of TRIPs have direct effect?

As a signatory to TRIPs, Pakistan is required to provide “exclusivity” to test data created by companies as a condition for obtaining marketing authorisation of pharmaceutical or agricultural chemical products. However, as yet the ordinance has no provision giving effect to Article 39(3) of TRIPs and the courts have not yet set the precedent that Article 39(3) has direct effect.

Article 1 of TRIPs generally allows signatories to determine the appropriate method of implementing the agreement within their own legal system and practice. However, Article 39(1) restricts this freedom where the issue involves the protection of undisclosed information and data submitted to the regulatory authorities. Therefore, when providing protection to undisclosed information and regulatory data, signatories must follow Articles 39(2) and (3) of TRIPs – they need not pass a national act of implementation to give effect to these provisions.

This interpretation finds further support in the fact that under Article 62(1), on the acquisition and maintenance of trademarks, geographical indications, industrial designs, patents and layout designs (topographies) of integrated circuits (Sections 2 to 6 of Part II of TRIPs), signatories are free to make the granted protection conditional on registration. By excluding the protection of undisclosed information (Section 7) from the scope of Article 62, Article 39(1), read with Article 1 of TRIPs, requires signatories to protect data submitted to the regulatory authorities as a pre-condition for obtaining marketing approval automatically (ie, without the need to apply for and pay a fee for the protection or maintenance of data rights). Therefore, the absence of a corresponding provision in the ordinance may not nullify the direct effect of Article 39(3).

According to Article 65(5) of TRIPs: “a member who has availed itself of a transitional period under paragraphs 1,2,3 or 4 of the said Article is required to ensure that any changes in its law, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of the TRIPs.”

On the other hand, Section 30(5) of the Pakistani ordinance – which excludes “acts, including tests, necessary for the approval of a product for its commercialization after the expiration of the patent” from the scope of rights conferred by a patent – creates a statutory presumption that third parties (ie, generic manufacturers) must create their own data if they wish to commercialise an off-patent drug.

The cumulative effect of Articles 1, 62(1), 65(5) and 39(1) of TRIPs, read with Section 30(5) of the ordinance, is to provide protection to “regulatory data” created by companies in Pakistan. Such protection has direct effect in that it does not necessarily require the issue of a national act of implementation, as distinct from data exclusivity. Therefore, the owners of pharmaceutical and agricultural patents must be aware of the legal position on data exclusivity in order to avoid any loss of valuable rights – ignorance of the law is no excuse.

Comment

While the law on patent-eligible subject matter is reasonably clear, the PK-PO’s divergent interpretations of the relevant provisions have created uncertainty, which may ultimately discourage companies from implementing technological innovations in Pakistan.This difficulty could be resolved by the courts through clarification of the regulations and the proper interpretation of claims. With regard to data protection and exclusivity, it is clear that such laws are a financial burden on generic drug manufacturers – and may be an indirect call for them to undertake R&D in order to self-build. This burden will ultimately ease once they start down the R&D road. A serious and strict approach towards the newly implemented Pakistani data protection regime is thus required.

 

PakPat World Intellectual Property Protection Services

132-P Marghzar Colony, Multan Road

Lahore-54780

Pakistan

Tel +92 4 2359 72904

Fax +92 4 2359 68322

Web www.pakpat.com.pk

Naeema Sadaf

Partner

[email protected]

Naeema Sadaf (MSc (physics) and LLB) is a partner and head of the patent and trademark division. Her practice focuses on all aspects of IP law, including patent validity and infringement analysis work, oppositions to trademark registration, infringement and unfair competition, and anti-counterfeiting and anti-piracy enforcement work in the chemical and mechanical sectors. She is also an author on various topics relating to developments in IP law practice, as well as key issues relating to the exploitation of traditional knowledge and indigenous biological resources.