Intellectual Property Protection for Drugs, Biologics and Medical Devices in the U.S. and European Union

1. Intellectual Property Protectionfor Drugs, Biologics and Medical Devicesin the U.S. and European Union Comparative EU and U.S. Science, Law and Policy in the Regulation of Pharmaceuticals and Medical Technology Chuck SchmalPatent & Trademark Attorney cps@uspatent.com

2. Patenting Medical Inventions • Definition of statutory subject matter in the U.S. is a broad, simple one which dates from the time of Thomas Jefferson • The European definition is the result of recent political debate between the representatives of over a dozen countries and shows clear evidence of compromise drafting

3. Patenting Medical Inventions in the U.S. • U.S. patent law generally takes a fairly liberal approach to the patenting of medical inventions. • Invention only has to meet standard tests for patentability (utility, novelty, and nonobviousness)

4. Patenting Medical Inventions in the EU • European Patent Office (EPO) takes a much stricter approach • European patent law explicitly excludes from patentability “methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body” • Policy: it is in the interest of public health that doctors and veterinarians should not be hindered by patents in the care they give to their patients

5. Patenting a Surgical Method in the U.S. • Example 1: A method of surgery for correcting vision using known surgical tools • Patentable in the U.S. • Sample claim: 1. A method for correcting vision, the method comprising the steps of: [recite the surgical steps].

6. Patenting a Surgical Method in the EU • Example 1: A method of surgery for correcting vision using known surgical tools • Not patentable in EU • Case law of the EPO has established that any surgical method, regardless of its purpose (e.g. therapeutic or cosmetic) is excluded from patentability

7. Patenting a Surgical Method in the EU • Note: non-surgical cosmetic methods are patentable • Non-surgical teeth straightening • Hair coloring • However, cosmetic methods having health implications are excluded • Methods of weight loss for obese people • Plaque removal from teeth

8. Patenting a Drug Treatment in the U.S. • Example 2: A method of treating asthma using a known drug previously used for treating headaches • Patentable in the U.S. • Sample claim: • 1. A method for treating asthma, the method comprising [administering the drug].

9. Patenting a Drug Treatment in the EU • Example 2: A method of treating asthma using a known drug previously used for treating headaches • Not patentable in the EU • Considered to be a therapeutic method

10. Patenting a Drug Treatment in the EU • HOWEVER, European attorneys have developed a special claim format approved by the EPO: “Swiss-style” or “second medical use” claim. • Example claim: “Use of [the known drug] to manufacture a medicament for the treatment of asthma.” • Only applies to drugs: cannot be used for second medical use of a known medical device.

11. Patenting a Drug Treatment in the EU • Problems with “Swiss-style” claims: • Not literally provided in the European Patent Convention (EPC) but adopted through a decision by the appeals board for the European Patent Office (EPO) • As a result, nonuniform interpretation between countries and within EPO itself. • For example, dosing regime claims (where novelty lies in the method of how the known drug is used) may be invalid in the United Kingdom but valid in other EPC countries. • EPC 2000 (effective December 13, 2007) now expressly allows protection of second (or further) medical indications. • Example Claim: “Substance X (known) for the treatment of disease Y.”

12. Patenting a Diagnostic Method in the U.S. • Example 3: A method of testing blood samples to diagnose diabetes • Patentable in the U.S. • Sample claim: 1. A method of testing blood samples, the method comprising [steps in the test].

13. Patenting a Diagnostic Method in the EU • Example 3a: An in vivo method of testing blood samples to diagnose diabetes • Not patentable in the EU • Excluded diagnostic methods are those carried out on a living human/animal body

14. Patenting a Diagnostic Method in the EU • Example 3b: A method of testing in vitro blood samples to diagnose diabetes • Patentable in the EU • Not excluded if samples permanently removed from the body (e.g. by syringe) • BUT, excluded if samples returned to the body (e.g. testing during dialysis)

15. Patenting a New Drug in the U.S. • Example 4: A new chemical compound useful in treating cancer • Patentable in the U.S. • Sample claim: • A pharmacological compound, comprising [chemically define the compound]. • Can also claim the method of treating a disease using the drug

16. Patenting a New Drug in the EU • Example 4: A new chemical compound useful in treating cancer • Patentable in the EU – law states that products, in particular substances and compositions, for use in excluded medical methods are not excluded • Sample claim: • A pharmacological compound, comprising [chemically define the compound]. • Cannot claim the method of treating a disease using the drug

17. Patenting a New Drug in the EU • The EPC does not restrict the patentability of pharmaceutical products. Rather, it restricts methods of treatment of the human/animal body by therapy, surgery or diagnosis. • Therefore, not possible to claim the method of treating a disease using the new drug, but can claim a drug for use in treating a disease

18. Patenting a New Drug in the EU • Practice has developed in EU of filing “first medical use” claims • Sample: [The new drug] for use as a medicament. • Also used for cases where a known chemical not previously used as a pharmaceutical is found to have a therapeutic effect. • Even if drug not patentable in its own right, can be patented for the first medical use made of the compound

19. Patenting a New Drug in the EU • First medical use claims are typically accompanied by “Swiss-style” claims directed to the specific disease(s) of interest • Sample: Use of [the new drug] to manufacture a medicament for the treatment of cancer. • Approved by the Swiss Patent Office and later affirmed by the EPO Board of Appeals • As noted before, second medical use claims now expressly allowed under EPC 2000, and therefore, more than one medical use can be claimed. • Example Claim(s): • “Substance X for the treatment of disease Y.” • “Substance X for the treatment of disease Z.”

