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US Patent and Trademark Office issues notice on patent application containing nucleotide sequencesIn brief: Partner Dr Robert Smyth, of US law firm Morgan Lewis & Bockius LLP, and Allens Arthur Robinson Patent Attorney Dr Kathryn Sunn provide an overview of a recent US Patent and Trademark Office notice on restriction requirements in patent applications containing nucleotide sequences. In 1996, the US Patent and Trademark Office (USPTO) held public hearings to address concerns relating to patent protection of nucleic acids described by their nucleotide sequences. The ease of using automated techniques for sequencing large numbers of nucleotides resulted in the filing of a growing number of patent applications, many of which recited thousands of individual nucleotide sequences. After the public hearings, the USPTO modified its restriction and unity of invention practice for the examination of patent applications that claim large numbers of polynucleotide molecules described by their nucleotide sequences (the 1996 notice). The modifications to the examination practice were made in an effort to encourage and promote growth in this technology, while taking into account the unprecedented search and examination challenges that such applications pose.1 In the 1996 notice, the USPTO permitted the applicant to claim, and to have examined, in a single application a reasonable number (normally up to 10) of independent and distinct inventions described by their nucleotide sequences. At that time, the USPTO determined that such a practice would not create an undue burden on the USPTO and would promote efficient, cost-effective examination of these types of applications. The USPTO made a similar revision to its practice for search and examination of applications filed under the PCT.2 Patent applications that prompted the public hearings and the 1996 notice often disclosed multiple, partially characterised, complementary DNA (cDNA) molecules, discovered by expressed sequence tag (EST) techniques, that were claimed and described by simple reference to a nucleotide sequence. At that time, and in many of those applications, little information was provided relating to function of the nucleic acid, nor was there significant description of the function or the information content (for example, protein-coding capacity) of the nucleic acid claimed. Consequently, such claims were, in many instances, simple in format and narrow in scope.3 The technology has since 1996 evolved and the types of nucleic acid, sequence-based claims have become more diverse and complex. In 1996, polynucleotide molecules were often claimed by simple reference to a nucleotide sequence. Polynucleotide molecules are now often claimed in a single application in a variety of complex formats (for example, reference to: the amino acid sequence of the protein encoded; the American Tissue Culture Collection (ATCC) number of a deposited plasmid containing the polynucleotide molecule; antisense, or interfering RNA).4 The GenBank database in 1996 contained 651,972,984 nucleotides in 1,021,211 sequences. In 2000, the database contained 11,101,066,288 nucleotides in 10,106,023 sequences, about a 17-fold increase in the number of nucleotides and about a tenfold increase in the number of sequences. These are some of the factors responsible for exacerbating the search and examination burden faced by the USPTO with respect to polynucleotide inventions claimed and described in currently filed applications in the US. It now requires significantly more computational time to run individual nucleotide sequence searches for examination purposes than in 1996, and there is significantly more pertinent prior art to consider. In addition, it currently takes more USPTO resources to correlate the claimed polynucleotide with the polynucleotide as defined in the prior art because it is increasingly common for both patent applicants and prior art references to describe a polynucleotide molecule in different ways.5
On 12 March 2007, the USPTO posted a notice (the 2007 Notice) on restriction requirements in patent applications containing nucleotide sequences. The 2007 notice rescinds the 1996 notice on the subject and is effective immediately.6 The 2007 notice states that the USPTO has rescinded the partial waiver of 37 CFR §§ 1.141 et seq issued in the 1996 notice, which allowed for examination of up to 10 nucleotide sequences in a single application. As such, claims to nucleotide sequences in all pending applications and future applications not yet under examination will be considered for independence, relatedness, distinction, and burden as for claims to any other type of molecule. In the absence of extenuating circumstances, the 2007 notice does not apply to currently pending applications in which an office action on the merits has been issued.7 Under the 2007 notice, the USPTO can restrict claims, such that only a single polynucleotide molecule will be examined per application. The USPTO cited the burden of searching multiple sequences in a single application, given the ever-expanding size and number of nucleotide sequence databases. Despite the 1996 notice, the practice of restricting claims to a single nucleotide sequence has been previously applied by many examiners. The 2007 notice eliminates the opportunity for applicants to argue that claims to multiple nucleotide sequences should be rejoined, based on the 1996 notice.8 Applicants for patent applications should carefully consider this new policy when drafting claims in new US applications, or PCT applications intending to enter the US National Phase and filing claim amendments in pending applications. Footnotes
Company newsIn brief: Regular news from the biotech industry.
