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Chemical Patent Enforcement in

CanadaPromise Little- Do Much

October 28, 2013


Canadian Inventions for Patents


Canadian Cultural Inventions

• THE SNOWBLOWER IN 1925;



• THE HOCKEY GOALIE MASK IN 1959;



• THE SOON TO BE NON-EXISTENT BLACKBERRY; and



• THE WONDERBRA - 1964


Unique Aspects of Canadian Patent Practice

NO DIFFERENCE



1. FILING – ACCEPTABLE DELAYS• late PCT national phase filing, 42 months, nominal fee;• 12 month grace period for inventors disclosure;Baker Petrolite Corp v Canwell Enviro-Industries Ltd (2002 FCA 158)• No on-sale bar

2. CLAIMS – no restriction on the number of claims/type;

3. EXAMINATION• defer for five years from Canadian filing date;• request advanced examination;• enter Patent Prosecution Highway (PPH);• application related to Green & Clean Technologies



4. DIVISIONAL PRACTICE• up to the day before parent case issues;• no voluntary divisional filing due to double patenting issues;

Whirlpool Corp v Camco Inc (2000 SCC 67)claims co-terminus or obviousness type double patenting

• no terminal disclaimer or continuation practice.

5. OWNERSHIP TRANSFER• assignable freely in whole or in part;• in joint ownership the assignment by one party cannot dilute the existing ownership right of the

other party

6. PROCEDURAL FLEXIBILITY DURING PROSECUTION• voluntary amendments and supplemental responses can be filed anytime and more than once;• final examination practice is rare.

7. NO OPPOSITION PROCEEDINGS • can file a Protest against a pending application


Patents - Criteria for Patentability


Patents - Criteria for Patentability

NOVELTYGoverned by Section 28.2 of the Patent Act .Apotex Inc v Sanofi-Synthelabo Canada Inc., [2008 SCC 61]

Established the two part test for anticipation:

1. Was the subject matter of the invention disclosed to the public by a single disclosure?

2. If there is such a clear disclosure, is the working of the invention enabled by that disclosure?


Patents – Criteria for PatentabilityOBVIOUSNESSGoverned by Section 28.3 of the Patent Act.Apotex Inc. v. Sanofi-Synthelabo Canada, Inc. [2008 SCC 61]

Established four part test for obviousness:

- identify the notional “person skilled in the art”, and identify the relevant common general knowledge of that person;

- identify the inventive concept of the claim in question or, if that cannot readily be done, construe it;

- identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed; and

-viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art, or do they require any degree of invention?


Patents – Criteria for Patentability

PATENTABLE SUBJECT MATTERGoverned by section 2 of the Patent Act

- Products, methods and improvements.

Chemical Arts:- selection patents;- new uses for old compounds;- treatment for natural conditions; and- diagnostic assays.



Selection PatentsApotex Inc. v. Sanofi-Synthelabo Canada, Inc. [2008 SCC 61]

Ruled that that the principle of selection patents is acceptable. In the chemical field, a selection patent is one that claims a selected compound or group of compounds chosen from a larger group of compounds claimed in a previous genus patent.


Patents – Criteria for PatentabilityThe Court held that the general principle of selection patents

was acceptable on the line of English case authority rooted in In re IG Farbenindustrie AG’s Patents (1930), 47 RPC 289 (Ch D) (IG Farbenindustrie) Establishing three conditions required for the validity of a selection patent and reiterated by the Court:

1. There must be a substantial advantage to be secured or disadvantage to be avoided by the use of the selected members;

2. The whole of the selected members (subject to “a few exceptions here and there”) possess the advantage in question; and

3. The selection must be in respect of a quality of a special character peculiar to the selected group. If further research revealed a small number of unselected compounds possessing the same advantage, that would not invalidate the selection patent. However, if research showed that a larger number of unselected compounds possessed the same advantage, the quality of the compound claimed in the selection patent would not be of a special character.



Methods of medical treatment claims can usually be amended into a use-style format to comply with section 2 of the Patent Act.

However, in the decision of Novartis Pharmaceuticals Canada, Inc.v. Cobalt Pharmaceuticals Co. 2013 FC 985, it was held that use claims were in fact methods of medical treatment as they included references to intermittent dosage and dosage ranges that lie with a physician’s skill or judgement.

“Use of zoledronic acid, a pharmaceutically acceptable salt thereof, or a hydrate thereof for the treatment of postmenopausal osteoporosis wherein the zoledronic acid, salt or hydrate is in a unit dosage form of about 5 mg which is administered intermittently, with a period of about one year between the first and each subsequentadministration, wherein each administration is intravenous.”



