UK and European Patent Law - a Review of Recent Developments and Forthcoming Issues Utah IP Summit 18 February 2011 Adrian Bradley

Outline EPO Procedural Changes. Substantive EP Law. ECJ Monsanto Decision. UK Developments. EU Patent. Conclusions.

EPO Procedural Changes Revision of the EPC relegated many of articles to implementing regulations. Regulations can be amended without a diplomatic conference. EPO have used this power to – address a number of perceived “procedural abuses”; – Increase procedural efficiency.

Divisional Applications Previously – only limitation on filing divisional application was pendency of parent. Perceived as creating uncertainty for third parties. New system of “voluntary” and “mandatory” divisionals.

Pardon? “the divisional application is filed before the expiry of a time limit of twenty-four months from the Examining Division's first communication in respect of the earliest application for which a communication has been issued” First communication? Earliest application? Request of CIPA – triggering communications now explicitly listed.

What the EPO Think

Right to Amend Applicant now has one opportunity to amend claims of own volition. If EPO was ISA, must address all objections within one month time limit. CIPA lobbying – now changed to six months from 1 April 2011.

Clarification of Field to be Searched In situations where complete search impossible, invitation issued to file a statement indicating the subject matter to be searched.

Costs Excess claims fees. Back renewals for divisional applications. London agreement – now covers 16 contracting states.

Monsanto - Facts Monsanto held European patent including claims to DNA sequence. Sequence, when present in plants, confers resistance to glyphosate. Soy meal imported from Argentina to the Netherlands had traces of DNA. Monsanto sued for infringement under Dutch portion of European Patent.

Referral of Dutch Court Article 9 of Biotech Directive: – The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material…in which the product is incorporated and in which the genetic information is contained and performs its function. EU legislation, thus referral to ECJ needed.

ECJ Decision “Performs” used in present tense. Function of DNA has to be being performed in infringing material. Monsanto argued claim to substance per se – Article 9 extended scope. ECJ referred to requirement for function of DNA sequence to be specified. Soy meal is “dead” and no longer carries patented traits; not conferring herbicide resistance.

Impact on Strategy Lessened if patent protection can be obtained in countries where crops produced. “Direct product” protection available in Europe.

Enlarged Board Decisions Dosage regimes. Essentially biological processes. Surgical methods. Time limit for appeal. Computer-implemented inventions. Pending decisions.

Dosage Regimes (G2/08) Known medicament for treatment of known indication. Only novel feature “use in the treatment by oral administration once per day prior to sleep”. A 53 European patents shall not be granted in respect of.... (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body. A 53 …shall not exclude the patentability of any substance or composition…for any specific use in a method...provided that such method is not comprised in the state of the art.

Divergent Case Law First line of cases - Mere dosage regime incapable of imparting novelty. Feature exclusively pertaining to skill of practitioner; thwarts purpose of 53(c). Second line - “Specific use” covered all therapeutic uses prohibited by 53(c). Legislator did not distinguish between new indication and new dosage regime.

The Decision “A seamless fit” Either - A method is prohibited by A 53(c), and so may be protected by via a claim to a composition for use in such a method; or Method is not prohibited by A 53(c), and may be claimed as such. Whole jurisprudence relating to novelty and inventive step applies.

Impact on Practice Useful protection available in Europe for novel and inventive routes of administration; dosage formats/regimes; patient populations. Focus should be on unexpected results compared with known therapies. “Swiss claim” no longer allowable.

Essentially Biological Processes (G1/08) Method for selectively increasing the level of anticarcinogenic substance in broccoli plants. Locating the relevant genes and identifying them with genetic markers. Lines selected by means of these markers and used in plant breeding.

Legislative Framework Article 53 - Exceptions to patentability European patents shall not be granted in respect of: (b) plant or animal varieties or essentially biological processes for the production of plants or animals…

The Decision Process involving sexually crossing whole plant genomes, and subsequent selection not patentable. Mere inclusion of step which assists the sexual crossing or selecting does not override this. Technical means, such as genetic markers, may themselves be patentable inventions; their use does not make an essentially biological process patentable.