Acrux completes sub-license of Evamist rights to KV Pharmaceutical16 May - Acrux's US licensee VIVUS announced the completion of its sub-license of rights, and the sale of assets, related to Acrux's small hand held skin spray, EvaMist™, for the treatment of menopause symptoms to KV Pharmaceutical. The agreement was subject to certain closing conditions, which VIVUS today reported have all been satisfied. It is expected that the Food and Drug Administration will complete its review of the New Drug Application for EvaMist by the 3rd quarter of 2007. Under the agreement, KV will make payments to VIVUS of US$10 million, followed by $US140 million on approval of the application, US$10 million on achievement of US$100 million net sales of EvaMist in a market year and other additional milestone payments. [Source: Company announcement] AstraZeneca's Schizophrenia drug approved by the FDA18 May – The US Food and Drug Administration has approved Seroquel XR, a once-daily treatment for schizophrenia in adult patients. The FDA approval was based on a placebo-controlled study of inpatients and outpatients experiencing an acute exacerbation of symptoms of schizophrenia. The US patent for Seroquel XR expires in 2017. The programme for the development of Seroquel XR was based on the needs of patients and physicians for medicines that offer a convenient once daily dosing. Seroquel XR will be launched in the USA in the second half of 2007. [Source: Company announcement] Bausch & Lomb enter US$4.5 billion merger agreement with Warburg Pincus16 May – Global eye health company Bausch & Lomb has entered into a definitive merger agreement with the global private equity firm Warburg Pincus, in a transaction valued at approximately US$4.5 billion. Under the agreement, affiliates of Warburg Pincus will acquire all the outstanding shares of Bausch & Lomb for US$65 per share. Bausch & Lomb's board of directors has unanimously approved the agreement. [Source: Company announcement] Bristol-Myers Squibb and Isis Pharmaceuticals enter cardiovascular disease collaboration9 May – Bristol-Myers Squibb and Isis Pharmaceuticals have announced a collaboration to discover, develop and commercialise novel antisense drugs targeting PCSK9 for the prevention and treatment of cardiovascular disease. PCSK9 helps regulate the amount of cholesterol in the bloodstream. Isis has licensed to Bristol-Myers Squibb exclusive access to its PCSK9 research program. Bristol-Myers Squibb will fund all activities under the collaboration, while both companies will be responsible for pre-clinical development. Bristol-Myers Squibb will pay Isis a US$15 million upfront licensing fee and will provide Isis with at least US$9 million in research funding over a three-year period. In addition to these fees and royalties, Isis will also receive up to US$168 million for the achievement of development and regulatory milestones for the first drug in the collaboration. [Source: Company announcement] Merck KGaA sells generic arm to Mylan13 May – Merck KGaA announced that it will sell its generics business to Mylan Laboratories for EUR4.9 billion. The transaction is expected to close in the second half of 2007 and is subject to regulatory approval. Merck and Mylan have signed a share purchase agreement whereby Mylan will acquire all Merck generics companies throughout the world, which combined represented EUR1.8 billion of sales in 2006. For the 2006 calendar year, the combined company would have had revenues of US$4.2 billion and approximately 10,000 employees. [Source: Company announcement] Peptech announces record profit17 May – Australian biotech Peptech announced a record profit of AU$137.7 million for its half year ending 31 March 2007. This represents one of the largest profits made by an Australian-listed biotech company. A significant portion of this profit was a result of the divestment of Domantis, which was acquired by GlaxoSmithKline in December 2006 for A$575 million, yielding a net gain to Peptech of AU$136.5 million. Peptech will shortly enter Phase I clinical trials of its lead anti-inflammatory compound PN0621, which will be the first domain antibody to be administered to humans. A product is expected on the market in 2011-12. [Source: Company announcement] Peptech and EvoGenix plan merger7 May - Australian biotech companies Peptech and EvoGenix announced plans to merge to form one of Australia's largest biotechnology companies. The focus of the merged company will be on developing significant antibody/protein-based franchises for the treatment of inflammatory diseases, bone disease and cancer. The merged company will be led by Peptech CEO Dr John Chiplin and a board comprising directors from both companies. The combined company will be renamed. The acquisition is to be implemented through a scheme of arrangement between EvoGenix and its shareholders. Peptech will acquire 100 per cent of the issued shares in EvoGenix for cash and shares totalling AU$1.12 per share. Peptech will offer 15 cents plus 0.5055 Peptech shares for each EvoGenix share on issue. This values EvoGenix at approximately AU$156 million. The EvoGenix Board of Directors unanimously recommended shareholders accept and vote in favour of the scheme. [Source: Company announcement]
BioTip: Patent protectionIn order to obtain patent protection for an invention, separate applications must be ultimately filed in each country where patent protection is required. The allowable scope of patent protection can vary greatly between countries, so it is important to ensure that an invention is claimed in an appropriate manner in each application. Although the written description of the invention cannot be varied after filing in most countries, the claims defining the monopoly being sought for an invention can be drafted or amended to meet formal requirements in different countries. Filing appropriate claims at an early stage can ultimately reduce patenting costs and prevent undue delays in prosecution of an application.
EventsInformation on the latest conferences See conferences in: June | November International Pharmaceutical Regulatory and Compliance Congress NEW– BioMelbourne Network BioBreakfast Genomics in Business 2007 International Intellectual Property Law and
Pharmaceuticals Pharma Partnering Event - One-To-One License Meetings Asian Patent Attorneys Association (APPA) Annual
Meeting
As active members of APAA, we look forward to attending what promises to be a very enjoyable and rewarding conference and, of course, to meeting many of our clients and contacts there. If you are planning to attend this meeting, please do take the opportunity to come and visit us in our Sydney or Melbourne office while you are in Australia. Let us know by getting in touch with Dr Trevor Davies (contact details set out below).
For further information, please contact:
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