What the jurisprudence establishes is that a claim to a vendible product, including a substance intended for the treatment of a medical condition, can be good subject matter for a patent claim. Thus, claims such as the following are proper subject matter:the substance X for the treatment of Y

the substance X in the form of a 5 mg tablet for the treatment of Y

What is improper subject matter is a claim that encompasses the skill of medical professional, such as:the closure of a surgical incision by the use of adhesive X

the use of substance X in a dosage range between A and B for the treatment of X

Justice Hughes also considered the patent disclosure providing that the mode of administration and dosage may be selected by the attending physician taking into account the particulars of the patient and describing intermittent administration regimens.



UTILITY Generally speaking, the threshold for meeting the utility requirement is quite low in Canada. The Patent Act provides that an invention must be “new and useful”.

Utility – demonstrated, but need not be disclosed, or proven conclusively. Post filing data cannot be relied upon.

(Teva Canada v. Pfizer Canada Inc. 2012 SCC 60)- soundly predicted, with a factual basis: a line of

reasoning by which predictions of that the claimed invention will meet the promise of utility and a proper disclosure.

In Apotex Inc. v. Wellcome Foundation Ltd [2002] SCC 77 held that only that one needed the elements of a factual basis, soundline of reasoning and proper disclosure. Subsequent cases have interpreted this to mean the factual basis and line of reasoningneeds to be disclosed, at least in part, in the patent.



PROMISE OF THE PATENT“The promise of the patent is the standard against

which the utility of the invention described in the patent is measured.”

Failure to meet the promise of the patent is a crushing hammer in the hands of those who challenge patents.

“explicit” promise - utility of the invention will be assessed against such a promise.



In recent Canadian decisions applying the promise doctrine, patents for what appear to be quite useful inventions have been declared invalid because the promised utility could not be established as of the applicant’s filing date.

These court decisions have become so controversial that Eli Lilly filed a Notice of Intent to submit a claim pursuant to Chapter 11 of the North American Free Trade Agreement (NAFTA), alleging that the application of the promise doctrine violates Canada’s obligations under NAFTA. The claim is based on a decision of the Federal Court (upheld on appeal) invalidating Eli Lilly’s patent for the drug Strattera, used to treat attention-deficit disorder. The Supreme Court of Canada refused to hear Eli Lilly’s appeal.


Patents – Criteria for PatentabilityLuckily, better decisions have arrived…………

Apotex Inc. v. Sanofi-Aventis, 2013 FCA 186

The FCA overturned the FC decision stating that the courts should avoid reading a promise into a patent where one does not explicitly exist. The patent did not promise that the clopidogrel bisulfatecompounds would be useful in humans only that the selected compounds had greater platelet aggregation inhibiting activity and less toxic than the unselected compounds.

In Apotex/Teva v Novartis, 2013 FC 141, the court found the promised minimum utility of the compound claims was in vitro selective enzymatic inhibition.

Failure to meet promises is equally applicable to mechanical patents (Bell Helicopter Textron Canada Limitee v Eurocopter, 2013 FCA 219)


Does invention do what patent promises?



Section 27(3) of the Patent Act governs the disclosure requirements for a patent.

Claims 6 and 7 claimed the uses of a specific compound for treatment of erectile dysfunction. However, the description did not identify which compound, if either of them, was effective for the treatment of erectile dysfunction.

Without further testing, a skilled person could not determine which of the claimed compounds was effective for the treatment of erectile dysfunction.

The description referred to especially preferred compounds, but didn’t specifically identify which of the compounds this referred to.

The disclosure failed to state in clear terms what the invention was.


Canadian Court Proceedings


Canadian Patent Litigation

- Initiated in Provincial or Federal Courts before a judge;

- No juries;

- Experts, adopted the approach of “hot tubbing” for panels of experts, no pre-trial examination of expert witnesses;

- Litigant’s have a right to privacy;

- Extraordinary remedies, Anton Piller Orders are available;

- No Markman hearings in patent cases, claim construction is a matter of law;

- To determine infringement the claims are first construed to determine the essential elements of the invention and the non-essential elements. Claims are given a purposive construction.

- No file wrapper estoppel;


Canadian Patent Litigation

- No treble damages; party claiming damages has the burden of proving the nature and extent of damages suffered;

- Costs of litigation, timeline 3-5 years $500,000+;

- Information obtained at discovery may not be used for any purpose collateral to the Canadian proceeding;

- Sealing and protective orders are generally granted to seek to preserve confidential information of the parties;

- Interloculatory relief is available.


Notice of Compliance (NOC)


Notice of Compliance

The Patented Medicines (Notice of Compliance) Regulations is a legislative scheme to link drug regulatory approval to patent protection.

Once engaged, a pharmaceutical patentee may delay regulatory approval for a second party (typically a generic) to sell the patentee’s medicine.

To enter the NOC, a patent must be listed on the Patent Registermaintained by the Minister of Health. Eligible patents for listing are those that claim the medicine or use of the medicine.