What Can be Claimed? Processes for producing plants by inserting or modifying a trait in the genome which do not rely on sexual crossing of whole genomes. Sexual crossing and selection steps should not be in the claims, since adding further technical processing steps before or after the steps of sexual crossing and selection does not render such processes patentable.

Impact on Practice Processes for producing plants by modifying a genome using genetic engineering continue to be patentable. Avoid framing claims including a step of sexual selection. Include claims to tools useful in selection and crossing, such as markers.

Surgical Methods (G 1/07) A 53 European patents shall not be granted in respect of.... (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body Case involved diagnostic method involving step of injecting 129 Xe into heart for imaging. Previous Enlarged Board decision held that not excluded as diagnostic method.

“Surgery” Defined by nature or purpose of intervention? Cannot be therapeutic purpose – 53(c) contains three distinct exclusions – would render surgical exclusion redundant. Multi-step method – one surgical step falls within exclusion. Whether it is possible to circumvent prohibition by disclaimer depends on circumstances. Impossible to give all-embracing definition.

Indicative Features of Surgical Methods “A claimed...method, in which, when carried out...maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise”

Impact on Practice Diagnostic/imaging methods not involving substantial physical interventions should be patentable (e.g. methods involving routine blood sampling). Some cosmetic/non-therapeutic techniques may be excluded if they involve substantial intervention. Consider use of terms such as “previously obtained,” “previously injected,” or “pre- adminstered agent” to circumvent the exclusion.

Pending Cases G 2/10 - “Does a disclaimer infringe Article 123(2) EPC if its subject matter was disclosed as an embodiment of the invention in the application as filed?” G 1/10 – Post-grant correction of errors in opposition proceedings.

UK Developments Reform of junior intellectual property court. “Patent Box”. Major cases in 2010.

Patents County Court Previously – cases could be brought before high court or the patents county court. Procedures similar – discovery, extensive cross-examination of witnesses, experts. Costs were of the same order of magnitude. Costs approximately 3x other European jurisdictions.

PCC Reform Claim based solely on statement of case and oral submissions. Parties can avoid trial altogether by mutual agreement. No discovery, experts or cross-examination as standard. Two day maximum trial. Maximum costs recoverable £50,000; £25,000 on damages enquiry.

PCC Reform II Proposal – case value ceiling of £500,000. Specialist judge – Colin Birss QC. Patent Attorney Litigators have rights of audience. Appeals – Court of Appeal expected to respect costs finding of PCC.

Patent Box Announced in pre-budget report. Consultation ongoing. Included in Finance Bill this year. Will come into force in % rate of corporation tax on income from patents. Likely to benefit established companies rather than innovators.

Trends in English Courts Continued deference to EPO Board of Appeal decisions. English procedure allows very thorough factual enquiry. TBAs act as a “coarse filter” of the validity of European patents.

Eli Lilly and Company v Human Genome Sciences Parallel proceedings before EPO and UK High Court. Board of Appeal found industrially applicable. UK court came to opposite conclusion. Careful to follow reasoning. Different finding on facts – English court allows far greater scrutiny.

EU Patent - Background Obtaining patents in Europe extremely costly. Unitary right granted for the whole European Union (population 500m). Proposed in early 1970's. Draft regulation agreed Language issue has proved insurmountable.

Enhanced Cooperation EU treaty provides when group of countries wish to move forwards immediately. EPC will be granting authority. Trilingual system. Approved by the Legal Affairs Committee on 27 January.

Next Steps... European Parliament as a whole will vote on the proposal during February. Competitiveness Council will examine it on 10 March.

Conclusions Increased procedural complexity at EPO. Useful clarification in medical and plant biotechnology fields. More cost-effective litigation in UK. EU patent..?