20. Patenting a New Medical Device in the U.S. • Example 5: A new heart valve • Patentable in the U.S. • Sample claim: • A heart valve, comprising [describe new heart valve features]. • Can also claim the method of implanting the heart valve

21. Patenting a New Medical Device in the EU • Example 5: A new heart valve • Patentable in the EU • Sample claim: • A heart valve, comprising [describe new heart valve features]. • However, cannot also claim the method of implanting the heart valve (falls under the medical methods exclusion)

22. Patenting a New Medical Device in the EU • EPO Board of Appeals has ruled that a method of refining the use of a pacemaker to reduce energy consumption is not a therapy even though the pacemaker has a therapeutic effect, and the method can therefore be patented. • The patented method “does not have the effect of preventing or treating a pathological condition.”

23. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses

24. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses

25. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses • Invented in the U.S. and client wished to protect the invention in both the U.S. and in Europe • Perceived commercial markets in both regions

26. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses • U.S. Patent No. 5,690,656 • Claims “Method for forming an anastomoses between first and second adjacent viscera, comprising the steps of: (a) inserting a first magnet… (b) inserting a second magnet… (c) allowing tissue compressed between the first and second magnets…to undergo ischemic necrosis.”

27. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses • U.S. Patent No. 5,690,656 • Also claims: “A device for forming an anastomosis between adjacent viscera, comprising: a first magnet… a first jacket having opposing first and second rims… a second magnet…. a second jacket having opposing third and fourth rims… wherein…the first and second magnets are self-centering when they are magnetically coupled through walls of the adjacent viscera.”

28. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses • European Patent No. EP 0 754 434 B1 • Claims only the device (a pair of magnets) in a fashion similar to the U.S. device claims • Does not (and cannot) claim the method of using the magnets inside the patient to form the anastomosis.

29. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses • What is effect? • Limits who is an infringer • In the U.S. • Manufacturer of the magnet set • Doctor (more likely hospital) performing the procedure • In the EU • Only the manufacturer of the magnet set • Doctor’s use not covered by a claim, therefore cannot be sued

30. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses • What is the effect? • Limits number of acts of infringement • In the U.S., both the sale and the subsequent use are actionable • if magnets are reusable, each successive procedure using the same set of magnets would be a separate act of infringement • In the EU, only the sale of the magnets to the doctor would be an act of infringement

31. Comparative Protection Real World Example:Method & Apparatus for Creating Abdominal Visceral Anastomoses • What is the effect? • Limits the monetary base for calculating damages • In the U.S., both the $500 sale of magnets and the $5,000 surgical procedure are available on which to base a claim of damages • In the EU, only the $500 sale of the magnets is available

32. Patenting Biotechnology Inventions in EU • So far, the decisions of the EPO Board of Appeals have been consistent with the USPTO • 1980: U.S. Supreme Court upheld the patenting of an oil slick eating bacteria (Diamond v. Chakrabarty) • 1987: USPTO approved Harvard patent for the “oncomouse” • the animals must be "given a new form, quality, properties or combination not present in the original article existing in nature in accordance with existing law." The oncomouse clearly met this criteria. • 1992: EPO accepted the Harvard Oncomouse patent and affirmed it on appeal • Over 20 genetically-modified animal patents have been issued by the EPO

33. Patenting Biotechnology Inventions in EU • EU Biotechnology Patent Directive • Clarifies what is patentable and is favorable to patenting transgenics • Plant and animal varieties (a whole genome that is distinct from other varieties) are patentable • Procedures for breeding plants and animals are not patentable

34. Patenting DNA and Protein Sequences in US/EU • Patentable as long as utility (US)/industrial applicability (EU) is disclosed in the application • EU Biotechnology Patent Directive: inventions capable of industrial application - even when they concern a product made of or containing biological material or a procedure for producing, processing, or using biological material - are clearly patentable. Even if a biological material preexists in the natural state, if it is separated from its natural environment or produced with a technical procedure it may still form the subject matter for an invention. For example, a naturally occurring human protein, if separated from the human body or produced by a technical procedure, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The one provision is that the industrial application must be clearly specified in the application for a patent. In the case of full-length sequence or the partial sequence of a gene, the function of the gene must be disclosed. • Not sufficient to simply show that a protein or nucleic acid sequence can be made and used • Function of the nucleic acid and/or protein is required, and claiming a use based upon a predicted (but not proven) function fails to meet the requirement

35. Specific Exceptions to Patentability in the EU • Art. 53(a) of the EPC states that European patents shall not be granted for inventions of which publication or exploitation would be contrary to order public or morality • Inventions likely to breach public peace or social order, or to seriously prejudice the environment are contrary to order public

36. Specific Exceptions to Patentability in the EU • Rule 23d of the EPC states the following patents shall not be granted: • Processes for cloning human beings • Processes for modifying the germ line genetic identity of human beings • Uses of embryos for industrial or commercial purposes • Although the EPO ethics group has stated that patents to modified stem cell lines can be granted • Processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes

37. Summary • Medical inventions are more difficult to patent in the EU • EU exclusion for medical therapy, surgery or diagnosis • Medical devices and pharma compounds are patentable in the EU • Drug treatments may be protected in EU by using first and second “medical use” claims • Transgenic animals are patentable in the U.S. and EU • Requirements for patenting of DNA sequences similar in the U.S. and EU • Must pass morality test in the EU