The Dolcera Blog

Claims 1,4,15 & 18-21 of US Patent Application No. 10/346,493(”Appln. 493″) filed by “Gleave”(Martin Gleave and Maxim Signaevsky)  were rejected by the examiner as anticipated or obvious under 35 U.S.C 102/103. Gleave appealed against the decision but the Federal circit affirmed the rejection.

Appln. 493(titled “Bispecific Antisense Oligonucleotides that inhibit  IGFBP-2 and IGFBP-5 and Methods of Using the same”) claims antisense oligodeoxynucleotides, pharmaceutical compositions containing them and method of treating cancer by using them.

The claims rejected by the examiner included Composition claims consisting of these antisense oligodeoxynucleotides, which were claimed to be complementary to a portion of a gene encoding human IGFBP-2/ IGFBP-5, “wherein the oligodeoxynucleotide is of sufficient length to act as an antisense inhibitor of human IGFBP-2 and human IGFBP-5″.

The examiner rejected the present claims over anticipation by prior art PCT Publication of Wraight et al. (WO 00/78341).This publication disclosed every fifteen-base long sense oligodeoxynucleotide in the IGFBP-2 gene and further also disclosed that these oligodeoxynucleotides may be bispecific(capable of acting as a inhibitor of IGFBP such as IGFBP-2 and/or IGFBP-3).

For a reference/document to be anticipatory, the following requirements should be satisfied:

1.     The reference should disclose each and every element of the claimed invention, explicitly or inherently. Those elements must be combined or arranged in the same way as in the claim.

2.     The reference must enable “one of ordinary skill in the art to make the invention without undue experimentation”.

Gleave claims that Wraight does not describe any particular individual antisense species, there are no particular selections and no understanding of what targets would be useful. Thus Gleave primarily argues that although a large and exhaustive list was disclosed to the public, no basis was provided for selecting some individual members over the others. In effect, he argues that what is actually disclosed is not more than a generic concept underlying the list.

However, the court held that Gleave’s argument failed for two reasons. The list disclosed in Wraight’s  application anticipates Gleave’s claims. Secondly, Gleave’s argument that Wraight’s application is a generic concept stating that one could make antisense constructs that target IGBFP, was also nullified as court held that a person of ordinary skill in the art having the IGFBP sequence is capable of envisioning how to make antisense sequences. Thus, Gleave does not hold right to patentability over Wraight.

In conclusion, the discovery of a new property/use of known composition even when the use/property are non-obvious over prior art cannot impart patentability to claims of the known composition. If a new use is  discovered, patentability can only be claimed for that method of use.

-Priyanka Goyal

Knowledge Scientist

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Follow-on Biologics or Biosimilars are generic versions of Biopharmaceutical products. The vastly increased complexity of Biosimilars as compared to common traditional small-molecule drugs and the complex means for the production of Biologics (Molecular cloning, fermentation and purification processes etc.) makes it all the more difficult to ensure that an imitator product is biologically and functionally equivalent to the original. Though the generic version uses the same mechanism of action and performs essentially the same role as the original version, it is difficult to create an exactly similar copy of the original version due to complex manufacturing processes and hence the name “Follow-on Biologics”.

With many Biopharmaceutical product patents nearing expiry in the US, the government has realized the importance of regulation at the level of approval to ensure safety and efficacy of Biosimilar products.

The Hatch–Waxman Act, 1984 was the conception point for regulation of the use of follow-on biopharmaceuticals. It provided incentives to generic manufacturers by lowering the cost of approval of Biosimilars as they have to demonstrate bioequivalence but not repeat the human trials for proving efficacy and safety of the product. The act also established minimum periods of market exclusivity for brand-name products.

The European Union has established a special approval procedure which is more stringent than required for chemical generics and also requires much more comprehensive information.

Other issue involving Follow-on biologics is the period of market exclusivity for brand-name biopharmaceuticals. A period of market exclusivity would provide the incentive for investment in research and development for newer Biopharmaceuticals but also hinder the price competition from Biosimilars which lower the cost of medicine and make it affordable to the general public.

While the debate is still on, White House believes a 7-year data exclusivity period “strikes the appropriate balance between innovation and competition.” Previously, PO Board adopted a resolution in September 2008 supporting legislation that “promotes continued innovation by providing at least 14 years of data exclusivity for an innovator’s biological product with additional periods of exclusivity available for new indications and/or for approval for use in the pediatric population. We can hope that to ensure safety and efficacy of Biosimilar products US Govt. will come up with a solution appeasing both companies and consumers.

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Priyanka Goyal
Knowledge Scientist
Dolcera

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An important issue in the field of patenting Biotech inventions is the patenting of Genes or seeds/plant material. Pharmaceutical and agri-bio industries favor and want gene patents for commercial returns and to invest the time and money needed to develop gene-based drugs or biotech crops. On the other hand, the patenting on genes and seeds might lead to costlier medicines/treatment of some diseases and the seeds/plant material might become inaccessible to the poor again due to the high expenses.

In July 2002, the Nuffield Council on Bioethics published its report, “The Ethics of Patenting DNA.” approving to patent of genes but subject to rigorous tests of patentability including novelty, inventiveness, and usefulness.

Further the council recommended that the claim for DNA sequences to be used as research tools should be hindered and that gene patents should not extend to gene therapy- Inserting a normal gene / correcting or replacing the faulty gene should be considered obvious and hence not patentable.

In September 2002, Commission on Intellectual Property Rights (CIPR), set up by the British government’s Department for International Development, published its report, “Integrating Intellectual Property Rights and Development Policy.” Concluding the regime of gene patenting and other expansions in practice of Intellectual property would not be beneficial to developing nations raising the price of medicine and other amenities and further accentuating poverty.

The importance of the matter however lies in the crucial understanding and practice of patent rights which are subject to monopoly rights and dissemination of knowledge at the same time.

Edited from Sue Mayer (Director of GeneWatch UK) opinion on Source

- Priyanka Goyal

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