Notice of Compliance

Typical Scenario:

Brand name drug company lists Patent, a generic drug company develops and wishes Health Canada to approve a generic version of drug for which a patent is listed.

Generic must respond to the patents on the register and does this either by (a) agreeing it will not get its approval (Notice of Compliance or NOC) until any listed patent expires, or (b) sending a document called an “allegation” to the brand name drug company in which it asserts that the patent would not be infringed by its product, or is invalid.

When it receives an allegation, the brand name drug company can then start a judicial review application, a kind of mini-patent action, for an order that the generic not get approval until the patent expires.

When the brand drug company starts the court case, Health Canada is automatically prevented from granting the NOC for 24 months to the generic drug. In other words, the brand immediately gets what amounts to an automatic interloctory injunction against competition.


CONCLUSION - TIPS

1. DO NOT PROMISE ANYTHING!


CONCLUSION - TIPS

2. INCLUDE AS MUCH INFORMATION AS POSSIBLE FOR THE FACTUAL BASIS AND SOUND LINE OF REASONING, E.G. REFERENCE TO THE STATE OF THE ART, HYPOTHESES, DESCRIPTIONS OF WORK DONE, TESTS AND RESULTS.


CONCLUSION - TIPS

3. ADD ADDITIONAL INFORMATION TO THE PATENT SPECIFICATION LEARNED DURING THE PERIOD BETWEEN PRIORITY FILING AND THE CANADIAN FILING DATE. NOTE, HOWEVER, THE CANADIAN FILING DATE FOR PCT APPLICATIONS IS THE PCT FILING DATE AND IT IS TOO LATE TO SUPPLEMENT THE DISCLOSURE UPON NATIONAL ENTRY IN CANADA.


CONCLUSION - TIPS

4. CONSIDER EACH CLAIM INDIVIDUALLY AND WHAT SUPPORT EXISTS IN THE DISCLOSURE FOR IT.


CONCLUSION - TIPS

5. ADD AS MANY CLAIMS AS POSSIBLE BECAUSE THERE ARE NO EXCESS CLAIM FEES. THE MORE CLAIMS THE BETTER CHANCE OF CATCHING AN INFRINGER AND THE MORE DIFFICULT IT IS FOR INVALIDATING ALL OF THE CLAIMS.


CONCLUSION - TIPS

6. WHEN CLAIMING A BROAD GENUS, CLAIM VARIOUS PREFERRED SUB-GENERA AND PREFERRED SPECIES DISCLOSED WHICH ARE ESPECIALLY RELEVANT TO THE WORK DONE. WHERE ONE IS CLAIMING NEW USES, HAVE CLAIMS THAT MIRROR THE ACTUAL COMMERCIAL USE AS SEPARATE INDEPENDENT CLAIMS, DISTINCT FROM POTENTIAL USES INFERABLE FROM INITIAL RESEARCH.


CONCLUSION - TIPS

7. BE AWARE OF HOW STATEMENTS OF ADVANTAGE, OR DISCUSSION OF POTENTIAL APPLICATIONS MAY BE ARGUED TO BE PROMISES OF THE PATENT. THINK ABOUT HOW THAT STATEMENT CAN BE SUPPORTED, EITHER WITH INFORMATION IN THE PATENT OR WITH INFORMATION THAT WOULD BE UNDERSTOOD AT THE FILING DATE OF THE PATENT.


CONCLUSION - TIPS

8. IF YOU INTEND TO LIST YOUR PATENT ON THE PATENT REGISTER, ADVISE YOUR AGENT EARLY IN PROSECUTION THAT A PATENT APPLICATION RELATES TO A PRODUCT FOR WHICH REGULATORY APPROVAL FROM HEALTH CANADA HAS OR WILL BE OBTAINED.

CLAIMS CAN BE ADDED OR AMENDED AT ANY TIME DURING PROSECUTION OF A CANADIAN PATENT APPLICATION, AND IF THERE ARE INITIALLY NO CLAIMS GIVING RISE TO A LISTABLE PATENT, AMENDMENTS CAN BE MADE THAT MAY DO SO.

ADD CLAIMS REFLECTING TO ALL ASPECTS OF THE INVENTION RELATED TO THE MEDICINE ITSELF OR ITS USE. FOR INSTANCE, IN THE CASE OF CONTROLLED DELIVERY, THE INVENTIVE ASPECT MIGHT ALSO BE EXPRESSED AS A USE, SUCH AS A USE OF THE DRUG ACCORDING TO A PARTICULAR DOSING REGIMEN/FORM KEEPING CLEAR OF MEDICAL TREATMENT LANGUAGE.

FOR DOSAGE, RECITE EACH POINT IN THE RANGE INDEPENDENTLY RATHER THAN THE RANGE.


Applause - thank you!


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